To be used in the absence of any other source document: records adverse events reported by participants, along with their assessment and follow-up. Aids in safety monitoring and regulatory reporting. Template & respective Instruction for use available for study coordinators.

Enables to link a participation code to participants’ details. For use on the recruitment site only. Template & respective Instruction for use available for study coordinators.

Tracks receipt, dispensing, and return of Investigational Medicinal Product/Device. Ensures accurate accountability at participant level. Template & respective Instruction for use available for study coordinators.

Fact sheet exploring Central Data Monitoring (CDM), its role in data quality and oversight, and clarifies terminology and guidance for implementation

Position paper offering recommendations for monitoring strategies in non-interventional studies, from new data collection to reuse of clinical data or samples

This interactive tool helps monitors and sponsor teams to assess monitoring needs by generating a monitoring risk score for each study. This helps to ensure effective, high-quality sponsor oversight.

To be used when drafting a combined routine monitoring visit and monitoring close-out visit report.

All-in-one document for listing screened and included participants, and for linking participation codes to the participants' details (for use at the investigator site only). Supports recruitment tracking. Template & respective Instruction for use available for study coordinators.

Enable the shortlisting of screened participant. Supports recruitment tracking. Template & respective Instruction for use available for study coordinators.

Tracks receipt, dispensing, and return of Investigational Medicinal Product/Device. Ensures accurate accountability at site level. Template & respective Instruction for use available for study coordinators.