Frequency and plans for auditing trial conduct {23}
RECRUITMENT
The project management group will meet weekly to review key metrics including balanced randomization, screen to enrollment rate, weekly recruitment, and retention rates. This team will be supported by a Data Safety and Monitoring Board (DSMB) and Institutional Review Board (IRB). The DSMB will meet annually for about 2 h per meeting with additional time for review of the DSMB report prior to the meeting. The IRB require that the study comply with ICH-GCP guidelines and provide annual review and renewal.