NOTICE: AS OF 12/16/24 THIS WIKI SITE IS NO LONGER MAINTAINED.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

• Dose Escalation Determination Form
• Dose Escalation Determination - Frequently Asked Questions

• CCR Pregnancy Report and Follow Up Form
• CCR Pregnancy Outcome Form

• 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

• Clinical Site Delegation of Authority Log
• Delegation of Authority & Staff Signature Log FAQ

• Participant Screening and Enrollment Log

• Coordinating Center Communication Plan for Multicenter Clinical Trials

• SROS Clinical Monitoring Plan
• SROS Clinical Monitoring Plan - NSR Device-Only Study

• Site Protocol Non-Adherence Log

• OSRO SROS ERD Review Criteria
• Clinical Site Essential Regulatory Document (ERD) Review Criteria Checklist

• Transmittal Form for Uncategorized Pre-SIV Submissions
• Transmittal Form for Uncategorized IMV Submissions

• SROS Source Location Record
• SROS Source Location Record (Non-NIH Sites)

• 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

• Risk-Based Assessment of Clinical Monitoring Plans
• Risk-Based Assessment for Pharmacy Monitoring Plans

• Sponsor-PI Coordination of Activities in IP Stability Studies

• Investigational Product Temperature Excursion Report

• Clinical Protocol Planned Deviation Request

• Protocol Closure Requirements Checklist