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Clinical trial companies see immense relevance on US FDA Electronic Submission Safety Reports

Clinical trial companies see immense relevance on US FDA Electronic Submission Safety Reports


Posted on April 30, 2024 Updated on April 27, 2024

Clinical trial companies see immense relevance on US FDA Electronic Submission Safety Reports. The guidance provides instructions about how the individual case safety reports (ICSRs) from investigational new drug (IND) need to be supported with Adverse Event Reporting System (AERS).

An ICSR captures information necessary to support the reporting of an adverse event related to an individual subject that is associated with the use of an FDA-regulated product. A safety report documenting a serious adverse event (SAE) experienced by a study subject during conduct of an IND-exempt BA/BE study must be submitted on Form FDA 3500A or in an electronic format.

A safety report documenting a fatal or life-threatening adverse event from the study must be submitted to FDA as soon as possible but in no case later than a week after becoming aware of its occurrence. Safety reports documenting other SAEs observed during the conduct of the study must be submitted to FDA as soon as possible but no later than 15 calendar days after becoming aware of the SAE occurrence.

The individual case safety reports are used by investigators, pharmaceutical companies, institutional review boards, ethics committees, contract research organizations, etc., to perform pharmacovigilance monitoring activities and to communicate information about these adverse events to FDA and other regulatory bodies. FDA also developed regional data elements for reporting, for example, on drug-device, said the global regulatory authority adding that these rules enable identification and rejection of premarket individual case safety reports that are incorrectly submitted to the post-market pathway in AERS.

Submitters should use the drug substance name or non-proprietary name of the drug in the appropriate data fields for study drugs. The name should fit within the established character lengths. Knowledge of the treatments and interventions received is necessary for interpreting the event, may be essential for the medical management of the subject. This is because it provides critical safety information about the study drug, which could have implications for the ongoing conduct of the study across monitoring, informed consent, other protocol modifications, said the global regulatory authority.

According to a section of Indian clinical research organisations during clinical trials, adverse drug reactions are typically recorded and reported according to standardized protocols. This helps regulatory authorities and healthcare professionals make informed decisions about the drug’s safety and appropriate use. Additionally, participants in clinical trials are closely monitored for any signs of adverse reactions, and mechanisms are in place to manage and mitigate these reactions if they occur. The recent US FDA guidance strengthens its need for submission.

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