Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25}
RTI
Proposed protocol and patient-facing material modifications are communicated to the Data Coordinating and Operations Center (DCOC) at University of Arkansas for Medical Sciences (UAMS) for submission to the cIRB at UAMS. Upon cIRB approval of the modification, the DCOC will send the amendment with an accompanying approval letter to sites via email, using a study-wide contact list. For changes to non-patient-facing material, the RTI DCC will update the study documents and send updated materials with an accompanying technical memo to sites via email, using a study-wide contact list. All final, updated documents will be posted to the study website hosted by the ISPCTN