Protocol submission Process

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

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

GCRC Application Process

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

The GCRC welcomes the submission of new clinical protocols by all investigators in the Institution, from all the medical specialties and the basic sciences.

To use the resources of the GCRC you must prepare an application packet, which consists of:

the protocol narrative and supplementary documents,
a data and safety monitoring plan,
a resource request form, and
a current biographical sketch.
The IRB application (Blue Form #2) and relevant appendices must accompany every GCRC application.

Important Note: These files are frequently modified and should be downloaded prior to each submission.

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