CIP #: PI:

Command Approval ofExtramural Post-Approval Actions

for Research Conducted at Naval Medical Center Portsmouth, VA

Contact NMCP Clinical Investigation Department at (757) 953-5939

STUDY TITLE
PRINCIPAL INVESTIGATOR
Name(Rank Name Degree): / PRD (MM/YY): 00/00
Command: / Department: / CITI (MM/DD/YY): 00/00/00
Phone/Pager: / CV (MM/DD/YY): 00/00/00
Email: / RIT (MM/DD/YY): 00/00/00
Active DutyCIV
RESEARCH TEAM MEMBERS
Name (Rank Name Degree): / PRD (MM/YY): 00/00
Command: / Department: / CITI (MM/DD/YY): 00/00/00
Phone/Pager: / CV (MM/DD/YY): 00/00/00
Email: / RIT (MM/DD/YY): 00/00/00
Active DutyCIVContractor - Company:
Name (Rank Name Degree): / PRD (MM/YY): 00/00
Command: / Department: / CITI (MM/DD/YY): 00/00/00
Phone/Pager: / CV (MM/DD/YY): 00/00/00
Email: / RIT (MM/DD/YY): 00/00/00
Active DutyCIVContractor - Company:
Name (Rank Name Degree): / PRD (MM/YY): 00/00
Command: / Department: / CITI (MM/DD/YY): 00/00/00
Phone/Pager: / CV (MM/DD/YY): 00/00/00
Email: / RIT (MM/DD/YY): 00/00/00
Active DutyCIVContractor - Company:
Name (Rank Name Degree): / PRD (MM/YY): 00/00
Command: / Department: / CITI (MM/DD/YY): 00/00/00
Phone/Pager: / CV (MM/DD/YY): 00/00/00
Email: / RIT (MM/DD/YY): 00/00/00
Active DutyCIVContractor - Company:
RESEARCH MONITOR
Name (Rank Name Degree): / PRD (MM/YY): 00/00
Command: / Department: / CITI (MM/DD/YY): 00/00/00
Phone/Pager: / CV (MM/DD/YY): 00/00/00
Email: / RIT (MM/DD/YY): 00/00/00
Active DutyCIVContractor - Company:

* Add more rows as needed* Add more rows as needed.

Approved Risk Rating: Minimal ______Greater than Minimal ______
Summary of Submission:

EXTRAMURAL PROTOCOL REVIEW COVER SHEET

Please provide the following information about this Extramural Post-Approval Action:

CID Assigned Protocol Tracking Number:
Date of Extramural IRB Approval for Initial Review:
Date of NMCP CO Approval for Initial Review:
Study Expiration Date:
Type of Post-Approval Action for CO Review:
Amendment
Continuing Review
Adverse Event
Final Report
Other:
Date of IRB Approval for the submitted action:
Protocol Version and/or Date:
Consent Version and/or Date:

Number of Local Subjects currently Enrolled, Active, Withdrawn, and Completed on the trial/project:

Total Enrolled:
Total Active:
Total Withdrawn:
Total Completed:

Please document below which of the following supporting documents from the Extramural IRB have been included:

Extramural IRB Action Form (Amendment form, etc.)

IRB Approval Notice

Reviewing IRB's Summary of Deliberations and Actions for Approval

Local Approved Consent

CID Recommendations

The documents included in this report and the IRB actions have been verified and can be recommended to the Commanding Officer, NMCP.

Head, RSPD: Kersten Wheeler, M.S.
Printed Name / Signature / Date
Commanding Officer, NMCP
Approval given in the minutes of the IRB __ - ______meeting on ______.
Meeting DateCO/XOSignature Date

NMCP CO Approval of Extramural Post-Approval ActionsVersion 07 April 17