Safety Reporting, sometimes referred to as Pharmacovigilance, is an important consideration for all health and social-care research. The following definitions, terminology and requirements, relating to Safety Reporting, can be applied to any health or social-care research project.
For CTIMPs and CIMDs all requirements must be strictly applied.
For all other health and social-care research projects, the researchers writing the protocol should determine what reporting requirements are proportionate to the nature of the study or intervention - with the exception of Suspected Unexpected Serious Adverse Reactions (SUSAR), see below. The intended approach should be clearly described in the protocol and will need to be approved by the Sponsor and by an Ethics Committee.
The study protocol should define the period during which safety reporting is conducted. This may be, for example, from Consent right through to the end of Follow-up, or it may be for a specific period during and immediately after an intervention. It may differ depending on the nature of the event - e.g. related events (see below) captured for a longer period than all other events.
An Adverse Event (AE) is any untoward medical occurence affecting a study participant. All AEs should be reviewed by an investigator (an appropriately qualified individual and delegated member of the trial team - in the case of a CTIMP, this must be a clinician). The review should include details of the nature, seriousness, severity, causality and expectedness of the event. This information should be recorded in the study record (in an AE reporting log) and, where appropriate, in the participant's clinical records.
A Serious Adverse Event (SAE) is an AE that meets one or more of the following criteria:
All SAEs should be recorded, as above, and reported to the Sponsor not more than 24 hours after the study team become aware of the event.
Safety reporting for UoB Sponsored studies is managed on our behalf by University Hospitals Bristol and Weston, in accordance with their Safety Reporting Standard Operating Procuedure (SOP) (PDF, 889kB).
Severity is distinct from Seriouness. It describes the extent of an event's effect upon the participant. It does not affect reporting requirements.
Causality is an assessment, conducted by an investigator, of whether an event is related to a research intervention. This should be determined based upon knowledge of the intervention, the timing of the event, the participant's medical history, the effect of treatment or alteration of the intervention, and any other pertinent factors.
An event is either:
An event determined to be in one of the last three categories - possibly, probably or definitely related - is an Adverse Reaction (AR), or Serious Adverse Reaction (SAR).
All SARs must be reviewed for expectedness. For CTIMPs, a Reference Safety Information (RSI) document must be defined in the Protocol - this will usually be a section within the Investigator Brochure or Summary of Product Characteristics. The RSI should list all serious adverse reactions that have been recorded twice or more. For CIMDs this should be detailed in your Clinical Investigation Plan. For all other studies, the protocol should contain an equivalent list of events, related to the intervention, that are expected.
Any event that is not listed in this way is unexpected.
An event that meets the serious criteria; is Possibly, Probably or Definitely Related to a study intervention; and is unexpected, with regard to that intervention, is a Suspected Unexpected Serious Adverse Reaction (SUSAR). It must be reported as described below.
Regardless of the nature of your study and your agreed safety reporting process, SUSARs must be reported to your Sponsor within 24 hours of the study team becoming aware of them. The Sponsor will then work with you to coordinate onward reporting, within the following timelines:
If you are, for example, working with a patient population who have significant co-morbidities and are likely to have a high number of unrelated SAEs - it may be appropriate to exclude certain events from routine SAE reporting. If this is your intention, the safety reporting section of your protocol should include a list of specific events that will be excluded from standard SAE reporting, and instructions for how these events will be managed and recorded.
