Alosi, Marlena C., Analysis of Efficiency and User Satisfaction Following The

Alosi, Marlena C., Analysis of Efficiency and User Satisfaction Following the

Introduction of Digital Source Documents and Resources in a Clinical Research Setting.

Master of Science (Clinical Research Management), November 2015, 111p., 2 tables, 17 figures, reference list of 23 sources.

Efficient and accurate data management processes are essential for the successful conduction of clinical trials. The clinical research industry is unique among biomedical fields in that much of the reporting is still conducted using paper-based systems. Recent trends towards exchanging paper-based documentation methods for electronic documentation methods have shown that implementation of digital resources have the potential to expedite clinical development. This practicum sought to evaluate paper-based and electronic documentation processes in a cancer clinic in regards to efficiency and user satisfaction, and determine which documentation form was superior in these areas. Retrospective analyses and a survey were used as the sources of data to assess for these differences. It was determined that the replacement of paper-based methods with electronic methods of documentation at this particular clinic resulted in both greater timeliness and higher user satisfaction.

ANALYSIS OF EFFICIENCY AND USER SATISFACTION FOLLOWING THE

INTRODUCTION OF DIGITAL SOURCE DOCUMENTS AND RESOURCES IN A

CLINICAL RESEARCH SETTING

Marlena C. Alosi, B.S.

APPROVED BY:

______Lad Dory, Ph.D., FAHA, Major Professor

______Patricia Gwirtz, Ph.D., FACC, Graduate Advisor

______Ray Page, D.O., Ph.D., Committee Member

______Melissa Pool, BSN, RN, Committee Member

______Joseph Warren, Ph.D., Committee Member

______Meharvan Singh, Ph.D., Graduate School of of Biomedical Sciences

ANALYSIS OF EFFICIENCY AND USER SATISFACTION FOLLOWING THE

INTRODUCTION OF DIGITAL SOURCE DOCUMENTS AND RESOURCES IN A

CLINICAL RESEARCH SETTING

INTERNSHIP PRACTICUM REPORT

Presented to the Graduate Council of the Graduate School of Biomedical Sciences

University of North Texas

Health Science Center at Fort Worth

in Partial Fulfillment of the Requirements

For the Degree of

MASTER OF SCIENCE

IN CLINICAL RESEARCH MANAGEMENT

By:

Marlena Alosi, B.S., EMT-P

Fort Worth, Texas November 2015

ACKNOWLEDGEMENTS

This writing piece and the practicum from which it came would have been impossible without the efforts of my advisory committee, whose members are Dr.

Patricia Gwirtz, Dr. Ladislav Dory, Dr. Ray Page, Dr. Joseph Warren and Mrs. Melissa

Pool. I appreciate your individual efforts during this practicum and hope that my gratitude is some small repayment for all of your assistance and guidance.

Additionally, the friendship and team spirit of the staff at The Center ensured that my internship experience was both constructive and memorable. Of particular note, I would like to name Kayla Blough, Brandi Halstead, Lori Hannan, Brian Franklin,

Melanie Page, Soraya Patrick and Rosemary Siddens. I am grateful to each and every one these department members and am very fortunate to have had the opportunity to not only work with them, but to find friends in them as well.

Lastly, and as always, I would like to recognize my wonderful family, friends, and co-workers at Napoli’s Restaurant for their understanding, flexibility, and encouragement during the months that I’ve been in this program. Above all, I am most fortunate to have the loyalty of Luis Garibay to aid me in my most trying times. His devotion and commitment to my goals will always serve as a source strength for me when I find my own beginning to wane.

TABLE OF CONTENTS

LIST OF TABLES...... v

LIST OF FIGURES...... vi

CHAPTERS

1. Introduction...... 1

2. Background and Literature Review...... 3

3. Specific Aims...... 7

4. Significance...... 8

5. Research Design and Methodology

a. Training Time to Completion…………………………………...…………..9

b. Quarterly Document Turn-Around Time...... 10

c. Physician Assessment of Laboratory Results Time to Completion………...11

d. User Satisfaction and Opinion Survey……………………………...………12

6. Results and Discussion

a. Training Time to Completion……………………………………...………..13

b. Quarterly Document Turn-Around Time...... 16

c. Physician Assessment of Laboratory Results Time to Completion…………20

d. User Satisfaction and Opinion Survey………………………………………29

iii

7. Summary and Conclusions

a. Electronic Source Documents and Resources...... 35

b. User Satisfaction and Opinions Regarding Electronic Processes………….....37

8. Internship Experience and Journal Summary...... 39

APPENDIX A: User Satisfaction and Opinion Survey...... 41

APPENDIX B: Internship Practicum Journal...... 46

REFERENCE LIST ...... 101

LIST OF TABLES

TABLE 1: Median Times to Completion for Physician Assessments and their corresponding statistical values …………………………………...... 25

TABLE 2: Statistical testing results from parametric Paired t-test and non-parametric Wilcoxon sign-rank test…………………………………...... 34

LIST OF FIGURES

FIGURE 1: Mean time to completion per training requirement in days for paper-based reporting method………………………….……………...... 14

FIGURE 2: Mean time to completion per training requirement in days for electronic- based reporting method……………...………………………………………….………15

FIGURE 3: Histograms displaying time to completion in days for Contract documents…………….....………………………………………………………….…..17

FIGURE 4: Histograms displaying time to completion in days for Regulatory documents…………………………………………….………………………..………..17

FIGURE 5: Boxplot graph showing TTC of paper-based signature acquisition method (PaperCon) compared to SIGNiX signature acquisition method (SXCon) for Contract documents………………………….…..…..19

FIGURE 6: Boxplot graph showing TTC of paper-based signature acquisition method (PaperReg) compared to SIGNiX signature acquisition method (SXReg) for Regulatory documents…………...... …...20

FIGURE 7: Histograms displaying time to completion in days for assessments completed by Physician A………………………………………………………………...…..……23

FIGURE 8: Histograms displaying time to completion in days for assessments completed by Physician B ……………………..……………………………………….….....……23

FIGURE 9: Histogram displaying time to completion in days for assessments completed by Physician C ………………………………………..………………………….……24

FIGURE 10: Boxplot graph showing time to completion for electronic method compared to paper-based method for Physician A…………………………………….…..……...26

FIGURE 11: Boxplot graph showing time to completion for electronic method compared to paper-based method for Physician B………………………………………....……..27

FIGURE 12: Boxplot graph showing time to completion for electronic method compared to paper-based method for Physician C……………………………………..….….…..28

FIGURE 13: Bar graph displaying mean scores per survey

Question………………………………………………………….…………..….……..30

FIGURE 14: Histogram displaying non-normality of score differences for Ease of

Understanding responses……………………………………….……………...….…...31

FIGURE 15: Histogram displaying skewed frequency distribution of score differences for Ease of Use responses……………………………...... ……31

FIGURE 16: Histogram displaying a slightly skewed frequency distribution of score differences for Facilitates Learning and Retention responses…..…………....32

FIGURE 17: Histogram displaying skewed frequency distribution of score differences for User Satisfaction with Reporting Method responses………………….32

vii

CHAPTER 1

INTRODUCTION

Effective data management practices are vital for the proper execution of clinical research trials1,2. Reporting requirements generally mandate that data be manually inputted into several different areas and the large volume of data required by the sponsor that funds the trial ensures that documentation-related tasks are a significant portion of what occurs in a clinical research setting2.

It has been estimated that the average clinical research trial will require reporting of 125 points of data per patient per month3. For a phase III clinical trial enrolling 2,000 patients, this can generate 3 million points of entered data over a 12-month period.

Considering that many of the data points will be reported multiple times throughout the clinical trial period, the actual number of data entry fields can actually be much higher than the number of data points. It is this reason, among others, that data management methods must be as efficient and effective as possible. Transitioning documentation processes from paper-based “wet-ink” procedures to digital platforms may be a way to facilitate this.

As may be anticipated, this transition from paper-based to digital methods has been seen to increase efficiency in regards to the time that it takes to enter data or

finalize a document4,5. The degree of benefit derived from work pathway conversions such as these is likely document-specific, with some workflows benefiting more than others.

Retrospective analyses of newly implemented processes are a useful tool for research department administrators to use to investigate if there is any measurable benefit that the new process may have over the replaced process, and also which processes benefit the most from transitioning. Objective performance measurements may be conducted to determine efficiency by comparing timeliness data from paper methods to timeliness of the newer digital method.

The primary focus of this practicum was to explore this subject further by using historical data available within a clinical research department. In particular, it was explored whether or not there exists a parallel relationship between use of electronic documentation methods and increase in efficiency. This efficiency was defined as Time to Completion (TTC) measured in days, unless stated otherwise. This was calculated using date values that were drawn from document creation or availability to document finalization dates.

A secondary objective of this practicum was to assess user opinions in regards to a work process that had been previously transitioned from paper to electronic. For this, a simple questionnaire was given. Quantifying employee satisfaction has the potential to add another perspective to process assessment and the results of satisfaction surveys may be used along with efficiency measurements to give a broader view of the process in question.

CHAPTER 2

BACKGROUND AND LITERATURE REVIEW

Clinical research is a highly regulated branch of scientific study that deals with investigations that utilize human subjects and tissues. A clinical trial is a type of scientific investigation that is defined by the National Institute of Health as being “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes”6. Clinical trials, in particular, are regulated by the Food and Drug Administration (FDA) in the United

States and International Conference on Harmonization internationally, and follow a specific protocol that is approved by a third-party entity known as an Institutional Review

Board (IRB)7,8. The field of clinical research management pertains to the coordination and organization of clinical trial activities with the dual intent of satisfying regulatory and ethical obligations.

Because of the immense volume of information that is required to run a successful clinical trial, digital technology is becoming increasingly pervasive in clinical research in order to help organize and retrieve these data. The FDA has anticipated this movement from paper to computer and released a guidance statement in September of 2013 defining the terms and conditions that relate to this switch9. An example of how this transition may ease site operations can be presented in a patient lab report that is followed from creation to finalization. In a paper-based system, a laboratory may generate a patient lab

report and the printout may then be signed by a physician to assess clinical significance prior to being included in the patient chart. This paper document would be considered a source document, which is an “original document, [datum], or record…[including] subject’s diaries”10. FDA regulations require that source documents be retained at the site conducting the clinical trial for a minimum of 2 years from the date of the marketing application approval or the end of the study11. This requirement still remains in place if this document was created and the data recorded in a digital format, yet now this document is much more easily filed, stored, searched and retrieved for later input into the sponsor-mandated Electronic Case Report Form (eCRF). In an industry where a clinic may be required to keep clinical trial documentation indefinitely10, the ability to store a dozen or more boxes of documents on one single hard drive has its obvious advantages.

Maintenance of records in an electronic format can be as vulnerable to documentation errors as paper format, yet safeguards can be more easily built into the documentation design. Mistake-proofing, or “the designing [of] processes that tend to reduce human error”, should be considered when creating a new system of any kind11.

This design consideration may prove particularly useful in clinical research when several individuals may participate in populating a form. One example of this is using fields that require data to be input in a particular format (such as DD/MM/YYYY). Free form text fields will usually have a higher rate of error than set format fields due to the mistake- proofing characteristic of formatted fields19. Additionally, Electronic Data Capture (EDC) vendors that host the eCRF can arrange for their EDC to auto-query a user’s input if the data is questionable. This feature may ultimately provide for higher quality data, as an error may noticed and remedied shortly after entry rather than months later (which may be the case for paper-based CRFs). Other advantages of note include the abilities to

conduct real-time analyses and remote monitoring visits, both of which have the capacity to reduce cost on the sponsor-side of research13.

The system of using EDCs with the ability to auto-query data is a sponsor- initiated technique of mistake-proofing, but sites also have the ability to build safeguards into their own processes. Utilizing technologies such as cloud storage to store and transmit redacted source documents incompatible with the EMR may lower the incidence of protocol deviations and query occurrence because information is much more rapidly transmitted from person to person. Furthermore, using a “cloud” service provides a method of automatic backup for documents that cannot be created and maintained in the clinic’s EMR system14. This may be vital for a traveling Clinical Research Coordinator

(CRC) who sees patients at several different locations and normally operates away from a computer and uses a mobile device that has cloud access.

Industry-wide, it’s a common theme to attempt to improve processes by adopting new electronic documentation practices. In a study concerning electronic trial master file

(eTMF) implementation, organizations reported reductions in the number of missing or incomplete documents, duplicate documents, expired documents, and an increase in audit and inspection readiness12. It has also been reported that EDC use may accelerate clinical development by 30%13. Sites participating in sponsor-initiated research will be required to use any electronic data management systems that the trial requires, but there is also a wide variety of electronic documentation methods and resources available for their use.

The clinical research department at The Center for Cancer and Blood Disorders

(CCBD) uses an EMR as a central processing system for patient health records. Sponsors in turn require that the research department complete online eCRFs for all subjects that participate in clinical research studies. Because of this, source data, or all information

contained within source documents7, must be extracted from the EMR and a patient’s paper records for input into the eCRF. This by itself is a large and essential task for the research department’s dedicated Data Coordinator who enters data into the eCRFs as information becomes available. Reducing the number of documents reviewed and steps the Data Coordinator must take to input data into the EDC would ultimately increase efficiency of data entry. Moreover, clinical research is still largely conducted on paper, as mandated per sponsor protocol. Because of this, CCBD has a library of regulatory binders that the clinical trial monitors will review periodically during their visits. This library, along with the paper-based subject medical records and source documents, takes up a lot of space within the department itself. Therefore, in order to increase data entry efficiency and conserve space, CCBD desires to phase-out the paper source documents and instead implement new digital record-keeping processes with preference for utilizing the EMR for trial data management if possible.

The Sarah Canon Research Institute (SCRI), the research organization that assists

The Center with its management of clinical trials, has introduced a few digital processes of its own to increase efficiency for all parties involved. One of these newer installations is the use of an online signature collection platform, SIGNiX, to streamline the process of collecting staff and physician signatures. Originally, wet-ink signatures would need to be obtained and the signed document returned to the Clinical Trials Specialist. This proved to be logistically challenging for an independent cancer center with several different locations and a central clinical research department only at the main location. Therefore,

SIGNiX was introduced as both a way to track signatures and to facilitate document packet timeliness. It is transitions like these that have the potential to provide measurable increases in efficiency and user satisfaction at CCBD.

CHAPTER 3

SPECIFIC AIMS

This practicum is composed of two parts with separate, yet synchronous, hypotheses: transitioning paper-based documentation methods to electronic methods will

(1) result in an increase in efficiency and (2) provide a parallel increase in user satisfaction. The objective of the review portion of this practicum is to compare the efficiency of past (paper-based) and current (electronic) documentation methods by assessing timeliness of document finalization. Efficiency is measured in Time to

Completion in days (TTC), unless otherwise stated. Three different sets of transitioned documentation methods were assessed: training completion reporting, regulatory and contract signature acquisition, and physician laboratory assessments.

The survey portion of this practicum was designed to compare user satisfaction with past and current methods of training reporting as well as time spent utilizing each method (paper or electronic). Survey participants were asked to quantify their opinions on a 1 through 10 point scale, with 1 being “100% Disagree” and 10 being “100%

Agree”. The survey results were used to assess for statistical differences based on reporting methods in both satisfaction and time-spent training.

CHAPTER 4

SIGNIFICANCE

Modifying documentation methods to increase efficiency and user satisfaction is important to the success of a data management system. Replacing paper-based processes with electronic systems has been shown to increase efficiency in regards to the lessened time that it takes to enter data/or complete a document12,13. Furthermore, an environment that leads to both a reduced paperwork burden and deviation/query rate will likely yield a more satisfying work experience for clinical research employees.

From an administrative standpoint, finding measurable benefit with new systems has intrinsic value. By collecting time-to-completion data and confirming the increased efficiency of certain newly implemented digital systems, the Office Manager in the

CCBD research department is able to understand which systems are time-saving and which may need improving. Moreover, employee satisfaction and the perception of ease of use are important characteristics of a new process that may aid with employee compliance and longevity of that process within an office14. Along this line, gathering user opinions and ratings can provide insight into a document or system’s true reality in a work setting, and not just the managerial ideal.

CHAPTER 5

RESEARCH DESIGN AND METHODOLOGY a. Training Time to Completion

This phase of the practicum began by collecting training completion dates from the completion certificates that trainees are required to complete to signify their successful training. The paper-based reporting method requires that a printed and signed certificate be returned to the research department, while online-based reporting only dictates completion of a form in Google. Time to Completion per certificate was calculated by subtracting the date of training availability from that individual’s training completion date. Date of availability was determined primarily by using the date that the training was sent out to the staff. On the occasion when this was not available, two alternate dates were used: the earliest observed date that the training was completed or the date of the Site Initiation Visit. The Site Initiation Visit date was not used if this date was more than seven days from the date that the first trainee completed the protocol training.

Two sample groups were created based on the method used to report training completion for that particular training requirement (paper-based certificates or online

Google form). Study records were used to determine which training requirements utilized paper-based reporting or electronic reporting methods. The SCRI-assigned study name was used to label each training requirement (e.g., GI 181). The mean TTC per training

requirement was obtained using an Excel database. Mean TTC was calculated using training completion dates of all personnel with a training requirement, unless otherwise stated. Personnel that are required to complete this training include the chemotherapy nurses, research department staff and clinicians.

The mean time to completion for each protocol version was used to conduct a

Welch’s t-test, with “paper” and “electronic” being the two independent variables for the test. Excel was utilized for database management and statistical processing and SPSS for creation of the corresponding graphs and charts.

b. Quarterly Document Turn-around Time

Here, TTC was assessed to compare turn-around time for contract and regulatory documents prior to and after the implementation of SIGNiX, a web-based electronic signature acquisition platform. The newer digital signature method utilizes a Part 11 compliant system that was sought out by SCRI to reduce reliance on paper documents.

Using SIGNiX, electronic document files are uploaded and are available in a signer’s queue. This list is password protected and signers must log in prior to signing their documents. SIGNiX went live at the CCBD site on September 5, 201415. Prior to this date, all documents used paper-based signature acquisition pathways that included printing the document, circulation throughout the clinic to obtain signatures, and mailing the finished document or a copy to SCRI.

Quarterly performance reports for a total of three quarters were mined for TTC data. Both contract and regulatory document dates were available in these reports. The retrospective data was divided into four sample groups: paper-based method for signature acquisition for contracts (PaperCon), paper-based method for signature acquisition for

regulatory documents (PaperReg), SIGNiX method of signature acquisition for contract documents (SXCon), SIGNiX method of signature acquisition for regulatory documents

(SXReg). In order to determine the best statistical approach to analyze the data, SPSS was used to create histograms and Excel was used to conduct Bartlett’s test for homogeneity of variances. From these quick assessments, it was determined that a Mann-

Whitney U test would be best for conducting tests for significant difference in medians.

This test was conducted using Excel and the boxplot and histograms were produced in

SPSS.

c. Physician Assessment of Laboratory Results Time to Completion

This phase of the study was designed to explore whether or not the use of electronic charting methods reduced Time to Completion for documented physician assessments. These physician assessments are of patient laboratory records, which are evaluated for clinical significance (CS). A laboratory value is deemed clinically significant if this value dictates a change in patient care (e.g., an elevated blood glucose value leads to a change in patient medication).

Patient charts for twelve breast cancer and two gastrointestinal cancer research patients were identified based on their physician’s use of both electronic and paper-based laboratory assessment pathways. Time to Completion data from both electronic physician assessments and paper-based physician assessments were collected from a total of 84 laboratory reports. Physician assessment dates greater than 50 days from the date of sample collection were excluded from the dataset to avoid instances where the physician was not notified in a timely manner of the assessment requirement.

The datasets were created by entering laboratory collection and physician assessment dates into an Excel spreadsheet along with an assigned physician letter (A, B or C) and type of signature that was used by the physician to signify their assessment

(“electronic” or “paper-based”). An additional dataset was made to test for a difference in method medians when the assessing physician variable was disregarded. This dataset was created to assess the overall difference in medians when comparing each assessment method as a whole. A Mann-Whitney U test to determine a statistical difference in TTC medians was conducted using Excel and the graphical representations of the data were created using SPSS.

d. User Satisfaction and Opinion Survey

To compare CCBD staff opinions and beliefs about a training reporting process that underwent the paper-to-electronic transition, satisfaction and opinion data were collected in the form of scaled opinions from protocol trainees (users). The questionnaire that housed these scaled questions was hosted through SurveyMonkey.com, an online survey company. Email invitations to complete the survey were sent to all staff with a protocol training requirement. User opinions were gauged using a 1 through 10 point scale, with 1 being “100% Disagree” and 10 being “100% Agree”. An additional, free- text question was included that asked users to estimate the amount of time that it took them to complete their training using each method. A test to compare difference between the sample means for each method-specific question was completed using a paired t-test in Excel. Graphical representations of the data were created using SPSS. This survey is available for review in Appendix A.

CHAPTER 6

RESULTS AND DISCUSSION a. Training Time to Completion

In order to assess the relationship between training reporting methods and completion timeliness, average TTC in days (from training availability date to training certification signature date) was determined for each protocol training requirement and these averages were used to conduct a two-sample Welch’s t-test. This particular two- sample statistical test was chosen for its robustness when variances between sample groups are unequal and its reliability when small and uneven sample sizes are present16,17.

The results of the test indicate that there is a significant reduction in TTC using the online-reporting method when compared to the paper-reporting method. Mean TTC values were 10 + 5 days for paper reporting methods and 5 + 2 days for electronic reporting methods. Figures 1 and 2 are bar charts that graphically represent the mean

TTC per training requirement, with each bar representing a separate protocol amendment.

The observed reduction in TTC may be attributed to the ease with which a trainee can now submit acknowledgement of their training completion. Whereas the paper reporting method required trainees to print, sign, and then return a document to the research department, the electronic reporting method only necessitates that the trainee follow a link and type in their name to record their training completion.

Figure 1: Mean TTC per training requirement in days for paper-based reporting method. “Nurses only” and “staff” represent nurse only and all other staff except nurses, respectively. Mean = 10 days, Var. = 28 days2 , S.D. = + 5 days

Figure 2: Mean TTC per training requirement in days for electronic-based reporting method. “Nurses only” represents nurse only sample. Mean = 5 days, Var. = 4 days2 , S.D. = + 2 days

Statistical Assessment

H0 = upaper = uelectronic , HA = upaper ≠ uelectronic

The mean TTC for the paper-based method across eight protocol training versions was 10 days. This was two times greater than the mean of 5 days for the electronic reporting method, which only had a sample size of six protocol training versions.

Welch’s t-test statistic was determined to be 2.58 using 13 degrees of freedom, resulting in a p of 0.023 that demonstrates a significant difference between the TTC means of paper- based and electronic reporting methods.

b. Quarterly Document Turn-around Time

TTC was assessed prior to and after the implementation of an online e-signature platform named SIGNiX. The site’s Contract Research Organization, which manages much of the site’s documents, implemented SIGNiX in order to begin converting their sites’ processes from paper to digital methods. This change in procedure produced a decrease in contract turn-around time, as indicated in the results presented in the statistical assessment area below. Conversely, using the chosen statistical test, the decrease in median turn-around time for regulatory documents after the implementation of SIGNiX was not seen to be statistically different. The may be due to the small sample size causing an insufficient amount of data to be present.

To determine which statistical test would be most proper for the data obtained, the sample groups were analyzed to determine frequency distributions and if the variances among the groups were homogenous. Figure 3 is a set of histograms that display the normality of the data from the PaperCon and SXCon sample groups. Figure 4 is a set of histograms that display the non-normality of the data from the PaperReg and SXReg groups. In sum, these histograms indicate that not all of the data is parametric. It was also noted that although the PaperReg and SXReg groups have non-normal distributions, the distributions have a similar shape to one another. Bartlett’s test for homogeneity of standard deviations was then used to assess homogeneity of variances. Data were entered in an untransformed format and the results showed that the standard deviations were homogenous (Contract TTC [PaperCon, SXCon] p value = 0.137, Regulatory TTC

[PaperReg, SXReg] p value = 0.805).

Because of the homogeneity of group variances, but non-normality of the

PaperReg and SXReg frequency distributions, a Mann-Whitney U test was chosen over

Welch’s ANOVA. This non-parametric test is preferable when comparison group variances and frequency distributions are similar17,18.

Figure 3: a.) Histogram displaying normality of TTC data for the PaperCon sample group. Mean = 10, S.D. + 7, N = 9 b.) Histogram displaying normality of TTC data for the SXCon sample group. Mean = 4, S.D. + 4, N = 8

Figure 4: a.) Histogram displaying non-normality of TTC data for the PaperReg sample group. Mean = 77, S.D. + 30, N = 7 b.) Histogram displaying non-normality of TTC data for the SXReg sample group. Mean = 31 days, S.D. + 33 days, N = 5

Statistical Assessment

H0 = medianpaper = medianSIGNiX, HA = medianpaper ≠ medianSIGNiX

The median TTC for the paper-based method of signature acquisition was 8 days for Contract documents and 71 days for Regulatory documents. When using SIGNiX, the median TTC values were 3 days and 28 days for Contract and Regulatory documents, respectively. Figures 5 and 6 are boxplots that graphically represent this data. A Mann-

Whitney U test was used to determine if the differences between the medians were statistically significant.

For the comparison between PaperCon and SXCon, the Mann-Whitney U test yielded U =5.85, df = 1, and p = 0.016. Therefore, the null hypothesis was rejected and there is likely a significant difference between the population’s true medians.

For the analysis of difference in medians between PaperReg and SXReg, the

Mann-Whitney U test yielded U = 3.50, df = 1, and p = 0.061. While not statistically significant, it should be remembered that the sample group medians for the two comparison groups were 71 days and 28 days, therefore a larger sample size would undoubtedly lead to significantly different means.

PaperCon SXCon

Figure 5: Boxplot graph with outliers showing TTC of paper-based signature acquisition method (PaperCon) compared to SIGNiX signature acquisition method (SXCon) for Contract documents. Median for PaperCon = 8 days (N= 9), median for SXCon = 3 days (N= 8), p = 0.016

PaperReg SXReg

Figure 6: Boxplot graph showing TTC of paper-based signature acquisition method (PaperReg) compared to SIGNiX signature acquisition method (SXReg) for Regulatory documents. Median for PaperReg = 71 days (N = 7), median for SXReg = 28 days (N = 5), p = 0.061

c. Physician Assessment of Laboratory Results Time to Completion

This portion of the practicum strove to examine the relationship between TTC of laboratory assessments and the method used by physicians to assess laboratory values for clinical significance. Time to completion was measured by subtracting the date of laboratory sample collection from the final date of physician assessment. Paper-based

physician assessments were printed laboratory reports that contained a physician’s wet- ink signature and electronic assessments were electronic source documents assessed wholly by using the clinic’s EMR. The workflow procedures between the two methods are fundamentally different, and each method has its own advantages and disadvantages.

The process for a paper-based assessment began with the printing of a laboratory report that required proof of physician assessment by the clinical trial sponsor.

“Clinically Significant” and “Not Clinically Significant” checkmark places were added next to the laboratory values requiring assessment and the report was then placed in the physician’s folder for delivery to the physician. Other reports and documents requiring physician approval were also maintained in these folders, and the timeliness of delivery to the physician depended upon the physician’s availability. A shortcoming of this method was that, if a physician was away from the clinic or out of town, the folder may not have been delivered for a few days to a couple of weeks. It was only after successful delivery of this folder that the physician was able to assess laboratory reports for clinical significance.

The electronic method of physician assessment required that the research nurse assess laboratory values and then forward the laboratory report to a physician’s queue for clinician approval. If the physician agreed with the nurse assessment of significance, the physician would then mark the laboratory report as “approved”. After this point, for research purposes, the physician approval date became the date of laboratory report assessment.

Use of electronic source documents was seen to reduce laboratory assessment completion time for Physicians A and B, but not C. Moreover, Physician C’s median

TTC for paper-based documentation methods was equal to the median TTC of the

electronic method. It is possible that this discrepancy is due to the small sample sizes of the groups and the electronic method is truly timelier, but it is also conceivable that neither method is more efficient than the other for this particular physician. With this being said, these results imply that the amount of benefit derived from using electronic source documents is dependent on the individual, with certain users obtaining greater value from it than others. When TTC was analyzed for all physicians combined, the results of the analysis showed that TTC was significantly less for the electronic assessment method.

In order to determine which statistical processing method would best suit the data, frequency distributions were created using SPSS while Bartlett’s test for homogeneity of variances was conducted using Excel. Physician A and C assessments were non- homogenous (p > 0.001, p = 0.042), whereas Physician B assessments were homogenous

(p = 0.07). It’s interesting to note that although Physician C assessments shared the same median, their variances were statistically different according to Bartlett’s. The histograms

(Figures 7-9) displayed a variety of distributions, from normal to non-normal. Due to this and the mixture of homogenous and non-homogenous variances, it was determined that a

Mann-Whitney U test would be best for these physician-grouped datasets and the combined dataset.

Figure 7: a.) Histogram displaying skewed distribution of TTC data for Physician A paper-based assessments. Mean = 18 days, S.D. + 15 days, N = 16 b.) Histogram displaying normality of TTC data for Physician A electronic assessments. Mean = 4 days, S.D. + 3 days, N = 8

Figure 8: a.) Histogram displaying normality of TTC data for Physician B paper-based assessments. Mean = 18 days, S.D. + 10 days, N = 11 b.) Histogram displaying non- normality of TTC data for Physician B electronic assessments. Mean = 6 days, S.D. + 5 days, N = 8

Figure 9: a.) Histogram displaying normality of TTC data for Physician C paper-based assessments. Mean = 9 days, S.D. + 5 days, N = 18 b.) Histogram displaying skewed distribution of TTC data for Physician C electronic assessments. Mean = 10 days, S D. + 8 days, N = 23

Statistical Assessment

H0 = medianpaper-based = medianelectronic , HA = medianpaper-based ≠ medianelectronic

The median TTC for the paper-based method of physician assessment were 12,

15, and 8 for Physicians A, B and C, respectively. The median Times to Completion for the electronic method of physician assessment were 4, 4 and 8 for Physicians A, B and C, respectively. Figures 10, 11 and 12 are boxplots that graphically represent this data.

Additionally, all physician TTC values were combined to determine overall medians for physician assessment times. A Mann-Whitney U-test was used to determine if the differences between medians were statistically significant and the results are presented below in Table 1.

Table 1: Median Times to Completion for Physician Assessments and their corresponding statistical values

Paper-based Electronic P-value Significant? median median Physician A 12 4 0.003 Yes

Physician B 15 4 0.006 Yes Physician C 8 8 0.96 No Combined 9 6 0.003 Yes

For Physicians A and B, the difference between medians was found to be statistically significant, with the analysis for Physician A showing the most significance.

Here, the p was seen to be 0.003, and it can be reasonably asserted that this physician derives the most benefit from use of this type of electronic source document. Physician B also had a reduction in TTC when using the EMR system to assess laboratory reports, and the results of the statistical test for a difference between medians supported this with a p of 0.006.

Physician C seemed to derive no added benefit from the use of electronic source documentation, as the medians were the same for both methods (p of 0.96). As mentioned earlier, individual variety in work styles will likely vary the amount of advantage that each physician gains from use of electronic documentation methods. For Physician C, each method appears to be equally efficient. Lastly, the combined values for all physicians yielded a significant difference in medians with a p of 0.003. This statistical outcome is valuable in that it supports the hypothesis that use of the electronic method leads to an overall decrease in TTC.

Figure 10: Boxplot graph showing TTC of electronic assessment method compared to paper-based assessment method for Physician A. Median for electronic = 4 days (N = 8), median for paper-based = 12 days (N = 16), p = 0.003

Figure 11: Boxplot graph with outlier showing TTC of electronic assessment method compared to paper-based assessment method for Physician B. Median for electronic = 4 days (N = 8), median for paper-based = 15 days (N = 11), p = 0.006

Figure 12: Boxplot graph showing TTC of electronic assessment method compared to paper-based assessment method for Physician C. Median for electronic = 8 days (N = 23), median for paper-based = 8 days (N = 18), p = 0.96

d. User Satisfaction and Opinion Survey

In this section, the satisfaction and opinion survey was used as a means to quantify protocol trainee perceptions of the electronic and paper-based reporting methods. The online survey (Appendix A) presented trainees with a 1 through 10-point scale and asked each survey respondent to score their opinions. Additionally, a free-text question allowed users to input their average TTC for each training method. Overall, respondents generally gave equal or higher scores to questions relating to the electronic reporting method and respondent mean scores for both methods are reported in Figure 13.

Invitations to partake in the survey were emailed to a list of staff members that are required to undergo periodic protocol training, as mandated by the study sponsors. A total of 17 respondents successfully submitted the online survey and their answers were statistically analyzed using Excel.

To determine if the data fulfilled parametric criteria, frequency distributions were created using SPSS and a test for homogeneity of variances was conducted using Excel.

Histograms revealed skewed or non-normal frequency distributions, as seen in Figures

14-17. Bartlett’s test for homogeneity of variances showed that the variances were heterogeneous for the response sets of “Ease of Understanding” and “Ease of Use” (p =

0.002 and 0.0008 respectively) but homogenous for “Facilitates Learning and Retention” and “User Satisfaction with Reporting Method” (p = 0.73 and 0.13 respectively). Because of this, the sample populations may or may not be parametric and it was decided that both paired-t tests and Wilcoxon sign-rank tests would be used to analyze the data. This was done in part because numerous statistical texts report that the results of parametric tests are usually not adversely affected when parametric assumptions are voided18, 19.

Figure 13: Bar graph displaying mean scores per survey question. Scores are from 1 through 10, with 10 being the “best” score possible

Figure 14: Histogram displaying non-normality of score differences for Ease of Understanding responses. Mean = - 0.94, S.D. + 1.7, N = 17. *Score difference is calculated by subtracting electronic method scores from paper-based method scores

Figure 15: Histogram displaying skewed frequency distribution of score differences for Ease of Use responses. Mean = - 2.06, S.D. + 2.4, N = 17. *Score difference is calculated by subtracting electronic method scores from paper-based method scores

Figure 16: Histogram displaying a slightly skewed frequency distribution of score differences for Facilitates Learning and Retention responses. Mean = - 0.06, S.D. + 1.4, N = 17. *Score difference is calculated by subtracting electronic method scores from paper- based method scores

Figure 17: Histogram displaying skewed frequency distribution of score differences for User Satisfaction with Reporting Method responses. Mean = - 2.9, S.D. + 3.2, N = 17. *Score difference is calculated by subtracting electronic method scores from paper-based method scores

Statistical Assessment

H0 = meanpaper - meanelectronic = 0, HA = meanpaper - meanelectronic ≠ 0

The statistical processing was conducted using Excel and the results are reported in Table 2. It was noted that, although the data did not fully satisfy parametric assumptions, the results for the parametric and non-parametric tests were the same. For the question “This reporting method encourages me to learn and retain information from the protocol” (Facilitates Learning and Retention), the difference between respondent scores for each method was not deemed to be significantly different. Conversely, a significant difference between scores was found for the other three questions; “This reporting method is easy to understand” (Ease of Understanding), “This reporting method is easy to use” (Ease of Use) and “I am satisfied with this reporting method” (User

Satisfaction with Reporting Method). For time spent training using each method, the respondent reported times were found to not be significantly different.

Table 2: Statistical testing results from parametric Paired t-test and non-parametric Wilcoxon sign-rank test

User Facilitates Satisfaction Ease of Time Ease of Use Learning and with Understanding Spent Retention Reporting Method Average - 0.94 - 2.06 - 0.06 - 2.90 0.91 Difference test -

P-value 0.03 0.003 0.9 0.002 0.3 Paired t Significant Yes Yes No Yes No Difference?

- 0.001 < P < 0.001 < P < 0.02 < P < 0.05 P > 0.2 0.005 0.005 P > 0.2 P-value

rank test

Wilcoxon sign Significant Yes Yes No Yes No Difference?

Note: The results were noted to be the same although the data does not meet all parametric criteria.

CHAPTER 7

SUMMARY AND CONCLUSIONS

a. Electronic Source Documents and Resources

During this practicum, it was hypothesized that an increase in efficiency could be achieved at the site by replacing paper-based methods with digital ones. For measurement purposes, efficiency was defined as Time to Completion (TTC) in days, unless otherwise stated. Retrospective reviews were conducted by collecting data points from data logs, performance reports, and patient charts. Statistical analyses were conducted to compare the mean or median TTC for paper versus electronic documentation methods.

The relationship between training reporting method and efficiency was assessed by sourcing data from a workplace data log. Mean TTC values for the electronic-based method were significantly shorter than those for the paper-based method (5 + 2 v. 10 + 2 days, respectively), clearly demonstrating that the electronic-based method increases the efficiency of this particular work process.

Document turn-around times for study start-up items were next examined to compare signature acquisition processes. Each document type (Contract and Regulatory) had a wet-ink and online signature cohort. Paper-based Contract documents had a significantly higher TTC compared to Contract documents finalized using SIGNiX (mean

TTC of 10 + 7 days v. 4 + 4 days, respectively). A similar trend was noted for the

Regulatory documents (mean TTC of 77 + 30 days v. 31 + 33 days for Paper-based and

SIGNiX, respectively); although the differences between the Regulatory TTCs did not reach statistical significance (likely due to small sample size), the trend is clear.

The final efficiency analysis compared TTC for different physician workflows that are used to assess clinical significance of laboratory reports. The median TTC values for two out of the three physicians were nearly 3-4 fold longer for the paper-based method when compared to the electronic one (12 and 15 days v. 4 days each, respectively). The electronic-based method did not improve the TTC for Physician C, who appears to be already efficient with the paper-based method (8 days using each method). The electronic-based method is significantly more expedient when the data are combined for all three physicians (6 + 6 days v 9 + 9 days, respectively). Clearly, additional physician assessments would be desirable, but the trend towards a significant increase in efficiency for the electronic method is already obvious.

The outcomes of these analyses lend strength to the hypothesis that electronic methods are more efficient in regards to timeliness. These results are supported by recently published studies. Implementation of electronic processes for study start-up has been shown to increase efficiency of document finalization by 27-50%22. This finding parallels the results of the analyses that compared paper-based methods of signature acquisition to the SIGNiX method, as both studies utilized study start-up document finalization times. In addition to this, transitioning methods from paper to electronic pathways has been reported to reduce clinical trial development time by 30%13. This includes all processes and workflows involved in clinical research and reflects the positive findings in this report that revealed a common trend towards lower completion times for electronic methods at the site.

The implication of these results for the future of clinical research is apparent as the industry becomes more reliant on electronic methods. Clinical research is a costly endeavor and transitioning away from paper processes will aid in both the reduction of errors, trial expenses and acceleration of the clinical development process13.

b. User Satisfaction and Opinions Regarding Electronic Processes

It was hypothesized that the introduction of electronic processes within the clinical research department would be well received, with a measurable increase in user satisfaction with electronic processes compared to paper-based processes. To assess this, a satisfaction survey was used to gather responses from staff that trained using both the paper-based and electronic training reporting method at the site.

In regards to User Satisfaction, respondents rated the paper-based method an average of 3 points lower on a 10-point scale. A European study also measuring user satisfaction of electronic and paper methods produced a similar result, with 79% of respondents agreeing that electronic documentation methods are preferable to paper methods23. The results of this practicum reveal 65% of respondents rating the electronic method as more satisfactory, with the majority of responses giving scores 3 points or higher for the electronic method. These differences are statistically significant, again supporting the original assumption that the electronic method is a more estimable approach.

This finding is important because employee compliance has been found to be associated with methods that individuals are more comfortable with14. Therefore, staff satisfaction with a newly integrated process is important for the success of the workflow changes that are always occurring in clinical research. As the methodologies evolve, it is

crucial that developers monitor subjective qualities such as user satisfaction with a process and perceived ease of use. Because of this, future research in the area of user opinions about workflows will be necessary as more paper to electronic conversions take place.

CHAPTER 8

INTERNSHIP EXPERIENCE AND JOURNAL SUMMARY

The Center for Cancer and Blood Disorders opened its central campus’ doors in

Fort Worth in 2005.20 This independent cancer center, which is not affiliated with any hospital or academic center, has a main location off of Magnolia Avenue, and several branch locations in Arlington, Burleson, Cleburn, Granbury, Huguley, Mineral Wells,

Stephenville and Weatherford. Research patients are seen at the Magnolia, Arlington,

Huguley and Weatherford branches. All labs and medications are centrally processed at the Magnolia branch, which also houses the headquarters for the research department.

This department is staffed with a BSN Office Manager, a Clinical Trials Specialist, a

Data Coordinator, two full-time Clinical Research Coordinator (CRC), a Medical

Assistant to aid the CRCs with labs, and a Pharmacy Technician who is in charge of the

Investigational Products. The Center is very active in regards to clinical research and currently has over two-dozen open clinical trials, which are administered by eleven

Principal Investigators.

The initial two months of the internship practicum was spent shadowing and learning from each staff member. This time was be divided up as follows: two weeks with the Clinical Trials Specialist, one week with the Data Coordinator, one week with each full-time CRC, one week with the Pharmacy Technician, one week with the Medical

Assistant, and a weekly one hour meeting with the Office Manager (who also served the primary mentor).

The Center provided many opportunities to experience and observe a wide variety of skill sets. Observations included tasks from the areas of clinical research management, pharmacy, office management, and oncology/hematology diagnosis and treatment. Tasks delegable to the intern included informed consent audits, training certification audits, sorting and filing patient questionnaires, clinical trial audits to record Principal

Investigator participation, patient charts usage and EMR to find requested information, and other small assignments that were appropriate for an intern. When a task was not entirely delegable to the intern, the staff often allowed the student to assist alongside in order to create a hands-on-learning experience. Some of these non-delegable tasks included query resolution, Serious Adverse Event reporting, pre-screening and screening of potential clinical trial patients, Investigation Product Accountability tasks, and updating a patient’s Adverse Event log.

In addition to participating in the day-to-day operations of clinical trial management at The Center, the student was permitted to observe many events that relate to the realm of clinical research management, but are not entirely appropriate for an intern to participate in. These included patient appointments with physicians, chemotherapy infusion treatments for patients, re-consenting patients to the latest informed consent, interactions with clinical research associates during their site visits, entering data into sponsor-required EDC and IVRS sites, entering data into the EMR, and numerous staff and site meetings.

APPENDIX A

USER SATISFACTION AND OPINION SURVEY

APPENDIX B

INTERNSHIP JOURNAL

Week 1

June 01, 2015 (Monday)

-Arrived at CCBD’s main campus at 0800 and spoke with the main campus’ on-site

Clinical Research Coordinator (CRC), until the majority of the staff arrived While conversing with theCRC, I learned that the research department’s work-day begins around 0830, with a 30 minute lunch break that is to be taken when convenient.

-Discovered that I will be following the Regulatory Specialist this week. By doing this I hope to become familiar with the department and to learn as much about the regulatory aspects of her job role as possible.

-Completed the new (2015) Site Progress Report for a BRE study

-Reviewed a BRE study regulatory binders and familiarized self with binder organization and document layout

-Query fulfillment: Searched in study subject files for missing questionnaire pages and scanned these to email

-Assisted the Regulatory Specialist in determining which staff members still need to complete protocol training by utilizing a master training record in the form of an Excel file

-Alphabetically organized “Study Training” area of regulatory binder LUN229

-Discussed the benefits of moving Study Training certificates to digital format with the

Regulatory Specialist

June 02, 2015 (Tuesday)

-Assisted Regulatory Specialist with documenting and inserting Protocol Training

Certificates into Regulatory Binders

-Discussed the possibility of using online tracking platforms to monitor the progress of staff protocol training (the “Site Training” areas of the regulatory binders must be updated prior to this new implementation)

- Alphabetically organized “Site Training” areas of several regulatory binders

-Followed Regulatory Specialist during her rounds and while doing so met Dr. Xiong and

Nurse Practitioner Shandy Grisham

June 03, 2015 (Wednesday)

-Assisted the Regulatory Specialist with editing the PI Research Dashboard on Google: deleted several columns as requested

-Assisted with organizing, scanning, and emailing study queries

-Found, copied, redacted, scanned to email, and re-filed study patient documents

- Again assisted with Protocol Training management

1. Documented receipt of completed staff training certificates in training master

Excel file

2. Alphabetically organized “Study Training” area of several regulatory binders

3. Inserted signed Protocol Training Certificates into regulatory binders

June 04, 2015 (Thursday)

-Observed Pre-Site Initiation conference call between Regulatory Specialist Dr. Robyn

Young and sponsor representative (took notes-see steno book)

-Went along to pick-up/deliver materials to the CCBD Arlington branch

1. Met CCBD’s other CRC; her main office is in Weatherford but she travels to

other sites when necessary

2. Toured the Arlington Branch

-Reviewed and answered Data Clarification Forms (DCFs) from Sarah Cannon Research

Institute (SCRI)

1. Documented the amended data that was requested

3. Scanned the DCFs to email for the Regulatory Specialist to sign and submit t

to SCRI

2. Filed DCFs in corresponding study binders once emailed.

-Disposed of a large amount of sensitive documents into shred boxes

-Toured CCBD’s main campus building

-Spent the remainder of the day reading online about topics related to potential research project. My project is likely to be about utilizing digital processes to increase user satisfaction and efficiency and decrease paperwork burden and errors.

June 05, 2015 (Friday)

-Focused on getting the Training Certifications organized into their corresponding regulatory binders and documented who still needed to complete which protocol training

-Brainstormed with Regulatory Specialist about revising the Training Certification document system. We aim to move the system from paper documentation to an online

Google Forms database. We intend to officially document training completion simply by printing the populated Excel sheets from Google and inserting them into the regulatory binders. This can be done either as the monitors require them or when all the staff has completed that particular protocol training.

-Attended a 3:00pm meeting with the Office Manager and the research department staff about how to properly consent patients

-Discussed next week’s goals and schedule with the Office Manager. Next week I intend to:

1. Continue working on solidifying my research topic

2. Finish organizing as many “Site Training” areas of the regulatory binders as

possible so that the Regulatory Specialist can implement her online method of

verifying/submitting protocol training

3. Shadow the Regulatory Specialist once more and learn as much as possible from her. This week she was a wonderful mentor and was always able to find small tasks for me to complete so that I could further my acquaintance with this office’s systems and methods.

Week 2

June 8, 2015 (Monday)

-Spent a majority of the day organizing the “Site Training” portion of regulatory binders

-Pre-screened patients for a retrospective Paroxysmal Nocturnal Hemoglobinuria (PNH) study:

1. Utilized a given list of potential study patients

2. Accessed patient records in EMR and compared patient histories to

inclusion criteria

3. Compiled list of patients for Dr. Skiba, the PI, that met preliminary

screening criteria

-Began auditing Informed Consent Forms (ICFs) per request of the Regulatory Specialist:

1. Created Excel spreadsheet to assist with the organization of patients from

11 studies

2. Retrieved consent form version dates from IRB Certificates of Approval

that are filed in corresponding regulatory binders

3. Compared consent form version to the consents that the patients on the

study signed

4. Documented which patients signed which consent forms for billing

purposes

June 9, 2015 (Tuesday)

-Audited ICFs for Active and Follow-up patients for most of the day. Ultimately, this consent audit will serve a purpose with billing.

-Trained another intern in the training certificate management system and assisted this intern with organizing the training area of the binders

June 10, 2015 (Wednesday)

-Transcribed Tumor Board Minutes from March, April, May Tumor Case Conferences

-Spoke with the CRC about how to document SAE vs. AE and reporting requirements for each

-Assisted the Regulatory Specialist with providing items to the visiting study monitors

-Followed her during her rounds and met Dr. Ganesa

-Assisted with assembling new Regulatory Binders for the BRE 257 Study

-Resumed the project of auditing patient consent forms

June 11, 2015 (Thursday)

-Attended Site Initiation Visit (SIV) for-See notes in wired spiral

-Walked with the sponsor representative on a tour around the Magnolia location

-Assisted Regulatory Specialist with procuring requested documents for sponsor representative

-Assisted with preparing for SIV visit for Friday morning (GYN 51)

-Resumed the project of auditing patient consent forms

June 12, 2015 (Friday)

-Completed auditing informed consents for billing purposes

-SIV for GYN 57 was cancelled, so assisted the Regulatory Specialist with sorting office paperwork until it was time to leave (5pm)

-My goals for next week are:

1. Spend time with the on-site CRC during her day-to-day tasks and assist her

when allowed

2. Observe the CRC’s method of navigating sponsor EDCs and completing

sponsor-provided forms

3. Discuss the advantages and disadvantages of using paperless processes with the

CRC

Week 3

June 15, 2015 (Monday)

-Discussed shadowing the Magnolia branch CRC this week

-Observed the on-site CRC while she documented deviations and conversed about the job roles of a CRC while doing so

-Went with the CRC to her visits to meet two patients

1.Asked permission to observe during the office visits

2. CRC discussed current medications, changes to health, new symptoms, and

picked up Quality of Life (QOLs) forms that were given to the patient earlier

3. Observed CRC updating the AEs using the current paper AE log

3. Dr. Young discussed future treatment plans and arranged next visit

-Entered data for SAE form

1. Examined patient charts and available hospital information

2. Found pertinent data and transferred to form

June 16, 2015 (Tuesday)

-Attended Tumor Board Case Review – See notes in wired spiral

-Attended 9am SIV for GU 122- See notes in steno book

-Went with CRC during her visits to meet patients

-Observed CRC as she sorted through patient charts and caught up on some items that needed to be addressed and filed

June 17, 2015 (Wednesday)

-Observed CRC compiling Treatment Plans for a new patient on BRE 231 who was just randomized and has her first treatment scheduled for tomorrow

-Reviewed patient charts and patient’s hospital records for new AEs and medications

-Worked on entering data for an Incyte SAE form

1. Examined patient charts and available hospital information

2. Found pertinent data and transferred to form

June 18, 2015 (Thursday)

-Finished Incyte SAE form from yesterday

1. Entered data into pdf form

2. Upon completion, gave form to CRC to review and sign

-Per request of Regulatory Specialist, performed an imaging deviation audit

1. Reviewed imaging protocols in regulatory binder to determine correct

imaging schedule and windows for study patients

2. Compared correct imaging schedule with patient’s actual imaging schedule

and noted the scans that occurred outside of the window (and were therefore protocol deviations)

-Attended Study Coordinator Meeting- see notes in steno book

-Shadowed CRC while she held study visits with her patients

-Reviewed pre-screened and screened patients to confirm eligibility

1. Used Aria EMR system to review patient information for inclusion/exclusion

criteria and marked areas that needed further investigation as necessary

June 19, 2015 (Friday)

-Completed yesterday’s patient screening and took note of what is still required and what has already been completed (patient still requires MUGA/ECHO, screening local lab work, and is currently on an anti-depression medication that disqualifies her if she cannot stop taking it)

--Completed follow-up SAE form for Grade 4 SAE

1. Used EMR and hospital records as sources of information

2. Populated digital SAE form with found data

3. Reviewed form for accuracy and gave to study coordinator

-Observed tele-conference meeting between Regulatory Specialist and Sarah Cannon

Research Institute-see notes in steno book

-Attended a weekly Intern Update meeting with the Office Manager to discuss internship progress and future plans and goals.

1. Will begin to compile list of processes that use a paper-based format and

brainstorm ways to perhaps move these to digital platforms

Week 4 June 22, 2015 (Monday)

-Observed Data Coordinator entering data into sponsor EDCs (Medidata, Genetech

[Roche], TrialMaster)

1. Sorted through papers in Patient Data tray and filled in data entry fields in

corresponding EDCs

2. Answered queries created by sponsor representatives

3. Filed papers from Patient Data tray in the Data Coordinator’s office into shadow charts

4. Scanned documents into EMR as necessary

-Observed the weekly Data Coordinator meeting and took notes-see steno book

-Sorted patient surveys, QOL assessments, and lab sheets for LUN study (will add into

LUN binder tomorrow)

June 23, 2015 (Tuesday)

-Attended LUN 283 Site Initiation Visit (SIV) and took notes-see notes in steno book

-Prepared for First Committee Meeting

-Held First Committee Meeting in the War Room

1.Presented synopsis of research topic

2.Answered Committee Members questions as they arose

3. Discussed Project Feasibility and methods of gathering data

4. Considered the use of a satisfaction survey and the necessity of an IRB

application if this is a chosen option

5. Set a defense date for November 10

-Emailed Dr. Dory and arranged a meeting with him for next week

-Emailed to reserve a room for the thesis defense

-Met with Dr. Page and discussed research topic

-Met with Melissa Pool (an experienced CRC and also the department office manger) and discussed research topic

June 24, 2015 (Wednesday)

-Sorted through external lab batch reports, patient surveys, and other documents for

LUN 265

1. Matched lab reports to patient diaries and data collection sheets

2. Determined which patients were still missing what information/survey

3. Observed Data Coordinator entering patient information into the EDC. Some of

the patient surveys (in the form of diary-type bound notebooks) required the use of

a ruler to measure patient scoring as a numerical percentage. Each scoring range

was 10 cm, and a patient placed a mark on the range line to indicate their selection.

Ex: A selection of 6.4 cm would be scored as 64%. This percentage was

entered into the EDC.

-Assisted Data Coordinator with filing and sorting tasks as they arose

-Observed a conference call between the sponsor and our department in regards to the study PRO 04

June 25, 2015 (Thursday)

-Assisted both the Regulatory Specialist and Data Coordinator with resolving queries and finding correct information for Data Clarification Forms (DCFs)

1. Used the EMR, patient shadow charts, and regulatory binders to find

required information

2. Scanned completed DCFs to email and filed in proper places (in front of the

document that they clarified)

-Filed papers from the Data Coordinator’s inbox (Patient Data tray) after he scanned them to the EMR

-Reviewed the PNH study with the Data Coordinator and showed him how to pre-screen the patients. This study is unique amongst our current studies in that only the PI will be able to screen the patients; therefore we facilitate the screening process by pre-screening candidates found by the physicians.

-Spent much of the day observing what job tasks are included in the “data coordinator” title. Also brainstormed with the Data Coordinator about methods to reduce his paperwork burden by using digital source documents.

-Observed a conference call between the sponsor, the Regulatory Specialist, and our data coordination team in regards to the study PRO 04. We are working with the sponsor

closely at this point because this study will undergo data lock soon and we would like to expedite the query process if possible.

June 26, 2015 (Friday)

-Spent much of this morning reading about regulatory requirements for source documents. I would like to convert the paper Adverse Event (AE) log to a data or cloud file if possible. This would perhaps expedite the process of physician review so that patients can more accurately continue or delay treatment as necessary.

-Was introduced to a visiting monitor during a Pre-site Initiation Visit (PSIV)

1. Visited Weatherford, Huguley and Arlington CCBD sites with the Regulatory

Specialist and a Monitor

2. Conversed with monitor about industry related topics, including the move

from paper to digital formats

-Assisted the Data Coordinator with answering queries related to LUN229 study

-Held weekly Intern Update meeting with the Office Manager and discussed the possibility of transferring the AE logs to a digital platform.

Week 5

June 29, 2015 (Monday)

-Today I will be at the Weatherford location with the intent of shadowing Dr. Page and acquainting myself with the different work culture present here. I hope to talk to the floating CRC (who sees patients at Weatherford, Huguley, and Arlington) about her preferences for a digital AE log.

-Observed Dr. Page meeting with:

1. Potential hemochromatosis patient. Patient had ferritin levels 4x the Upper

Limit of Normal (ULN) and exhibited what might be interpreted as darkening

of the skin on the feet that can occur when hemochromatosis is present. Iron

studies were normal, though, while CRP was elevated.

2. Several other follow-up (FU) patients for a variety of conditions ranging

from lymphoma, breast cancer, cancer of the appendix, myelodysplastic

syndrome (MDS), and hairy cell leukemia.

3. A FU patient who may have recurrent myeloma

4. A patient who underwent surgery for esophageal cancer recently and is now in

complete remission. Dr. Page recommended that he return for FU every 3

months.

5. A patient with neuroendocrine tumors of the intestine and mesentery that

were resected. Tumors were pT3 and N2.

6. Ovarian cancer patient who decided to discontinue her taxol maintenance

because her symptoms were interfering with her daily functioning (memory

loss was beginning to occur)

7. Melanoma patient post-surgery who has a deep melanoma (>4.0 mm) and

who is recommended to receive interferon for 52 weeks

-Listened in on a ViaOncology Pathways conference call for lung cancer. Leading oncologists who specialize in lung cancer were present during the call, and it was exciting to see treatment algorithms change during the course of the call. Items that were discussed:

1. Adding Nivolumab (sp?) to a treatment arm for NSCLC, non-squamous

2. Adding Bevicuzumab (sp?) along with Cisplatin and pemetrexed as a

treatment option for mesothelioma

3. Considering Pathways user comments and suggested changes. Leading experts

attending the conference call either agreed or disagreed to several regimen changes

based on oncology practitioner suggestions

June 30, 2015 (Tuesday)

-Shadowed the floating CRC for the majority of the day.

-Per request of the Office Manager, noted the differences in workplace culture when compared to the Magnolia branch

-Prescreened a patient for two separate studies per request of the floating CRC

-Spoke with the CRC about her interests and preferences for the upcoming digital AE log. She would like to have a notes section that is separate from the source document, if possible. I believe that is a very reasonable suggestion and I will look into making a separate note area as easily (and quickly) accessible as possible

-Left Weatherford branch early in order to meet Dr. Dory for a 2pm appointment.

Unfortunately, it turns out that Dr. Dory is sick today so we will move our appointment to a date to be determined later.

July 1, 2015 (Wednesday)

-Attended 0730 Tumor Board at Weatherford Hospital and took notes-see steno book.

Today there was a geneticist and radiologist present for consultation. The pathology for today’s cases, if available, was presented on the projector screen.

-Shadowed Dr. Page at the Weatherford location. Some of the patients that were seen were:

1. An elderly woman who has just had her first FU scan post-chemotherapy

for Lung cancer. Although the woman’s lungs look free from cancer, she has a

few worrisome hot spots in other areas of her body (one in liver, one in

rectum, and lesions in her upper thoracic spine). Plan is for MRI and

sigmoidoscopy to rule out metastasis.

2. A woman with neutropenia that may be immune mediated. Neutropenia was refractory to Neupogen, but responds to steroids and therefore the patient is to be maintained on a low, minimally effective dose of prednisone in order to make it through chemo.

3. Colon CA patient with rising liver enzymes and CEA (a tumor marker)

previously had several rounds of Folfox and Avastin with full response. She

later had a hepatic artery embolization and now is recovered with the hopes

of resuming cancer treatment. Her favorable response on Folfox and Avastin

will likely mean that this is the next treatment for him. Patient also likely has

iron deficiency anemia and therefore will need iron studies done today.

4. Gastric CA patient with esophagectomy. Patient is feeling well today and is only receiving B12 shots regularly. Dr. Page suggested that the patient receive his

B12 at his general practitioner’s office in order to avoid the drive and extra expense of a specialist doctor’s visit.

5. Lung CA patient who was hospitalized for respiratory failure (intubated)

and is now suffering from hallucinations. The gentleman was referred to the

neurologist in town to determine the source of the hallucinations.

6. A clinical trial patient who progressed on the study regimen and is now

suffering from severe fatigue and difficulty breathing/shortness of breath.

physician, patient is likely having symptoms related to his radiation therapy

of the lungs and fibrosis is causing the cough and SOB. 20mg Prednisone is

prescribed and patient will return in 3 weeks.

7. A breast CA patient with lymphedema that is currently being treated with

sleeves and a pump. She is doing well and her tumor marker is decreased today in comparison to her December marker evaluation.

8. Metastatic breast CA patient who had bone involvement. She is having mild

leg/hip pain today but is on Xeloda and is otherwise doing well.

9. Late middle aged woman who was recently diagnosed with high grade bladder cancer after surgical biopsy. Referred to Dr. Page to discuss treatment options.

Considering that her cancer has invaded her bladder muscle, her best chance of cure is with cystectomy followed by chemotherapy. Her right ureter is currently obstructed and is causing hydronephrosis.

10. A long-term follow-up patient who was initially diagnosed with breast CA

at the age of 36. Her cancer returned 20 years later but was cured once more.

She is now 72 and doing well.

11. 66 year old male with rectal carcinoma patient who is newly diagnosed and

needed staging, radiation therapy, and a PET appointment. The daughter and wife

were present and helping to ask questions. The proposed treatment plan is 6 weeks

of Xeloda whole undergoing radiation therapy. After this he will take a 6 week

break and then get reassessed to determine his cancer status.

12. An 80 year old patient transferred here from another oncologist. He has a

history of superficial bladder cancer and prostate cancer, both were treated

successfully. He is currently getting regular Lupron shots monthly. Dr. Page

referred him to a urologist for FU of his bladder cancer and Dr. Page will be

managing him for prostate cancer history and the patient agrees to try Lupron shots

every 3 months.

-Observed interactions between the Office Manager and Dr. Page relating to clinical trial patients that were seen at the center today, as well as questions concerning a Foundations study that The Center will be participating in.

-Spoke with Dr. Skiba about recruiting patients to the PNH study

July 2, 2015 (Thursday)

-Today I shadowed the floating CRC to learn about her job roles.

-Met with her at the Weatherford location to reconsent a follow-up patient

-Rode with her to the Arlington location for an active patient’s visit and went over AEs and changes in medication with this patient.

-Observed her consent a new patient to a LUN study. She had previously gone over the

ICF with the patient and the patient had been discussing with family the advantages and disadvantages of going on study. After consideration at home, the patient came into the

Arlington branch today for chemotherapy and sought out the CRC while there. The patient had no study-specific questions and was given a copy of the signed consent when she was finished reviewing and signing.

-Completed a Grade 5 SAE report for sepsis

1. Used Adobe Acrobat to create a fillable form from the sponsor-provided

SAE reporting document

2. Used patient data from hospital reports to complete the form and turned

document over to the CRC to review for accuracy and completeness

Week 6

July 6, 2015 (Monday)

-Home sick with Illness-emailed the Office Manager prior to 0830

July 7, 2015 (Tuesday)

-Attended 0730 Tumor Board at Magnolia branch and took notes-see steno book

-Prescreened two patients for separate clinical trials (BRE 242 and BRE 231)

1. Used EMR to access patient records and history

2. Reviewed inclusion/exclusion and marked areas that required further

investigation by the CRC or the PI. Both candidates look preliminarily eligible

for their respective possible studies and may benefit from further candidacy

review.

-Spoke with the Regulatory Specialist about Tyndall storage project. The issue is that source and regulatory documents must be maintained on site for 2 years prior to storage with Tyndall, so this leads to a large amount of boxes being stored on site. Storage with

Tyndall is conducted by barcoding and cataloguing boxes (contents are noted on Tyndall database) and then boxes are marked with a date beyond which they may be stored.

-Attended a short meeting with Dr. Warren

-Attended a meeting with Dr. Dory to discuss the topic of my thesis and a plan of action for the month of July. This month I intend to:

1. Draft, revise, and finalize a research proposal

2. Create and implement a digital AE log to be used by The Center’s CRCs

3. Begin (and hopefully complete) an IRB application for the surveys that I

would like to include with my project. These surveys would be user

satisfaction surveys for the chemotherapy nurses in regards to the switch from paper to digital certificate of training submission.

July 8, 2015 (Wednesday)

-Assisted the Regulatory Specialist with Tyndall records search

1. Used clinical research patient list to search through a printed records database

2. Noted BoxBar number in order to retrieve boxes that contain clinical research

information

-Audited physician enrollment records for clinical trial involvement for the purposes of updating the physician CVs

1. Used physician enrollment records to create a Word document that lists all

clinical trials that physicians have enrolled patients to beginning in 2012

2. Created an Excel file that lists study number, title, and protocol of all studies on

Word document for easy copy-paste as necessary

July 9, 2015 (Thursday)

-Assisted the Regulatory Specialist with Tyndall records search

1. Used clinical research patient database (all patients that the center has ever

enrolled) to search through Tyndall electronic records database

2. Entered corresponding patient File number in clinical research patient database

-Modified Journal Entry Sign-able forms for the Office Manager to sign off on at the end of the week. I was previously using Adobe, but I’m trying an online signing application on Google Drive to increase ease-of-use. The only disadvantage in making this switch is that Adobe had the ability to create signatures that were Part 11 compliant, but this application does not.

-Drafted a digital AE form for use in CRC iPads

1. Created an AE log spreadsheet using Numbers (iOS version of Microsoft’s

Excel)

2. Experimented with converting this to PDF for physician review/signature

(works fine)

-Researched applications to support this eSource document system. Applications that may be applied to this system in the future are:

1. MS Excel for iOS, Numbers – Source document data entry platform (Free)

2. Notability – For direct physician signatures (Part 11 Compliant, cost is $2.99)

3. Adobe – For physician signatures through email (Part 11 Compliant, Free)

4. MyScript Stylus – For handwriting to typed entries to aid CRC in data entry

(Free)

5. Pop for iOS – For additional notes that will not be included in the eSource

document (cost is $0.99 per download)

-Spoke to the Regulatory Specialist about the SCRI SignIX retrospective data to be used in data analysis

July 10, 2015 (Friday)

-Today I mostly worked on my research proposal and edited the draft of the digital AE log.

-Spoke to the Office Manager about obtaining the SCRI data report on “regulatory in” document turnover times. She spoke to a SCRI employee today who may be able to expedite our receipt of these reports. One of the things that I must consider in regards to this is what date range would I like to be using for the analyzed data. Currently I’m thinking that reports for one quarter and one year will be acceptable.

- Attended Intern Review meeting and presented draft of digital AE log. We uploaded this draft to the Office Manager’s full size iPad and used the Numbers application to open and test the fields. CCBD’s information department was consulted in regards to using

Google Drive as a storage medium. It was determined that this is acceptable only if all patient identifiers have been removed from the form. This will work fine with clinical research patients because each patient has a subject number with initials that has been assigned. We also discussed this draft with the CRCs and they were able to see the current draft in use on the iPad.

-Participated in a company birthday party for the CRC!

Week 7

July 13, 2015 (Monday)

-Today I am to work the Pharmacy Technician, but she does not have much Research related tasks for me to observe until 2pm. Until then I will be going where I am needed in the department.

-Edited Research Proposal draft

-Observed the on-site CRC labeling and centrifuging a port-draw blood sample for a study patient because the Medical Assistant, who is tasked with managing the labs, is on vacation leave.

-Observed the Pharmacy Technician pulling drug for study patients

-Began compiling research involvement list for a nurse practitioner who is also a Sub-

Investigator

-Read LUN 305 protocol highlights sheet from PPSIV and highlighted important areas for further PI and study staff review

-Created Excel file that lists all of the titles and protocols for studies present at CCBD beginning in 2012. This file will later be used to assist administrative staff with updating physician CVs.

July 14, 2015 (Tuesday)

-Attended 0900 SIV for the GU 120 study

-Finished compiling research involvement list for a nurse practitioner who is also a Sub-

Investigator

-Edited second Research Proposal draft

-Disassembled and disposed of expired study lab kits

-Assisted the Pharmacy Technician with reviewing drug inventory

1. Counted Investigational Product in locked research drug cabinets and compared

this to regulatory records

2. Noted expiration dates and removed expired drug as necessary

July 15, 2015 (Wednesday)

-Observed the Pharmacy Technician for the majority of the day

-Finished Excel file that lists all of the titles and corresponding protocols for studies present at CCBD

-Edited second Research Proposal draft

July 16, 2015 (Thursday)

-Observed the Pharmacy Technician for a large portion of the day as she fulfilled her research department obligations. This particular employee works in both the Pharmacy and Research Department. Some of the things that I was able to watch her do were:

1. Inventory of refrigerated Investigational product

2. Receive investigational product in the mail and input shipment receipt into the

IVRS

-Returned a re-useable, cooled shipping container to Eli Lilly (per request of the sponsor) by calling and arranging a UPS pickup

-Met with my Major Professor on the UNTHSC campus for a meting relating to my

Research Proposal

-Edited second Research Proposal draft

July 17, 2015 (Friday)

-Assisted another intern with extracting ICFs from patient charts and re-filing in new

ICF-specific sections of regulatory binders

-Observed the Pharmacy Technician retrieving study drug for mixing and administration to patient

-Attended LUN 291 SIV and took notes- see steno book

-Resumed assisting the other intern with extracting and re-filing ICFs

-Attended weekly Intern Review meeting with Site Mentor. We discussed:

1.) Implementation of digital AE log pilot program with the on-site CRC

2.) Next week I will be shadowing the on-site Medical Assistant

Week 8

July 20, 2015 (Monday)

-Edited third Research Proposal draft for the majority of the day.

-Spoke to my Site Mentor about what I should be learning and observing from the MA this week

July 21, 2015 (Tuesday)

-Purchased 50lb dry ice from a local dry ice business for use in packaging frozen samples

-Shadowed the Regulatory Specialist during a Medical Liaison meeting between a

Peregrine representative and the Principle Investigator and took notes-see steno book

-Broke-down and disposed of lab kits that need to be destroyed

-Observed and assisted the MA for the majority of the day. Some of the tasks that I assisted with or witnessed were:

1. Creating blood smears from hematology (purple) top tubes using a little

instrument that pierces the top of the tube and, when quickly pressed to and

withdrawn from the slide, leaves a drop of blood.

2. Centrifuging hematology tubes and removing aliquots of serum from

centrifuged samples

3. Packaged and shipped frozen biological samples in dry ice

July 22, 2015 (Wednesday)

-Arranged and labeled EKGs and took inventory of EKG materials

-Created Google inventory sheets for and inventoried 2 studies

-Shadowed the MA during her processing of samples and EKG test administration (EKG was cancelled due to patient abdominal discomfort)

-Assisted the Regulatory Specialist with re-arranging boxes and equipment

-Packaged a box of Sponsor-provided safety alert letters to be sent to SCRI

-Consulted with on-site stat lab to inventory centrifuges for a study (we have 2 boxes of

Minispin microcentrifuges here in the office). Determined that a sponsor-provided centrifuge is already set-up in the lab and that the two additional centrifuges in the office are merely extra and may go into storage until returned to sponsor

July 23, 2015 (Thursday)

-Observed the MA packaging a paraffin-embedded tumor tissue sample for shipment to laboratory to be tested for a receptor

-Updated personal Study, Title and Protocol list with new studies

-Attended a meeting with onsite mentor and MA about goals and future plans for laboratory kit management. These goals are:

1. Update all laboratory kit inventories and re-order new supplies, remove expired

kits and closed studies as necessary

2. Create inventory Google sheets for new studies and share these sheets with all

of the study coordinators for them to update as they use kits

3. Keep Google inventory sheets updated and re-order kits as necessary, based on

these sheets.

July 24, 2015 (Friday)

-Attended the SIV for MM58 and took notes-see steno book

-Continued assisting the MA with laboratory kit inventory, with the majority of this time being spent creating Excel sheets. The information to be included on these sheets is:

Sponsor name, protocol number, investigator number, project number, which kits require specialized shipping (dry ice, only shipping on certain days etc), re-ordering information, laboratory kit vendor holidays, and a list of the kits required for the study. The main two purposes of these inventory sheets is to maintain a record of the number of available kits for each study and to detail which kits will require specialized shipping (ie. Using dry ice)

-Attended weekly Intern Review meeting with Site Mentor and a guest appearance from the PI. This week we discussed:

1. The possibility of me communicating with SCRI concerning the retrospective

data. I am able to do this from now on because the Site Mentor cc’ed me in the

original email to SCRI

2. The FDA Electronic Signature Certification Form requirement

3. Electronic signatures and Part 11 compliance

Week 9

July 27, 2015 (Monday)

-Inventoried kits with the MA and created Laboratory Kit Inventory sheets in Excel

-Began scanning sponsor-provided Laboratory Manuals to the research department’s

Google Drive

-Met with Dr. Warren and Dr. Dory on campus to discuss finalized research proposal and future plans for my research project.

July 28, 2015 (Tuesday)

-Finished inventorying kits from the MA and scanned additional laboratory manuals to the Google Drive

-Attended a conference on Biosimilars and how clinical research in Biosimilars will be different from Biologics.

July 29, 2015 (Wednesday)

-Today I will be shadowing a nurse practitioner who sees patients for two of the oncologists. She is a very busy clinician and I am fortunate to be given this opportunity to observe her today. Some of the patients that we visited with were:

1. A patient who started Arimidex 4 weeks ago. During this follow-up visit she

admits to having hot flashes from this AI drug, but not enough to warrant a

change in medications.

2. Several long-term follow-up breast cancer patients

3. A patient with carcinoma of the tongue whose carcinoma returned in his jaw.

The tumor in the jaw warranted resection and was followed by jaw reconstruction

and surgery. The patient is on a gastric feeding tube and is here today with severe

swelling of the jaw with possible cellulitis of the neck. A prescription is ordered

for 1g Vancomycin to be given in the infusion room at The Center for 2 days and

a broad spectrum oral antibiotic.

4. A patient beginning Cycle 1 Day 1 for her breast cancer treatment. Although

patient had already undergone a chemotherapy training meeting with a nurse, a

review of information relating to treatment was given and the patient was allowed

to ask questions.

5. A lymphoma patient undergoing RCHOP who came in today with febrile

neutropenia. She will need to be admitted to the hospital for treatment of fever

and investigation into the causative agent. The nurse practitioner arranges the

patient’s admission to the hospital.

-Emailed a SCRI representative to further discuss the possible use of SCRI’s Sales Force data for my research project.

July 30, 2015 (Thursday)

-Completed scanning and uploading Laboratory Manuals to Google Drive. As a background, manuals that were uploaded were for laboratory kits that are currently housed in the research department.

-Updated inventory for a new laboratory kit shipment and uploaded the new laboratory manual to Google Drive.

-Edited and reformatted digital AE log

July 31, 2015 (Friday)

-Finished editing and reformatting digital AE log (2nd draft)

-Downloaded the newest edition of Title 21 CFR and printed the Part 11 pages. Reviewed these pages to ensure that the digital AE log is compliant and took notes for use during the weekly Intern Review meeting.

-Assisted the Regulatory Specialist with minor office tasks:

1. Re-organized regulatory binders

2. Scanned-to-email pages from regulatory binders that a monitor requested upon

her last visit

3. Reviewed a study protocol and provided the Regulatory Specialist with specific

notes regarding a possible protocol deviation

-Attended weekly Intern Review meeting with site mentor and mainly discussed electronic signatures and the digital AE log. If the physician will only be assessing and signing this log immediately after or during the meeting with the patient, then this log will not require a true electronic signature, but only a handwritten signature executed to electronic record. We also talked about where this digital AE log would be stored for review by staff and the monitor. After a test-run, it was decided that the signed .pdf format of the log can easily be uploaded to Aria. Lastly, a few edits were suggested for this version.

Week 10

Aug 3, 2015 (Monday)

-Reviewed, edited, and submitted journal entries for the last two weeks

-Created Draft 3 of digital AE log and emailed to Site Mentor and on-site CRC

-Brainstormed methods to collect data concerning Data Clarification Forms (DCFs), protocol deviations, and queries for use in my project’s statistical analyses. I’ve identified a couple of sources that I may be able to pull data from with approval from my On-Site

Mentor and the Regulatory Specialist:

1. Remote or Interim Monitoring Visit letters (contains lists of “action” items)

2. Protocol Deviation log that is included in some regulatory binders

Aug 4, 2015 (Tuesday)

-Retrieved packages and mail from mailroom

-Reviewed mail for IRB Correspondence

-Spent several hours updating training audit log to reflect new individually reported training (both for chemotherapy nurses and other study staff)

-Notified Office Manager of new IRB-approved documents and filed the printed documents in their corresponding regulatory binder

-Filed Patient Treatment Sheets

-Read about the IRB approval process at UNTHSC

Aug 5, 2015 (Wednesday)

-Reviewed mail for IRB Correspondence and notified Office Manager of new approved protocol

-Worked with the Office Manager in filling a sponsor-provided Drug Destruction Form

1. Reviewed the IP Accountability Log

2. Matched medication bottle numbers from patient-returned bottles to bottle

numbers in the IP Accountability Log

3. Manually counted IP using standard pharmacy technician process

4. Modified and populated the Drug Destruction Form with IP bottle numbers, lot

numbers, and remaining pill count

-Began adding Medical Record Numbers to the Patient Screening Log for 2015. This required using the EMR to match patient information to a name in the Screening Log.

Aug 6, 2015 (Thursday)

-Completed adding Medical Record Numbers to the Patient Screening Logs for the years of 2014-2015 and emailed completed document to the Office Manager and Regulatory

Specialist

-Assisted Data Coordinator with minor copying and filing tasks

-Re-organized regulatory binders on shelves so that more binders could be included in the

Regulatory Specialist’s office

-Spent the remainder of the afternoon studying

Aug 7, 2015 (Friday)

-Helped the MA unbox, review, inventory, and put away new laboratory kits for a study that will be opening soon (BRE 251)

-Emailed my Major Professor to give a biweekly update along with the most recent versions of the Digital AE Log (both Numbers and Excel editions)

-Assisted with small tasks around the office and studied when no additional work was available

Week 11

Aug 10, 2015 (Monday)

-Retrieved mail and consolidated safety letters from sponsors into one stack

-Assisted the Regulatory Specialist and Data Coordinator with minor tasks in preparation for a monitor visit and sponsor-initiated audit

1. Filed items in regulatory binders

2. Retrieved laboratory documents from EMR and printed abnormal lab values for

assessment of clinical significance by physician. Added CS/NCS stamp to these

laboratory reports.

-Identified and Printed copies of source documents to be given to the sponsor for patients on GI 184

-Printed and redacted sponsor-requested documents for two more clinical trial patients

-Began designing user satisfaction surveys

-Began IRB Exempt Review Application for the surveys that I plan to use with my research

Aug 11, 2015 (Tuesday)

-Retrieved mail and shipped box of safety letters to SCRI

-Separated training certifications for study related training (Ex: Rave, CITI…)

-Removed contents from regulatory binders and filed into boxes for long term storage

-Observed SCRI study update teleconference

-Attended 6pm physician’s dinner and observed a Biodesix representative presenting a lecture about Veristrat and Genestrat products. The research department also took this

time to give a presentation on regulatory items and to hold an open forum to discuss research affairs.

Aug 12, 2015 (Wednesday)

-Assisted the Regulatory Specialist with re-organizing study filing areas in her office and disposed of old materials as necessary.

-Added documents to regulatory binders

-Created an Excel document listing the expiration dates for physician Curriculum Vitaes, licenses, and CITI training

-Aided the Data Coordinator with document retrieval for CRFs

-Filed patient treatment sheets

-Outlined online survey which will be conducted using the Survey Monkey platform

Aug 13, 2015 (Thursday)

-Purchased 50 lbs. of dry ice from a local vendor

-Filed items in regulatory binders for the majority of the day

-Aided the Data Coordinator with printing and redacting source documents for CRFs

-Delivered IP to the Arlington branch and brought back two boxes to the Magnolia branch

1. Noted temperatures and times of returned drug at both departure and arrival

(42*F/1259 and 32*F/1336)

2. Observed the Office Manager filling out the Drug Delivery form

Aug 14, 2015 (Friday)

-Today the Research Department attended a series of annual training seminars hosted by the Sarah Cannon Research Institute. The lectures that were presented were:

1. “Hematology Response Criteria” by Dr. Nicole Bartosh

2. “Personalized Medicine: Genomics 101” by Dr. Holli Dilks

3. “Customer Focus” by Fran Palmieri and Dawn Love

4. “SCRI Overview” and general forum

5. “Quality Session” by Paula Thomas

6. “mySCRI 2.0 Training and CRMS CCS Sneak Peek” by Matt Belsante and

Leann Frazier

-During a break I was able to speak to a SCRI representative about obtaining Sales Force data for my data analyses comparing regulatory turnaround time for paper documents vs. digital documents. This SCRI representative said that she would be able to assist me in my search for this data and that she would email me next week.

-Assisted the floating CRC with pre-screening a patient for the BRE 245 study

Week 12 Aug 17, 2015 (Monday)

-Today I spent the greatest part of the day assisting the Office Manager with IP accountability logs and accounting for drug prior to it being entered into a drug- destruction for. During this time I also took inventory of the ambient, refrigerated and -

20*F drug supply.

Aug 18, 2015 (Tuesday)

-Attended Magnolia’s Tumor Board and took notes-see steno book

-Assisted the Regulatory Specialist with filing and retrieving documents for studies that are closing out

-Observed a Regulatory meeting between the Office Manager and the Regulatory

Specialist. Today the main discussion was about IRB correspondence, study start-up documents, and annual CTEP documents from HHS.

-Filed documents for BRE 194

Aug 19, 2015 (Wednesday)

-Split the temperature-log binder into two binders (“2014 and Older” and “2015-

Present”) and duplicated a Note-to-file relating to backup temperature logs

-Filed documents in regulatory binders for the following studies:

1. LUN 214

2. LUN 229

3. LUN 265

4. GU 122

5. LUN 286

6. LUN 263

7. MM 23

8. MM 27

9. GU 75

10. GU 113

11. BRE 238

Aug 20, 2015 (Thursday)

-Assisted the Regulatory Specialist with completing an annual NCI physician registration application

-Completed annual IRB Site Progress Reports for the following studies

1. LUN 214

2. BRE 233

3. BRE 234

-Filed documents in regulatory binders for the following studies:

1. BRE 241

2. BRE 245

Aug 21, 2015 (Friday)

-Worked with another intern to print and redact source documents for all patients on the

BRE 203 study. These documents were scanned and emailed to the Data Coordinator so that he may forward them to the sponsor at a later date.

- Attended weekly Intern Review meeting with my site mentor and discussed how I can assist the department during the transition to a new Regulatory Specialist (our current one is leaving next week to work with SCRI). I plan to help our current Regulatory Specialist as much as possible with filing next week so she can focus on other priorities.

Week 13

Aug 24, 2015 (Monday)

-Spent the majority of the day auditing contracts for research studies

- Filled in IRB exempt review application

Aug 25, 2015 (Tuesday)

- Filed documents in regulatory binders for the following studies:

1.) GI 200

-Assisted the Regulatory Specialist with query resolution

1. Printed labs to be assessed for subjects -009, -013, and -015 in the BRE 231

study

2. Took notes concerning query responses

-Assisted the Data Coordinator with entry of data into the eCRF by reviewing source documents for required information

-Observed bi-monthly teleconference between SCRI staff and the Regulatory Specialist.

The purpose of this phone conference is to review studies and their progress at the site.

-Learned how to mail patient follow-up letters via certified mail. This is required on the occasions when a patient cannot be reached by phone after 3 call attempts.

-Reviewed a patient’s chart for completeness prior to an interim monitoring visit

Aug 26, 2015 (Wednesday)

-Recorded Novartis IND reports onto the Novartis IND Log for the Principal Investigator to review

-Assisted the Data Coordinator with entry of data into the eCRF by reviewing source documents for required information

-Filed laboratory print-outs

-Scanned and faxed follow-up patient worksheets for an older study

-Sorted study documents into their respective inboxes

Aug 27, 2015 (Thursday)

-Assisted the Data Coordinator with entry of data into the eCRF by reviewing source documents for required information

-Attended Data Coordinator portion of BRE 251 SIV

-Assembled Regulatory Binder for LUN 291

-Filed documents for the following studies:

1. PRO 04

2. PRO 11

3. GI 194

-Discussed the procedure for managing Safety Letters with the Regulatory Specialist:

1. N2301- record into log in IND binder

2. All other SCRI studies- send IND letters to SCRI (retain Quorum

acknowledgement letters in regulatory binder, Note: these may need to retrieved

from Quorum’s portal)

Aug 28, 2015 (Friday)

-Assisted Data Coordinator for most of the day

-Completed IRB application

-Attended weekly Intern Review meeting with my onsite mentor and discussed the IRB application for my research project. I plan to submit this application next week if I am able to receive all necessary signatures and supporting documents.

Week 14

Aug 31, 2015 (Monday)

-Again assisted the Data Coordinator for most of the day

-Left early to meet with my major professor on campus to discuss the IRB Exempt

Review Application

Sept 1, 2015 (Tuesday)

-Audited laboratory results for study patients and printed missing laboratory results for physician assessment

-Filed documents for the Data Coordinator

-Learned about data entry processes for Medidata and Inform

Sept 2, 2015 (Wednesday)

-Assisted the Regulatory Specialist with packaging and labeling boxes for long term storage

-Created an excel master sheet which documents box numbers and contents for long-term storage

-Aided the Data Coordinator with entry of laboratory reference ranges into sponsor EDCs

-Filed active and screening patient documents

Sept 3, 2015 (Thursday)

-Out of town

Sept 4, 2015 (Friday)

-Out of town

Week 15

Sept 7, 2015 (Monday)

-Closed for Labor Day

Sept 8, 2015 (Tuesday)

-Assisted the Office Manager with organizing equipment records

-Uploaded refrigerated settings to three new USB Temperature Loggers (Track-It)

Sept 9, 2015 (Wednesday)

-Assisted the Data Coordinator with his data entry by finding relevant source data

-Learned about using Perceptive’s MyTrials EDC management system

-Filed source documents

-Printed and redacted RECIST criteria imaging for two patients

-Began auditing medications and AEs for a complex patient on GI 184

-Scanned to email documents that were requested by a monitor

Sept 10, 2015 (Thursday)

-Finished auditing medications and AEs for a complex patient on GI 184

-Audited Pathology Assessments for all patients that were enrolled to BRE 238 at this site

-Scanned to email documents that were requested by a monitor

-Organized and faxed long-term follow-up documents to sponsor for TAILORX study

-Assisted the Data Coordinator with obtaining source data for query resolution (LUN

229)

-Filed documents for the Data Coordinator

-Filed regulatory documents for PRO 02

Sept 11, 2015 (Friday)

-Filed patient charts and source documents

-Discussed a new task that I will be completing; delivering and returning documents that must be signed to Primary Investigators and Sub-Investigators

-Learned about using a Genentech EDC management system

-Held Intern Review Meeting with the Office Manager and discussed set tasks that I will be completing. These tasks include:

1. Printing and filing the temperature logs on Mondays

2. Assisting the Office Manager with drug shipment packaging to the satellite

sites

3. Keeping the screening log updated

Week 16

Sept 14, 2015 (Monday)

-Printed temperature log records and discovered that the ambient temperature recording device had not been recording for a full week. Spoke to the Office Manager about this and agreed that a note to file would be needed. I was able to acquire a manual temperature record from the pharmacy department, but two weekend days were still unaccounted for. A note to file was written and given to the Office Manager for approval.

-Typed up the LUN 264 screening log using Excel and acquainted myself with

OncoAnalytics.

-Edited patient information in OncoAnalytics to include inclusion/exclusion details in the patient notes

-Assisted the Data Coordinator with acquiring and redacting source documents for BRE

203 query resolution

Sept 15, 2015 (Tuesday)

-Filled out drug return form for LUN 264 IP and reviewed the completed form with the

Office Manager (ended up ultimately not using this form)

-Confirmed that temperature recording devices were functioning properly and printed available record from the last 24 hours. Returned devices to their IP areas.

-Accounted for all on-site IP for LUN 264 (pending destruction and current inventory)

-Delivered and received documents for physicians to assess/sign

-Filed documents into patient charts

-Sorted documents for LUN 265

-Assisted the Data Coordinator with finding source documents to resolve queries (BRE

203)

-Learned how to submit DICOM images for central imaging processing (BRE 231)

-Packaged empty binders for long-term storage

-Assisted the Data Coordinator with LUN 265 source data reporting and learned how to use the site data collection tool for this study.

Sept 16, 2015 (Wednesday)

-Sorted and filed LUN 265 patient materials (QOLS, laboratory requisition forms etc)

-Became acquainted with IO bridge

Sept 17, 2015 (Thursday)

-Began researching low-temperature data loggers for our two -20*F freezers.

-Filed documents in the Data Coordinator’s inbox

-Created screening and enrollment log for LUN 282

Sept 18, 2015 (Friday)

-Requested a calibration quote from MicroDaq for the Monarch Rugged Track-It data logger

-Filed documents from the Data Coordinator’s inbox

-Created Pre-Screening and Enrollment Logs for two studies

-Updated and sent to respective sponsors our personal Pre-Screening and Enrollment logs for the following studies:

1. BRE 245

2. LUN 264

3. LUN 282

4. LUN 286

-Reviewed the monitor notes concerning the BRE 245 Regulatory Binders with the

Office Manager

-Held my weekly intern review meeting with the office manager. This meeting was short this week and we briefly discussed Screening and Enrollment logs and the use of

Oncoanalytics.

Week 17

Sept 21, 2015 (Monday)

-Compared low-temperature data loggers and compiled a printed list of these.

-Created new patient charts for a couple of LUN 282 patients.

-Filed documents from the Data Coordinators inbox

Sept 22, 2015 (Tuesday)

-Filed documents for the Data Coordinator and made folders for new patients

- Assisted the data coordinator for much of the day. Today we mostly focused on entering data into an EDC per monitor request.

Sept 23, 2015 (Wednesday)

-Requested off for testing purposes

Sept 24, 2015 (Thursday)

-Once more, assisted the Data Coordinator for the majority of the day. I was shown how lab normal values (reference ranges) are required to be entered into the EDC for lab reporting purposes. I feel that this could be a potential area of improvement, as the EDC has the ability to import a .csv (comma separated values) document. This document would provide these values in lieu of manual entry. If LabCorp (the stat lab that The

Center uses for most of it’s local testing) has a .csv document available, this would save the Data Coordinator at least one hour per each EDC upon initial lab normal value entry.

-Was informed that I will now be in charge of the -20*F freezer temperature recording as well. The temperature wheel in there now is currently in need of calibration.

-Updated the Low-temperature data logger comparison list with pictures and calibration quotes

Sept 25, 2015 (Friday)

-Created a Pre-Screening and Enrollment Log for LYM 89

-Updated Oncoanalytics with patients on the following studies

1. LYM 89

2. BRE 245

3. LUN 264

4. LUN 282

5. LUN 286

-Updated and sent to respective sponsors our personal Pre-Screening and Enrollment logs for the following studies:

1. BRE 245

2. LUN 264

3. LUN 282

4. LUN 286

-Printed temperature records for refrigerated data logger and scanned to email monitor requested documents

-Filed documents for the Office Manager (regulatory) and for the Data Coordinator

(patient-specific)

-Held weekly Intern Review meeting with the Office Manager. We discussed alternate uses for Oncoanalytics other than screening purposes. Additionally, I presented her with the comparison chart for low-temperature tracking devices and she agrees that the

Monarch Rugged Track-It will be our best option because of its durability and the fact that it uses the same software as our current temperature data loggers.

Week 18 Sept. 28, 2015 (Monday)

-Changed -20*F temp wheel chart and printed records from Ref 1 and Amb 2. Sometime this week I would like to compile the other data files that I have for these devices into

Excel file(s). This would allow us to email the monitors the temperature records instead of scanning the paper records to monitor email addresses.

-Discovered that my IRB Exempt Review application requires two additional forms

(HIPAA Waiver and Chart Review Form), so I began filling out these forms to be signed by my major professor.

-Assisted the Office Manager with checking for completion of items noted during LYM

89’s last monitoring visit

-Filed documents in regulatory binders for LYM 89 and LUN 282.

Sept 29, 2015 (Tuesday)

-Compiled Excel sheets that include temperature data logger information from Sept 07 to

Sept 28. These sheets will be all-inclusive files from now on and eventually we will

simply email these to the monitors instead of scanning pages from the temperature record binders. Currently I am in the process of looking for the temperature files that are older than September so that I may import these into this Excel file as well.

-Assisted the Data Coordinator by organizing patient charts and looking for information to resolve queries

-Scanned to email source documents for LUN 229

-Requested missing source documents. Our department Medical Assistant will place an order for these using the EMR.

-Scanned to email monitor requested documents

-Filed documents for the Office Manager

Sept 30, 2015 (Wednesday)

-Assisted the Data Coordinator with setting up monitor suites

-Answered monitor questions regarding BRE 194 and scanned to email monitor requested documents

-Checked for GI 194 Pre-screening updates and faxed the GI 194 Pre-Screening and

Enrollment Log to PPD

-Assisted the Data Coordinator with LUN 265 query responses

-Created Pre-Screening and Enrollment Log for BRE 242 (GU 75 does not require one because it is not enrolling patients. Addendum: BRE 242 is no longer enrolling patients as well and did not require a Pre-Screening and Enrollment Log)

- Granted patient access in EMR for tomorrow’s monitors

Oct 1, 2015 (Thursday)

-Assisted the Office Manager with filing documents in GU 75’s Investigator Site File

(ISF) and verified its completeness

-Received requested medical records from our department Medical Assistant and forwarded these to the Data Coordinator

-Scanned to email monitor requested documents for GU 75

-Assisted the Office Manager with filing documents in BRE 223’s Investigator Site File and Pharmacy Binder and verified the Pharmacy Binder’s completeness

-Attended a conference call with Oncoanalytics (see steno book for notes)

-Left early to meet with Dr. Dory, my major professor. We discussed my IRB application and a deadline for the rough draft of my thesis (Oct. 19).

Oct 2, 2015 (Friday)

-Assisted the Data Coordinator with query responses for LUN 229

-Held weekly intern review meeting with the Office Manager. This week we continued our discussion about temperature data loggers for the -20*F freezer. The cost of calibration for our current device (a temperature wheel) is $233, but a new USB device that uses familiar software is only $199 plus tax. We will likely purchase the new USB device instead of calibrating the temperature wheel.

-Scanned to email Friday’s updated Pre-Screening and Enrollment logs

-Began auditing medications and AEs for a patient that is recently deceased

-Left early to turn in IRB application packet

Week 19

Oct 5, 2015 (Monday)

-Downloaded temperature records from Track-It data loggers, printed records, added

.CSV file data to Track-It Temperature records excel master file, changed temperature wheel

-Began an AE and medication audit for a complicated lung cancer patient who passed away

Oct 6, 2015 (Tuesday)

-Continued AE and medication audit for the lung cancer patient

Oct 7, 2015 (Wednesday)

-Assisted the Data coordinator with query resolution

-Filed documents for Data Coordinator

-Worked on thesis in spare time

Oct 8, 2015 (Thursday)

-Filed documents for Data Coordinator and Office Manager

-Read more about the Monarch Rugged Track-It Data Logger that we may be purchasing for the two -20*F refrigerators. I was able to find a brochure for this model and I sent an informational email to the Office Manager with this brochure attached. She should also have price and purchasing information from my first discussion with her about this data logger.

-Met and had lunch with personnel from Flatiron, the software company that designed

Oncoanalytics

-Worked on thesis when not occupied

Oct 9, 2015 (Friday)

-Woke early to work on thesis prior to meeting with Dr. Warren on campus

-Left campus to meet with Dr. Page at MCO

-Updated and sent out Friday’s Pre-screening and Enrollment logs

-Returned to campus for an informational luncheon, met with Dr. Dory and then met with

Dr. Gwirtz

-Returned to MCO and finished the day by filing documents and assisting the Data

Coordinator

Week 20

Oct 12, 2015 (Monday)

-Downloaded and printed temperature data from the Track-It data loggers then added this new data to the excel Track-It Temperature Records file and temperature record binders

-Changed temperature wheel

-Filed documents for the Office Manager

-Filed GI 194 documents in regulatory binder

-Spent the rest of the day working on the statistical analyses for thesis

Oct 13, 2015 (Tuesday)

-Assisted GI 194 monitor as needed

-Scanned to email Monitor requested documents for BRE 231

-Learned how to use SPSS for statistics portion of project

-Packaged and shipped out box of INDSRs to SCRI

Oct 14, 2015 (Wednesday)

-Picked up drug from MCO and delivered to Weatherford

-Spent the remainder of the day working on thesis

-Received notification from UNTHSC’s IRB that my project is officially approved

Oct 15, 2015 (Thursday)

-Picked up IRB documents from UNTHSC’s IRB office

-Assisted both CRCs with pulling lab kits.

-Was notified that we no longer have a departmental Medical Assistant so I will be helping the CRC with lab kits from now on. So far this will consist of ensuring that she has the proper lab kits for her patients that week and conducting a lab kit audit. Due to time restrictions imposed by my project, I will have to conduct this lab kit audit tomorrow or Monday. I spoke to the CRC and assembled her lab kits for this week. She will give me next week’s schedule for kit-pulling purposes tomorrow or Monday.

-Filed documents for Data Coordinator

-Spoke with Data Coordinator about GI 198 Lab Normal Values. He discovered that deleting and re-entering the protocol number somewhere in a query area of the EDC will allow the values that we entered to be used by the EDC.

-Coordinated with the Office Manager on an email to my survey study population. The survey was mailed to potential participants

-Spent the rest of the day working on thesis

Oct 16, 2015 (Friday)

- Created and sent to CRA the BRE 257 Pre-screening and Enrollment log

-Updated and sent to respective sponsors Friday’s Pre-Screening and Enrollment logs for the following studies:

1. BRE 245

2. LUN 264

3. LUN 282

4. LUN 286

-Spoke with CRC about her lab kit needs

-Copied all active studies current Lab Kit Inventory to new “Laboratory Kit Inventory”

Database and updated inventory for the following studies:

1. BRE 223

2. BRE 238

3. GI 199

-Retrieved mail and packages, as usual, and unpacked parcels

- Stocked kits and supplies that arrived in mail

-The Office Manager is assisting the floating CRC at other sites today, so there will be no

Intern Review meeting. Instead, I emailed the Office Manager a quick update of current items of interest.

-Received patient schedule from CRC for next week and ensured that her lab kits were pulled and labeled with a sticky note with patient information

-Spent the remainder of the day working on thesis

Week 21

Oct 19, 2015 (Monday)

-Continued editing laboratory inventory sheets

-Updated Laboratory Kit Inventory for the majority of the day

Oct. 20, 2015 (Tuesday)

-Assisted the Data Coordinator with Pathology Assessment and Residual Tumor Burden related queries for BRE 238

-Continued editing/creating laboratory inventory sheets in Excel master file

-Updated Laboratory Kit Inventory for BRE 203, BRE 231, BRE 233

-Discussed sample shipping plans tomorrow with CRC and identified the possible need for shipping materials (boxes, waybills) for BRE 233. This study specifically uses

Marken for its shipping needs.

-Created screening log for BRE 231 and updated Oncoanalytics for all studies

-Spent the remainder of the day working on thesis

Oct. 21, 2015 (Wednesday)

-Updated and sent screening log for GI 194

-Filed documents for Data Coordinator

-Assisted BRE 238 monitor and scanned study documents to email

-Assisted the Office Manager with drug inventory for BRE 238

-Assisted the CRC with lab kits

Oct. 22, 2015 (Thursday)

-Printed and prepared labs for physician assessment

-Assisted GI 199 Monitor and scanned study documents to email

-Continued editing/creating laboratory inventory sheets in Excel master file

-Learned how to review Informed Consent notes in the EMR for accuracy and filed patient consents after doing so

-Received and stocked new lab kit shipments

-Worked on thesis in spare time

Oct. 23, 2015 (Friday)

-Ensured that the on-site CRC has the lab kits that she needs for next week and that all kits are labeled properly

-Continued editing/creating laboratory inventory sheets in Excel master file

-Sorted regulatory documents

-Reviewed Informed Consent notes in the EMR for accuracy and set aside consents to file on Monday

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