REGISTRATION NOW CLOSED
CTU Registration Process
The Registration Process has been established for CTUs responsible for coordinating multi-centre clinical trials or other well-designed studies. The UKCRC Registration process is designed to help improve the quality and quantity of available expertise to carry out clinical trials in the UK.
Forms & Guidance
Registration Workshop - for presentation slides click here.
Applications can be made from any CTU in the UK responsible for leading the design, the central/national coordination and the overall analysis of multi-centred randomised controlled trials (phase II-IV) or other well-designed studies* using the application proforma. CTUs with responsibility for only the local coordination of trial activity and supply of local data to a central coordinating CTU would not be eligible for registration. CTUs working in any disease/topic area are eligible to apply.
The Registration process and the UKCRC Registered CTU Network is operated on a self funding basis. For this reason, there is a Registration application fee of £500 which covers the administration and International Review Panel costs. For unsuccessful applications there will be no refund. Fees are payable online to make a payment please Click Here
Please note that applications which have been submitted without the correct fee will not be considered. Payment (in full) should be received before the application deadline of 05 April 2012.
Depending on the number of successful applications a subsequent annual registration maintenance fee of around £2000 will be payable on designation as a successfully UKCRC Registered CTU. This maintenance fee will cover the delivery of the UKCRC Registered CTU Work Programme.
In order to obtain Full Registration status, CTUs were required to demonstrate:
- A track record and experience of coordinating multi-centre randomised controlled trials (phase II-IV) or other well-designed studies*
- Presence of a core team of expert staff to develop studies
- Presence of robust quality assurance systems and processes to meet appropriate regulations and legislation (e.g. the principles of Good Clinical Practice, the NHS Research Governance Framework, the Data Protection Act and the UK regulations that implement the EU Directive for Clinical Trials)
- Evidence of longer-term viability of capacity for trials coordination and the development/maintenance of a trials portfolio, including core funding or evidence of a rolling programme of grants, with evidence of commitment from the host institution.
All currently registered CTUs are invited to re-apply for Registration. Applications will also be accepted from CTUs that have not previously applied.
It is recognised that some new and evolving CTUs may be developing relevant expertise and experience that is worth building on, but that these CTUs may not yet meet all of the criteria for Full Registration status. Therefore, evaluation criteria for Provisional Registration has been developed which recognises CTUs that are clearly working towards possessing sufficient experience and expertise to obtain Full Registration. CTUs will be awarded Provisional Registration only if they are able to demonstrate evidence of the competencies for Provisional Registration.
It is expected that Units awarded Provisional Registration should demonstrate they have the capacity and ability to meet the full criteria in 3 years.
It is recognised that some clinical trials are managed by collaborative groups where the expertise required may not exist within the same research group. Applications from collaborative groups are eligible, and these include groupings within the same host organisation, as well as geographically distinct collaboratives. In all cases, there will need to be clear evidence of formal arrangements and assignments of responsibilities between the groups and clarity about the roles of each group. Sufficient detail should be provided in the proforma to enable the UKCRC CTU Registration Committee to be confident that formal arrangements are in place for collaboration, that all key competencies are met, and that the partnership would be capable of continued success in the face of changes in key personnel.
If successful, the collaborative group will be Registered, not the individual components of the collaboration. It is also recognised that new or smaller CTUs may have relevant expertise and experience that may be worth building on, but which fall short of the full complement of infrastructure, resources, and experience required for Registration. It is hoped that rather than lose such expertise and commitment, these CTUs could either collaborate with another unit to fulfil the totality of requirements for UKCRC CTU Registration or apply for Provisional Registration. Such CTUs should demonstrate that they have the capacity and ability to meet the full criteria over time (expected within a 3 year timeframe).
*Must run one randomised control trial.
APPLICATION FORM & WORD VERSION (It is recognised that completing the form will require contributions from different individuals. To assist applicants we have provided a word version so that questions can be easily disseminated. However, Applications should only be submitted in pdf format).
KEY COMPETENCIES & EVALUATION CRITERIA