Plans for assessment and collection of outcomes {18a}
Risk-based monitoring of the trials shall be conducted by qualified and experienced CRAs and shall be in accordance with a Monitoring Plan that clearly describes the strategy, methods, responsibilities, and requirements for monitoring the trials.In accordance with applicable regulations, GCP, and ISGlobal procedures, CRAs shall meet with the site prior to the start of the study to review with the site staff the protocol and their responsibilities to satisfy regulatory, ethical, and ISGlobal requirements. When reviewing data collection procedures, the discussion shall also include training on the electronic source requirements, entry into the clinical trials’ database, as well as access and security procedures.The investigator and the head of the institution (where applicable) agrees to allow the monitor direct access to all relevant documents. The investigator must ensure the provision of reasonable time, space, and qualified personnel for monitoring visits.As the trials make use of electronic source reporting, most data will be monitored remotely, and queries will be resolved electronically to reduce monitoring time on site.Upon completion or premature discontinuation of the study, the CRA will conduct site closure activities with the investigator and site staff in accordance with applicable regulations, GCP, and ISGlobal SOPs.