VUMC General Clinical Research Center



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Office use only (P. No.)      

|Protoc|Protocol Short Title (54 characters max.): Date submitted:       (m/d/yyyy) |

|ol | |

| |*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: |

| |Total number of patients in study?       Total at Vanderbilt?       |

| |Duration of study (years):       |

| |Proposed Study Subject Category: |

| |IRB Status: IRB #:       IRB Approval Date:       |

| | |

|Invest|Principal Investigator Name: *Enter First Name, MI, Last Name Degree: |

|igator|Title: , specify if other: *Enter Other Department / Division: *Type here |

|s |Phone #: *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 |

| |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 |

| | |

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

Top of Form

[pic]To support a protocol associated with a peer reviewed externally funded grant

NIH Training Grant *specify

NIH Research Grant *specify

CDC

Industry Sponsor *specify

Foundation specify *specify

State *specify

VA *specify

Other: *specify

[pic]To help me develop a manuscript

[pic]To generate pilot data for inclusion in a future grant proposal

[pic]To support an ancillary study of a funded grant

[pic]Other: *specify

Bottom of Form

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 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, 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/Gender |

|Ethnic Category |Females |Males |Total |

|Hispanic or Latino |0 |0 |0[pic]0 |

|Not Hispanic or Latino |0 |0 |0[pic]0 |

|Ethnic Category Total of All Subjects |0[pic]0 |0[pic]0 |0[pic]0 |

| |

| |

|Racial Categories |Females |Males |Total |

|American Indian/Alaska Native |0 |0 |0[pic]0 |

|Asian |0 |0 |0[pic]0 |

|Native Hawaiian or Other Pacific Islander |0 |0 |0[pic]0 |

|Black or African American |0 |0 |0[pic]0 |

|White |0 |0 |0[pic]0 |

|Racial Categories: Total of All Subjects* |0[pic]0 |0[pic]0 |0[pic]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 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: CRC@Vanderbilt.edu

* 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 |Avg No. Of Hospital |Required Nursing Care |Diet Needs |

| |Inpatients |Days per Inpatient |⁄ |⊕ |

|Year 1 |0 |0 | | |

|Year 2 |0 |0 | | |

|Year 3 |0 |0 | | |

|Year 4 |0 |0 | | |

|Year 5 |0 |0 | | |

|Total |0[pic]0 | | | |

| | | | | |

|Outpatient Information |

|Year |Number of |Avg No. Of Visits per|Avg Hours per |Diet Needs |

| |Outpatients |Outpatient |Outpatient Visit |⊕ |

| | | |⁄ | |

|Year 1 |0 |0 | | |

|Year 2 |0 |0 | | |

|Year 3 |0 |0 | | |

|Year 4 |0 |0 | | |

|Year 5 |0 |0 | | |

|Total |0[pic]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: Thomas.L.Davis@vanderbilt.edu, (615) 322-3011.

|Biochemical |

|Test |Test Types |# Tests/ |Total Tests |

| | |Subject |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 |

| |

|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 |

|Standa|Aldosterone |0 |0 |

|rd | | | |

|Inpati| | | |

|ent | | | |

|Tests | | | |

| |Basic Met Panel ** |0 |0 |

| |CBC (Hemogram) |0 |0 |

| |CBC, Diff, Plts. |0 |0 |

| |Cholesterol |0 |0 |

| |Comp Met Panel ** |0 |0 |

| |CRP |0 |0 |

| |CSF Culture |0 |0 |

| |CSF Cytology |0 |0 |

| |CSF Glucose |0 |0 |

| |CSF Protein |0 |0 |

| |HGBA1c |0 |0 |

| |Insulin – Plasma |0 |0 |

| |Liver Function Panel ** |0 |0 |

| |PT |0 |0 |

| |PTT |0 |0 |

| |Renin – Plasma |0 |0 |

| |Thyroxine – T4 |0 |0 |

| |Urinalysis w/ microscopy |0 |0 |

| | |0 |0 |

| | | | |

|Other |*Type additional request here |0 |0 |

|Inp. | | | |

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

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

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

| | | | |

|Standa|Aldosterone |0 |0 |

|rd | | | |

|Outpat| | | |

|ient | | | |

|Tests | | | |

| |Basic Met Panel ** |0 |0 |

| |CBC (Hemogram) |0 |0 |

| |CBC, Diff, Plts |0 |0 |

| |Cholesterol ** |0 |0 |

| |Comp Met Panel ** |0 |0 |

| |CRP |0 |0 |

| |CSF Culture |0 |0 |

| |CSF Cytology |0 |0 |

| |CSF Glucose |0 |0 |

| |CSF Protein |0 |0 |

| |HGB A1c |0 |0 |

| |Insulin – Plasma |0 |0 |

| |Liver Function Panel ** |0 |0 |

| |PT |0 |0 |

| |PTT |0 |0 |

| |Renin - plasma |0 |0 |

| |Thyroxine – T4 |0 |0 |

| |Urinalysis w/ microscopy |0 |0 |

| |fMRI 90 Minutes |0 |0 |

|Other | | | |

|Outp. | | | |

| |*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: Hope.Campbell@vanderbilt.edu, (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

| Drug |Cost |

|      |$0.00 |

|      |$0.00 |

|      |$0.00 |

|      |$0.00 |

|Pharmacy Fees | |

|Initiation Fee |$0.00 |

|Dispensing Fee |$0.00 |

|Other:      |$0.00 |

17.

|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: Beth.Malow@vanderbilt.edu,, |

|(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 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.

If 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 |Total Cost for |

| | | |Entire Study |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 |Cost |

|1. |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. |Analysis | | |

| |a. 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 Information

Describe your support request and provide a cost estimate of the support:

* type here

Bionutrition Support Required (check all items that apply)

*Contact Dr. Maciej Buchowski with questions at: Maciej.Buchowski@vanderbilt.edu, (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: Daniel.Byrne@vanderbilt.edu, (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: Vikki.Thurman@vanderbilt.edu (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: Paul.Harris@vanderbilt.edu, (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: tara.helmer@vanderbilt.edu (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: jnikki.mckoy@vanderbilt.edu (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: |

|Agreem|That all information in this application is complete and true to the best of my knowledge. |

|ent |That all key personnel on this protocol are IRB-certified. |

| |That I will provide all information requested by VICTR in a timely manner. |

| |That I will inform the Program Director and Research Safety Advocate of any adverse events. |

| |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.

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Electronic Protocol Application

For more information see the CRC Web site at -

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