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General

Registration Criteria

Section 1

 Section 2

Section 3

Section 4

Section 5

Section 7

Section 9

 

Can any CTU apply for UKCRC Registration?

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.

 

Who decides whether a CTU should be UKCRC Registered?

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.

  

What is the difference between Full and Provisionally Registered Units?

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. .

 

Our CTU deals only with non-CTIMP trials, is there any criteria that any of our 5 (or 3) trials need to be CTIMP trials?

No

 

What is the definition of multi-centre trial being applied? We perform RCTs using multiple identification, recruiting and treating sites but some are in the same geographical region, say a single PCT, whereas some are more geographically widespread – is this sufficient to be a multi-centre trial?

Yes if more than one site.

 

In terms of the Summary of Portfolio, should we assume that each study is represented only once, e.g. if a study has had the main trial results published but there are other manuscripts in analysis, e.g. health economics or methodological analyses, then should that study only be counted in the "published studies” section?

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.

 

You ask for Senior Statisticians, Senior Trial Managers and IT/IS persons "funded independently of specific research grants". Does this mean that those posts cannot be funded from any research grants, either one individual or a combination? Different institutions have differing funding/finance models, so it would be useful to get clarity on the type of staff who can be included.

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

 

Is it possible for us to 'make a case' regarding our use of ACCESS as the main software for database design in the light of our exclusively non-CTIMP trial portfolio?

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.

 

Can we include trials that started out as MRC funded, but have migrated to NETSCC and recruit in the UK?

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

 

Are feasibility trials eligible instead of phase 3 trials?

If the trials are multicentre then, yes.

 

Can we submit applications that are funded, have all authorisations but not active to recruitment, due to delays?

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

 

If a clinical trial is UK based but all centres are overseas would that still be acceptable?

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

 

Does the host institution have to be a University?

No – But you do need to demonstrate their support.

 

Some of the sections in the CV template do not apply to particular roles such as IS, can we submit our own?

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

 

In section 7 is it acceptable to state extent of availability based on principle?

Yes.

 

How formal should our governance structure be in order to assure the committee that there is a clear strategic direction?

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

 

How formal should collaboration be?

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.

 

We have different titles for the roles specified in section 2.

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

 

Is my MS Access system enough to satisfy the IS criteria?

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

 

Is there an expectation for CTUs to provide remote data capture?

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

 

Is a paper based system for SOPs acceptable for smaller CTUs?

Yes so long as it is well managed.

 

When is the next call for registration?

Registration is now open.

 

Can the Director and key staff be the same individuals?

Yes.

 

Can more than one CTU apply for registration from an institution?

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.

 

Some of our studies are at a stage where they are still recruiting but have already started follow-up for some participants. Could I then count that study in both ‘Recruiting’ and ‘Follow-up’ on the form or should I go with the predominant activity?

Suggest that the predominant activity is reported.

 

In section 1.1 ‘Who was involved in the design from your unit?’ On the PDF this only allows one line for the answer, i.e. one person. For quite a number of applications/studies we are or have been involved in up to 4 people from our unit have contributed to the study design. Is there any guideline on how or who to report for this particular question?

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

 

Will there be an appeals process?

No.

 

In response to the item "Is your unit responsible for the data management, data entry and central monitoring of ALL study sites?" how should we answer if the actual data entry is remote, i.e. is done by site staff, albeit under the oversight of the CTU?

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

 

In regards to the item "Will your unit be responsible for the primary publication of the study?" I suspect that in most cases it will be the Chief Investigator/lead applicant for funding who will have primary responsibility, i.e. will take the lead on the primary publication, in the sense of lead authorship, though of course the CTU will make a major contribution. How should a CTU respond in these circumstances?

Answer yes if you are undertaking the statistical analysis.

 

Do we need to send in our SOP's?

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