Amendments
Sponsors must file a CTA-A when the proposed changes to the protocol:
• affect the selection, the criteria for selection, monitoring, or dismissal of a clinical trial subject
• affect the evaluation of the clinical efficacy of the drug
• alter the risk to health of a clinical trial subject
• affect the safety evaluation of the drug; or
• extend the duration of the clinical trial
Amendments are also subject to a 30-day default review.