Safety Reporting (Research other than Clinical Trials of Investigational Medical Products (CTIMPs)) for UK Health Departments’ Research Ethics Service (RES)
Serious adverse event
In research other than CTIMPs, a serious adverse event (SAE) is defined as an untoward occurrence that:
a) results in death;
b) is life-threatening;
c) requires hospitalisation or prolongation of existing hospitalisation;
d) results in persistent or significant disability or incapacity; or
e) consists of a congenital abnormality or birth defect; or
f) is otherwise considered medically significant by the investigator.
A SAE occurring to a research participant should be reported to the REC where in the opinion of Chief Investigator (CI) the event was:
- related – that is, it resulted from administration of any of the research procedures, and
- unexpected – that is, the type of event is not listed in the protocol as an expected occurrence.
|SAE||Chief Investigator (CI) or sponsor.||Within 15 days of the CI becoming aware of the event.||SAE report form for non- CTIMPs, available from the HRA website.||The REC which issued the favourable ethical opinion.|
|Urgent safety measures||Chief Investigator or Sponsor. Or exceptionally by the local Principal Investigator (PI).||Immediately (by telephone) Within 3 days (in writing)||
Noting in writing setting out the reasons for the urgent safety measures and the plan for further action.
The REC which issues the favourable ethical opinion.
Approvals Officer/REC Manager will acknowledge within 30 days.
|Progress reports||To be submitted by sponsor, sponsor’s legal representative or Chief Investigator (CI). Must always be signed by CI.||
Annually (starting 12 months after the date of the favourable opinion).
The REC may exceptionally request more frequent reports.
|Annual progress report form (non-CTIMPs), available from the HRA website.||The REC which issued the favourable ethical opinion.|
|Declaration of the conclusion or early termination of the research||Sponsor or CI.||
Within 90 days (conclusion).
Within 15 days (early termination).
The end of the trial should be defined in the protocol.
|End of study declaration form, available from the HRA website.||The REC which issued the favourable ethical opinion.|
Note: This is only applicable for project-based research (i.e. not research tissue banks or research databases) that have received a favourable ethical opinion from a REC
|Sponsor or CI.||
Within one year of the conclusion of the research.
|Final Report, submitted via the HRA website or via IRAS, depending on the type of study.||Submitted centrally to the research ethics service.|
All reports will be acknowledged within 30 days. If any issues are raised, the REC may write to the Chief Investigator or sponsor for further information or clarification.