Written evidence submitted by University of Cardiff (CTF0035)

Cardiff University recognises the importance of clinical trial transparency, and a significant amount
of activity has been undertaken within the last year. In response to the two questions in your email:

 Verification that your institution has systems in place to comply with international clinical
trials regulations
The latest version of the University’s Code of Practice for Research Integrity and Ethics (CoP)
requires that summary results must be posted on every relevant registry within 12 months
of the trial completion. The latest version of the CoP was approved by the University
Research Integrity and Ethics Committee in May 2019 and released in August 2019.

Processes in place to ensure that summary results are posted on the relevant registries
within 12 months include:
 A Memorandum of Understanding (dated March 2018) with the University’s Centre
for Trials Research (CTR), requiring CTR to: ensure that all trial results are placed in
the public domain.
 A Memorandum of Understanding (MoU) is signed between the Sponsor, Trials Unit
and Chief Investigator for each trial. The template MoU (dated April 2019) specifies
that results must be published on the relevant registries within 12 months of trial
completion.
 Guidance for uploading trial results to EudraCT (June 2018)
 SOP on the Generation, review and approval of a Clinical Trial Report (September
2016)
 Study Closure SOP and Study Closure Checklist (August 2016)

 Verification that all relevant data has been uploaded to the EU clinical trials database, for
clinical trials where your institution is sponsor or co-sponsor

80.6% of Cardiff University’s ‘Due Trials’ have reported results on the EU Trial Register. With
the aim of achieving 100% compliance, a tracker is in place to review entries on the EU Trials
Register, ISRCTN and clinicaltrials.gov. The tracker is regularly reviewed and updated at
monthly meetings between Sponsor representatives and the Centre for Trials Research.
Progress is reported to University’s Clinical Trial Governance Group, the Open Research Task
and Finish Group and the University’s Research Integrity and Ethics Committee.