Case #14: Good Clinical Practice and GCP units
Cases are examples of questions and inquiries we recieve in the Guidance Function, which we would like to share for inspiration.
A researcher contacted the Guidance Function with an inquiry regarding a clinical trial and asked for information about what Good Clinical Practice means.
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the conduct of a clinical trial involving human subjects. GCP describes the ethical and scientific aspects of a clinical trial and could be descripted as the clinical trial’s “ISO standard”. GCP includes all aspects of a clinical trial, from the planning phase, the implementation of the project, and the reporting of the results. The purpose of GCP is to ensure that the subjects’ rights, safety and well-being are taken care of. Furthermore, ensuring that the collected data is valid, complete, and well documented.
In Denmark there are three GCP units located in Copenhagen, Aarhus/Aalborg and Odense. The GCP units offer guidance and monitoring of medicine and medical device trials to ensure the GCP guidelines are fulfilled. The GCP units offers to be responsible for the monitoring of clinical medical trials, which are led and initiated by non-commercial or public researchers affiliated with university hospitals, regional hospitals and universities in Denmark. This offer applies to all public trials that are obligated to notify the Danish Medicines Agency.
Further information can be found at the GCP units’ website: English – GCP-Enhederne, GCP og Lægemiddelforsøg – GCP-Enhederne
In this case, we assisted the researcher to achieve an overview of what Good Clinical Practice is and introduced the researcher to the GCP units. We also included links to the GCP unit’s general website and a link and contact information to the GCP unit in the region of the researcher.
Please feel free to contact us if you need guidance in your research project. Our services are free, and we aim to reply to any inquiries within 2-4 working days.
The Guidance Function offers first-level support for Danish and international researchers in need of help to navigate the requirements and processes surrounding research projects.
Tel. +45 2494 7969