HRPP/IRB

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Tool Kit

How to Determine What to Apply
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Investigator’s Handbook for Biomedical Sciences

Investigators Handbook for Social and Behavioral Sciences

Training Tools

Web-based Collaborative IRB Training Initiative (CITI) Course

CLICK HERE for CITI Instructions

National Institutes of Health (NIH) On-line Course

This course satisfies the NIH human subjects training requirement for obtaining Federal funds. Please note: This is not a required course for the Vanderbilt IRB. However, it can be used to fulfill the IRB’s continuing education requirement.

Work Plans

Compliance PlanCompliance Plan
Education PlanEducation Plan
Outreach PlanOutreach Plan

Protocol Development

Sample Behavioral Sciences Protocol
Sample Health Sciences Protocol

CTEP Protocol Development Guidelines

Additional Forms

  
Data Use AgreementData Use AgreementData Use Agreement
Coded Data AgreementCoded-Data-AgreementCoded-Data-Agreement
Confidentiality Agreementconfidentiality_agreementconfidentiality_agreement
FDA FormsLink to FDA Forms

The Device Development Tools have been moved to StarBRITE, under “Planning and Implementation”.

Information and Resources

Protection of Minors
Statement on ICH-GCP
Statement on Electronic Signatures
HIPAA Hybrid Designation