SOCRA CCRP Reporting & Timelines (Q & A) 2024
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
A sponsor shall within _____ days of anniversary date the IND went into effect provide a brief report Answer- 60
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
A sponsor shall within _____ days of anniversary date the IND went into effect provide a brief report Answer- 60
