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Tool Kit

  How to determine what application to use

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  Investigator’s Handbook for Biomedical Sciences

Investigators Handbook for Social and Behavioral Sciences

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 Agreement
Coded Data AgreementCoded-Data-Agreement
Confidentiality Agreementconfidentiality_agreement
FDA FormsLink to FDA Forms

Information and Resources

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