SOCRA CCRP Reporting & Timelines Exam
With Correct Answers
A nnsponsor nnwho nndetermines nnand nnunanticipated nnAE nnpresents nnunreasonable nnrisk, nntermination nnshall
nnoccur nnwithin nn_____ nnworking nndays nnand nnnot nnlater nnthan nn___ nnworking nndays nnafter nnsponsor nnfirst
nnreceived nnnotice nnof nneffect nn- nnANSWER: nn✔ nn5, nn15
IRB nndeterminations nnfor nnemergency nnsituations nnare nnto nnbe nnretained nnby nnIRB nnfor nnat nnleast nn___ nnyears
nnafter nncompletion nnof nnclinical nninvestigation nn- nnANSWER: nn✔ nn3
Al nnIRB nnrecords nnneed nnto nnbe nnkept nnfor nn____ nnyears nnfollow nncompletion nnof nnresearch nn- nnANSWER: nn✔
nn3
FDA nnwill nnprovide nnwritten nndetermination nnwithin nn____ nndays nnafter nnFDA nnreceives nnIND nnor nnIDE nn-
nnANSWER: nn✔ nn30
If nnimmediate nnuse nnof nntest nnarticle nnis nnrequired nn(as nndetermined nnby nnPI) nnwhere nnindependent
nndetermination nncannot nnbe nngranted, nna nnstatement nnwith nnexemption nnfrom nnbut nnPI nnand nnindependent
nnclinician nnmust nnbe nnsubmitted nnto nnIRB nnwithin nn___ nnworking nndays nnafter nnuse nnof nnarticle nn- nnANSWER:
nn✔ nn5
An nninstitution nnor nnorganizations nndecision nnto nndisband nna nnregistered nnIRB nnalso nnmust nnbe nnreported nnto
nnOHRP nnin nnwriting nnwithin nn___ nndays nnafter nnpermanent nncessation nnof nnORBs nnreview nnof nnsupported
nnresearch nn(45cfr46.505) nn- nnANSWER: nn✔ nn30
For nnFatal nnor nnlife nnthreatening nnUnexpected nnADRs nnor nnadverse nnevents nnregulatory nnagencies nnshould
nnbe nnnotified nn____ nnbut nnno nnlater nnthan nn____ nncalendar nndays nnafter nnfirst nnknowledge nnby nnsponsor,
nnfollow nnby nna nncompleted nnas nnpossible nnreport nnwithin nn____ nnadditional nncalendar nndays nn- nnANSWER:
nn✔ nnASAP, nn7, nn8 nn(total nn15 nndays)
IRB nnmust nnrenew nnregistration nnevery nn___ nnyears nn(45CFR46.505) nn- nnANSWER: nn✔ nn3
With Correct Answers
A nnsponsor nnwho nndetermines nnand nnunanticipated nnAE nnpresents nnunreasonable nnrisk, nntermination nnshall
nnoccur nnwithin nn_____ nnworking nndays nnand nnnot nnlater nnthan nn___ nnworking nndays nnafter nnsponsor nnfirst
nnreceived nnnotice nnof nneffect nn- nnANSWER: nn✔ nn5, nn15
IRB nndeterminations nnfor nnemergency nnsituations nnare nnto nnbe nnretained nnby nnIRB nnfor nnat nnleast nn___ nnyears
nnafter nncompletion nnof nnclinical nninvestigation nn- nnANSWER: nn✔ nn3
Al nnIRB nnrecords nnneed nnto nnbe nnkept nnfor nn____ nnyears nnfollow nncompletion nnof nnresearch nn- nnANSWER: nn✔
nn3
FDA nnwill nnprovide nnwritten nndetermination nnwithin nn____ nndays nnafter nnFDA nnreceives nnIND nnor nnIDE nn-
nnANSWER: nn✔ nn30
If nnimmediate nnuse nnof nntest nnarticle nnis nnrequired nn(as nndetermined nnby nnPI) nnwhere nnindependent
nndetermination nncannot nnbe nngranted, nna nnstatement nnwith nnexemption nnfrom nnbut nnPI nnand nnindependent
nnclinician nnmust nnbe nnsubmitted nnto nnIRB nnwithin nn___ nnworking nndays nnafter nnuse nnof nnarticle nn- nnANSWER:
nn✔ nn5
An nninstitution nnor nnorganizations nndecision nnto nndisband nna nnregistered nnIRB nnalso nnmust nnbe nnreported nnto
nnOHRP nnin nnwriting nnwithin nn___ nndays nnafter nnpermanent nncessation nnof nnORBs nnreview nnof nnsupported
nnresearch nn(45cfr46.505) nn- nnANSWER: nn✔ nn30
For nnFatal nnor nnlife nnthreatening nnUnexpected nnADRs nnor nnadverse nnevents nnregulatory nnagencies nnshould
nnbe nnnotified nn____ nnbut nnno nnlater nnthan nn____ nncalendar nndays nnafter nnfirst nnknowledge nnby nnsponsor,
nnfollow nnby nna nncompleted nnas nnpossible nnreport nnwithin nn____ nnadditional nncalendar nndays nn- nnANSWER:
nn✔ nnASAP, nn7, nn8 nn(total nn15 nndays)
IRB nnmust nnrenew nnregistration nnevery nn___ nnyears nn(45CFR46.505) nn- nnANSWER: nn✔ nn3
