Research completion
Overview
Completion or end of trial/study is normally considered as the date when the last participant has their last visit (of all sites, if multi-site) and sample processing has concluded.
The definition of research end must be clearly described in the protocol. The Chief Investigator must notify the MHRA (Clinical Trials (CTIMPs) and Device Trials) REC, CTRG and relevant NHS trust (if applicable) within 90 days of the end of the research. Completion of a Clinical Trial (CTIMP) must be reported by completing the End of Trial Form.
A final Clinical Trial DSUR may be sent at the same time or on the next due date.
Archiving
In line with the Medicines for Human Use (Clinical Trials) Amendment Regulations 2006, OUH R&D requires that all essential documents be retained for at least five years after the completion of Clinical Research, or for a longer period if there are other applicable requirements e.g. clinical trials leading to a marketed product, or genetic studies.
If the study involves minors under 18 years old, essential documents should be archived until the youngest subject reaches 21 years old, or five years after the conclusion of the study, whichever is longer.
Publication and Final Report
The publication policy should be addressed in the protocol, a written agreement or a departmental SOP.
The Chief Investigator must provide a summary of the clinical research within one year of research completion to the MHRA (if a CTIMP/Device Trial), REC, R&D and other NHS trusts (if applicable).
Please inform R&D of the reference when your paper is accepted for publication.