When a healthy volunteer/patient suffers a negative health reaction to a drug being tested in clinical trials, an adverse event is reported and filed containing various data about the drug, its dose, its purported effect, patient health prior and after an adverse event, patient reaction to the drug prior and after adverse event among others. Individual case safety report (ICSR) is one of the many reports filed under adverse event reporting during clinical trials.
In order for an ICSR to be legitimate, the report must satisfy four conditions.
- Identifiable patient at the time of the reaction/event
- Identifiable reporter at the time of the reaction/event
- Reaction of patient/Event
- The drug suspected of causing reaction/event
Once these conditions are satisfied an ICSR if filed for the adverse event that has occurred. The event is categorized based on the level of serious health effect on the affected patient.
Events are categorized as Adverse event (AE), Severe adverse event (SAE), Severe adverse reaction (SAR), Suspected unexpected serious adverse reaction (SUSAR), Life-Threatening (LT).
ICSR reporting timelines primarily vary based on the seriousness of an event and the nature of the reporter. Also, timelines in pharmacovigilance make use of a concept called calendar days rather than weekdays or weekends. This is due to the fact that clinical trials and events occurring in the trials are dynamic in nature and required continuous monitoring and documentation.
If a regulatory authority is the reporter of the AE
In the case of a non-serious AE, 90 calendar days are provided to file an ICSR. Periodic reporting is required in case of SAE and SAR which means they will have to report an event falling under the two categories within 15 calendar days and follow up with regular periodic reports. In the case of SUSAR (LT/fatal), the regulatory authority has a timeline of 7 calendar days to begin filing ICSR. If SUSAR is not fatal the regulatory authority has 15 calendar days to file an ICSR.
If a Principal Investigator is the reporter of the AE
A non-serious AE needs to be reported under 90 calendar days. For SAE and SAR reporting is required within 15 calendar days. 15 calendar days is the timeline given for reporting a SUSAR (LT/Fatal).
If an ethics committee is the reporter of the AE
Periodic reporting is required for filing an ICSR for AE and SAE. For fatal and non-fatal SAR the ethics committee decides the timeline to report an ICSR. 7 calendar days for SUSAR (LT/Fatal) and 15 calendar days for SUSAR (non-fatal) are the timelines for an ethics committee.
Regulatory reporting timelines are important for filing ICSRs to maintain the objectives of pharmacovigilance which is to ensure the safety of patients/volunteers during the process of clinical trials through adequate data collection, ordered data compilation and timely reporting of events that have the potential to harm patients/volunteers involved in the trials.