Sponsorship

A sponsor is required for all clinical research.

The sponsor's role is to:

  • take legal responsibility for initiating and managing the study
  • provide insurance for the study

The sponsor is not necessarily the funder and many funding bodies are unable to provide sponsorship.

University sponsorship process

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The University usually assumes sponsorship when a University employee has designed the study and is acting as the chief investigator.
 

The University must actively consent in writing if it is to act as sponsor.

If you would like the University to sponsor your study, please contact CTRG as early as possible:

  • For clinical trials, please contact at the time of funding application.
  • For other clinical research studies please send your documents for sponsorship review when they are prepared. Timelines for the review process will be agreed at the time the application is assigned to a member of the CTRG team for review (which, depending on workload, may be several days after you send us your full document set). It is important that you adhere to these timelines to allow CTRG to process your application efficiently.
     

Before submission to a research ethics committee all relevant study documentation for research proposals must be reviewed by CTRG staff.

Note that CTRG will need to review your documentation prior to submission if the study is going to CUREC, involves only healthy volunteers and includes the following:

  • administration of a drug or food product (non-CTIMP)
  • NHS staff or data

Please see the CUREC pages for more information.

The purpose of the CTRG sponsorship review is to:

  • check that the proposed research and written protocol are appropriate
  • assess the quality of the application to anticipate REC queries
  • ensure appropriate information is provided to potential participants in outward facing documents
  • confirm that information sheets and consent forms follow HRA REC guidelines
  • ascertain that requisite legislation and guidance is being applied
  • ensure University insurance will cover the participants for harm as a consequence of negligence
  • confirm whether no-fault cover will also apply
     
  • All substantial amendments are approved by CTRG before submission to CUREC, NHS REC and HRA (NHS sites in England), the MHRA or NHS trusts (with NHS sites outside England).
  • Non-substantial amendments including changes in end date, additional sites for non-CTIMP, minor administrative changes are notified to CTRG and to the relevant REC.
  • All annual progress reports, development safety update reports (CTIMPs only) and end of trial/study notifications must be copied to CTRG.

CTRG maintain a database of all University-sponsored and hosted clinical research to facilitate compliance with applicable governance, regulations and reporting timelines. It is vital you send us regular study updates as the database is used for preparing annual insurance returns to the University’s insurance provider, including data on the number of participants, number of sites and start/end dates.
 

Insurance and indemnity

For most studies, CTRG can confirm indemnity within the letter of sponsorship.

However, certain categories of research must be referred by CTRG to the University insurance officer for individual consideration before doing so.

Research involving any the following will need to be referred:

  • children under 5 years old
  • investigation of processes of conception/contraception
  • participants who are pregnant
  • participants from outside the UK
  • administration of drug/device/vaccine which has been designed, developed or manufactured by the University
  • any genetically engineered product

CTRG will liaise with the insurance officer to determine whether cover can be arranged and, if so, any potential cost.

Unless your study is on the CTRG database, indemnity is not assured.

It is important that both the IRAS form and the participant information sheet include the correct indemnity statements. This is assessed individually on review of the study or trial. CTRG will advise on appropriate wording.

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