- How to declare the end of a study
The end of the trial is normally defined as the last visit of the last participant, unless otherwise specified in the protocol. There are different processes to go through depending on whether you are undertaking a Clinical Trial of Investigational Medicinal Products (CTIMPs) or undertaking any other research. For all research studies other than CTIMPs, it is the responsibility of the Chief Investigator to notify the HRA and REC that gave a favourable opinion of the research, the Sponsor and R&D Department of the end of the study. The end of the study is defined as the final date or event specified in the protocol, not the completion of data analysis or publication of the results.
The Chief Investigator should complete a Declaration of the end of a study form available from NRES and send it to:
- Main REC that provided a favourable opinion;
- Research Sponsor: where Lancashire Teaching Hospitals NHS Foundation Trust is the Sponsor, please send documents to the Research Governance team;
- Please send copies of the End of Study form to the Research Access team
For a CTIMP the end of the clinical trial must be formally defined in the research protocol. It is a legal requirement of the current regulations that the competent authority (MHRA) and main REC are notified that the clinical trial has ended. For CTIMPs, this responsibility is often delegated by the Sponsor to the Chief Investigator for the clinical trial. The Chief Investigator (CI) is responsible for submitting the Clinical Trial Report to the MHRA no later than 1 year after the end of the trial.
- Funding Body Requirements
Funding bodies require a final report outlining how their funds have been used and the outcomes of the study.
- Dissemination of research findings
Health and social care research is conducted for the benefit of patients, users, care professionals, and the public in general. Therefore, all those pursuing health and social care research must open their work to critical review through the accepted scientific and professional channels. The obvious route to inform the research community is through publication in scientific journals. However dissemination strategies can also include: presentation at local, regional and national conferences and meetings; informing research participants of research findings and informing service users of findings.
- Archiving of Research Documents
Following the close of a trial it is necessary to archive all trial related documentation to ensure that all study documentation are:
- Stored correctly and confidentiality maintained;
- Not passed on without the appropriate consent;
- Accessed in-line with Trust policies and procedures;
- Only used for the defined purpose;
and to ensure:
- Patient safety in using and recording information;
- Up-to-date information is stored;
- Staff awareness of responsibilities and accountability;
- Information is accessible when required;
Storage of personal data is subject to the Data Protection Act 1998 and, in clinical trials, the applicable elements of the UK Clinical Trial Regulations.
Please contact the Centre for Health Research and Innovation regarding the procedure for archiving all study documents on ALL research studies that are sponsored by or hosted by Lancashire Teaching Hospitals NHS Foundation Trust. The length of time for archiving is dependent upon each individual protocol and/or guidance from the commercial sponsor.
Further details can be found in the document