Results should be made available in a place they can be seen and in a way that they can be understood by the public.

The HRA request a final report for studies they have approved, which is submitted using their Final Report Form, and which they publish on an accessible website.

It is also important to maintain your registration record, uploading results to the registry or database used to make that study public.

Reporting results to ISRCTN is straightforward. If you have published the results in a peer-reviewed journal, you can provide a link to the publication on PubMed or the DOI. If you have not published within 12 months or do not intend to publish, you should upload a basic results summary here.

Guidance on reporting results to clinicaltrials.gov is here.

EudraCT

CTIMPs that were running before January 2021 are registered on the EudraCT database. Results must be uploaded to the database within 12 months of the ‘end of trial’ or within 6 months of the ‘end of trial’ for paediatric studies.  

This task is delegated to Chief Investigators of CTIMPs co-sponsored by the University of Edinburgh and NHS Lothian.

Registering with EudraCT

The CI or delegated person in the research team should:

• Register as a user to provide results data with EudraCT click here to register
• Contact ACCORD with the username, e-mail address and EudraCT number to request to be assigned as a results user to that trial QA@accord.scot
• Data can then be uploaded

MedDRA Coding Adverse Events for Upload

All Adverse Events (AEs) must be coded to System Organ Class (SOC) using the MedDRA web-based tool. 

• Contact ACCORD to request a MedDRA ID and password and additional guidance on where to access training at QA@accord.scot

Uploading Data

If you require any guidance for uploading result related information, contact ACCORD at resgov@accord.scot.

Confirming Upload

When your upload is complete, you must submit a confirmatory e-mail to the Medicine and Healthcare products Regulatory Agency (MHRA). 

• Title the email ‘End of trial: result-related information: EudraCT XXXX-XXXXXX-XX’ and e-mail to CT.Submission@mhra.gsi.gov.uk
• Copy the Sponsors in this e-mail at QA@accord.scot  
• Note you will not receive an acknowledgment e-mail or letter from the MHRA

There is no requirement to submit an end of study report to the MHRA.  An end of study report should be sent to the Research Ethics Committee and the Sponsor.  Further information on CTIMP reporting can be found in ACCORD SOP CR011 Clinical Study Report Preparation.

Further guidance on uploading data is available on the EudraCT website. 

Commission Guideline 2012/C 302/03 also provides further information on posting results.