The Guidelines for Good Operational Practice (GGOP) are a framework of common standards for professional and operational practice in clinical research and are mainly used by the SCTO’s CTU Network, investigators, and sponsors. They are intended to guarantee participant safety and high-quality standards and to ensure careful use of restricted academic budgets.These GGOP were included in the International Compilation of Human Research Standards (2021 edition), which was collated by the U.S. Department of Health & Human Services (HHS).
The GGOP document is divided into two main parts and includes four appendices.
- Part I describes the establishment and maintenance of a quality management system
- Part II describes CTU services supporting the implementation and maintenance of clinical research management.
Its four appendices can be downloaded as individual PDFs and cover the following topics:
- Appendix 1: Glossary
- Appendix 2: Data Management Guidelines
- Appendix 3: Guidelines for Risk-Based Monitoring
- Appendix 4: Training and Education in Clinical Research Switzerland
Whenever there are any major regulatory changes or evidence for improvement, the SCTO works together with its CTUs and associated network partners to update the main document. Updates are usually made within two years of its publication. The appendices are continually reviewed, adjusted, and replaced as deemed necessary. The SCTO’s Auditing Platform is currently conducting a thorough review of version 3.0 to reflect the latest parameters in clinical research.
Appendix 3 (Risk-Based Monitoring) is is complemented by the Risk-Based Monitoring Score Calculator, first released together in June 2019.
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 until further notice.