Clinical Research and GCP Update

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Clinical trial registration

• Clinical trials should be registered on existing and established international registers such as the ISRCTN registry or ClinicalTrials.gov. • For trials involving both UK and EU sites, there should be a record in the EU Clinical Trials Register (except for adult Phase I studies). • In the UK, any favourable opinion given by a REC is subject to the condition that the clinical trial is registered on a publicly accessible database. • Registration should occur before, and no later than 6 weeks after, the first participant is recruited.

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Summary of results

• Sponsors should publish summary results within one year (6 months for paediatric studies) in the public register (or registers) where the trial has been included. • The clinical trial summary report does not need to be submitted to the MHRA. • A short confirmatory email (with a link to the information) must be sent to the MHRA once the result-related information has been uploaded to the public register. • For any clinical trial not on a public register, summary results should be submitted to the MHRA.

• A final report should also be submitted to the REC within the same timeframe.

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