- By ICR Secretariat
- Posted Thursday, November 2, 2017
Joint Statement on the Application of Good Clinical Practice to Training for Researchers
This joint statement advocates a proportionate approach to the application of GCP training to researchers.
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
Researchers can sometimes be required, inappropriately and often disproportionately, to undertake GCP training when they do not conduct research in the field of clinical trials of investigational medicinal products (CTIMPs) or where their involvement in the trial is minimal and entirely within their professional expertise.
This document clarifies the requirements and expectations for researchers and staff involved in different types of research:
- For all CTIMPs it is the high level “conditions and principles” of GCP set out in the UK Clinical Trials Regulations that must be complied with and interpreted in proportion to the risks posed to the participants and to the integrity of the results.
- Sponsors of CTIMPs which are not to be included as part of a marketing authorisation application can choose to comply with ICH GCP as a standard in its entirety but may take a more proportionate approach depending on the
nature of the trial.
- Staff involved in the conduct of clinical trials need to be appropriately trained but the specific training does not need to follow a generic syllabus, format or prescribed timing. It should be appropriate and proportionate to the activities undertaken by staff involved in the clinical trial.
Other types of research:
- There is no legal requirement for other types of research (i.e. studies which are not clinical trials of investigational medicinal products) to be conducted in accordance with the conditions and principles of GCP.
- Such research should be conducted in a manner that provides public assurance that the rights, safety and wellbeing of research participants are protected and that research data are reliable. Members of the research team in such studies are expected to be qualified by education, training or experience but should not be required or expected to undertake GCP training.
To read the full report follow the link above or click here.