Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25}
Plans for protocol modifications will first be approved by the sponsor (NIH). Then, any modifications will be approved by the IRB and updated in ClinicalTrials.gov. Participants will be notified of the protocol changes, if applicable, at their next study visit, where they will complete an updated informed consent form if necessary. Any protocol deviations will be documented in the protocol deviation form and reported to the IRB.