Reporting Timelines Flashcards
510k Premarket notification
The sponsor notifies the FDA 90 days before selling the device
A significant risk device investigation completion notification
Must be reported to the FDA by the sponsor within 30 working days, and an initial report submitted to the FDA, IRBs, and sites within 6 months (this report if or NSR devices also)
“Active protocol”
Defined as any protocol the IRB has reviewed within the last 12 months
Annual Reports
Must notify the FDA within 60 days of the IND effective anniversary date, no initial report, the sponsor reports
Clinical Trial Results Report
Sponsor notifies the FDA within 1 year
Clinical Trials results
The sponsor sends to the FDA & sites within 1 year after trial completion
Deviation from protocol-important
Notify the FDA within 5 working days, no initial report, the site reports to the sponsor and IRB
Device UADE reported to FDA, sponsor, and IRB
Notify the FDA within 10 working days, submit the intial report ASAP, reported by the sponsor
Device used without consent reported to sponsor and IRB
Notify the FDA within 5 working days, no initial report, the site reports
Emergency expanded access submission submitted after FDA’s authorization
Notify the FDA within 15 working days , no initial report, sponsor reports
Emergency immediate use
Notify the FDA within 5 working days, no initial report, the site notifies
Emergency immediate use IRB determinations
The site must keep for 3 years after completion of the trial
Emergency immediate use without independent determination -IRB notified
Notify the FDA within 5 working days, no initial report, the site reports
Expanded access IND goes into effect
30 days after the FDA receives the IND as long as the FDA does not respond no or hold, the sponsor submits
FDA terminates IND - sponsor response
The sponsor responds within 30 days
FDA 483 sponsor response
Notify the FDA within 15 working days , no initial report, sponsor reports
FDA approval or withdrawal
Notify the FDA within 5 working days, no intital report, the sponsor reports;
sponsor notifies IRB and investigators
FDA determination after IND or IDE
The FDA will notify the sponsor within 30 days
FDA follow-up inspections
The FDA follows up for 2 years after the initial inspection
FDA notifies sponsor if they terminate IND
The FDA will notify the sponsor within 30 days
FDA response to sponsor IND hold lift request
The FDA will notify the sponsor within 30 days after receipt
Final report to sponsor and IRB
Within 3 months after study completion, from the site
Findings from other animal studies - previously unknown significant risk
Notify the FDA within 15 calendar days, no initial report, reported by the sponsor
Findings from other human studies - previously unknown significant risk
Notify the FDA within 15 calendar days, no initial report, reported by the sponsor
HIPAA Privacy Rule - required to account for disclosures
Must keep for 6 years from date of creation
If an IND is inactive for how long, will it be grounds for termination
FDA will inactivate after 5 years
IND can be inactivated if no subjects are enrolled after
1 year, the FDA will inactivate
IND Clinical Hold Explanation to sponsor
The FDA will notify the sponsor within 30 days
IND will be inactivated if on hold for
1 year, the FDA will inactivate
IND withdrawal
Notify the FDA ASAP or upon completion of the study, no initial report, the sponsor reports
IND withdrawal - due to Safety
Stop the study and notify the FDA within 5 working days, no initial report, the sponsor reports
IRB contact or chair person changes
The site and sponsor notifies the FDA within 30 days
IRB detemines SR and sponsor does not
Notify the FDA within 5 working days, no intital report, the sponsor reports
IRB Registration
-is effective for 3 years
-must be updated within 90 days
-report disbanding it must be submited within 30 days
IRB suspension or termination
Notify the FDA promptly, no initial report, the IRB reports
Misconduct Inquiry
Must be completed within 60 calendar days
Misconduct Investigation
Must start within 30 days of inquiry completion
New Investigator/Study Site
The sponsor notifies the FDA within 30 days
New protocol info
The sponsor notifies the FDA within 30 days
Progress Reports
The site sends to the sponsor & IRB, the sponsor to the IRB and FDA (for SR devices) no later than once per year
Recall and device dispostion
The sponsor notifies the FDA within 30 days
the sponsor notifies FDA and IRB
SAE’s that are fatal or life threatening
Notify FDA within 7 calendar days, submit the initial report within 8 additional calendar days, reported by the sponsor
SAE’s that are not fatal or life threatening
Notify the FDA within 15 calendar days, no intial report, reported by the sponsor
Serious UADRs that are fatal or life threatening
Notify FDA within 7 calendar days, submit the initial report within 8 additional calendar days, reported by the sponsor
Serious ADR with an increased rate
Notify the FDA within 15 calendar days, no intial report, reported by the sponsor
Serious UADR’s that are not fatal or life threatening
Notify the FDA within 15 calendar days, no intial report, reported by the sponsor
Sponsor & investigator holds records for
2 years after marketing is approved or it becomes inactive (IRB is 3 years)
Sponsor notifies FDA of change to IDE
Notify the FDA within 5 working days, no initial report, the sponsor reports
Sponsor request for reg hearing
Notify the FDA within 10 days of sponsor receipt of FDA notification of nonacceptance of IND, no initial report, reported by the sponsor
Sponsor submits to FDA investigator names
Every 6 months
Sponsor submits to FDA investigator names
within 30 days of adding new PI for drugs
Study will re-activate after a hold after the FDA has received an amendment
30 days after the sponsor submits the amendment
Termination due to UAE
Notify the FDA within 15 working days of sponsor notification, no initial report, sponsor reports
The FDA will give review a PMA within
180 days after the sponsor submits
Transfer custody of record
notify the FDA within 10 working days after transfer, no initial report, reported by the sponsor
UADE - unreasonable risk
Terminate within 5 working days after making determination; and notify the FDA no more than 15 working days after receiving risk notice, reported by the sponsor
Unanticipated problems
Notify the FDA promptly, no intial FDA report, the site and sponsor report
Updated FDF
Must be completed by the site 1 year after study completion
Withdrawal IRB approval - report
Notify the FDA within 5 working days, no initial report, the site and sponsor reports
site to sponsor and sponsor to FDA
