Guidance for results under new UK regulations

New requirements

On 28th April 2026, new regulations will come into place in the UK. You can find out more about the regulations on the Health Research Authority’s website.

The regulations have a section on Transparency (see HRA guidance), which will cover how the results of Clinical Trials of Investigational Medicinal Products in the UK should be reported.

For a trial which completes on or after 28th April 2026, a summary of results must be made publicly available in all registries that it has been registered in, within one year of completion.

For example, if a trial which has been registered on ISRCTN collects its last data on 1st May 2026, results must be uploaded and publicly available on ISRCTN before 1st May 2027.

When reporting results, the requirement is to add a basic summary of results, as well as a plain English summary of results if the trial was submitted for combined review after 28th April 2026.

Per the World Health Organisation’s guidance (item 23 of their Trial Registration Data Set), the basic summary of results must consist of the four following sections:

Participant Flow: A flow diagram showing participants involved at each stage of the study (namely enrolment, intervention allocation, follow-up, and data analysis). Please see an example of a flow diagram.

Baseline Characteristics: Table(s) showing demographic data and any clinical characteristics for participants at baseline, as well as any measures assessed at baseline that are used in analysing a primary outcome measure. Please see an example of a baseline characteristics table.

Outcome Measures: Table(s) of the results for the outcome measures listed in the ISRCTN study record. It is essential you should report on the primary outcome measure listed in the ISRCTN study record. Secondary outcome measures can also be reported here. Please see an example of an outcome measures table.

Adverse Events: Table(s) of all anticipated and unanticipated serious adverse events (life-threatening) and other adverse events (non-life-threatening), which will include a description of the adverse event and the number of participants affected. If there were no adverse events associated with your study, then please include a statement to the effect of “There were no adverse events associated with this study.”

Reporting results on ISRCTN

To report your results to ISRCTN and add them to your clinical trial record, we need two separate files – your basic summary of results (containing the four sections listed above), and your plain English summary of results.

If you haven’t already uploaded an up-to-date protocol for your trial, you will need to also do this at the same time, as well as link to any results publications you have already published, as these also form part of the basic summary of results.

You can submit your files to be uploaded to your record by either:

Using the file upload function on our Report Your Results page

Emailing info@isrctn.com with your files and the details of the trial record they relate to

Please note that the file upload process on the Report Your Results page is not instantaneous and requires manual oversight from the editorial team, so results will not appear straight away.

For an example of a clinical trial record which contains basic results, a plain English summary of results, and a protocol, please see ISRCTN1062149.

Tips to bear in mind when reporting your results

We recommend uploading or emailing your files as PDFs, or as Word documents

Basic results and plain English summary of results must be uploaded as two separate files

Your basic results must only include the four sections listed – Participant Flow, Baseline Characteristics, Outcome Measures and Adverse Events. No other sections should be included.

All of the outcome measures reported in the trial record registered must be reported in the basic results

Ensure results are emailed or uploaded in good time before the one year deadline for making results public, in case any changes are required

If your study is registered in multiple registries, results will also need to be added to those as well