The legislation regarding the initiation and conduct of clinical trials in the UK is very detailed. This section is intended to provide a summary of the current legislation and links to sites where more information can be found.
The Medicines and Healthcare products Regulatory Agency (MHRA) is the government body that has responsibility for regulating clinical trials within the UK.
The MHRA conducts mandatory inspections for compliance with Good Clinical Practice (GCP).
The University of Glasgow was inspected by the MHRA in December 2007 and jointly with NHS Greater Glasgow & Clyde in December 2013. The agency made some recommendations at the time of the inspections which the University has since incorporated into current working practice.
It is important to be aware of what type of research is covered by the clinical trials legislation. The MHRA has produced an algorithm to help researchers to determine whether their research is a clinical trial. Investigators are strongly advised to use this tool to establish whether their research is classed as a clinical trial, and to contact the University Research Regulation and Compliance Office for further advice.
It is important that potential clinical trials are identified as early as possible as additional costs, such as regulatory approval fees, may need to be incorporated into the research budget. Some clinical trials may also require the University to purchase additional insurance.
Clinical trials sponsorship
Each clinical trial must have a sponsor. A sponsor is an organisation or institution that takes on the legal responsibility for the initiation and management of a research study, but is not necessarily the funder. If you wish the University to act as co-sponsor for your clinical trial you should contact the Research Regulation and Compliance Office as early as possible. If the University agrees to act as co-sponsor you must be aware of what the University expects from you as an investigator.
**The University of Glasgow does not sole sponsor drug clinical trials**
Please Note: The University sponsorship policy regarding Research Governance Framework Studies is significantly different to the policy for sponsorship of clinical trials. Please consult the Research Governance Framework section of these pages for more information.
At present, all non-commercial clinical trials led by a University of Glasgow employee are co-sponsored with NHS Greater Glasgow & Clyde (NHS GG&C). The University will only co-sponsor a clinical trial when it is appropriate to do so.
Before co-sponsorship can be agreed all trial protocols must be risk assessed by the NHS and the University. During the risk assessment the Research Regulation and Compliance Office will record key details of the trial. If both the NHS and the University agree to co-sponsor a study, a letter will be sent to the investigator confirming sponsorship status. Please contact the Research Regulation and Compliance Team for full details of the adoption process.
The roles and responsibilities of the co-sponsors are set out in study specific co-sponsorship agreements that have been developed between the University and NHS GG&C. These agreements must be in place before a clinical trial can commence.
Where the University agrees to act as co-sponsor, it must ensure adequate insurance/indemnity is in place.
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Regulatory and ethical approvals
Once sponsorship has been agreed by all parties, investigators must seek appropriate regulatory and ethical approvals for their proposed clinical trial. The easiest way to achieve this is by using the Integrated Research Application System (IRAS). IRAS captures the information needed for the relevant approvals from the following organisations:
- Administration of Radioactive Substances Advisory Committee (ARSAC)
- Gene Therapy Advisory Committee (GTAC)
- Medicines and Healthcare Products Regulatory Agency (MHRA)
- NHS/HSC R&D Offices
- NRES/NHS/HSC Research Ethics Committees
- Confidentiality Advisory Group (CAG), formerly the National Information Governance Board (NIGB)
- National Offender Management Service (NOMS)
- Social Care Research Ethics Committee
The University Research Governance Office can assist in gaining the approvals outlined above.
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Post approval and completion
During the course of a clinical trial an investigator may wish to alter the trial protocol. Some administrative changes can be detailed in the form of a letter to the regulatory and ethical authorities. However, some more substantial changes have to be communicated to the appropriate authorities via a substantial amendment. Investigators should contact NHS GG&C and the University's Research Governance Office to discuss the submission of amendments. Both sponsors must agree to the amendment before submission to the regulatory authority and ethics committee.
Investigators should contact the University Research Governance Office and NHS GG&C upon completion of their clinical trial. An end of trial declaration must be submitted to both the MHRA and the Ethics Committee.
Details of how to complete the end of trial declaration form and a substantial amendment form can be found on the MHRA website (see below). Once an end of trial declaration and an end of trial study report has been submitted all essential trial documents must be archived. The University requires data to be securely held for a period of ten years after the completion of a research project, or for longer if specified by the research funder or sponsor. However there are some exceptions i.e. paediatric studies. Please contact the Research Governance Office for further advice on archiving.
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