Changing Approved Protocol

All amendments to approved protocols must be submitted to the IRB and GCRC SAC for review and approval prior to commencement of the revised study or use of the revised consent/permission/assent forms.

If an investigator has opted to add GCRC staff as study contacts to his/her protocol in IRIS, the GCRC staff will obtain the changes through IRIS and no additional submission need be made to the GCRC.

If the investigator opts to not add GCRC staff as study contacts in IRIS, then changes must be submitted electronically to Ruby A. Benjamin-Garner at Ruby.A.Benjamin-Garner@uth.tmc.edu. The changes must include a memo outlining a summary of the changes plus a revised protocol with the changes highlighted in different formatting (underlined, different font, colored, etc).