vumc general clinical research center - vanderbilt ... · web viewhuman cell function clinical...

Vanderbilt Institute for Clinical and Translational ResearchPress F1 while in any field for context-sensitive help

Office use only (P. No.)

Prot

ocol

Protocol Short Title (54 characters max.): Date submitted: (m/d/yyyy) *Enter short title if full title > 54 characters

Protocol Full Title:*Enter full protocol title here ( title must match IRB study title )

Study Location: CRC MCN Pediatric CRC Community Based: *Enter location(s): Practice Based: *Enter location(s): Other: *Enter other

Single-Center Study Multi-Center Study Clinical Study Phase: *Select from listTotal number of patients in study? Total at Vanderbilt? Duration of study (years): Proposed Study Subject Category: *Select from listIRB Status: *Select from list IRB #: IRB Approval Date:

V April 2008 Submit using e-mail attachment to [email protected]

E l e c t r o n i c P r o t o c o l A p p l i c a t i o n

For more information see the CRC Web site at - http://www.mc.vanderbilt.edu/gcrc/

mailto:[email protected]

http://www.mc.vanderbilt.edu/gcrc/


Inve

stig

ator

sPrincipal Investigator Name: *Enter First Name, MI, Last Name Degree: *Select from listTitle: *Select from list, specify if other: *Enter Other Department / Division: *Type herePhone #: *PI Phone # Email: *PI email address Pager #:

If you are a research trainee, please list the name and contact information of your mentor(s) Mentors must review and approve your VICTR application prior to submission.Name of Mentor / Faculty Advisors who reviewed and approved this submission:Name: Phone #: Email:

Study Coordinator: Phone #: Email: *Contact email address 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




What is the PRIMARY reason you are requesting this support? Pick one

To support a protocol associated with a peer reviewed externally funded grant

NIH Training Grant *specifyNIH Research Grant *specifyCDCIndustry Sponsor *specifyFoundation specify *specifyState *specifyVA *specifyOther: *specify

To help me develop a manuscript

To generate pilot data for inclusion in a future grant proposal

To support an ancillary study of a funded grant

Other: *specify

Do you plan to publish a paper from this research? Yes No




Do you plan to write a grant submission from this research? Yes No

Research Type

Clinical research can be classified into many types. Some types are redundant. Please choose from among the following the subtype(s) which best describe your research. (Check all that apply)

T1 Translational research is the process of making or applying discoveries in research subjects or patients.

Human gene function Human cell function Clinical physiology or pathophysiology Clinical therapeutics Clinical trial Psychiatric/psychologic/behavior Repository Retrospective data / specimen analysis for hypothesis generation or protocol development or

assessment of feasibility

T2 Translational research is the process of making or applying discoveries in practice and community settings.

Clinical epidemiology Surveillance/analytical epidemiology Behavioral research Quality improvement research Community engaged research

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.

Brief Study Abstract (no more than 100 words) * Type here

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 hereb) Data expected, analysis and interpretation * Type herec) Problems and solutions if appropriate * Type here

6. Human Subjects Research Considerationsa) Risks and potential risks to Study Subjects: * Type here

b) Source(s) of Research Material(s): * Type herec) 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, and elderly):

* Type here

8. Data and Safety - Monitoring Plan**As per NCRR requirements, ALL protocols submitted to VICTR 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 VICTR 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 Scientific Review Committee.

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 VICTR Scientific Review 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/GenderEthnic Category Females Males Total

Hispanic or Latino 0 0 0Not Hispanic or Latino 0 0 0Ethnic Category Total of All Subjects 0 0 0

Racial Categories Females Males Total




American Indian/Alaska Native 0 0 0Asian 0 0 0Native Hawaiian or Other Pacific Islander 0 0 0Black or African American 0 0 0White 0 0 0Racial 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 VICTR Requested SupportDescribe 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: [email protected]

* Type here





Summary of Requested Clinical Research Center Services

13. Space, Nursing and Nutritional Services:

Identify projected needs for CRC 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.

Inpatient Information

Year Number of Inpatients

Avg No. Of Hospital Days per Inpatient

Required Nursing Care

Diet Needs

Year 1 0 0 Year 2 0 0 Year 3 0 0 Year 4 0 0 Year 5 0 0

Total 0

Outpatient Information

Year Number of Outpatients

Avg No. Of Visits per Outpatient

Avg Hours per Outpatient Visit

Diet Needs

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.Diet Codes: R=Regular Diet, S=Special Diet.

CRC Nursing Needs* Enter special CRC nurse needs here

* Do you need nursing support at Pediatric CRC? Yes No

Special Diet Needs* Enter special diet needs here

CRC Medical Supply Needs* Enter special medical supply needs here




14. CRC Core Laboratory Tests and Analyses*Contact Dr. Tom Davis with questions at: [email protected], (615) 322-3011.

BiochemicalTest i) Test Types # Tests/

SubjectTotal Tests Requested

Catecholamine Serum Urine Whole Blood Plasma 0 0Catecholamine Serum Urine Whole Blood Plasma 0 0Nitrogen Serum Urine Whole Blood Plasma 0 0Basic Metabolic Panel1 Serum Urine Whole Blood Plasma 0 0Comprehensive Metabolic Panel2 Serum Urine Whole Blood Plasma 0 0Hepatic Function Panel3 Serum Urine Whole Blood Plasma 0 0Renal Function Panel4 Serum Urine Whole Blood Plasma 0 0Urea/BUN Serum Urine Whole Blood Plasma 0 0Creatinine Serum Urine Whole Blood Plasma 0 0Sodium Serum Urine Whole Blood Plasma 0 0Potassium Serum Urine Whole Blood Plasma 0 0Chloride Serum Urine Whole Blood Plasma 0 0CO2 Serum Urine Whole Blood Plasma 0 0Glucose Serum Urine Whole Blood Plasma 0 0Calcium Serum Urine Whole Blood Plasma 0 0Magnesium Serum Urine Whole Blood Plasma 0 0Aliquot Serum Urine Whole Blood Plasma 0 0Total Protein Serum Urine Whole Blood Plasma 0 0Albumin Serum Urine Whole Blood Plasma 0 0SGOT (AST) Serum Urine Whole Blood Plasma 0 0SGPT (ALT) Serum Urine Whole Blood Plasma 0 0GGT Serum Urine Whole Blood Plasma 0 0LDH Serum Urine Whole Blood Plasma 0 0Alkaline Phosphatase Serum Urine Whole Blood Plasma 0 0Total Bilirubin Serum Urine Whole Blood Plasma 0 0Direct Bilirubin Serum Urine Whole Blood Plasma 0 0Phosphorus Serum Urine Whole Blood Plasma 0 0Total Cholesterol Serum Urine Whole Blood Plasma 0 0Triglycerides Serum Urine Whole Blood Plasma 0 0Melatonin Serum Saliva Whole Blood Plasma 0 06-Sulfatoxymelatonin Serum Urine Whole Blood Plasma 0 0Cortisol Serum Saliva Whole Blood Plasma 0 0Nt-pro BNP Serum Urine Whole Blood Plasma 0 0Pregnancy Test Serum Urine Whole Blood Plasma 0 01 Basic Metabolic Panel: Crea, Na, K, Bun, Glu, Ca, Cl, CO22 Comprehensive Metabolic Panel: BMP, TP, Alb, AST, ALT, TBIL, Alk Phos3 Hepatic Function Panel: DBIL, TBIL, Alk Phos, TP, AST, ALT, Alb4 Renal Function Panel: BMP, Alb, PO4

Tests are assayed on a Routine Basis Monday through Friday.





15. Requested VICTR Support for Hospital Ancillary Services

Name of Test or Procedure # Tests / Subject

Total Tests For Entire

Study

Stan

dard

Inpa

tient

Tes

ts

Aldosterone 0 0Basic Met Panel ** 0 0CBC (Hemogram) 0 0CBC, Diff, Plts. 0 0Cholesterol 0 0Comp Met Panel ** 0 0CRP 0 0CSF Culture 0 0CSF Cytology 0 0CSF Glucose 0 0CSF Protein 0 0HGBA1c 0 0Insulin – Plasma 0 0Liver Function Panel ** 0 0PT 0 0PTT 0 0Renin – Plasma 0 0Thyroxine – T4 0 0Urinalysis w/ microscopy 0 0

0 0

Oth

er

Inp.

*Type additional request here 0 0*Type additional request here 0 0*Type additional request here 0 0*Type additional request here 0 0

Stan

dard

Out

patie

nt T

ests

Aldosterone 0 0Basic Met Panel ** 0 0CBC (Hemogram) 0 0CBC, Diff, Plts 0 0Cholesterol ** 0 0Comp Met Panel ** 0 0CRP 0 0CSF Culture 0 0CSF Cytology 0 0CSF Glucose 0 0CSF Protein 0 0HGB A1c 0 0Insulin – Plasma 0 0Liver Function Panel ** 0 0PT 0 0PTT 0 0Renin - plasma 0 0Thyroxine – T4 0 0Urinalysis w/ microscopy 0 0fMRI 90 Minutes 0 0

Ot

her *Type additional request here 0 0

*Type additional request here 0 0*Type additional request here 0 0

** These tests are available in the VICTR-CRC Core Lab. If you are requesting these tests from the hospital lab, provide a scientific justification.




16. Drug and Investigational Pharmacy Support (check only items that apply)*Contact Hope Campbell with questions and fee quotes at: [email protected], (615) 343-6537.

Requesting VICTR pay for any drugs used in this study?*If checked, describe drugs, amounts, and costs

Requesting VICTR pay for the Investigational Pharmacy costs?*If checked, describe services and costs

17.


Drug Cost $0.00 $0.00 $0.00 $0.00

1) Pharmacy FeesInitiation Fee $0.00Dispensing Fee $0.00Other: $0.00

Test and Equipment # Tests/ Subject Total Tests Requested

Body Composition – Bod Pod 0 0

Body Composition – DEXA 0 0

Body Composition – Bioelectrical Impedance 0 0

Body Composition – Underwater Weighing 0 0

Resting Metabolic Rate – Metabolic Cart 0 0

Resting Metabolic Rate – 24 Hour EE (Chamber) 0 0

Treadmill Testing –VO2 Max 0 0

Physical Activity Monitoring Pedometers 0 0

EEG 0 0

Tilt Testing 0 0

EKG without interpretation 0 0

Echocardiograph equipment only 0 0

Forearm Blood Flow equipment only 0 0

Doppler Blood Flow equipment only 0 0

Actigraphy 0 0

Exhaled Nitric Oxide analyzer 0 0

Other: 0 0

Other: 0 0

Other: 0 0

Other: 0 0

Other: 0 0

Other: 0 0




18.Sleep Core

Section A: Sleep Study * Please contact Dr. Beth Malow with questions at: [email protected],,

(615) 322-0283Sleep 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 hereTotal number of participants in Year 1: 0Total 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 NoOther 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: SchedulingList 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 SupportPlease check one of the following

I currently have grant support that can be used to offset the cost of the VICTR Sleep Core.I do not currently have grant support that can be used to offset the cost of the CRC Sleep Core, but plan to use my pilot data to obtain grant support to offset the cost of the VICTR 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




19. Special Assays or Additional Information:The VICTR provides support for ancillary testing from the VUMC Research Core Facilities. http://www.vanderbilt.edu/oor/cores/facilities.phpIf you need support from these cores, please contact the core for availability and pricing information and provide the information to us in the table below.

Name of Test or Procedure # Tests / Subject

Total Tests For Entire

Study

Total Cost for Study

*Type additional request here 0 0 $0.00*Type additional request here 0 0 $0.00*Type additional request here 0 0 $0.00*Type additional request here 0 0 $0.00*Type additional request here 0 0 $0.00*Type additional request here 0 0 $0.00*Type additional request here 0 0 $0.00

20. T2 Support

Description Cost1. Participant Recruitment and Retention:

food, transportation, childcare, stipends, etc.

$0.00

2. Measurement (people and resources):a. Data Collection: interpreters, data collectors, focus group facilitators, purchase access to databases, etc.

$0.00

b. Equipment: consultants, CRC equipment (e.g. portable Bod Pod), digital audio or video recorders, cell phones, etc.

$0.00

c. Labs: web survey tools, GIS databases, phone surveys, existing datasets, etc.

$0.00

3. Intervention:a. Physical space outside CRC walls in community

$0.00

b. Intervention: purchase or creation of print materials (design, layout, printing), computer automated phone tools, etc.

$0.00

4. Analysisa. Transcription: software, qualitative analysis software, etc.

$0.00

b. Monitoring: phone calls, CATI (computer automated telephone interview systems), etc.

$0.00

5. Other: $0.00

Additional InformationDescribe your support request and provide a cost estimate of the support:



http://www.vanderbilt.edu/oor/cores/facilities.php


* type here




Bionutrition Support Required (check all items that apply)*Contact Dr. Maciej Buchowski with questions at: [email protected], (615) 343-4192.

Diet instruction or nutrition education Nutrient intake analysis (e.g.,diet records, 24 hr recall, food frequency questionnaire, weighed meals, etc.) Nutrient controlled diet Growth assessment: (e.g., skinfold, circumference, segment measures, etc.) Daily energy balance assessment Daily nutrient balance assessment Other? *Enter other bionutrition needs, otherwise leave blank

Biostatistical Support Required (check all items that apply)*Contact Dan Byrne with questions at: [email protected], (615) 322-4228.

Protocol Review Study design consultation Sample size estimation Statistical analysis consultation Software tool selection/training Manuscript review

Primary Biostatistician for this study:*Name/phone/email

Research Subject Advocate (check all items that apply)*Contact Vicky Thurman with questions at: [email protected] (615) 343-6452.

Protocol Review Human subject risks, study alternatives, protections and mitigation support DSMP/DSMB planning support Serious Adverse Event (SAE) definitions; procedures assistance HIPAA compliance Other *Enter other RSA needs, otherwise leave blank

Informatics (check all items that apply)*Contact Dr. Paul Harris with questions at: [email protected], (615) 322-6688.

Protocol Review Web-Based Research Database (REDCap Classic) Web-Based Survey Tool (RedCap Survey) Research volunteer subject recruitment registry Poster printing and use of shared computing environment

Expert Consultation for Translational 1 Support (check all items that apply)*Contact Tara Helmer with questions at: [email protected] (615) 322-5571

. Protocol Review for Grant Submission Manuscript Review for Publication Submission Research Hypothesis Generation Studio Research Design Studio Research Implementation Studio Research Analysis Studio Research Translation Studio








Expert Consultation for Translational 2 Support (check all items that apply)*Contact Nikki McKoy with questions at: [email protected] (615) 343-3031

. Protocol Review for Grant Submission Research Hypothesis Generation Studio Research Design Studio Research Implementation Studio Research Analysis Studio Research Translation Studio

* Studio type descriptions are on the last page.

As Principal Investigator, I agree:1. That all information in this application is complete and true to the best of my knowledge.2. That all key personnel on this protocol are IRB-certified.3. That I will provide all information requested by VICTR in a timely manner.4. That I will inform the Program Director and Research Safety Advocate of any adverse events.5. That I will credit the CTSA NIH/NCRR grant 1UL1RR024975-01 in any subsequent published

literature.





The Research Design Studio will assist investigators with the formulation and execution of translational research projects by providing support in 1) the creative activity that examines study designs and generates alternative designs for the research questions and hypotheses, including multidisciplinary perspectives that will aid in generating innovative options and 2) the process of refining the study design, conducting relevant pilot work, selecting measurements, and developing the analytical plan.

The Manuscript Studio will assist the researcher in preparing a manuscript to enhance the chance of publication a high impact journal.

The Hypothesis Generation Studio will assist investigators with the formulation and execution of translational research projects by providing support in 1) the initial creative activity that generates research questions and hypotheses, including bringing together multidisciplinary groups to explore innovative and important areas to explore and 2) refining specific research questions and hypotheses.

The Research Implementation Studio will assist investigators with the formulation and execution of translational research projects by providing support in 1) the creative activity that examines plans for implementation and study protocols and generates alternative approaches, including multidisciplinary perspectives that will aid in generating innovative options and 2) the process of refining the study implementation plan, including the recruitment and retention protocols, data collection protocols, safety and monitoring protocols, data capture, storage, and security protocols.

The Research Analysis and Interpretation Studio will assist investigators with the formulation and execution of translational research projects by providing support in 1) the creative activity that examines the interim and final analytical plans and interpretation, including multidisciplinary perspectives that will aid in generating innovative options and 2) refining study interim and final analysis plan, including data monitoring, cleaning analysis, and methods for presentation.

The Research Translation Studio will assist investigators consider 1) how to make the findings of their research relevant to specific communities and 2) next steps in their research program such as improving the cultural relevance of interventions, modifying procedures and protocols for special settings or populations, conducting research on the economic impact of clinical innovations, and evaluating the potential implications of their work on public policy.



vumc general clinical research center - vanderbilt ... · web viewhuman cell function clinical...

Documents