SOCRA CCRP REPORTING & TIMELINES
QUESTIONS WITH CORRECT ANSWERS
\.A sponsor who determines and unanticipated AE presents
unreasonable risk, termination shall occur within _____ working days
and not later than ___ working days after sponsor first received notice
of effect - ANSWERS-5, 15
\.IRB determinations for emergency situations are to be retained by IRB
for at least ___ years after completion of clinical investigation -
ANSWERS-3
\.Al IRB records need to be kept for ____ years follow completion of
research - ANSWERS-3
\.FDA will provide written determination within ____ days after FDA
receives IND or IDE - ANSWERS-30
\.If immediate use of test article is required (as determined by PI) where
independent determination cannot be granted, a statement with
exemption from but PI and independent clinician must be submitted to
IRB within ___ working days after use of article - ANSWERS-5
, \.An institution or organizations decision to disband a registered IRB
also must be reported to OHRP in writing within ___ days after
permanent cessation of ORBs review of supported research
(45cfr46.505) - ANSWERS-30
\.For Fatal or life threatening Unexpected ADRs or adverse events
regulatory agencies should be notified ____ but no later than ____
calendar days after first knowledge by sponsor, follow by a completed
as possible report within ____ additional calendar days - ANSWERS-
ASAP, 7, 8 (total 15 days)
\.IRB must renew registration every ___ years (45CFR46.505) -
ANSWERS-3
\.No more than _____ days after imposing a clinical hold on an IND will
the division director provide sponsor a written explanation for the hold
- ANSWERS-30 days
\.If all investigators covered by an IND Regina on clinical hold for ______
or more, IND will be inactivated - ANSWERS-1 year
\.A sponsor shall within _____ days of anniversary date the IND went
into effect provide a brief report - ANSWERS-60
QUESTIONS WITH CORRECT ANSWERS
\.A sponsor who determines and unanticipated AE presents
unreasonable risk, termination shall occur within _____ working days
and not later than ___ working days after sponsor first received notice
of effect - ANSWERS-5, 15
\.IRB determinations for emergency situations are to be retained by IRB
for at least ___ years after completion of clinical investigation -
ANSWERS-3
\.Al IRB records need to be kept for ____ years follow completion of
research - ANSWERS-3
\.FDA will provide written determination within ____ days after FDA
receives IND or IDE - ANSWERS-30
\.If immediate use of test article is required (as determined by PI) where
independent determination cannot be granted, a statement with
exemption from but PI and independent clinician must be submitted to
IRB within ___ working days after use of article - ANSWERS-5
, \.An institution or organizations decision to disband a registered IRB
also must be reported to OHRP in writing within ___ days after
permanent cessation of ORBs review of supported research
(45cfr46.505) - ANSWERS-30
\.For Fatal or life threatening Unexpected ADRs or adverse events
regulatory agencies should be notified ____ but no later than ____
calendar days after first knowledge by sponsor, follow by a completed
as possible report within ____ additional calendar days - ANSWERS-
ASAP, 7, 8 (total 15 days)
\.IRB must renew registration every ___ years (45CFR46.505) -
ANSWERS-3
\.No more than _____ days after imposing a clinical hold on an IND will
the division director provide sponsor a written explanation for the hold
- ANSWERS-30 days
\.If all investigators covered by an IND Regina on clinical hold for ______
or more, IND will be inactivated - ANSWERS-1 year
\.A sponsor shall within _____ days of anniversary date the IND went
into effect provide a brief report - ANSWERS-60
