Good Clinical Practice (GCP)
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct and record of research involving humans. There are 13 principles of GCP (listed below) and compliance with GCP provides public assurance that the rights, safety and well-being of research subjects are protected and respected, in line with the principles enunciated in the Declaration of Helsinki and other internationally recognized ethical guidelines. It also ensures the integrity of research data.
Further detailed information can be found on the European Medicines Agency - Good Clinical Compliance website.
Definition of Good Clinical Practice (GCP)
Definition from EU Directive 2001/20/EC article 1, clause 2:
“Good clinical practice is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.”
Compliance with this good practice provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible and accurate. The principles of good clinical practice are outlined in articles 2 to 5 in the EU Directive 2005/28/EC . ICH Topic E 6, the ICH Note for Guidance on Good Clinical Practice is an international standard for GCP. It was adopted by the CPMP (CPMP/ICH/135/95) I July 1996 and became operational in the European Union (EU) in January 1997. The ICH Note for Guidance on GCP replaced the previous European Community GCP Guidelines, which were implemented in 1991.
GCP - 13 Principles
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Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
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Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
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The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
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The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.
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Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
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A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion.
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The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.
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Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
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Freely given informed consent should be obtained from every subject prior to clinical trial participation.
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All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.
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The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
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Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.
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Systems with procedures that assure the quality of every aspect of the trial should be implemented.
GCP Training:
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) and Medical Research Council GCP guidelines both 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)." To comply with these regulations, all members of staff must maintain a complete record of their ongoing personal development to demonstrate that they are competent to perform duties appropriate to their role in each trial.
The University runs training sessions on Good Clinical Practice.
Further Information
The Medicines for Human Use (Clinical Trials) Regulations 2004