Handling Adverse Drug Experiences ADEs

Safety concerns are present throughout the drug development process. From the filing of INDs, through the conduct of clinical trials, to the approval process of the NDA/BLA and the marketing of the drug, safety is the primary concern of any clinical program.

Management of safety is a principal responsibility of the sponsor monitor. The monitor has responsibility for informing the investigator about the safety requirements of the study. This will include a discussion of expected and unexpected adverse events, how to report adverse events should they occur, and how to characterize the adverse events in terms of project-specific definitions.

Monitors are expected to review CRF and source documents with particular attention to potential safety problems. On the CRF, the adverse events section and laboratory results section are reviewed for important findings. Often, relevant notes are made by the investigator in the comment section of the CRF. In source documents, safety issues may be uncovered in the progress notes of hospital charts or the interpretative reports of various diagnostic tests, e.g. chest X-rays, ECGs. Safety problems can manifest themselves in many ways. Monitors must be alert to exaggerated changes from baseline with expected pharmacological effects, acute and chronic effects and multiple drug treatment reactions.

Monitors are often the first company representatives to learn about an adverse event. The timeliness of reporting the event to management is important in satisfying regulatory reporting requirements. In general, the expectation is that the sponsor will learn of the event within 24 h of its occurrence. The sponsor monitor will transmit the information about the event to headquarters within 24 h and headquarters will get the information to the drug safety department within 24 h. The monitor should immediately notify appropriate senior managers of serious ADEs that are unexpectedly discovered. These strict timelines are designed to keep us in compliance with the regulatory authorities. Failure to adhere to the reporting timelines required for regulatory authorities is evidence of negligence on the part of the sponsor. The sponsor monitor is responsible for assuring adherence to reporting systems for managing serious adverse events.

The sponsor monitor is responsible for the timely follow-up of all serious adverse events. The cases must be followed to completion. The monitor needs to collect all required follow-up information on ADEs.

To be successful, monitors need to be competent in:

• Basic medicine and therapeutics.

• Recognizing clinical signs and symptoms.

• Interpretation of laboratory findings.

• Medical practice, nomenclature, and terminology.

• Relevant regulatory requirements.

• Protocol requirements.

The sponsor needs to provide on-going review of safety data for investigational products.

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