Edinburgh Clinical Trials
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How to get your trial adopted and access support

Information on how to get your trial adopted, how you can access ECTU support and use our services.

ECTU Trial Portfolio and UKCRC Registration

Funders of large scale academic clinical trials (e.g. NIHR) often request that a Registered Clinical Trials Unit is involved in the application.  As clinical trials are often high value and high risk (in terms of budget and delivery) projects, funders require the reassurance that there is the infrastructure in place to manage such projects.

The process of obtaining the necessary registration requires ECTU to demonstrate a track record in delivering studies, a quality framework to which the studies are operated and sustainability. 

To utilise the ECTU registration number on research applications, the study must be formally adopted into the ECTU Trial Portfolio.

There are a number of criteria which are considered when adopting a study into the ECTU Trial Portfolio.

  • The trial poses an important question, the results of which have the potential to impact on the care and/or treatment of patients
  • The trial will aim to be published in a high impact journal
  •  The trial must be well-designed and methodologically sound
  • The trial design has been reviewed by ECTU and ACCORD for risk assessment and feasibility
  • The funding secured is sufficient to ensure the completion of the trial
  • The trial will be conducted in accordance with ECTU SOPs
  • The trial dataset will be managed by a data management system overseen by ECTU
  • ECTU will be represented by a co-applicant on the funding application and will be acknowledged in the publications.

For adopted studies where trial management sits outwith the ECTU core team, a charge of £100 per annum, per study will be levied (as a contribution to the UKCRC annual renewal fee).  

ECTU Supported Studies

ECTU also supports studies not in the trial portfolio.  Such support is often on a ‘pick n’mix’ basis where researchers can request such support as needed.

Examples of such support are

  1. Statistical & methodological advice and input; ECTU has a team of statisticians and health economists who are able to advise on the design, powering and feasibility of clinical studies.  They can also support analysis and reporting as agreed.
  2. Data management; ECTU offers a data management system which supports the generation of a suitable data management plan and process for the robust and regulatory-approved holding and management of research data.
  3. Clinical Services: ECTU has a team of clinical research nurses who can advise on the feasibility of clinical studies and recruit and follow up patients in both primary and secondary care settings.

Studies supported in this way are not eligible to use the UKCRC registration number.

 

For enquiries on accessing ECTU support please complete the enquiry form  and/or email your contact details as below.

 

Edinburgh Clinical Trials Unit

Contact details

Address

Street

University of Edinburgh
level 2, NINE Edinburgh BioQuarter
9 Little France Road

City
Edinburgh
Post Code
EH16 4UX