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SOCRA CCRP Reporting & Timelines Exam With Correct Answers $13.49   Add to cart

Exam (elaborations)

SOCRA CCRP Reporting & Timelines Exam With Correct Answers

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  • Course
  • SOCRA CCRP
  • Institution
  • SOCRA CCRP

SOCRA CCRP Reporting & Timelines Exam With Correct Answers,

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  • August 6, 2024
  • 4
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers
  • SOCRA CCRP
  • SOCRA CCRP
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Lectphilip
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

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