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Clinical Trials of Investigational Medicinal Products (CTIMP's)
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Sponsor approved work instructions and template |
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How to use this website |
If you have any questions about Clinical Trials of Investigational Medicinal Products,
contact the R&D Quality Assurance Team Tel: 0113 392 6473
What is a Clinical Trial
of an Investigational Medicinal Product (CTIMP)?
A clinical trial that is within the scope of the UK Medicines for Human Use (Clinical Trials) Regulations 2004, i.e. a trial that tests the safety or efficacy of an investigational medicinal product. Does your study involve a drug and your are unsure if it is a CTIMP?
You must confirm with the R&D Quality Assurance Team.
For more information, please see Is the trial within the scope of the UK Regulations? station in the Clinical Trials Tool Kit
If you have any doubt if you are undertaking a CTIMP research project, please contact the R&D Quality Assurance Team who will confirm this with you.
What are the Clinical Trials Regulations 2004?
An EU Directive has been issued with the aim of harmonising the different rules and procedures for clinical trials throughout the EU. The Directive has been transposed into law in this country under the Medicines for Human Use (Clinical Trials) Regulations 2004. The Regulations will help to ensure that the rights, safety and well-being of clinical trial subjects are protected by requiring sponsors of trials to be responsible for designing, conducting, recording and reporting clinical trials according to internationally recognised principles of good clinical practice.
What research is affected by the Regulations?
The Regulations have wide reaching implications for all clinical trials of investigational medicinal products (CTIMPs)
The EU Directive and the implementing UK Regulations cover only investigations/studies which are undertaken to ascertain the efficacy or safety of a medicine in human subjects and which follow an ethically and regulatory approved research protocol. Non-interventional studies are excluded from the Regulations.
Sponsorship
It is a statutory requirement that all clinical trials that fall under the Medicines for Human Use (Clinical Trials) Regulations 2004 have a named Sponsor. Therefore all research carried out within the Leeds Teaching Hospitals NHS Trust (LTHT) or the University of Leeds (UoL) requires a Sponsor to be identified prior to the trial commencing. How to identify a Sponsor for the CTIMP?
The Sponsor must satisfy itself that the study meets all relevant standards and ensures that arrangements are put and kept in place for adequate management, monitoring and reporting.
The 3 main components of Sponsorship are
• Authorisation and Ethics committee opinion
• Good Clinical Practice and Conduct
• Pharmacovigilance
If your CTIMP will require sponsoring by the LTHT or UoL then you must contact the Quality Assurance Department at the draft protocol stage, following the approved process for trial set up and acceptance of sponsorship .
For clinical trials that are being sponsored by the LTHT or UoL, the Sponsor requires that researchers utilise this website and the work instructions and templates herein. All work instructions and template documents have been approved by the Sponsor and are compliant with the relevant regulatory and GCP requirements. The Sponsor has delegated specific duties to the research team, these are detailed within the work instructions, however the Sponsor (as named on the Clinical Trial Authorisation from the MHRA) remains legally accountable for all aspects of Sponsorship.
If another organisation has formally agreed to undertake the role of sponsor for your CTIMP and the trial is to take place within the LTHT or UoL, then confirmation of the sponsor acceptance must be submitted with the R&D application .
Quality Control
The Quality Assurance (QA) Department spans the Leeds Teaching Hospitals NHS Trust and University of Leeds, as part of the pan-Leeds Strategy Board for Health, which is an agreement between the two organisations to work closely together as a research partnership. The QA Department works on behalf of both organisations, when acting as Sponsor for CTIMPs.
