SOCRA CCRP Reporting & Timelines Exam Questions With solved Solutions

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