Amending Approved Protocols

CORIHS:

All amendments to approved protocols must be submitted to CORIHS for review and approval prior to commencement of the revised study or use of a revised consent/permission/assent form. Adverse events that occur on-site will be reviewed by the full committee at a convened meeting. Those occurring at another center conducting the study (i.e., in the case of multi-center studies) will be reviewed in a timely manner. Three copies of all materials pertaining to the amendment or adverse event(s) should be submitted for review.

GCRC:

Changes to consent/permission/assent forms that are required as a result of an amended protocol, or subsequent to review of adverse events (i.e., addition to the risks section of the consent form), should be made to the most current CORIHS-approved version. The revised version would be used to consent new subjects for enrollment in the study. Copies of all amended and approved CORIHS paperwork must also be submitted to the GCRC Administrative Office. The GAC may need to review the changes if there are significant financial implications resulting from the change or the protocol was modified due to Serious Adverse Events.