When is research sponsorship required?
All research carried out within the NHS or social care will require a research sponsor in accordance with the UK Policy Framework for Health and Social Care Research (2017).
In addition, all trials involving an Investigational Medicinal Product (IMP) will require a research sponsor under the Medicines for Human Use (Clinical Trials) Regulations 2004.
University sponsorship approval will also be required for clinical trials carried out outside the UK to ensure the appropriate sponsor oversight on behalf of the University, ensuring compliance with sponsor responsibilities and other applicable legislative requirements.
The UK Policy Framework for Health and Social Care Research (2017) states that “The sponsor is the individual, organisation or partnership that takes on overall responsibility for proportionate, effective arrangements being in place to set up, run and report a research project”.
The Sponsor is responsible for ensuring that arrangements are in place for the research team to access resources and support to deliver the research as proposed and that agreements are in place which specify responsibilities for the management and monitoring of research. They are also responsible for identifying and addressing poorly designed or planned research and poor quality research proposals, protocols or applications, as well as ensuring that proposals are scientifically sound. Sponsors must also ensure that arrangements are in place to review significant developments as the research proceeds, particularly those that put the safety of individuals at risk, and to approve modifications to the study design. The UK policy framework for health and social care research requires that the sponsor be confirmed prior to the commencement of a study.
Clinical trials of Investigational Medicinal Product/s (CTIMPs) are governed by the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended). These require that all CTIMPs must declare an agreed sponsor to the Competent Authority prior to the commencement of the trial. The Competent Authority in the UK is the Medicines and Healthcare Products Regulatory Agency (MHRA).
The University does not allow individuals to sponsor trials, and any University employee or student that wishes to deliver a study within the NHS or social care must apply to the University for sole or co-sponsorship.
In certain cases, the University’s decision to sponsor a study shall be dependent on the study being ran through a UK-CRC registered Clinical Trials Unit.
Some general principles of University sponsorship are outlined below and set out in detail in the University Sponsorship and Oversight Policy, which can be accessed via the link on the top right-hand side of this page.
Please contact the Research Governance Team via email@example.com if you require further information.
How do I apply for sponsorship?
The Research Governance Team in R&IS should be contacted at the earliest opportunity via firstname.lastname@example.org for advice and guidance regarding whether University sponsorship will be required, how to apply and the timescales involved.
All applications for University sole or co-sponsorship should be made on the University Sponsorship Application Form.
The completed form should be submitted to the Research Governance Team via the above email address along with the following documentation:
- Research Protocol
- Participant Information Sheet (PIS) - If the study involves more than one participant group, please provide a PIS for each
- Consent Form - If the study involves more than one participant group, please provide a consent form for each
- Evidence of Peer Review
- Evidence of funding
- Chief Investigator and applicant's academic CV
- Relevant training certificates including GCP
- A draft copy of your Integrated Research Application System (IRAS) form
- Data Flow Map
- Health Research Authority (HRA) Organisation Information Document (OID) and Schedule of Events (SoE)
- If applicable - Questionnaires
- If applicable - Interview Schedule (If the study will use semi-structured interviews with no strict schedule, the applicant should still submit an outline of the types of questions that will be asked)
- If applicable - Recruitment material (Poster, email, leaflet, social media posts)
- If applicable - For studies that involve any work overseas, the applicant should submit the above documents translated.
Sponsorship and study types
|Type of study||Definition||Sponsorship model|
Clinical Trial of an Investigational Medicinal Product.
A clinical trial that tests, or uses as a reference, a pharmaceutical form of an active ingredient or placebo. This can include a product with a marketing authorisation when used or assembled in a way different from the approved form, or for an unapproved indication, or to gain further information about an approved use.
All CTIMPs are legally required to comply with the Medicines for Human Use (Clinical Trials) Regulations 2004 and associated amendments and fall under the regulation and inspection of the MHRA.
The University may act as sole sponsor or agree to co-sponsor with an appropriate NHS Trust.
The University will usually expect a CTIMP to be managed by a UK-CRC registered CTU.
|Interventional study||A clinical study in which participants are assigned to receive one or more interventions (or no interventions) so that researchers can evaluate the effects of the intervention on biomedical or health related outcomes. Participants may receive diagnostic, therapeutic or other types of interventions. Randomised controlled trials or studies that are non-CTIMPs may also be interventional studies.||
The University may act as sole or co-sponsor.
The University shall usually expect a UK-CRC registered CTU to be involved in medium-high risk interventional studies.
|Non-interventional/ observational studies||
This study type may involve patients, NHS staff or healthy volunteers as participants, but the study does not affect any clinical care that the participant may be receiving.
Examples include studies involving:
The University may act as a sole or co-sponsor.
The University shall generally not require the involvement of a CTU. However, this is dependent on the nature of the study.
How are sponsorship applications assessed?
All applications for University sponsorship are referred to the Sponsorship & Oversight Committee for review. The Committee may approve sole or co-sponsorship, issue conditional approval or refuse sponsorship. The over-arching principles of University sponsorship are set out in the University Sponsorship and Oversight Policy, which can be accessed via the link on the top right-hand side of this page.
A calendar of Committee meetings can be accessed here. Applicants will be notified of the Committee's decision within ten working days.
In exceptional circumstances, an 'Intention to Sponsor' letter or signature may be provided to enable applications to proceed prior to full sponsorship review taking place. This decision will be made at the discretion of the Chair of the Sponsorship & Oversight Committee.
Withdrawal of sponsorship
The University has the discretion to withdraw sponsorship of a study where information provided on the original application changes without prior approval of the Sponsorship & Oversight Committee, including but not limited to changes to:
- The Chief Investigator;
- Co-sponsor status;
- Randomisation strategy.
Sponsorship may also be withdrawn if there is a failure to comply with the University’s Research Code of Practice by the CI or any member of the study team.
Responsibilities of the Chief Investigator
The Chief Investigator (CI) is the individual with responsibility for the day-to-day running of a study, and for the safety of the study participants. This includes, but is not limited to, responsibility for the study budget, overseeing the work of the study staff, ensuring that the study is conducted rigorously and on time, that the results are made available and that all necessary regulations are complied with at all times.
CIs and their research teams are also required to comply with all relevant requirements of Standard Operating Procedures (SOPs), which are applicable to all University of Warwick sponsored studies, including those ran outside Warwick Clinical Trials Unit and Warwick Medical School. These are available on the Warwick Clinical Trials Unit web pages and can be accessed via the following link:
In the case of a study that are being under taken by a student as part/fulfilment of an academic qualification, the application for sponsorship should be made in the name of the student’s University-employed supervisor, with that supervisor taking on the responsibility for and being named as the CI.
The University has certain defined expectations of the CI. These shall be agreed on a case-by-case basis and include but are not limited to a duty of the Chief Investigator to ensure that:
- There are adequate resources in place for the running of the trial or study, in terms of funds, staff, facilities, and infrastructure;
- The medical care of trial subjects and/or study participants is assured at all times;
- Staff involved in the trial or study have the appropriate Good Clinical Practice (GCP) training to demonstrate the ability to deliver their delegated elements of the trial;
- Regular and timely communication is maintained throughout the trial and/or study with the sponsor, the NHS Research Ethics Committee, and the MHRA as appropriate;
- There is full compliance with the protocol;
- Investigational Medicinal Product (IMP) accountability, where required, is assured, with site responsibility clearly delegated to an appropriate pharmacist;
- The trial’s un-blinding and randomisation procedures are followed at all times, where applicable;
- That GCP guidelines on informed consent are followed at all times;
- That records and reports are appropriately created, managed, stored, and archived, including the Trial Master File, Site Files, CRF and source documentation, financial agreements;
- That, where appropriate, the Development Safety Update Report (DSUR) is submitted to the MHRA, and the annual report to the NHS Research Ethics Committee and sponsor;
- That all Serious Adverse Events (SAEs) are reported to the sponsor;
- That trial subjects and/or study participants are promptly informed in the eventuality that the trial or study ends prematurely or is suspended;
- That the final report is provided to the NHS Research Ethics Committee, sponsor, and regulatory authorities, as appropriate.