VUMC General Clinical Research Center
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Office use only (P. No.)
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Protocol / Protocol Short Title (54 characters max.): Date submitted: (m/d/yy)*Enter short title if full title > 54 characters
Protocol Full Title:
*Enter full protocol title here ( title must match IRB study title )
Visit Location: GCRC Pediatric CRC
Single-Center Study Multi-Center Study Clinical Study Phase: *Select from listN/APilotPhase IPhase I & IIPhase IIPhase II & IIIPhase IIIPhase III & IVPhase IV
Total number of patients in study? Total at Vanderbilt?
Duration of study (years):
Is this a rare disease study with a TDN (Therapeutic Development Network)? *Select from listYesNoUnsure
Proposed Study Subject Category: *Select from listA1 - Investigator Initiated (GCRC expenses)A2 - Investigator Initiated (Industry expenses)B - Patient Care/ResearchD - Industry Initiated (Industry expenses)
IRB Status: *Select from listNot SubmittedIn ProcessApprovedRevision IRB #: IRB Approval Date:
Investigators / Principal Investigator Name: Degree: *Select from listMDPhDDDSPharmDOther-Specify
Title and Department:
Phone #: Email: Pager #:
Primary Contact Person If Other Than PI:
Phone #: Email: Pager #:
Study Coordinator:
Phone #: Email: Pager #:
Co-Investigators:
First Name, Last Name, Degree / Phone Number /
(a) Department
*Enter Co-Investigator #2 full name / CI-2 phone # / CI-2 Department*Enter Co-Investigator #3 full name / CI-3 phone # / CI-3 Department
*Enter Co-Investigator #4 full name / CI-4 phone # / CI-4 Department
*Enter Co-Investigator #5 full name / CI-5 phone # / CI-5 Department
*Enter Co-Investigator #6 full name / CI-6 phone # / CI-6 Department
If you have submitted your IRB application and your Protocol to the IRB, you do not need to complete # 1- 9. We will obtain your submission from the IRB.
If you have submitted an exempt IRB application or if you have not submitted an IRB application, then complete this application.
1. Statement of the Problem this Study Will Address
* Type here
2. Hypothesis and Specific Aims
* Type here
3. Background and Significance
* Type here
4. Preliminary Studies; Progress Reports
* Type here
5. Research Design and Methods
Answer the question: “What will be done in order to accomplish the specific aims or test the hypothesis”?
a) List of procedures and time-table. * Type here
b) Data expected, analysis and interpretation * Type here
c) Problems and solutions if appropriate * Type here
6. Human Subjects Research Considerations
a) Risks and potential risks to Study Subjects: * Type here
b) Source(s) of Research Material(s): * Type here
c) Adequacy of Protection Against Risks: * Type here
d) Describe Recruitment Plan and enrollment process: * Type here
e) Describe inclusion / exclusion criteria * Type here
7. Statement Regarding Exclusion of Specific Subject Categories:
If applicable, justify exclusion of specific subject categories (gender, ethnicity, children, elderly):
* Type here
8. Data and Safety - Monitoring Plan*
*As per NCRR requirements, ALL protocols submitted to the GCRC must have a data and safety-monitoring plan. The minimal requirements for a DSMP according to the NCRR Advisory Council include: 1) Adverse event (AE) grading and attribution scale; 2) Plan for unanticipated AE reporting; 3) Plan for annual reporting of AEs; and 4) Plan for safety review (by whom and at what frequency). The level of detail on the DSMP should be commensurate with the level of risk entailed in the study. If you have any questions concerning what information is required, please contact the GCRC Research Subject Advocate (Vikki Thurman). If you are unsure whether your study might need a DSM Board please contact Ms. Thurman. In situations where it is unclear whether a study requires a DSMB or not, the ultimate decision is made by the GAC.
A. Do you have a DSM Board? Yes No
B. Summarize the DSMP For This Protocol: * Type here
9. References/Literature Cited
* Type here
10. Sample Size Justification and Statistical Analysis Plan:
(The GCRC Scientific Advisory Committee will not approve studies that lack a sample size justification or a statistical analysis plan)
* Type here
11. Targeted/Planned Enrollment: Enter Number of Subjects in the Table Below
Sex/Gender
Ethnic Category
/ Females / Males / TotalHispanic or Latino / 0 / 0 / 0
Not Hispanic or Latino / 0 / 0 / 0
Ethnic Category Total of All Subjects / 0 / 0 / 0
Racial Categories / Females / Males / Total
American Indian/Alaska Native / 0 / 0 / 0
Asian / 0 / 0 / 0
Native Hawaiian or Other Pacific Islander / 0 / 0 / 0
Black or African American / 0 / 0 / 0
White / 0 / 0 / 0
Racial Categories: Total of All Subjects* / 0 / 0 / 0
*The “Ethnic Category Total” of All Subjects must be equal to the “Racial Categories Total” of All Subjects.
12. Funding Sources Other Than GCRC Requested Support
Describe Funding for this Protocol (Departmental/VUMC, NIH, Other Federal Agencies, Industry, Foundation, or other support).
• A copy of the study funding budget is required with this application.
• For industry sponsored trials, a copy of the clinical trial agreement is required with application.
Send sponsor budget or grant and clinical trial agreement to:
* Type here
Summary of Requested GCRC Services
13. Space, Nursing and Nutritional Services:
Identify projected needs for GCRC space, nursing and nutritional services in the tables below. Note that total number of patients in the two tables should agree with the gender/minority tables on the previous page and also with numbers in your main protocol description.
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Inpatient InformationYear
/ Number of Inpatients / Avg No. Of Hospital Days per Inpatient / Required Nursing Care¤ / Diet Needs
Å
Year 1 / 0 / 0
Year 2 / 0 / 0
Year 3 / 0 / 0
Year 4 / 0 / 0
Year 5 / 0 / 0
Total
/ 0Outpatient Information
Year
/ Number of Outpatients / Avg No. Of Visits per Outpatient / Avg Hours per Outpatient Visit¤ / Diet Needs
Å
Year 1 / 0 / 0
Year 2 / 0 / 0
Year 3 / 0 / 0
Year 4 / 0 / 0
Year 5 / 0 / 0
Total
/ 0¤ Nursing care Codes: C=Complete, P=Partial, S=Self Care, A=Constant Attendants, V=VCH.
Å Diet Codes: R=Regular Diet, S=Special Diet.
GCRC Nursing Needs
* Enter additional GCRC nurse needs here
* Do you need nursing support at Pediatric CRC? Yes No
Special Diet Needs
* Enter additional special diet needs here
GCRC Medical Supply Needs
* Enter special medical supply needs here
Sleep Core
Section A: Sleep Study Number
* Please contact Dr. Beth Malow with questions at: ,,
(615) 322-0283
Sleep research studies are a shared resource and there may be scheduling constrains. Overnight studies are generally performed Monday, Tuesday, Wednesday, and Thursday evenings. Other studies (multiple sleep latency tests, hospital wireless) are scheduled around the overnight studies in a way that maximizes access for users. We will make every effort to meet your scheduling needs within our constraints.
Describe briefly the flow of sleep studies for a participant. (Example: Participant undergoes two consecutive nights of PSG with a multiple sleep latency test after the second night. If at least one of the nights is positive for sleep apnea, participant will return for a CPAP trial).
* Type here
Total number of participants in Year 1: / 0
Total number of requested overnight PSGs (baseline PSGs, CPAP studies) in Year 1: / 0
Do these PSGs include a full head EEG? / Yes No
Do these PSGs include continuous BP monitoring? / Yes No
Other studies requested (list total number requested in Year 1 next to each study type)
Multiple Sleep Latency Test: / 0
Hospital Wireless studies: / 0
Section B: Scheduling
List your preferences for nights of PSG and other studies. (Example: Preference #1: Participant will undergo a Monday and Tuesday PSG with a multiple sleep latency test on Wed. Preference #2: Participant will undergo a Tuesday and Wednesday PSG with a multiple sleep latency test on Thurs). As stated above, because this is a shared resource, we have constraints on scheduling but will make every effort to accommodate users.
Preference #1: * Type here
Preference #2: * Type here
Section C: Grant Support
Please check one of the following
I currently have grant support that can be used to offset the cost of the GCRC Sleep Core.
I do not currently have grant support that can be used to offset the cost of the GCRC Sleep Core, but plan to use my pilot data to obtain grant support to offset the cost of the GCRC Sleep Core.
Section D:
Additional Needs (e.g., Actigraphy, Specialized Sleep Scoring, Measurement of CPAP compliance) Please describe any additional needs for your protocol
* Type here
14. GCRC Core Laboratory Tests and Analyses
*Contact Dr. Tom Davis with questions at: , (615) 322-3011.
BiochemicalTest / i) Test Types / # Tests/ Subject / Total Tests Requested
Catecholamine / Serum Urine Whole Blood Plasma / 0 / 0
Catecholamine / Serum Urine Whole Blood Plasma / 0 / 0
Nitrogen / Serum Urine Whole Blood Plasma / 0 / 0
Basic Metabolic Panel1 / Serum Urine Whole Blood Plasma / 0 / 0
Comprehensive Metabolic Panel2 / Serum Urine Whole Blood Plasma / 0 / 0
Hepatic Function Panel3 / Serum Urine Whole Blood Plasma / 0 / 0
Renal Function Panel4 / Serum Urine Whole Blood Plasma / 0 / 0
Urea/BUN / Serum Urine Whole Blood Plasma / 0 / 0
Creatinine / Serum Urine Whole Blood Plasma / 0 / 0
Sodium / Serum Urine Whole Blood Plasma / 0 / 0
Potassium / Serum Urine Whole Blood Plasma / 0 / 0
Chloride / Serum Urine Whole Blood Plasma / 0 / 0
CO2 / Serum Urine Whole Blood Plasma / 0 / 0
Glucose / Serum Urine Whole Blood Plasma / 0 / 0
Calcium / Serum Urine Whole Blood Plasma / 0 / 0
Magnesium / Serum Urine Whole Blood Plasma / 0 / 0
Aliquot / Serum Urine Whole Blood Plasma / 0 / 0
Total Protein / Serum Urine Whole Blood Plasma / 0 / 0
Albumin / Serum Urine Whole Blood Plasma / 0 / 0
SGOT (AST) / Serum Urine Whole Blood Plasma / 0 / 0
SGPT (ALT) / Serum Urine Whole Blood Plasma / 0 / 0
GGT / Serum Urine Whole Blood Plasma / 0 / 0
LDH / Serum Urine Whole Blood Plasma / 0 / 0
Alkaline Phosphatase / Serum Urine Whole Blood Plasma / 0 / 0
Total Bilirubin / Serum Urine Whole Blood Plasma / 0 / 0
Direct Bilirubin / Serum Urine Whole Blood Plasma / 0 / 0
Phosphorus / Serum Urine Whole Blood Plasma / 0 / 0
Total Cholesterol / Serum Urine Whole Blood Plasma / 0 / 0
Triglycerides / Serum Urine Whole Blood Plasma / 0 / 0
Melatonin / Serum Saliva Whole Blood Plasma / 0 / 0
6-Sulfatoxymelatonin / Serum Urine Whole Blood Plasma / 0 / 0
Cortisol / Serum Saliva Whole Blood Plasma / 0 / 0
Nt-pro BNP / Serum Urine Whole Blood Plasma / 0 / 0
Pregnancy Test / Serum Urine Whole Blood Plasma / 0 / 0
1 Basic Metabolic Panel: Crea, Na, K, Bun, Glu, Ca, Cl, CO2
2 Comprehensive Metabolic Panel: BMP, TP, Alb, AST, ALT, TBIL, Alk Phos
3 Hepatic Function Panel: DBIL, TBIL, Alk Phos, TP, AST, ALT, Alb
4 Renal Function Panel: BMP, Alb, PO4
· These tests are to be ordered for research purposes only. They cannot be used for diagnostic or treatment purposes.
· Tests are assayed on a Routine Basis Monday through Friday.
15. Requested GCRC Support for Hospital Ancillary Services
* COST/TEST ARE ESTIMATES AND SUBJECT TO CHANGE. USE ONLY FOR GCRC PROTOCOL SUBMISSION PURPOSES.
Name of Test or Procedure / *Estimated Cost / Test / # Tests / Subject / Total Tests For Entire Study / Total Amount RequestedStandard Inpatient Tests / Aldosterone / $80.00 / 0 / 0 / $0.00
Basic Met Panel ** / $36.00 / 0 / 0 / $0.00
CBC (Hemogram) / $17.00 / 0 / 0 / $0.00
CBC, Diff, Plts. / $27.00 / 0 / 0 / $0.00
Cholesterol / $39.00 / 0 / 0 / $0.00
Comp Met Panel ** / $40.00 / 0 / 0 / $0.00
CRP / $7.00 / 0 / 0 / $0.00
CSF Culture / $35.00 / 0 / 0 / $0.00
CSF Cytology / $34.00 / 0 / 0 / $0.00
CSF Glucose / $13.00 / 0 / 0 / $0.00
CSF Protein / $13.00 / 0 / 0 / $0.00
HGBA1c / $15.00 / 0 / 0 / $0.00
Insulin – Plasma / $26.00 / 0 / 0 / $0.00
Liver Function Panel ** / $37.00 / 0 / 0 / $0.00
PT / $16.00 / 0 / 0 / $0.00
PTT / $24.00 / 0 / 0 / $0.00
Renin – Plasma / $78.00 / 0 / 0 / $0.00
Thyroxine – T4 / $25.00 / 0 / 0 / $0.00
Urinalysis w/ microscopy / $13.00 / 0 / 0 / $0.00
F MRI 90 Minutes / $675.00 / 0 / 0 / $0.00
0
Other Inp. / *Enter information here / $0.00 / 0 / 0 / $0.00
*Enter information here / $0.00 / 0 / 0 / $0.00
*Enter information here / $0.00 / 0 / 0 / $0.00
*Enter information here / $0.00 / 0 / 0 / $0.00
0
Standard Outpatient Tests / Aldosterone / $80.00 / 0 / 0 / $0.00
Basic Met Panel ** / $36.00 / 0 / 0 / $0.00
CBC (Hemogram) / $17.00 / 0 / 0 / $0.00
CBC, Diff, Plts / $27.00 / 0 / 0 / $0.00
Cholesterol ** / $39.00 / 0 / 0 / $0.00
Comp Met Panel ** / $40.00 / 0 / 0 / $0.00
CRP / $7.00 / 0 / 0 / $0.00
CSF Culture / $35.00 / 0 / 0 / $0.00
CSF Cytology / $34.00 / 0 / 0 / $0.00
CSF Glucose / $13.00 / 0 / 0 / $0.00
CSF Protein / $13.00 / 0 / 0 / $0.00
HGB A1c / $15.00 / 0 / 0 / $0.00
Insulin – Plasma / $26.00 / 0 / 0 / $0.00
Liver Function Panel ** / $37.00 / 0 / 0 / $0.00
PT / $16.00 / 0 / 0 / $0.00
PTT / $24.00 / 0 / 0 / $0.00
Renin - plasma / $78.00 / 0 / 0 / $0.00
Thyroxine – T4 / $25.00 / 0 / 0 / $0.00
Urinalysis w/ microscopy / $13.00 / 0 / 0 / $0.00
fMRI 90 minutes / $675.00 / 0 / 0 / $0.00
Other Outp. / 0
*Enter information here / $0.00 / 0 / 0 / $0.00
*Enter information here / $0.00 / 0 / 0 / $0.00
*Enter information here / $0.00 / 0 / 0 / $0.00
0
a. Total Amount Requested from GCRC for Ancillaries / $0.00
b.
** These tests are available in the GCRC Core Lab. If you are requesting these tests from the hospital lab, provide a scientific justification.