Annual Reports Requirements for Safety

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 Annual Reports Requirements for Safety are listed in the 21CFR Part 312.33(b). This list includes summary information obtained during the previous year’s clinical and nonclinical investigations:

(1) A narrative or tabular summary showing the most frequent and most serious adverse experiences by body system.

(2) A summary of all IND safety reports submitted during the past year.

(3) A list of subjects who died during participation in the investigation, with the cause of death for each subject.

(4) A list of subjects who dropped out during the course of the investigation in association with any adverse experience, whether or not thought to be drug-related.

Responsibilities of sponsors and investigators for Safety per 21CFR Part 312.50 Subpart D, includes “ensuring that FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug.” “Important safety information is required to be relayed to investigators in accordance with § 312.50.”

Investigator record keeping and record retention per 21CFR Part 312.62 Subpart D(a): An investigator is required to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation. Case histories include the case report forms and supporting data including, for example, signed and dated consent forms and medical records including, for example, progress notes of the physician, the individual’s hospital chart(s), and the nurses’ notes. The case history for each individual shall document that informed consent was obtained prior to participation in the study.

Investigator Safety Reports per 21CFR Part 312.62 Subpart D(b): An investigator must immediately report to the sponsor any serious adverse event, whether or not considered drug related, including those listed in the protocol or investigator brochure and must include an assessment of whether there is a reasonable possibility that the drug caused the event. Study endpoints that are serious adverse events (e.g., all-cause mortality) must be reported in accordance with the protocol unless there is evidence suggesting a causal relationship between the drug and the event (e.g., death from anaphylaxis). In that case, the investigator must immediately report the event to the sponsor. The investigator must record nonserious adverse events and report them to the sponsor according to the timetable for reporting specified in the protocol.