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SOCRA CCRP EXAM 2024 Questions And Answers Latest Top Score.
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SOCRA CCRP EXAM 2024 Questions And Answers Latest Top Score.
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SOCRA CCRP EXAM 2024 Questions AndAnswers Latest Top Score.
A zpatient zreceived zan zinitial zdose zand zhad zno zinitial zreaction. zThe zprotocol zsays zthe
zpatient zneeds zto zincrease zit zby z20%. zThe zinitial zdose zwas z370mg^3/m; zwhat zis zthe znext
ztreatment? z- zcorrect zanswer. z z z z444mg^3/m
Which zcountries zare zincluded zin zthe zICH zGCP? z- zcorrect zanswer. z z z zEuropean zUnion,
zJapan, zUnited zStates, zCanada zand zSwitzerland
What zis zthe zmonitor znot zresponsible zfor? z
A) zPatient zinformation
B) zSponsor zSOP
C) zProtocol/ICF
D) zReporting zto zIRB z- zcorrect zanswer. z z z z
According zto zICH zE6, zan zinspection zis zdefined zas: z- zcorrect zanswer. z z z zAn zofficial zreview
zof zdocuments, zfacilities, zrecords, zand zany zother zresources zrelated zto za zclinical ztrial.
An zinvestigator zshall zsubmit za zfinal zreport zto zthe zsponsor zand zthe zreviewing zIRB zwithin.
z- zcorrect zanswer. z z z z3 zmonths zafter ztermination zor zcompletion zof zthe zinvestigation zor zthe
zinvestigator's zpart zof zthe zinvestigation.
The zresponsibility zfor zensuring zthat zthe zinvestigator zunderstands za zclinical ztrial zlies zwith
zwhich zindividual/or zorganization?
A) zFDA
B) zIRB
C) zSponsor
D) zCoordinator z- zcorrect zanswer. z z z zC) zSponsor
Records zinspection z- zcorrect zanswer. z z z zA zsponsor, zIRB, zor zinvestigator, zor zany zother
zperson zacting zon zbehalf zof zsuch za zperson zwith zrespect zto zan zinvestigation, zshall zpermit
, zauthorized zFDA zemployees, zat zreasonable ztimes zand zin za zreasonable zmanner, zto
zinspect zand zcopy zall zrecords zrelating zto zan zinvestigation.
Entry zand zInspection z- zcorrect zanswer. z z z zA zsponsor zor zan zinvestigator zwho zhas
zauthority zto zgrant zaccess zshall zpermit zauthorized zFDA zemployees, zat zreasonable ztimes
zand zin za zreasonable zmanner, zto zenter zand zinspect zany zestablishment zwhere zdevices
zare zheld z(including zany zestablishment zwhere zdevices zare zmanufactured, zprocessed,
zpacked, zinstalled, zused, zor zimplanted zor zwhere zrecords zof zresults zfrom zuse zof zdevices
zare zkept).
Who zis zresponsible zfor zmaintaining zthe zclose zout zreport? z- zcorrect zanswer. z z z zSponsor
Records zidentifying zsubjects. z- zcorrect zanswer. z z z zAn zinvestigator zshall zpermit
zauthorized zFDA zemployees zto zinspect zand zcopy zrecords zthat zidentify zsubjects, zupon
znotice zthat zFDA zhas zreason zto zsuspect zthat zadequate zinformed zconsent zwas znot
zobtained, zor zthat zreports zrequired zto zbe zsubmitted zby zthe zinvestigator zto zthe zsponsor zor
zIRB zhave znot zbeen zsubmitted zor zare zincomplete, zinaccurate, zfalse, zor zmisleading.
If zan zinvestigator zuses za zdevice zwithout zobtaining zinformed zconsent, zthe zinvestigator
zshall zreport zsuch zuse zto zthe zsponsor zand zthe zreviewing zIRB zwithin z- zcorrect zanswer. z z z
z5 zworking zdays.
What zFDA zdocument zmust zall zinvestigators zsigned zprior zto zparticipating zin za zdrug
zclinical ztrial? z- zcorrect zanswer. z z z z1572
The zcontents zof za zprotocol zshould zgenerally zcontain:
(A) zTrial zobjectives zand zpurpose
(B) zAssessment zof zefficacy
(C) zData zhandling zand zrecordkeeping
(D) zAll zof zthe zabove z- zcorrect zanswer. z z z z(D) zALl zof zthe zabove
An zinvestigator zshall znotify zthe zsponsor zand zthe zreviewing zIRB zof zany zdeviation zfrom
zthe zinvestigational zplan zto zprotect zthe zlife zor zphysical zwell-being zof za zsubject zin zan
zemergency zno zlater zthan z- zcorrect zanswer. z z z z5 zworking zdays.
Sponsor zmust zreport zto zFDA zand zall zinvestigators zin zan zIND zsafety zreport zof zpotential
zserious zrisks zno zlater zthan z- zcorrect zanswer. z z z zAs zsoon zas zpossible zbut zno zlater zthan
z15 zcalendar zdays
Device: zWithdrawal zof zIRB zapproval z- zcorrect zanswer. z z z z5 zworking zdays
The zFDA zform z483 zis zused zfor z- zcorrect zanswer. z z z zInspectional zObservations
What zis zthe zfederal zdepartment zresponsible zfor zhelping zpeople zof zCanada zmaintain zand
zimprove ztheir zhealth? z- zcorrect zanswer. z z z zHealth zCanada
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