CCRP SOCRA Practice Exam Verified Questions And Correct Answers Latest Already Graded A+

CCRP SOCRA Practice Exam Verified
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nn Questions And Correct Answers 2025-
nn nn nn nn




2026 Latest Already Graded A+
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nn
nn nn


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The nnresponsibility nnfor nnensuring nnthat nnthe nninvestigator nnunderstands nna nnclinical nntrial
nnlies nnwith nn
nn
which nnindividual/or

nnorganization?
nn

A) FDA nn
B) IRB nn
C) Sponsor nn
D) Coordinator nn- nnCORRECT nnANSWER-C) nnSponsor nn
nn

nn What nnis nnthe nnminimum nnnumber nnof nnIRB
A) 3 nnnn
nnMembers? nn
B) 5 nn

C)
nn6
nn

D) nn10 nn- nnCORRECT nnANSWER- A nnsignificant nnrisk nndevice nnis nndefined nnas nnan
B) nn5 nninvestigational nndevice nnthat nnis: nn
nn

A) nnIntended nnas nnan nnimplant nnand nnpresents nna nnpotential nnfor nnserious nnrisk nnto nnthe
nnhealth, nnsafety, nn
nn
or nnwelfare nnof nna
nnsubject
nn

B) nnPurported nnor nnrepresented nnto nnbe nnfor nna nnuse nnin nnsupporting nnor nnsustaining
nnhuman nnlife nnand nn
nn
presents nna nnpotential nnrisk nnto nnthe nnhealth, nnsafety, nnor nnwelfare nnof
nna nnsubject
nn

C) For nna nnuse nnof nnsubstantial nnimportance nnin nndiagnosing, nncuring, nnmitigating, nnor
nntreating nndisease, nnor nnotherwise nnpreventing nnimpairment nnof nnhuman nnhealth nnand

nnpresents nna nnpotential nnfor nnserious nnrisk nnto nnthe nnhealth, nnsafety, nnor nnwelfare nnof nna

nnsubject. nn nn
nn

D) All nnthe nnabove nn- nnCORRECT nnANSWER-D nn) nnAll nnof nnthe nnabove nn
nn

With nnrespect nnto nnIRB/IEC nnmembership, nnboth nnthe nnFDA nnand nnthe nnICH nnrequire
nnthat: nn

A) A nnmajority nnof nnthe nnmembers' nnprimary nnarea nnof nninterest nnis nnin nna nnscientific nnarea
nn

B) At nnleast nnone nnmember nnholds nna nnPh.D. nndegree nnor nnequivalent nn
C) At nnleast nnone nnmember's nnprimary nnarea nnof nninterest nnis nnin nna nnnonscientific nnarea nn

, D) A nnmajority nnof nnthe nnmembers nnare nnfrom nnor nnhave nnties nnto nnthe nninstitution nnof
nnrecord nn- nnCORRECT nnANSWER-C) nnAt nnleast nnone nnmember's nnprimary nnarea nnof

nninterest nnis nnin nna nnnonscientific nnarea nn
nn

In nna nnnon-emergency nnsituation, nnunder nnwhich nnof nnthe nnfollowing nnconditions, nnif
nnany, nnmay nn
nn
subjects nnbeen nnrolled nninto nna nnstudy nnprior nnto nnIRB/IEC
nnapproval?
nn

A) The nninvestigator nnprovides nnhis/her nnwritten nnapproval nn
nn

B) The nnstudy nndrug nnhas nnan nnFDA nnapproved nnmarketing nnapplication nn
nn

C) The nnFDA nnprovides nnwritten nnapproval nnof nnthe nnIND nn
nn

D) nnSubjects nncannot nnbe nnenrolled nnuntil nnIRB/IEC nnapproval nnhas nnbeen nnobtained nn-
nnCORRECT nn
nn
ANSWER-D) nnSubjects nncannot nnbe nnenrolled nnuntil nnIRB/IEC nnapproval nnhas nnbeen
nnobtained
nn

A nnsubject nnhas nnbeen nnenrolled nnon nna nnstudy nnand nnwas nnrandomized nnto nnthe nnnon-
treatment nnarm. nnThe nnprotocol nnoutlines nnstudy nnprocedures nnfor nnall nnsubjects nnto nnbe
nnperformed nnwithin nnone nnweek nnof nnenrollment. nnWhich nnof nnthe nnfollowing nnstatements

nnabout nnthis nncase nnis nncorrect? nn
nn

A) nnThis nnsubject nndoes nnnot nnneed nnto nnundergo nnany nnof nnthe nnstudy nnprocedures nnsince
nnthe nnsubject nn
nn
is nnenrolled nnon nnthe nnnon-treatment
nnarm
nn

B) nnThis nnsubject nnshould nnundergo nnall nnstudy nnprocedures nnas nnoutlined nnin nnthe
nnprotocol nn
nn

C) nnThis nnsubject nnonly nnneeds nnto nnundergo nnthe nnstudy nnprocedures nnthat nnpertain
nnspecifically nnto nn
nn
the
nnsubject
nn

D) nnThis nnsubject nncan nnundergo nnthe nnstudy nnprocedures nnwhenever nnit nnis nnconvenient
nn- nn

CORRECT nnANSWER-B) nnThis nnsubject nnshould nnundergo nnall nnstudy nnprocedures nnas
nnoutlined nnin nnthe nnprotocol nn
nn

A nnpurpose nnof nnmonitoring nnclinical nntrials nnis nnto nnverify nnthat: nn
nn

A) The nnrights, nnsafety, nnand nnwell-being nnof nnhuman nnsubjects nnare nnprotected nn
nn

B) Investigators nnreceive nnadequate nnpayment nnfor nntheir nnparticipation nnin nnthe nnclinical
nntrial nn
nn