Timelines Flashcards
(28 cards)
Deviations in case of emergency when and to who
asap and to the sponsor (if important, then sponsor and IRB)
What is the time frame for notifying the IRB of an emergency use of a drug?
5 working days
Report to sponsor and IRB
This is the required reporting time to ensure patient safety and regulatory compliance.
What is the reporting deadline for a sponsor withdrawal of IRB approval?
5 working days
To FDA, other IRBs, and Investigators
Timely communication is crucial for maintaining research integrity.
What is the reporting time for fatal or life-threatening SUSAR?
7 days
PI reports to sponsor and IRB (sponsor reports to FDA)
SUSAR stands for Suspected Unexpected Serious Adverse Reaction.
What is the deadline for reporting unanticipated UADE to the IRB?
10 working days
PI reports to sponsor and IRB (sponsor reports to FDA)
UADE stands for Unanticipated Adverse Device Effect.
What is the time frame for sponsors to report other SUSAR?
15 days
PI to the sponsor (sponsor usually submits to IRB and FDA if necessary)
This applies to serious adverse events that are unexpected.
How long do PIs have to respond to Form 483?
15 working days
Form 483 is issued by the FDA to notify a company of non-compliance.
What is the reporting deadline for newly found reportable AEs?
15 days
PI to the sponsor (sponsor usually submits to IRB and FDA if necessary)
Adverse Events (AEs) must be reported promptly to ensure participant safety.
What is the deadline for sponsor release of IND safety reports?
15 days
From the sponsor to the FDA and Investigators
IND stands for Investigational New Drug.
What is the reporting timeframe for a sponsor to the FDA for a device recall?
30 days or 10 working days
Sponsor to the FDA and irbs an PIs
Timely reporting is essential for public safety.
When are IND annual reports due?
Within 60 days of annually
Sponsor to FDA (and PIs)
Annual reports summarize the progress of the IND.
What is the timeline for the final report from PI to sponsor post-study?
3 months
PI to sponsor and IRB
Sponsors submit theirs to FDA, IRB, and PIs
The final report is essential for evaluating study outcomes.
What is the deadline for the final report for IND or IDE?
Within 6 months after study finish
Sponsor to FDA
This report provides comprehensive results from the study.
What is the retention period for FDFs after study completion?
Before sub-investigator starts & 1 year after completion
FDF stands for Financial disclosure form.
How long after the initial inspection are FDA follow-up inspections conducted?
2 years
Follow-up inspections ensure continued compliance with regulations.
What is the record retention period for all other records?
2 years
This includes data that supports the research findings.
How long must IRB records be kept according to ICH?
3 years
IRB records are crucial for ethical oversight of research.
After how many years of inactivity can INDs be terminated?
5 years
This policy helps to maintain an updated database of active INDs.
What year was the Nuremberg Code established?
1947
The Nuremberg Code established ethical principles for human experimentation.
What year was the Declaration of Helsinki adopted?
1964
The Declaration of Helsinki outlines ethical principles for medical research involving human subjects.
What year was the Belmont Report published?
1978
The Belmont Report identifies basic ethical principles and guidelines for research involving human subjects.
What year were FDA regulations first established?
1980
FDA regulations govern the conduct of clinical trials and drug approvals.
When were the FDA regulations revised?
1981
Revisions often reflect changes in scientific understanding and ethical considerations.
What year was the Common Rule established?
1991
The Common Rule is a federal policy regarding human subjects protection.
