Research Reporting Requirements

During the conduct period of a research project you are required to provide:
• study initiation report
• annual progress updates and safety reports to review bodies*

Following the end of research project you are expected to:
• notify review bodies that the study has ended and provide end of study reports*
• make arrangements for future use of research data and samples
• fulfil commitments to study participants, such as providing information of the research outcomes and after care protocols
• publish and disseminate results of the research

*The SEHSCT IRD Office will accept copies of reports submitted to the REC as fulfilling NHS reporting requirements.

Study Initiation Report
It is the responsibility of the Innovation, Research and Development Office to ensure we are recruiting patients to approved projects. To this end we require some information from you at the outset of your project conduct. These details are dependent on the type of research you are carrying out.
(Dates provided should be in reference to research activity carried out within SEHSCT only)

SEHSCT Project Initiation Report

Annual Progress Reports
A progress report should be submitted to the relevant review bodies 12 months following the date favourable opinion/approval was received from the Research Ethics Committee and annual report should be submitted yearly thereafter until the end of the project. The SEHSCT Research Office will accept copies of the reports submitted to the Ethics Committee as fulfilling NHS reporting requirements. If your project did not require Ethical Approval please complete the SEHSCT (R&D approval only) annual report template. If your project has not started within 12 months of approval the report should focus on the reasons for the delay.

Templates for the different forms (dependant on the type of research) are available below:

Annual Progress Report^ (CTIMP, REC Approved)
Annual Progress Report (non-CTIMP, REC Approved)
Annual Progress Report (R&D Approval Only)
^For CTIMPS this annual progress report is in addition to the Annual Safety Report

Declaration of End of Study (EOS) and Final Report
The Declaration of EOS is due within 90 days of the end of study date. As with annual progress reports, the template used depends on the category of research. If your project did not require Ethics Committee Approval then please complete the SEHSCT (R&D Approval Only) version of the form.

Declaration of End of Study (CTIMP, REC Approved)
Declaration of End of Study (non-CTIMP, REC Approved)
Declaration of End of Study (R&D Approval Only)

A summary of the final study report is due within a year of the conclusion of the research project. While there is no standard template for a final report summary it should contain, at a minimum, information on whether the study achieved its objectives, the main findings and arrangements for publication and dissemination of the research (including commitments to participants). SEHSCT R&D SOP 22, Appendix 3 outlines the requirements of a final report.

If you experience any problems when downloading SOPs or associated documents, or have any comments, please contact us:

Telephone : 028 9055 3101
E-Mail : research.development@setrust.hscni.net