Registration FAQ

Yes, but CTUs are advised to only make an application if they can provide evidence that the unit meets the essential criteria for either Full or Provisional Registration. Please note that CTUs that have made an unsuccessful application since 2016 are unable to apply again during this round.

An international panel of clinical trials experts review all applications for CTU Registration. Expertise on the panel include: Clinical epidemiology, Clinical Trials Unit Director, Experienced triallist, Information Systems, Trial Management, Statistics, Funder/ triallist. A list of all members is available on the registration page.

All Registered CTUs have provided evidence that their work is of high quality. In order to obtain Full Registration status, CTUs were required to demonstrate:

– a track record and experience of coordinating multi-centre randomised controlled trials 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
– evidence of longer-term viability of capacity for trials coordination and the development/maintenance of a trials portfolio.

Provisional CTUs tend to be newer and evolving CTUs and have not yet built a track record but have relevant expertise and experience that is worth building on. Evaluation criteria for Provisional Registration were developed for CTUs that did not meet the criteria for Full Registration status, but that are working towards possessing sufficient expertise to enable Full Registration within 3 years.

No.

Yes if more than one site.

One publication must be main trial results. It says in the form that publications must be from separate clinical trials (or other well designed studies) that best demonstrate your units activity. Published protocols from different studies do qualify.

The criterion says “ideally all funded independently of specific research grants” You should describe the nature of their contracts in question 2.4.

Yes. Trial databases should provide a robust and secure store for trial data. There should be separation of data entry screens from backend data; an audit trail logging date-stamped changes (who, when, what – ideally even why); access should be controlled by user login, preferably refined by role; multi-user access with associated record locking is a requirement; a regular backup mechanism is essential, ideally utilising a transactional rather than file approach. Whatever system is used, it must be validated – that is, there is detailed a functional specification and extensive evidence of successful testing against this specification. The process for designing and implementing trial databases using the system should also be clearly defined by standard procedures.

Yes, if the trial would satisfy eligibility for NIHR portfolio if funded today.

If the trials are multicentre then, yes.

If you don’t have other alternatives yes but explain how they demonstrate your trials unit’s activity.

Yes, if you have gone through competitive funding and if it meets NIHR Portfolio eligibility (or equivalent devolved nation’s portfolio eligibility).

No – But you do need to demonstrate their support.

Yes – the CV Template is just a guide, do substitute relevant sections.

Yes.

This varies across institutions. however, in the pats the International Review Panel have felt concerned about the lack of formal arrangements in some institutions.

Describe your local situation and explain how it works collaboratively however, the International Review Panel has been concerned in the past where no formal governance arrangements have been in place. You also need to submit supporting letters from Partners.

Regardless of title, the question is concerned about who fulfils the function.

The Review Panel has expert representatives of all key specialist areas, including IT.

Yes, if you can demonstrate it includes all necessary functionality e.g. user access control, robust backup, audit trail etc.

There is no expectation, this is not part of the core competencies.

This means where data is entered onto the clinical trials data capture system directly by site or the patient, regardless of whether there is a paper Case Report Form (CRF).

This is where a bespoke database has been developed to specifications provided by the CTU rather than them using a commercially available package.

If ‘Sealed Envelope’ refers to the company of that name and the CTU is using that company and provides specifications, oversight and funding for randomisation, then the Panel would consider the CTU to be undertaking randomisation. If the query refers to use of actual sealed envelopes then the CTU needs to explain in the application how these are generated, what the security is around their use and any plans to move away from such a system.

Yes so long as it is well managed.

Registration is now open.

Yes.

Yes. However, the International Review Panel have been concerned in the past when they have received multiple applications from one institution and felt that where this was the case the CTUs should be collaborating and the host institution should have a clear rationale for supporting multiple CTUs. In addition, NETS CC are advising that only one application per institution for NETS CC Pump Priming will be supported.

Studies should not be counted twice. In this scenario, a study should be reported as recruiting even if there are more patients in follow-up than in recruitment.

Assign the lead person to this i.e. the one who has made the most contribution or the one who is most senior.

No

It is acceptable to say that you are involved in all processes as you have set up the data entry system.

Answer yes if you are undertaking the statistical analysis.

Only if requested and, if so, within the timeline stated.  Failure to do so will affect your registration application.