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.
- Research recruitment
- 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.
To find out about statistical support for research studies please go to the Biostatistics group page.
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.
The investigator site file (ISF) for all non-UCL/UCLH sponsored studies (this includes commercial sponsored and externally sponsored non-commercial studies, where UCLH is a site) are to be archived with Iron Mountain. Staff are to request boxes, labels and arrange collection using their IM-Connect username and password.
If a department or user does not have access to Iron Mountain’s portal IM-Connect (www.ironmountainconnect.com) a request should be sent to uclh.medicalrecordsMH@nhs.net with details of the department name, study budget code, the authorised user name with email address, address & telephone number for where the deliveries and collections will be used which will then enable Medical Records to create an account.
For information and FAQs on how Brexit may affect your research, see our dedicated Brexit page