SOCRA CCRP REPORTING & TIMELINES WITH COMPLETE SOLUTIONS 100% VERIFIED
LATEST UPDATE!!
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 - (ANSWER)5, 15
IRB determinations for emergency situations are to be retained by IRB for at least ___ years after
completion of clinical investigation - (ANSWER)3
Al IRB records need to be kept for ____ years follow completion of research - (ANSWER)3
FDA will provide written determination within ____ days after FDA receives IND or IDE - (ANSWER)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 - (ANSWER)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) -
(ANSWER)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 - (ANSWER)ASAP, 7, 8 (total 15 days)
IRB must renew registration every ___ years (45CFR46.505) - (ANSWER)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 - (ANSWER)30 days
If all investigators covered by an IND Regina on clinical hold for ______ or more, IND will be inactivated -
(ANSWER)1 year
LATEST UPDATE!!
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 - (ANSWER)5, 15
IRB determinations for emergency situations are to be retained by IRB for at least ___ years after
completion of clinical investigation - (ANSWER)3
Al IRB records need to be kept for ____ years follow completion of research - (ANSWER)3
FDA will provide written determination within ____ days after FDA receives IND or IDE - (ANSWER)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 - (ANSWER)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) -
(ANSWER)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 - (ANSWER)ASAP, 7, 8 (total 15 days)
IRB must renew registration every ___ years (45CFR46.505) - (ANSWER)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 - (ANSWER)30 days
If all investigators covered by an IND Regina on clinical hold for ______ or more, IND will be inactivated -
(ANSWER)1 year
