Periods for submission of written and telephone reports extended to 15 and 7 calendar days respectively; faxes acceptable in lieu of telephone reports.
Form 3500A (same as proposed form for postmarketing reports) allowed.
Disclaimer to apply to all safety information so as not to constitute a statement or admission of a causal link between drug and a subsequent adverse event.
Current annual death and serious adverse experiences report to be supplemented by semiannual reports; semiannual report not to take place of annual report.
Report all deaths, serious adverse experiences, and study discontinuations due to adverse experiences, whether or not unexpected, and whether or not caused by the study drug.
Data required from IND studies, worldwide premarketing studies, and foreign postmarketing trials or reporting systems.
Data to be presented cumulatively as well as for a 6-month period.
Worst case analysis of data required—presumption against drug then attempt to refute presumption.
Submission of all available autopsy reports and medical reports of deaths required; sponsor to clarify inconsistencies between reports and cause of death reported to FDA by the sponsor.
FDA may modify reporting requirements, e.g., when it would interfere with a blinded (masked) study, in which neither patients nor study staff are aware of which patients are receiving control treatment until the end of the trial.
Data on events not defined as serious adverse reactions.
Agency to determine when it is needed and the information required.
Should contain results of cumulative analyses in other reports as well as analyses of lesser events.
Generally, 30 days from request to comply.
FDA may require a final report or study summary of a study at its discretion.