September 2020: United Kingdom Regulatory Update

MHRA issued on September 01, 2020, a new guidance on registering and results posting of clinical trials and related requirements as from 01 January 2021.

Registration of your clinical trial:

Actions for those involved in registering clinical trials
You should use existing and established international registers such as ISRCTN registry, or, to ensure the public is aware of your trial. For trials involving both UK and EU sites a record in the EU Clinical Trials Register will exist (other than adult Phase 1 studies).

If a sponsor wishes to request a deferral of study registration within the required timeframe, in accordance with current transparency rules (e.g. due to commercial sensitivity), they should contact the Health Research Authority (HRA) at [email protected].

The UK makes information about trials being conducted in the UK available to the public, patients, researchers and clinicians via the HRA research summaries website and UK “Be Part of Research” website.

Publishing trial results:
The time frame for publishing the summary of results is within 6 months of the end of trial for paediatric clinical trials or within one year of the end of trial for non-paediatric clinical trials.

Actions for those publishing results
You should publish your summary results within these timeframes in the public register (or registers) where you have registered your clinical trial.

You do not need to submit this clinical trial summary report to the MHRA as well; however, you must send a short confirmatory email to [email protected] once the result-related information has been uploaded to the public register and provide a link. If your clinical trial is not on a public register, summary results should be submitted to the MHRA.

You should also submit a final report to the Research Ethics Committee within the same timeframe for reporting the summary of results.

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