End of Trial Declaration - Clinical Trials Toolkit
For CTIMPs not submitted through Combined Review, an End of a Trial Form must be sent to MHRA within 90 days of the trial's end, with no further substantial amendments allowed. A Clinical Trial Summary Report is required. The form must also be sent to the ethics committee, and NHS R&D offices notified. For non-CTIMPs, notification to the relevant ethics committee is required.
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For CTIMPs not submitted through Combined Review, an End of a Trial Form must be sent to MHRA within 90 days of the trial's end, with no further substantial amendments allowed. A Clinical Trial Summary Report is required. The form must also be sent to the ethics committee, and NHS R&D offices notified. For non-CTIMPs, notification to the relevant ethics committee is required.
If a trial is terminated early, the sponsor should notify the MHRA within 15 days using the End of Trial Form. The sponsor must provide reasons for early termination and describe follow-up measures. A Clinical Trial Summary Report must be produced. The Declaration of the End of a Trial Form must also be sent to the ethics committee.