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Policy for Clinical Research
Introduction
This Policy should be read in conjunction with the University’s Code of Good Practice for Research and seeks to ensure that, in addition to the principles that are to be enshrined in all research undertaken by members of the University, the statutory requirements applying to clinical research are fully observed.
Sponsorship
The Sponsor is an institution or organisation that takes on the legal responsibility for the initiation and management of the research study, but is not necessarily the funder. Commercial Funders of a Clinical Trial will normally also act as Sponsor, but most of the main funding bodies that provide grants for research are now not able to take on the responsibilities of Sponsor.
Non-CTIMP Trials
For Trials that do not involve Investigational Medicinal Products the University may assume sole Sponsorship of a Clinical Trial where it is appropriate to do so, ie where a University employee or research student has designed the study and is acting as the Chief Investigator. Sponsorship of any clinical research carries a Department of Health requirement to comply with the Department of Health's Research Governance Framework for Health and Social Care 2005. In these cases, the University must actively consent in writing to acting as Sponsor of the study. The Intellectual Property Manager, acting for the University, is responsible for providing consent for Sponsorship in these cases, through the IRAS electronic authorisation system or in writing. The Researcher must, as early as possible, provide to the Intellectual Property Manager a copy of the Protocol for the trial, evidence that ethical approval has been sought and granted from an appropriate University ethics committee and demonstrate that consideration has been given to the necessity for special approval from the University’s insurers – Clinical Trials and Trials/Studies involving Human Participants.
CTIMP Trials
Sponsorship of a Clinical Trial (or aspects of a trial) carries with it the legal responsibility to ensure compliance with the Medicines for Human Use (Clinical Trials) Regulations 2004, Amendment 2006 and Amendment (No. 2) 2006 (PDF, 44 KB) and the Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008.
IMP is defined as a pharmaceutical form of an active substance or placebo being used as a reference in a clinical trial, and includes a medicinal product which has a marketing authorisation but is, for the purposes of the trial
(a) used or assembled (formulated or packaged) in a way different from the form of the product authorised under the authorisation, or
(b) used for an indication not included in the summary of product characteristics under the authorisation for that product, or
(c) used to gain further information about the form of that product as authorised under the authorisation. This means that IMPs include any medicines given to subjects in the course of a research study or trial, whether or not these are already licensed for the same or another indication – full definition.
However, if in doubt, researchers should always seek advice and confirmation from the Medicines and Healthcare Products Regulatory Agency’s Clinical Trials Helpline, clintrialhelpline@mhri.gsi.gov.uk and seek a written statement confirming whether the project falls under the Regulations. All correspondence sent to and received from MHRA should be retained in the Trial Master File.
It is now a firm policy, ratified by the Clinical Trials Sponsorship Committee (CTSC) in September 2010, that all CTIMP trials involving University of York staff as Chief Investigator will be co-sponsored with a suitable partner organisation, usually the York Teaching Hospital NHS Foundation Trust. The R and D Unit of the Trust provides specified ‘infrastructure’ services to the University, including SOP training, advice on CTIMP management and department or research team audits. All staff wishing to participate in CTIMP research studies are required to familiarise themselves with CTIMP Standard Operating Procedures (SOPs) published on the Unit’s website at www.research.yorkhospitals.nhs.uk and managed by the R and D Unit. A full roll-out of these SOPs will be implemented by 1st April 2011.
Procedures for approval and management
Early discussions
Before a proposal is submitted to a funding body, the University’s Intellectual Property Manager and the Head of R and D at the Trust should be consulted. In particular, they will want to ensure that adequate funding is being sought to ensure adequate monitoring of the trial, the costs of the Experimental Medicine Unit facilities and other non-University facilities, such as pharmacy have been considered as well as the usual CTIMP costs of production, labelling of IMPs to the Good Manufacturing Practice standard, CTA application fees, any other third party costs as appropriate. The University’s insurers should be consulted, through the Insurance Office in Health, Safety and Welfare Department and an initial advice on the cost of insurance and the probability of non-negligent harm cover being required should be discussed with the Insurance Officer. The Insurance Officer will consult the Insurers and inform the Chief Investigator of the results. The insurers must have accepted coverage of the Trial in principle before formal agreement for co-sponsorship can be applied for – written confirmation will be provided by the Insurance Officer.
Standard Operating Procedures
Staff will use the CTIMP Standard Operating Procedures (SOPs) published on the Unit’s website and managed by the R and D Unit, supplemented by study specific protocols as appropriate. In particular, Sponsorship must be agreed by the North and East Yorkshire R and D Committee. The procedures for initial feasibility review, further development and final approval, all explained in R and D/CTIMP/S02 will apply.
Approvals
The University’s Clinical Trials Sponsorship committee, through the Intellectual Property Manager who is a member of the Trust’s R and D Committee and the Clinical Trials Sponsorship Committee, should be kept informed of the progress of a trial approval through the three stages above and be given a chance to comment on any issues it may wish to have brought to the attention of the R and D Committee.
Only when the R and D Committee has given final approval for a study, may the Chief Investigator and research team apply for a EudraCT number and the necessary external approvals: ethics approval, a Clinical Trials Authorisation (CTA) and, if NHS patients or use NHS facilities is involved, Trust Management Approval.
Thereafter, conduct of all aspects of the research will need to be the subject of study-specific contracts. As Co-Sponsors, the University and the Trust will be co-signatories to such agreements with any relevant third parties. Contracts will be negotiated by the University’s Intellectual Property Manager and the Trust’s Head of R and D.
Added 15th February 2011
