Research Adverse Events
Definitions
The requirement and process for recording and reporting adverse events will vary considerably depending on the nature of the research. For research in health or social-care settings there is more likely to be an expectation of reporting than in other fields, research into medicnal products and medical devices has much more strict, legally mandated, requirements. Intentions regarding safety reporting should be set out in your study protocol and will need to be approved by your Research Ethics Committee (REC) and, where applicable, by your Sponsor.
However, the same terminology can be applied in all cases. In the following definitions 'trial procedure' is any procedure that is mandated by the study protocol and that would either not be conducted on or by partipants if they weren't participating - or would not be conducted in the same manner.
Adverse Event (AE)
Any untoward medical occurrence in a study participant, including physical, psychological or emotional changes, clinically significant abnormal laboratory findings, a new symptom or illness or a worsening of an existing condition.
This includes events that are not causally related to any trial procedure. The causality of all such events such be considered, to determine whether they are an...
Adverse Reaction (AR)
Any AE which, in the opinion of an appropriately qualified investigator is 'Possibly', 'Probably' or 'Definitely' related to a trial procedure.
Serious Adverse Event (SAE)
Any AE which meets one or more of the following criteria:
- Results in the death of the participant
- Is life-threatening.
- Requires inpatient hospitalisation or prolongation of existing hospitalisation.
- Results in persistent or significant disability / incapacity.
- Is a congenital anomaly or birth defect.
- An AE which, in the opinion of the investigator is sufficiently severe or significant to require expedited reporting but does not fit any of the five SAE definitions. Otherwise referred to as an Important Medical Event.
Serious Adverse Reaction (SAR)
An AE that both meets the Serious criteria and is determined to be related to a trial procedure.
Suspect Unexpected Serious Adverse Reaction (SUSAR)
An SAR which was not an expected reaction to the related trial procedure.
In the case of a Clinical Trial of an Investigation Medicinal Product (CTIMP) Expected events will be listed in the Reference Safety Information for the Investigational Medicinal Product. For other research, any expected reactions should be listed in the protocol.
Regardless of the study specific recording and reporting arrangements (see below) a SUSAR must be reported as soon as the research team become aware of it. In health and social care research, they should be reported to the study Sponsor, who will report them onwards to the relevant REC and (where applicable) the MHRA. For other human-participant research, they should be reported directly to the REC.
These events are described as "Suspected" because they should be reported as soon as there is any possibility of an event meeting these criteria - even if detailed investigations are still ongoing.
Recording and reporting
For a CTIMP, the following processes are mandatory. For a Clinical Investigation of a Medical Device, the reporting requirements for SARs are mandatory.
For all other research, it is mandatory that recording and reporting procedures be considered, that procedures relevant and proportionate to the nature of the research be documented in the protocol and approved by the study Sponsor (for research in health and social-care settings) & REC, and that these procedures are followed throughout the course of the study.
As above, regardless of the applicable procedures, SUSARs must be reported as soon as the research team become aware of them.
Adverse Events and Adverse Reactions
All AEs should be recorded in study records associated to the participant and (where appropriate) in the participant's clinical record.
All AEs should be assessed by an appropriately qualified member of the study team to determine the causality (whether they are an AR) and whether they meet the serious criteria (whether they are an SAE / SAR).
Serious Adverse Events
SAEs should be reported within 24 hours of the research team becoming aware of them.
NB. SAEs also require recording in the study record, as per AEs.
Reporting for studies approved by an NHS REC (sponsored by the University)
SAEs are handled on behalf of the University by University Bristol and Weston NHS Trust (UHBW). They should be reported in accordance with UHBW Bristol Research Safety Reporting Standard Operating Procedure. UHBW will regularly inform the University about SAEs. Expedited reporting takes place where necessary to agree corrective / preventative actions.
In addition, all SAEs should be reported to the NHS Research Ethics Committee in the Annual Progress Report.
An adverse event reporting template is available within the UHBW SOP.
Reporting for studies approved via a Faculty / School Research Ethics Committee (F/S REC)
All SAEs should be reported to the Research Governance and Ethics Officer, who will notify the relevant F/S REC.
Generic templates for reporting adverse events are available: template 1 (Office document, 27kB), template 2 (Office document, 11kB).
Serious Adverse Reactions
SARs should be reported in the same manner as SAEs - in addition they should be assessed to determine whether they constitute a SUSAR.
NB. While causality and the serious criteria involve clinical judgement, expectedness is determined only by whether an SAR of the same nature has been reported previously - as recorded in the Reference Safety Information or Protocol.
If the event is Unexpected, it should be reported as a SUSAR, as above.