FDA writes safety reporting guidelines for drug and device investigators

Posted on October 01, 2021 | Through Mary ellen schneider

The United States Food and Drug Administration has released draft guidelines for clinical trial investigators, outlining their safety reporting obligations for drugs and investigational devices.

The Disorganized, released on September 29, 2021, focuses exclusively on the role of investigators – not sponsors – and merges the latest final guidelines from 2009 and 2012 on safety reporting that were previously mixed with advice to sponsors. The previous guidelines will remain in effect until the new document is finalized. The FDA has issued separate draft guidelines for sponsors earlier this year (RELATED: FDA Releases New Draft Guidance on Sponsor Role for Safety Reporting Requirements, Regulatory guidance June 25, 2021).

“Most of the information about the safety of a drug before it is marketed comes from clinical trials,” the FDA wrote in the draft guidelines. “Adverse event reports from investigators are therefore of critical importance, as it is investigators who observe subjects’ responses to an investigational drug. “

The draft guidance provides guidance to clinical researchers on how to identify safety information that raises an “unforeseen issue involving a risk to humans or others” for the investigational drugs or “unanticipated adverse reactions of the drug. device ‘and how this information should be reported. It applies to investigational new drug demand studies (IND) and investigational device exemption studies (IDE).

IND studies

Clinical investigators should immediately report serious adverse events (SAEs) to the trial sponsor – as soon as possible after recognizing the SAE but usually no more than one calendar day – whether or not they believe the event is. drug-related and even if the SAE is listed in the safety monitoring plan or investigator’s leaflet as an anticipated event.

The exception to this reporting requirement is if the SAE involves study parameters, such as myocardial infarction in a trial evaluating a cardiovascular drug. In these cases, ESA would be reported as stated in the study protocol, unless there is evidence to suggest that the drug caused the event, such as death from anaphylaxis after exposure to the drug.

The information reported should include a specified subject, a suspected drug, the source of the report if not the investigator, and a clinical description of the event. The clinical description should assess whether there is a “reasonable possibility” that the drug caused the adverse event. It is the sponsor’s responsibility to determine if an event is unexpected, the FDA explained.

“The FDA interprets a reasonable possibility to mean that there is evidence to suggest a causal relationship between the drug and the adverse event,” the FDA noted in its guidance to investigators. “Factors that should be taken into account when assessing causation include, but are not limited to, the temporal relationship between the event and the administration of the drug; biological plausibility, based on the mechanism of action of the drug or similar drugs of the same class; non-clinical evidence; and challenge-challenge information.

Investigators should report non-serious AEs as specified in the study protocol.

Under the draft guidelines, investigators are required to report events to the IRB if the adverse event is a serious or unexpected problem. The guidance specifies that investigators should review all IND safety reports and safety information reports from IND-free bioavailability / bioequivalence studies received. Investigators should submit this information directly to the IRB unless they have confirmation that the sponsor has sent the information to the IRB. Some additional events that should be reported to the IRB by investigators include medication error reports, breach of privacy or confidentiality, and premature destruction of study records, as they involve unforeseen issues. related to study procedures.

IDE studies

For IDE studies, researchers should report unexpected device adverse reactions (UADEs) to trial sponsors and IRBs as soon as possible, but no later than 10 working days after the investigator finds out the effect.

“What is considered a UADE should vary depending on the specific device and how the device is used in the study,” the FDA wrote in the investigator’s guidance. “Therefore, sponsors are required to include risk information in the investigation plan, which can help investigators identify and assess potential UADEs.”

Investigators are also responsible for providing progress reports on anticipated and unanticipated adverse reactions of the devices at regular intervals, but at least once a year, to sponsors, controllers and IRBs, according to the draft guidelines.

The agency is accepting public comments on the investigator’s guidelines until November 29, 2021.

Investigator Responsibilities – Safety Reports for Drugs and Investigational Devices: Guidance for Industry

© 2021 Society of Regulatory Affairs Professionals.

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