John Sealy Hospital, 5th floor, J5A Outpatient, J5B Inpatient,  J508 Administrative Offices, route 0264,

Voice: 409-772-1950, Fax: 409-772-8097

 

 

Closing A GCRC Protocol

View/Read:

GCRC Application Instructions

DSMP

GCRC Notices

Download:

Protocol PHS 398 Template

Resource Request Form (GCRC Application Packet and Instruction)

Link to:

NIH Biosketch Form

IRB Human Subjects Training

IRB Forms

Other Useful Links

 Last Modified: 10/11/03

A protocol should generally not be completely closed with the GCRC and IRB until data analysis is complete and publications have been prepared. A study may be closed to enrollment, but GCRC resources may still be used for follow-up visits, data analysis, etc. If a study is to remain active in any sense, there must be current IRB approval.

When a study is completed in full, a memo should be sent to the IRB and the GCRC requesting that the protocol be closed.

 

The links provided below will help you in this process...

(Download this set of instructions)

BEFORE your Protocol can be Approved
AFTER your Protocol has been Approved

REQUIREMENTS FOR USING THE GCRC

INVESTIGATOR’S RESPONSIBILITIES

TYPE OF STUDY

STUDY INITIATION

GCRC APPLICATION PACKET & INSTRUCTIONS*

ACKNOWLEDGING THE GCRC

GCRC ADMINISTRATIVE STAFF

ANNUAL REPORTS & RENEWALS

GCRC APPLICATION REVIEW PROCESS

CLOSING A GCRC PROTOCOL

*download/save file to your computer