Forms and Instructions - Forms and Instructions - CCR Wiki

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Created by Hestick, Jody (NIH/NCI) [E], last modified on Jun 24, 2024

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

SROS Clinical Monitoring Plan

Site Protocol Non-Adherence Log

OSRO SROS ERD Review Criteria

CCR-OSRO Sponsor Investigational Product Preparation Form

CCR CAPA Template

Investigational Product Transfer Authorization

IND Annual Reports - Data Reporting Process and Logic

Sponsor-PI Coordination of Activities in IP Stability Studies

Last updated by Hestick, Jody (NIH/NCI) [E] on Jun 24, 2024