THE 2021 REGISTRATION CALL HAS 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.
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.
Please note that this call is open to all CTUs that meet the published registration criteria. Currently registered CTUs do not need to apply during this round unless specifically notified to do so.
Fees – Application Fee
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 of the review process and the costs relating to the International Registration Review Committee. For unsuccessful applications there will be no refund. Fees are payable online. To make a payment please visit the on-line store.
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 12 noon on Friday 06 August 2021.
Annual Registration Fee
Please note that upon successful registration an annual registration maintenance fee of £3000 will be payable. This maintenance fee will cover the delivery of the UKCRC Registered CTU Work Programme and will be payable for each year that membership continues.
The annual registration maintenance fee is payable via the online store. Further details will be made available in due course.
In order to obtain Full Registration status, CTUs are 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.
*Must run one randomised control trial.
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 have been developed which recognise 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 within 3 years.
It is recognised that some clinical trials are managed by collaborative groups where the full range of expertise required may not exist within each individual 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).
Host institutions with multiple registered clinical trials units or unregistered research groups within their organisation that have taken the decision to combine the expertise into one distinct CTU are eligible to apply.
The following scenarios provide an example of how you should apply if one or more of the units/groups merged hold registration status:
If an Existing Fully Registered CTU (lead CTU) within the host institution merges with an unregistered research group or provisional registered CTU and the new merger takes on the identity and processes of the existing Fully Registered CTU then you must complete the Renewals proforma and provide details and clear evidence of the merger in section 9 in order to satisfy the Review Committee that all key competencies are met and the new merger is capable of continued success. If the new merger does not take the identity and processes of the Fully Registered CTU then you must apply as a new applicant.
If two or more Fully Registered CTUs within the host institution merge and the new merger takes on the identity of one of the existing Fully Registered CTU (Lead CTU) then you must complete the Renewals proforma and provide details and clear evidence of the merger in section 9 in order to satisfy the Review Committee that all key competencies are met and the new merger is capable of continued success. If the new merger does not take the identity and processes of a Fully Registered CTU then you must apply as a new applicant using the standard form.
If the merger is between two provisional registered units you should apply as a new applicant using the standard form and provide further information in section 9.
Please note that in all instances if the units/groups merge under a new organisation name then you should apply as a new applicant.
(CTUs holding Full Registration and undergoing quinquennial review should use this form) see information and Guidance Notes for more details).
Information on the membership of the International Registration Review Panel can be found here.