Facilitates organised tracking of essential trial documents and all site-related communications. Supports compliance, transparency, and effective document management throughout the study. Template & respective Instruction for use available for study coordinators.

These guidelines outline risk-based monitoring for clinical trials and provide a framework for proposing an appropriate monitoring risk category for each study.

Tracks delegation of trial-related duties from the Investigator to authorised staff. Ensures accountability and compliance with GCP. Template & respective Instruction for use available for study coordinators.

Structured document including a step-by-step checklist for monitors covering all the important aspects of a monitoring close-out visit.

Enables the development of monitoring plans aligned with Swiss and international standards, supporting risk-based strategies for clinical research.

Structured document including a step-by-step checklist for monitors covering all the important aspects of a site initiation visit.

Logs details of monitoring visits at a study site(s). Supports oversight and documentation of site interactions. Template & respective Instruction for use available

Structured document including a step-by-step checklist for monitors covering all the important aspects of a routine monitoring visit.

Up-to-date list of events including protocol deviations, and facilitates their reporting, assessment, handling and follow-up.Template & respective Instruction for use available for study coordinators.

Enables the recording of events occurring during the study, including deviations from the protocol and the corrective and preventive measures taken, particularly in the case of significant deviations. Template & respective Instruction for use available for study coordinators.