Whilst a research study is active (recruiting or in-follow up), researchers will be required to report information to the study sponsor, host Trust or organisation and/or regulators.
- Updates on recruitment, reaching study milestones
- Amendments - any changes to the study
- Incidents which may happen on your study
- Complaints from participants
- Information relevant to financial management and invoicing related to the study
The sponsor and/or NHS Trust will also request other updates as and when required in order to faciliate local or national reporting requirements.
Researchers should ensure that any significant changes which affect the conduct, safety, progression of financing of a study are reported to the relevant sponsor and/or R&D office.
To find out more about how UCLH use Patient information in health and care research, go to the HRA site.
End of study
Once you have notified your REC that the study has ended, the next step is to send a Final Report which provides a publicly available summary to the Research Ethics Service in support of transparency requirements.
For information on closing down or archiving your study or setting up site or study records, please refer to Resources and Templates.
For information and FAQs on how Brexit may affect your research, see our dedicated Brexit page