Reporting Flashcards
A sponsor & investigator shall retain records for _ after marketing is approved or an investigation becomes inactive
2 years
A sponsor needs to report IND safety reports to the FDA & investigators within
15 calendar days
A sponsor shall notify all IRBs & investigators within _ if there is a withdrawal of FDA approval
5 working days
A sponsor shall within _ of the anniversary date the IND went into effect, provide a brief report
60 days
A sponsor should submit to the FDA a current list of names of investigators participating every
6 months
A sponsor who determines an unanticipated AE presents unreasonable risk, termination shall occur within _ working days and no later than _ working days after sponsor firsts received notice of the effect
5, 15
All IRB records need to be kept for _ following completion of research
3 years
An IND will be terminationed if the IND remains inactive for
5 years
An institution or organizations’ decision to disban a registered IRB must be reported to OHRP in writing within _ after permanent cessation of review of supported research
30 days
Deviation from protocol that are emergecy situations should be reported within _ after emergency
5 working days
FDA will provide written determination within _ after receiving IND or IDE
30 days
For fatal or life-threatening unexpected ADRs (adverse device reactions) or adverse events (SAEs), regulatory agencies should be notified _ but no later than _ after first knowledge by the sponsor, followed by a completed report within _ additional calendar days
ASAP, 7 calendar days, 8 calendar days
For unexpected but not fatal or life-threatening SAEs
the sponsor has 15 calendar days to send to all investigators and the regulatory authorities
How long is IRB registration with HHS effective for?
3 years
If a research study is prematurely terminated/suspended
-must notify the sponsor, IRB, and regulatory authorities
-promptly informa reserach subjects and assure appropriate therapy & follow up
Investigator shall report to the sponsor within _ if there is a withdrawal of IRB approval
5 working days
If all investigators covered by an IND remain on clinical hold for _ or more, IND will be inactivated
1 year
If an investigator uses a device without consent, it needs to be reported to the sponsor & IRB within
5 working days
If FDA proposes to terminate the IND they will notify the sponsor w/in
30 days
If immediate us of a test article is requried (as determined by the PI) where independent determination cannot be granted, a stated with exemption from the PI & an independent clinician must be submitted to the IRB within _ after the use of the article
5 working days
If no subjects are enrolled within _ or if an IND remains on hold for _, the IND can be inactivated
2 years, 1 year
In significant risk devices, a sponsor shall notify the FDA within _ after completion of an investigation and shall submit a final report within_
30 working days, 6 months
IRB determinations for emergency situations are to be retained by the IRB for at least _ after completion of the clinical investigation
3 years
IRB must renew registration every
45 CFR 46.505
3 years
IRB registration info must be updated within _ after changes occur regarding the contact person who provided the IRB registration or the IRB chairperson
90 Days
No more than _ after imposing a clinical hold on an IND will the FDA division director provide the sponsor a written explanation for the hold
30 days
Serious, unexpected ADRs that are not fatal or life-threatening must be filed _ but no later than _ after first knowledge by sponsor that case meets criteria
ASAP, 15 calendar days
Sponsor will notify the FDA, IRBs, and all investigators within _ after learning of a recall & device disposition
30 working days
The clinical investigator shall updated FDF with any relevant changes that occur during the course of the study and for _ following its completion
1 year
The FDA has _ to respond to a sponsor request to lift an IND hold
30 calendar days after receipt
The sponsor must provide noticied to the FDA within _ when making a change to an IDE
5 working days
The sponsor request for a regulatory hearing must be made within _ days of sponsor receipt of FDA notification of nonacceptance of an IND
10
Unanticipated devices AE (UADE) should be reported by investigator to the sponsor and IRB within _ of knowledge of effect
10 working days
Within _ after termination or completion of a trial, submit a final report to the sponsor & IRB
3 months
