Under the regulations overseeing CTIMP studies, “serious breaches” of GCP or the trial protocol must be reported to the MHRA.
The Sponsor of a clinical trial must notify the licensing authority (MHRA) in writing within 7 days of any serious breach.
For the purposes of this regulation, a “serious breach” is a breach which is likely to affect to a significant degree:
- the safety or physical or mental integrity of the subjects of the trial
- the scientific value of the trial.
The Sponsor should be notified immediately of any case where the above definition applies during the trial conduct phase in line with the Sponsor’s SOP on this issue.
For CTIMPs sponsored by the Royal Brompton and Harefield hospitals, the Assessment and notification of potential serious breaches of GCP or the trial protocol of a CTIMP study sponsored by the Royal Brompton and Harefield hospitals' SOP must be followed.
All serious breaches associated with CTIMP studies at Royal Brompton and Harefield hospitals, regardless of whether they are sponsored or hosted by Royal Brompton and Harefield hospitals, should be reported to the GCP and Research Governance and Regulatory Compliance Manager, Ira Jakupovic (or via email to safetyreporting@rbht.nhs.uk).