This online training will provide you with an overview of definitions, requirements, and procedures related to safety management in clinical research.

This online training will provide you with an overview of definitions, requirements, and procedures related to safety management in clinical research.

Logs all reported adverse events experienced by participants. Aids in safety monitoring and regulatory reporting. Template & respective Instruction for use available

Tracks participant screening outcomes, enrolment status, and identifiers. Supports recruitment tracking and subject confidentiality. Template & respective Instruction for use available

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

This template supports researchers in identifying suitable PPI contributors for their projects. It offers guidance on describing PPI activities and outlines the desired skills, experience, and knowledge.

This template helps researchers plan and track public and patient involvement (PPI) activities in an initiative or a research project.

This fact sheet explores central data monitoring (CDM), its role in data quality and oversight, and clarifies terminology and guidance for implementation

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

An R package for evaluating user defined functions across parameter grids, then visualising and comparing the output. It assists in estimating trial power, sample size, and other design considerations.