Reporting Timelines Flashcards
A sponsor shall provide an annual report within ___ days of the anniversary date the IND activation.
60
Unexpected fatal/life-threatening suspected ADR reports must be notified to FDA ___, but in no case later than ___
ASAP; 7 calendar days but most cases, protocol-specific
Sponsor needs to report IND safety reports to FDA and investigators within ___
15 calendar days
Grounds for termination of IND: If it remains ___
Inactive for 5 or more years.
What are the two criteria for a IND to be inactive?
1) No enrollment within 2 years
2) On hold per FDA for 1 year
Upon receiving rejection of IND, the sponsor needs to request for regulatory hearing within ___
10 days
For an IND, when does the Investigator need to submit the final report to the sponsor?
No specific time constraints, can be contingent on sponsor request but should be completed following study completion
For IDE, when does the sponsor need to report an unexpected adverse device event?
ASAP, in no event later than 10 working days after discovery.
When IRB withdraws approval of the investigator, the investigator shall report to the sponsor within ___
5 working days
How often are progress reports and what is the traffic for those communications?
Annual reports are the minimal expectation.
Twice a year for sig risk device studies.
Investigator -> Sponsor -> FDA
For sig risk devices, sponsors shall notify FDA within ___ following study completion, and the final report should be submitted within ___
30 days; within 6 months
Who communicates protocol deviations and what is the timeline of it?
The investigator shall report to sponsor ASAP but no later than 5 working days. The sponsor will then report to FDA if the deviation impacts study integrity.
Devices utilized w/o ICF should be reported to sponsor and IRB within ___
5 working days
For IDE, describe how final reports work: (NSR; 2)
- Investigator complete detailed reports of findings, AEs, and etc per CRF guidelines and submit to sponsor within 3 months
- Sponsor integrates investigator detailed reports from sites and preps for submission to FDA , usually within 6 months following study completion.
How often do sites need to update current investigator list?
q6months
Recall and device disposition: A sponsor shall notify FDA when an investigator returns/repairs any units of device and the notice shall occur within ___ after the request is made and should state the reason why:
30 working days
If an IRB determines that a device is a sig risk device, despite initial proposal indicating otherwise, then the sponsor shall submit to FDA a report of the IRB’s decision within ___ after the sponsor first learns of the IRB’s determination.
5 working days
How long do FDF be made for following study completion?
1 year
After FDA receives IND or IDE, FDA must provide written determination to ___ within ___
Sponsor; 30 days
FDA has ___ after receipt to respond to a sponsor request to lift an ___ hold.
30 days; IND
Serious unexpected ARs (SADR) that are non-fatal must be filed ___ but no later than ___ after initial discovery.
ASAP; 7 calendar days
For fatal/life threatening unexpected AEs, regulatory agencies should be notified ASAP to initiate consideration for ___. This must occur no less than ___ after discovery followed by a ____
Suspension or unexpected limitations of a protocol
7 calendar days
A complete report within 8 additional calendar days
Under 21 CFR Part 812, what is required if a device study results in a serious adverse event?
10 working days
Within how many days must an investigator submit a final report to the sponsor and the reviewing IRB after completion of a clinical investigation involving a medical device?
A. Within 7 calendar days
B. Within 15 calendar days
C. Within 30 calendar days
D. Within 90 calendar days
C
