SOCRA Reporting Timelines Flashcards
IND Safety Reports (21 CFR 312.32)
Expedited Safety Reports
____: Report any unexpected fatal or life-threatening suspected adverse reactions.
Within 7 calendar days
IND Safety Reports (21 CFR 312.32)
Expedited Safety Reports:
____: Report any other serious and unexpected adverse experiences associated with the use of the drug.
Within 15 calendar days
Annual Reports (21 CFR 312.33)
____: Submit an annual report within 60 days of the anniversary date that the IND went into effect. This report should provide a brief summary of the status of each study, including the number of subjects exposed, a summary of adverse events, and any significant changes in the research or investigational plan.
Every 12 months
Protocol Amendments (21 CFR 312.30)
____: Submit changes to the protocol that significantly affect the safety of subjects or the scope of the investigation as soon as possible but no later than XX days after the changes are implemented.
Immediate reporting ; 30
Information Amendments (21 CFR 312.31)
____: Submit information amendments as necessary to update the FDA on new toxicology, chemistry, or technical information, as well as updates that are not covered by protocol amendments or safety reports.
As needed
Clinical Hold Responses (21 CFR 312.42)
____: If a clinical hold is placed on an IND, the sponsor must address the deficiencies and provide the necessary information to the FDA to resolve the hold as quickly as possible.
Prompt response
Withdrawal of an IND (21 CFR 312.38)
___: Notify the FDA and all participating investigators in writing if the sponsor decides to withdraw an IND.
Immeditely
End of Study Report (21 CFR 312.44)
____: Submit a final report when a study is completed or terminated, detailing the reason for termination and summarizing the results.
Within 30 days
Investigator Reports (21 CFR 312.64)
____: Investigators must report any adverse events immediately to the sponsor.
Immediate Reporting
Investigator Reports (21 CFR 312.64)
____: During the course of the study, provide progress reports to the sponsor at regular intervals, typically quarterly or as specified in the protocol.
Quarterly Reports
Notification of Withdrawal (21 CFR 312.38)
____: If a sponsor decides to withdraw an investigational new drug (IND) application, they must notify the FDA and all participating investigators immediately in writing.
Immediate
Changes to an IND (21 CFR 312.30)
____: Changes that significantly affect the safety of subjects, the scope of the investigation, or the scientific quality of the study must be reported to the FDA as soon as possible, but no later than 30 days after the change.
Immediate
Treatment Use in Emergency Settings (21 CFR 312.310)
____: Sponsors or their representatives must notify the FDA within 15 working days of providing an investigational drug for emergency use.
Emergency Notification
Postmarketing Safety Reports for Approved Products (21 CFR 312.32)
____: Manufacturers must submit postmarketing safety reports for approved drugs and biologics within the specified timelines outlined in 21 CFR 314.80 for drugs and 21 CFR 600.80 for biologics.
Timely Reporting
