Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25}
MINOR
Any modifications to the protocol that may impact the conduct of the trial will require a formal amendment to the protocol. All amendments to the protocol must be approved by the internal review board of each participating center. Administrative changes to the protocol, minor corrections, and/or clarifications that have no effect on the way the trial is to be conducted will be agreed upon among the participating centers.