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Created by Hestick, Jody (NIH/NCI) [E], last modified on Dec 11, 2024

NOTICE: AS OF 12/16/24 THIS WIKI SITE IS NO LONGER MAINTAINED. PLEASE REFER TO THE NEW LOCATION HERE.

Forms and Instructions

Download forms to fill in information.

Serious Adverse Event Report Form
- Instructions for the Serious Adverse Event Form
- Serious Adverse Event Reporting FAQs

CCR OSRO Financial Disclosure Form
- Instructions for the CCR OSRO Financial Disclosure Form

Form FDA 1572 Instructions

Investigator Agreement for Investigational Device Exemption

Clinical Study Report Instructions and Template

Protocol Signature Page

Cost Estimation Request for CCR Sponsored Studies

Participant Screening and Enrollment Log

Coordinating Center Communication Plan for Multicenter Clinical Trials

Site Protocol Non-Adherence Log

CCR-OSRO Sponsor Investigational Product Preparation Form

CCR CAPA Template

Request for Authorization to Transfer Investigational Product

IND Annual Reports - Data Reporting Process and Logic

Sponsor-PI Coordination of Activities in IP Stability Studies

Investigational Product Temperature Excursion Report

Clinical Protocol Planned Deviation Request

Protocol Closure Requirements Checklist

Last updated by Hestick, Jody (NIH/NCI) [E] on Dec 11, 2024