Trial Close-Out Phase

The End of Trial Declaration station follows the Early Termination station and precedes the Statistical Data Analysis station. This station follows the parallel processes of Safety Reporting, Progress Reporting, Ongoing Management & Monitoring, and GCP & Serious Breach Reporting, and also potentially an MHRA Inspection, Audit, Substantial Amendments, Addition of New Sites & Investigators, Temporary Halt, and Early Termination. The End of Trial Declaration is a legal requirement which is relevant to all trials. This station is part of the ‘trial close-out phase’ group of stations.

For CTIMPs, a Declaration of the End of a Trial Form must be sent to the MHRA within 90 days of the global end of the trial that is documented in the protocol*.  Once the ‘end of trial’ has been declared, no further substantial amendments are possible and a Clinical Trial Summary Report must be produced within the timelines detailed in the Clinical Trial Summary Report station. Further details relating to ‘end of trial’ requirements, including the requirements a local end of trial declaration, can be found on the MHRA website.

The Declaration of the End of a Trial Form must also be sent to the ethics committee and further information can be found on the HRA website. NHS R&D offices will also require notification in accordance with local policies/procedures. 

*Note: The definition of the end of the trial should be documented in the protocol. Research Ethics Committees SOPs (V 7.4 Section 10.94) provide guidance on the definition for the End of a Trial.

For non-CTIMP research, notification to the relevant ethics committee is required. The ‘Declaration of the End of Study’ for non-CTIMPs is available on the HRA website.

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