Reporting timelines Flashcards
A sponsor must notify all reviewing IRBs and participating investigators of an FDA approval withdrawl within XXX days
5 working days
Significant Risk Device Determination
5 working days
No consent obtained after using device
5 working days
Investigator submits FINAL REPORT to IRB & Sponsor within?
3 months/90days
Unanticipated Adverse Device Effect, Sponsor to FDA
10 working days
Unanticipated Adverse Device Effect, Investigator to Sponsor & IRB
ASAP, 10 working days
Recall and Device Disposition report to FDA within how many days?
30 working days
Deviation from Investigational Plan
5 working days
The time it takes to submit an IND depends on the severity of the event. When would the sponsor have to submit for a follow up or serious unexpected but non-fatal? IND Safety Report, Sponsor to FDA & Site
15 calendar days
Unexpected Fatal or life threatening suspected adverse reaction, Sponsor to FDA
7 calendar days
A sponsor shall within X days of the XXX date that the IND went into effect, submit a brief report of the progress of the investigation
60 days of anniversary of IND
IND application goes in effect in how many days
30 days after FDA receives IND.
sponsor shall maintain adequate records for X years
2
The sponsors request for a regulatory hearing must be made within ___ of the sponsors receipt of FDA’s notification of nonacceptance.
10 days
Sponsor to report non threatening unexpected ADRs (adverse drug reactions)?
15 calendar days after first knowledge.
For emergency use of a drug, where immediate use of the product was required and the patient was not able to be consented, how long does the sponsor have to notify the FDA of the use of the product?
5 working days
For an IND, how soon should the sponsor report serious unexpected life-threatening safety events to FDA?
7 calendar days
INDs that are “Inactive” for ___+ years may be terminated
5 years
IRB must maintain records for X years
3 years
Sponsor submits FINAL REPORT to IRB within?
6 months
Sponsor must notify FDA of completion or termination within XX days
30 working days
The sponsor of a clinical trial must submit a final report to ClinicalTrials.gov no later than
1 Year after the primary completion date:
Records custody. An investigator or sponsor may withdraw from the responsibility to maintain records for the period
required in paragraph (d) of this section and transfer custody of the records to any other person who will accept responsibility for
them under this part, including the requirements of §812.145. Notice of a transfer shall be given to FDA not later than XXX working
days after transfer occurs
10 working days
