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The Medicines for Human Use (Clinical Trials) Regulations 2004 (the Regulations) have regulated clinical trials in the UK since they came into force on the 1 May 2004.
Within the Regulations, provisions prohibit certain activities without specified requirements being met; of note are the ‘no person shall…’ clauses. These include Regulation 12 and Regulation 28 which require (among other things), that anyone conducting a clinical trial shall not do so unless the trial has received an appropriate authorisation, favourable ethical opinion and that conduct adheres to the conditions and principles of good clinical practice. (These conditions are set out in Schedule 1 of the Regulations).
The regulations relate to persons or organisations that participate in any aspect of a human clinical trial, including the laboratories that are responsible for the analysis of clinical samples.
The analysis of samples collected from patients and healthy volunteers participating in clinical studies forms a key part of the clinical trials process, providing important data which is used to make decisions on an investigational medicinal product’s safety, efficacy and mechanism of action. This data may also contribute to the initiation of new drug development and research projects. Consequently, it is essential that laboratory analysis is performed to an acceptable standard which will ensure patient safety is not compromised and that data are unbiased, accurate and complete.
The transposition of the EU Clinical Trials Directive 2001/20/EC into UK law (Statutory Instrument 2004 No.1031: The Medicines for Human Use (Clinical Trials) Regulations 2004 as amended) provides provision for the inspection of clinical laboratories. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has responsibility for monitoring clinical laboratories for compliance with the Clinical Trials Regulations. Compliance is assessed by inspections which on average are performed once every two years. However, it is important to note that the frequency of inspections may be increased or reduced depending on the level of compliance maintained by the laboratory and that an inspection ‘for cause’ may be performed at any time
What is 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 and Schedule 1, Part 2 of the UK Clinical Trial Regulations.
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) in 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.
Guidance on the maintenance of regulatory compliance in laboratories that perform the analysis or evaluation of clinical trial samples
The following guidance document has been produced by the MHRA's Inspection Group in order to provide clinical laboratories with information that will help them develop and maintain quality systems which will comply with the Clinical Trials Regulations. It is also designed to provide information on the expectations of the MHRA’s inspectors who may be assigned to inspect facilities that perform work in support of human clinical trials.
The MHRA Inspection Group would welcome your comments on the content of the document, all of which will be considered when the guidance is reviewed in 12 to 18 months time.
Please send any comments to GCPClinLab@MHRA.gsi.gov.uk
Fees for GCP Clinical Laboratory inspections are charged at a daily rate.
Please see the follow sections for further information:
Good Laboratory Practice: Events
Good Clinical Practice
Contacts for further information
Any enquiries concerning GCP for Clinical Laboratories should be sent to GCPClinLab@mhra.gsi.gov.uk
For enquiries relating to a specific GCP Clinical Laboratory inspection; please contact the appropriate inspector:
Andrew Gray - firstname.lastname@example.org
Samantha Atkinson - email@example.com
For further information or other general enquiries regarding GCP issues please see the Good Clinical Practice section.