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Clinical trials conducted within Ireland and the European Union must comply with the European Union clinical trial legislation. (3) It applies to the conduct of clinical trials on human subjects involving medicinal products. The legislation defines the steps that must be taken regarding adverse event reporting and the timeline investigators and sponsors alike must comply with. The legislation does not distinguish between the different phases of a clinical trial.
An adverse event is 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 the treatment.” a serious adverse event is defined as “Any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.” It is the responsibility of the investigator to report any serious adverse events to their sponsor immediately, unless said event is identified as not requiring so in the protocol. The investigator must make this report no later than 24 hours after they became aware of the serious adverse event.
The reporting of non-serious adverse events, which fall under the definition of an adverse event, and/or laboratory abnormalities will follow the agreed upon reporting requirements in the clinical trial protocol. The time periods in which they should be reported should also be specified in said protocol.
A suspected unexpected serious adverse reaction (SUSAR) is a reaction that has not been predicted in the protocol. The investigator has no more than 7 days to report such reactions to the sponsor. Further information regarding the reaction must then follow within an additional 8 days. They should include the specifications of the event, as well as possible guidance in the protocol. Once the sponsor has been made aware of the SUSAR they have the responsibility to report the information to the competent authorities concerned and the Ethics Committee within a maximum of 15 days. Each Member State shall then immediately enter the SUSAR to an investigational medicinal product into the European database, which will only be able to be accessed by the Agency, the Commission and certain Member States.
The European database referred to is the Eudravigilance Clinical Trials Module. This system monitors the safety of medicines. It reports any suspected adverse reactions related to medicines, which enables early detection of potential safety issues.
The investigator does not need to actively monitor participants in the trial after it has ended, unless it says otherwise in the protocol. Adverse reactions do not include misuse and/or abuse of the product. It implies a possible causal relationship between the event and medicinal product.
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