Any research being carried out within the NHS or Health and Social Care context in the UK must have a Sponsor who is willing to undertake the lead for the management and arrangements relating to a research trial.
The Sponsor of a clinical trial may in fact be any one of a number of entities including the main funder; the Chief Investigator’s employing organisation or the lead organisation providing health or social care.
Individual researchers are not able to undertake the role of Sponsor within NUH.
NUH is willing to undertake this sponsorship role and in doing so agrees to take on the responsibility for ensuring that proper arrangements are in place to initiate, manage, monitor and finance a clinical trial.
NUH is willing to undertake the role of Co-sponsor for clinical trials where the main sponsor is situated outside of the UK (e.g. within Europe) and will also act as the UK representative for internationally sponsored clinical trials. In both situations you should contact the R & D Department at the earliest opportunity to make the necessary arrangements in terms of research governance, financing and contracts.
Single Site NUH Sponsored Clinical Trial
The R & D Department has generated the following agreements for use in NUH sponsored studies so as to clearly outline the respective parties’ responsibilities for trial management.
Bipartite (Sponsor and Chief Investigator) Delegation of Responsibility Agreement
NUH as Sponsor may delegate certain responsibilities to the Investigator. It is the Chief Investigator’s responsibility to ensure that both themselves and their Research Team are fully versed in and fully understand their responsibilities under this agreement
Tripartite (Sponsor, Clinical Trials Unit and Chief Investigator) Delegation of Responsibility Agreement
NUH as Sponsor will on occasion utilise the resources of the Clinical Trials Unit to perform some of the tasks required for efficient trial management. In such cases the responsibilities of the three (3) parties to the agreement are clearly defined and each should ensure they are fully versed in and understand their responsibilities under this agreement