Investigators are required to report Adverse Events (AEs) which take place during a research study to the Royal Brompton and Harefield hospitals' Research Office.
AEs are defined as any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product, and which does not necessarily have a causal relationship with this treatment.
If you have any queries about safety reporting, please contact the Research Office:
- Telephone: 0207 351 8109.
1. CTIMPs sponsored by Royal Brompton and Harefield hospitals:
It is essential to recognize serious or unexpected events to ensure the safety of research subjects and to gain a full understanding of any treatment or practice. Adverse Event (AE) reporting for all CTIMPs sponsored by Royal Brompton and Harefield hospitals must be undertaken in accordance with the Royal Brompton and Harefield hospitals' Pharmacovigilance SOP.
Royal Brompton and Harefield hospitals accepts the responsibility of Pharmacovigilance for all SAE/Rs occurring in a clinical trial that is sponsored by the Royal Brompton and Harefield hospitals' and falls within the remit of the Medicines for Human Use (Clinical Trials) Regulations 2004.
Serious Adverse Events/Reactions (SAEs/Rs) occurring in a CTIMP study sponsored by Royal Brompton and Harefield hospitals must be reported to the Research Office by completing the SAE Reporting Form. The investigator and/or a delegated member of the research team must complete the form as soon as they become aware of the event. The form should be sent to the Research Office immediately via email or by fax to 020 7351 8578.
The Research Office will acknowledge receipt of the SAE report by email within 5 working days of being informed.
The research team must supply any additional information or respond to Research Office queries as soon as the information becomes available. It is the responsibility of the investigator to ensure that all AEs are followed up until resolution.
Suspected Unexpected Serious Adverse Reactions (SUSARs) occurring during the conduct of Royal Brompton and Harefield hospitals sponsored CTIMPs are subject to expedited reporting to MHRA. Expedited reporting to the e-SUSAR database will be undertaken by the Research Office.
2. CTIMPs hosted at RB&HFT:
It is the responsibility of the Principal Investigator (PI) to ensure that all SAE/Rs, which occur in a subject, are reported to the study Sponsor immediately in line with the Sponsor’s procedure. The immediate report must be made orally or in writing and be followed by a detailed written report on the event.
Further information can be found in the Standard Operating Procedure (SOP) for Recording and Reporting of Safety Information for Externally Sponsored CTIMPs.
3. All OTHER RESEARCH STUDIES in Royal Brompton and Harefield hospitals
If a research participant experiences an SAE it should be reported to the Research Office and the REC that gave a favourable opinion of the study (the ‘main REC’), wherein the opinion of the CI the event was:
- ‘related’: that is resulted in 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.
Reports of related and unexpected SAEs should be submitted within 15 days of the CI becoming aware of the event, using the NRES SAE Reporting Form. The form should be completed in typescript and signed by the CI.
4. ADVERSE INCIDENT reporting:
Any adverse incident may be defined as: “any event that causes, or circumstance arising during NHS care that could have or did lead to unintended or unexpected harm, loss or damage”. Incidents of a clinical origin i.e. related to direct patient care (e.g. medication error, medical equipment failure or patient fall) are termed ‘Patient Safety Incidents’. Those of non-clinical origin (e.g. property loss, theft, fire, verbal abuse or threatening behaviour or an incident involving a member of staff or a member of the public) are termed non-clinical adverse incidents. It is irrelevant if either type of incident resulted from human error, a systems failure, a combination of minor errors or no error at all. If it was not intended and caused or had the potential to cause, harm it is classed as an incident and the Quality and Safety Department must be informed via the online incident reporting system, Datix.
The reporting should be undertaken in line with the Royal Brompton and Harefield hospitals' Adverse Incident Management and Reporting Policy.