Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25}
MINOR
Protocol amendments which may affect the conduct of the study or the potential safety or benefits to participants will require a formal amendment to the protocol. This formal amendment will be approved by the steering committee and must be approved by the UCSF IRB, Tanzanian IRB, and NIAMS. Administrative changes (minor corrections or clarifications that have no effect on the conduct of the trial) will not need to undergo a formal amendment process. These minor changes will be recorded by the coordinating center.