The SCTO’s Guidelines for Good Operational Practice (GGOP) represent a framework of common standards for professional and operational practice in clinical research.

The Guidelines for Good Operational Practice reaches its third iteration. Both the Guidelines themselves and its Appendix 1 (glossary) were newly revised in early 2018. Please note that version 3 of the GGOP is published separate from all its Appendices. These can be downloaded as individual PDFs.

The SCTO is proud to have our GGOP publication included in the International Compilation of Human Research Standards (2021 Edition), collated by the U.S. Department of Health & Human Services (HHS).

The GGOP were thoroughly polished by the SCTO and experts from the CTU Network in early 2018. In addition to a more reader-friendly language throughout, revisions included updates in content and structure to reflect latest parameters in clinical research:

• Bringing the GGOP into line with the adoption of ICH E6 (R2), giving important guidance and insight into various topics, such as sponsor/investigator responsibilities and risk-based monitoring. 
• Complying with the revised European Standard ISO 9001:2015, including the emphasis on the strategic direction of the organisation and its relevant stakeholders as well as their expectations. Yet another major focus is an increased emphasis on risk-based thinking. 
• Integrating the recent structural developments within the CTU Network since the GGOP’s last review, such as the introduction of thematic Platforms which serve as pools of expertise. 

Current standards and legal regulations also led to the revision of our Guidelines for Risk-Based Monitoring. Our Monitoring Platform presents practical monitoring solutions for clinical studies.

• Risk-Based Monitoring (RBM) Score Calculator
• Guidelines for Risk-Based Monitoring, published as Appendix 3 of the Guidelines for Good Operational Practice (GGOP), Version 3.0

Appendices 2 (Data Management Guidelines) and 4 (Training and Education in Clinical Research in Switzerland), all marked “Under revision”, are currently being revised. The prior versions of them are available (below) until further notice. All annexes can be downloaded as individual PDFs.

To obtain competent answers to general monitoring questions or to offer feedback on these resources, contact us at monitoring@scto.notexisting@nodomain.comch.