Frequency and plans for auditing trial conduct {23}
ICH, PEx
Monitoring will be performed according to the International Committee for Harmonisation (ICH) guidelines, in particular E6 (also known as Good Clinical Practice (GCP). Data will be evaluated for compliance with the protocol and accuracy in relation to source documents. Following written operating procedures, monitors will verify that for the PEx Cohort (including any nested sub-studies), data are generated, documented, and reported in compliance with the protocol, GCP, applicable regulatory requirements.A risk-based approach has been used to develop a monitoring plan. Risk-based monitoring differs from conventional monitoring as it prioritizes specific risks for this project as opposed to conducting routine site visits with complete source data verification. This has identified and defined the data and processes critical to data quality and the processes required to minimize them. Quality indicators and thresholds that would trigger an investigation and/or corrective action have been set and documented in a Data Monitoring Plan.Obligations expected of sites to assist the sponsor in monitoring the study may include hosting site visits, providing information for remote monitoring, or putting procedures in place to monitor internally. Any additional processes for defining, assessing, reporting, and monitoring nested sub-studies will be outlined in their relevant subprotocols.