Frederic C. Bartter
General Clinical Research Center (GCRC)

Category A Study Activation Requirements

Once your study has received final approval as a Category A study (visit costs covered by the NIH grant), the following items must be completed prior to study activation (scheduling the first patient): 

·         All study staff who will see subjects on the GCRC must be VA employees, credentialed at the VA, or have WOC (Without Compensation) appointments prior to study start.  The forms to obtain a WOC appointment are located here: http://gcrc.uthscsa.edu/wocproc.htm. 

·         All study staff who will see subjects on the GCRC must provide evidence of having completed the required human research training.

·         Please provide a list of the research staff and investigators who will participate in this study to the VA R&D office.  The fax number for the R&D office is 567-6550.

For this study, the GCRC must have on file (if you have not already submitted them):

·         The original letter of approval and most recent letter of approval from the IRB

·         An IRB-stamped VA consent form with HIPAA-approved language

·         A copy of the approval letter from the VA R&D

·         Certification of training for human subject research

·         A GCRC Data and Safety Monitoring Plan (DSMP)

Please be reminded that copies of all correspondence with the IRB, including protocol and consent form changes, study complications, and documentation of current co-investigators and physicians involved in patient care must be sent to both the VA R&D and GCRC committees.

Inservice:  At least five working days prior to the start of the study, an in-service for the GCRC staff must be scheduled.  In-service time can be arranged with Sharyn Pryor, RN (VA 617-5300, ext 1-4757) or Terri Barnett, RN (VA 617-5300, ext 1-5248).  All in-services are video taped.

 

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                        Date page last modified:  09/06/07 01:33 PM