Good Clinical Practice (GCP) is an ethical and scientific international quality standard provided by the International Conference on Harmonisation (ICH) for designing, conducting, performing, monitoring, auditing, recording, analysing and reporting of clinical trials, or studies that involve the participation of human subjects.
Governments have transposed GCP into regulations for clinical trials. Compliance to this standard provides assurance to the public that clinical trial data and reported results are credible and accurate. It also demonstrates that the rights, safety, integrity, confidentiality and well being of trial subjects are protected, consistent with the principles enshrined in the Declaration of Helsinki.
GCP can add to the quality of work and help to establish the most efficient and effective way to adhere to its guidelines. As healthcare practitioners, physicians, scientists, and researchers, everyone wants safe and effective treatments for patients. Adherence to GCP is the best way to ensure this in a clinical trial. It is also in the best interests of the participants.
Conducting clinical research in accordance with the principles of GCP helps to ensure that participants in clinical research are not exposed to undue risk, and that data generated in the research is legitimate and correct. Thus, GCP serves not only the interest of clinicians and those involved in the research process, but also protects the rights, safety, and wellbeing of subjects at the same time as ensuring that investigations are scientifically sound and advance public health goals.
The principles of GCP state that: Each individual involved in conducting a trial should be qualified by EDUCATION, TRAINING AND EXPERIENCE to perform his or her respective task(s) as per the Guidelines for GCP. GCP training forms one component of the systems for ensuring high quality research. It’s a key requirement for anyone carrying out, or involved, in clinical research and clinical trials to ensure they are best prepared to carry out their duties.
GCP training provides the research community with insight into the rules and regulations that are applicable to clinical trials, highlights the roles and responsibilities of a principle investigator, the complexities of informed consent, personal information, storage of materials, etc. It serves as a basic education platform on the standards of practice for conducting research.
The training should be appropriate and proportionate to the type of research undertaken, and should cover the responsibilities of researchers as they are set out in relevant legislation and standards. There is no set requirement for the frequency of such training. Researchers are expected to maintain awareness of current standards through reference to published guidance and relevant policies. Training should be updated when legislation has changed, new policies or practice have been implemented, different research activities are to be undertaken, or a significant period of time has elapsed since research activities have been conducted.
