The guidance document provides practical recommendations for all relevant aspects of data sharing in accordance with legislation in Switzerland

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

Documents SIV agendas and attendees along with their training status. Verifies site readiness and staff preparedness before trial start. Template & respective Instruction for use available

Documents SIV agendas and attendees along with their training status. Verifies site readiness and staff preparedness before trial start. Template & respective Instruction for use available

Records training activities and qualifications of trial personnel. Ensures all staff are trained in protocol and regulatory requirements. Template & respective Instruction for use available

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

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

Records training activities and qualifications of trial personnel. Ensures all staff are trained in protocol and regulatory requirements. Template & respective Instruction for use available

A standardized template for documenting the statistical analysis of observational studies.

SCTO GitHub, an online platform where all codes developed by the STAT Platform are stored This platform is for storing, sharing and collaborating on code.