Existing Data Review Protocol Template

This protocol template applies to retrospective research studies involving existing data. If your study involves prospective data collection, use the Non-Intervention Study Protocol Template This is a tool to facilitate rapid protocol development. It is not intended to supersede the role of the Investigator in the authoring and scientific development of the study protocol. All sections may be modified as necessary to meet the scientific aims of the study and development of the study protocol.

General Instructions: Text in blue is example text. Text in red is instructional and must be removed from final protocol. Title Page – List the Principal Investigator only; do not list Co-Investigators. [Co-Investigators are listed on the Investigator Form.] Within the protocol template the following formats have been applied:  Font: Time New Roman, Black, 12 font for Section headings and text, 10 font for tables.  Footers contain an automatic page number and Headers contain Study number for the document. To edit/add revision date, click on [View] [Header and Footer]. Prepare protocol to answer the questions posed by the IRB in its forms: Application for Exempt Status; Waiver of Informed Consent; HIPAA Compliance; and have your Data Collection Sheet prepared in order to be submitted with the application. If an honest broker is to be used to collect, document and de-identify information from medical records and/or from an existing databank (i.e., DBBR, tumor registry) for the PI, and the research is not FDA regulated, the study may be considered “Non-Human Subject Research”. Please contact the Office of Research Subject Protection at 716-845-7676 for more details. The IRB Application for Determination of Exempt Status is prepared based on the protocol text which must spell out how the study meets the criteria for Exempt status. An administrative review by the IRB is required for a final Exempt determination. Provide the CRS Regulatory person with a copy of your Data Collection Sheet or spreadsheet to be attached to the HIPAA Compliance Form. To ensure that your research meets data security expectations and is HIPAA compliant, a copy of your protocol and data collection sheet should be given to the data manager once you have received approval. Cooperating departments (Medical Records, Diagnostic Radiology, Pathology, Laboratory Medicine, etc.) will need a copy of your protocol approval before they will release existing records or data. TITLE: Insert full study title including study phase.

Add Roswell Park Cancer Institute Study Roswell Park Cancer Institute number. Study Number: EDR XXXXXX

Initial Date: dd month yyyy

Add date or delete row if not applicable. Amendment 1: dd month yyyy

Principal Investigator Roswell Park Cancer Institute Principal Investigator: Elm and Carlton Street Buffalo, New York 14263 716-845-XXXX [email protected] Only add Network Sites where the Roswell Network Site(s): Park Cancer Institute IRB is the IRB of record. Delete row if not applicable.

Confidentiality Statement Any and all information presented in this document shall be treated as confidential and shall remain the exclusive property of the party(ies) mentioned above. The use of such confidential information must be restricted to the recipient for the agreed purpose and must not be disclosed, published, or otherwise communicated to any unauthorized persons, for any reason, in any form whatsoever without the prior written consent of the party(ies) above.

PRIVATE AND CONFIDENTIAL INFORMATION OF ROSWELL PARK CANCER INSTITUTE Template Version Date: 01 June 2011 Page 2 of 7 TABLE OF CONTENTS 1 Background...... 4 2 Rationale...... 4 3 Objectives...... 4 4 Methodology...... 4 5 Target Accrual and Study Duration...... 4 6 Informed Consent...... 5 7 Subject Confidentiality and Data Security...... 5 8 Results...... 7 9 References...... 7

PRIVATE AND CONFIDENTIAL INFORMATION OF ROSWELL PARK CANCER INSTITUTE Template Version Date: 01 June 2011 Page 3 of 7 Roswell Park Cancer Institute Study Number:

1 BACKGROUND Provide background information, including relevant literature citations, that describes the current state of knowledge on the topic and places into context the purpose of the study. A major cause of delayed motility following resection of colorectal cancer is small bowel obstruction. The problem is particularly prominent following abdominoperineal resection, but may be aggravated by radiation therapy. Adhesions, tumor recurrence and internal hernias are major causes.

2 RATIONALE Provide a description of the purpose of this study and the justification for the route of administration, dosage, dosage regimen, and treatment period(s) for this therapy/combination therapy in this disease.

3 OBJECTIVES Provide a detailed description of the objectives of the study. Relationships between intestinal obstruction and 1) type of antecedent operation, 2) adjuvant therapy, 3) tumor extract, 4) preoperative subject’s status and 5) fever recurrence, will be examined.

4 METHODOLOGY Provide a detailed description of the study design and methods for data collection and analysis. The retrospective date range of the record/data set must be stated. If the research involves collaboration with an outside institution/investigator, describe the nature of the collaboration and the process for which data will be shared. This is a survey of experience at Roswell Park Cancer Institute. No correlations to other data are planned. Analysis of cases of small bowel obstruction following colorectal surgery at Roswell Park Cancer Institute will be conducted via a review of charts of subjects with bowel obstructions between January 1, 1973 and December 31, 1985. Data will be abstracted from medical records, the tumor registry, the CR database, and analyzed.

5 TARGET ACCRUAL AND STUDY DURATION Provide the target number of subjects/documents to be enrolled within this study. RPCI recommends the accrual process to take up to 3 years. In multicentre trials, provide a statement to describe the expected number of subjects to be enrolled and from where (Roswell Park Cancer Institute, community) or number of samples that will be obtained. Indicate the duration of time anticipated to complete the study (months/years), and the planned number of study subjects. The expected duration of subject participation, and a description of the sequence and duration of all trial periods, including follow-up, if any. A maximum of X medical records will be reviewed. This review will take X year(s) to complete.

6 INFORMED CONSENT Refer to IRB Form: “Request for Waiver of Documentation or Elements of Informed Consent”. [NOTE TO INVESTIGATORS: In general, informed consent of subjects, or parental permission for children involved in research, must be sought and documented in accordance with, and to the extent required by, HHS regulations at 45 CFR 46.116 and 45 CFR 46.117 respectively. However, the IRB may approve a consent or parental permission procedure that does not include, or that alters, some or all of the elements of informed consent, or may waive the requirements to obtain informed consent (45 CFR 46.116(c) or (d)). In assessing the level of risk to determine whether a waiver of informed consent or parental permission is appropriate, the IRB will consider the risk of investigators accessing the subjects’ identifiable private information.]  State whether informed consent will be obtained from subjects.  If the investigator is planning to request a waiver of informed consent, describe in detail the study criteria that justify the waiver by addressing the following conditions: o Whether the research involves more than minimal risk to the subjects. o Whether the waiver of consent will adversely affect the rights or welfare of the subjects. o Whether the research could be practicably carried out without the waiver. [If the above conditions can not be addressed satisfactorily, the investigator may need to request an alteration of elements of informed consent or a waiver of documentation of informed consent. In these cases, contact the Office of Research Subject Protection (716-845-7676) for more information.].

7 SUBJECT CONFIDENTIALITY AND DATA SECURITY Refer to IRB “HIPAA Compliance Form”. [NOTE TO INVESTIGATORS: HIPAA Authorization (separate or within a consent form) must be obtained from every subject where you will be using or disclosing PHI (protected health information – the 18 protected items see Policy #206.2). If you want the IRB to grant a WAIVER of HIPAA Authorization (usually where Informed Consent is waived, HIPAA Authorization can be waived), complete the HIPAA Compliance Form and include the information indicated below in the protocol.].  Describe the minimum personally identifiable data (of the 18 PHI elements) that are needed for the research objective in terms of both accessing and recording and state whether the research can be practically conducted without the PHI.  Indicate if there will be: o Only de-identified data accessed and recorded. o A limited data set (a limited data set means the only identifiers in the data set are elements of dates (e.g., date of birth, date of diagnosis) or broad geographic data (i.e., town, state, zip code).

o Coded data (Coded data means a unique code is assigned to each subject on the data collection sheet, and that code corresponds to identifiers (e.g., medical record number) that are maintained in a separate document). o Data with identifiers in the data collection file. This information will assist in indicating whether or not there needs to be HIPAA authorization or waiver or honest broker for the research study.  If there will be coded data: o Describe how the unique code will be derived and assigned for each subject, and describe how the link will be managed including which identifiers will be documented. o Describe the plan to destroy the link (the document containing the identifiers) as early as possible within the research process, or provide the reason retention of the link and identifiers is justified.  If there will be data with identifiers in the data collection file: o Describe the plan to remove identifiers from the data collection file as early as possible within the research process, or provide the reason retention of the identifiers is justified.  State which data elements will be collected (attach a copy of the data collection sheet).  Describe how research data will be protected and maintained in terms of the following: o The source(s) of data to be accessed and collected. If data will be transferred from existing data bases, describe the process for data transfer. o Where data files (and data link files, if applicable) will be stored - provide the storage locations of electronic data (e.g., shared servers, desk/laptop computers) and paper files (e.g., office file cabinets). o How data files (and data link files, if applicable) will be secured to protect identifiers from improper use and disclosure (e.g., encrypted / password-protected files). o Who will have access to the data files (and data link files, if applicable) and why. o If data will be accessed by multiple research personnel – how will that access be done? If data will need to be downloaded on a thumb drive or other portable media in order to share, transfer, or use data – the thumb drive, portable media and/or laptop must be encrypted (Contact IT for questions on encryption). o State that any paper files containing identifiers (if applicable to the research) will not be taken off RPCI premises.  State whether subject identity will be disclosed in the event of publication or sharing of data.  State whether PHI will be re-used or disclosed for purposes other than research use.  List any outside entities (i.e., sponsor, regulatory agency, data management, etc.) to whom PHI will be disclosed. PRIVATE AND CONFIDENTIAL INFORMATION OF ROSWELL PARK CANCER INSTITUTE Template Version Date: 01 June 2011 Page 6 of 7 Roswell Park Cancer Institute Study Number:

8 RESULTS The Roswell Park Cancer Institute experience will be considered for publication.

9 REFERENCES List all appropriate references.

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