Article in the IFAPP newsletter about the easy-GCS

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

This template includes a step-by-step checklist for monitors and covers all the important aspects of a monitoring close-out visit.

This template helps design monitoring plans aligned with Swiss and international standards, supporting risk-based strategies for clinical research.

This template includes a step-by-step checklist for monitors and covers all the important aspects of a site initiation visit.

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

This template includes a step-by-step checklist for monitors covering all the important aspects of a routine monitoring visit.

Documents protocol deviations and corrective actions. Provides rationale and context for trial irregularities for audit trails. Template & respective Instruction for use available

Documents protocol deviations and corrective actions. Provides rationale and context for trial irregularities for audit trails. Template & respective Instruction for use available

Presentation by swissmedic and Swissethic on the overview of the most significant changes in the new HRA ordinances in 2024 with a particular focus on the Clinical Trials Ordinance (ClinO) and Human Research Ordinance (HRO).