When is research sponsorship required?
All research carried out within the NHS or social care will require a research sponsor in accordance with the Department of Health Research Governance Framework for Health and Social Care, Second Edition, 2005.
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.
The Research Governance Framework for Health and Social Care 2005 states that “The sponsor is the individual, or organisation (or group of individuals or organisations) that takes on responsibility for confirming there are proper arrangements to initiate, manage and monitor, and finance a study”.
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 ensuring 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 Research Governance Framework 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 firstname.lastname@example.org 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 email@example.com 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 supporting study documentation including (where applicable) a draft Integrated Research Application System (IRAS) form, study protocol and other participant facing documents such as questionnaires, participant information leaflets and consent forms.
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 unnaproved 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 will co-sponsor CTIMPs 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 University Sponsorship Committee for review. The Sponsorship 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.
The Sponsorship Committee meets on a monthly basis, and papers are circulated to members one week in advance. The 2016/2017 calendar of Committee meetings can be accessed here. Applicants will be notified of the Committee's decision within five working days.
In exceptional circumstances, an 'Intention to Sponsor' letter 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 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 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: http://www2.warwick.ac.uk/fac/med/research/hscience/ctu/conducting/planning/sop/
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 unblinding and ramdomisation 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.