Investigator Information

Protocol Application

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Coordinators are strongly advised to contact GCRC administration prior to submitting protocols (one week before deadline is recommended).

Please Note: If your protocol has already been reviewed at the GAC and decision was "deferred", you have to resubmit the entire package of the revised application (i.e., GCRC application, protocol summary, consents, biosketches, and so on) as if you were submitting for the first time. If decision was "final approval is pending review and receipt" you only need to send an electronic copy of revised application (changes underlined) and response memo. Please include the GCRC comments and your responses below these comments in a single file.

1. Protocol Application Form - This is the latest (11/17/08) version of the Protocol Application Form. Instructions and links have been updated. Previous changes: updated submission deadline, section for plan for the inclusion of children, additional requirements for young investigators have been added. Users may open this form in Microsoft Word and edit the fields.
2. Instructions for protocol application - Updated 8/18/05 with more detailed instructions in some sections. Previous changes: addition of regulations surrounding inclusion of children and addition of requirement for at least one M.D. per protocol, additional requirements for young investigators, more detailed monitoring plan to include DSMB information, and an improved GCRC utilization section, a technical support and information page at the end. Data Safety and Monitoring Template
3. Scheduled Advisory Commitee meeting dates and submission deadlines

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