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ACRP CP Exam Review 2024 – 2025 (Complete Solution)
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ACRP CP Exam Review 2024 – 2025 (Complete Solution)
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ACRP CP Exam Review 2024 – 2025(Complete Solution)
AdversesDrugsReactions(ADR)s-
sAllsnoxioussandsunintendedsresponsesstosasmedicinalsproductsrelatedstosanysdoses(causalsre
lationshipsissatsleastsasreasonablespossibility).sRegardingsmarketedsmedicinalsproducts:sasre
sponsestosasdrugswhichsissnoxioussandsunintendedsandswhichsoccurssatsdosessnormallysused
sinsmansforsprophylaxis,sdiagnosis,sorstherapysofsdiseasessorsforsmodificationsofsphysiologica
lsfunction
AdversesEvents(AE)s-
sAnysuntowardsmedicalsoccurrencesinsaspatientsorsclinicalsinvestigationssubjectsadministere
dsaspharmaceuticalsproductsandswhichsdoessnotsnecessarilyshavesascausalsrelationshipswiths
thisstreatment.s(ICHsGCPsE6s1.2)
Audits-
sAssystematicsandsindependentsexaminationsofstrialsrelatedsactivitiessandsdocumentsstosdete
rmineswhethersthesevaluatedstrialsrelatedsactivitiessweresconducted,sandsthesdatasweresreco
rded,sanalyzedsandsaccuratelysreportedsaccordingstosthesprotocol,ssponsor'ssstandardsopera
tingsproceduress(SOPs),sGoodsClinicalsPractices(GCP),sandsthesapplicablesregulatorysrequire
ment(s).
AuditsTrails-sDocumentationsthatsallowssreconstructionsofsthescoursesofsevents.
Blinding/Maskings-
sAsproceduresinswhichsonesorsmorespartiesstosthestrialsareskeptsunawaresofsthestreatmentsas
signment.sSingle-blindingsusuallysrefersstosthessubject(s)sbeingsunaware,sandsdouble-
sblindingsusuallysrefersstosthessubject(s),sinvestigator(s),smonitor,sand,sinssomescases,sdatasa
nalyst(s)sbeingsunawaresofsthestreatmentsassignment(s).s(ICHsGCPsE6s1.10)
CasesReportsForms(CRF)s-
sAsprinted,soptical,sorselectronicsdocumentsdesignedstosrecordsallsofsthesprotocolsrequiredsin
formationstosbesreportedstosthessponsorsonseachstrialssubject.
ClinicalsTrial/Studys-
sAnysinvestigationsinshumanssubjectssintendedstosdiscoversorsverifysthesclinical,spharmacolo
gicalsand/orsotherspharmacodynamicseffectssofsansinvestigationalsproduct(s),sand/orstoside
ntifysanysadversesreactionsstosansinvestigationalsproduct(s),sand/orstosstudysabsorption,sdis
tribution,smetabolism,sandsexcretionsofsansinvestigationalsproduct(s)swithsthesobjectsofsasce
rtainingsitsssafetysand/orsefficacy.
ClinicalsTrial/StudysReports-
sAswrittensdescriptionsofsastrial/studysofsanystherapeutic,sprophylacticsorsdiagnosticsagentsc
, onductedsinshumanssubjects,sinswhichsthesclinicalsandsstatisticalsdescription,spresentations,s
andsanalysissaresfullysintegratedsintosassinglesreport.s(ICHsGCPsE6s1.13)
Comparators(Product)s-
sAnsinvestigationalsorsmarketedsproducts(i.e.,sactivescontrol),sorsplacebo,susedsassasreference
sinsasclinicalstrial.
Compliances(insrelationstostrials)s-sAdherencestosallsthestrial-
relatedsrequirements,sGoodsClinicalsPractices(GCP)srequirements,sandsthesapplicablesregulat
orysrequirements.
DirectsAccesss-
sPermissionstosexamine,sanalyze,sverify,sandsreproducesanysrecordssandsreportssthatsaresim
portantstosevaluationsofsasclinicalstrial.
Documentations-
sAllsrecords,sinsanysforms(including,sbutsnotslimitedsto,swritten,selectronic,smagnetic,sandsopt
icalsrecords,sandsscans,sx-
rays,sandselectrocardiograms)sthatsdescribesorsrecordsthesmethods,sconduct,sand/orsresultss
ofsastrial,sthesfactorssaffectingsastrial,sandsthesactionsstaken.
EssentialsDocumentss-
sDocumentsswhichsindividuallysandscollectivelyspermitsevaluationsofsthesconductsofsasstudys
andsthesqualitysofsthesdatasproduced.
GoodsClinicalsPractices(GCP)s-
sAsstandardsforsthesdesign,sconduct,sperformance,smonitoring,sauditing,srecording,sanalyses,s
andsreportingsofsclinicalstrialssthatsprovidessassurancesthatsthesdatasandsreportedsresultssar
escrediblesandsaccurate,sandsthatsthesrights,sintegrity,sandsconfidentialitysofstrialssubjectssar
esprotected.
ImpartialsWitnesss-
sAsperson,swhosissindependentsofsthestrial,swhoscannotsbesunfairlysinfluencedsbyspeoplesinvo
lvedswithsthestrial,swhosattendssthesinformedsconsentsprocesssifsthessubjectsorsthessubject'ssl
egallysacceptablesrepresentativescannotsread,sandswhosreadssthesinformedsconsentsformsan
dsanysotherswrittensinformationssuppliedstosthessubject.
InformedsConsents-
sAsprocesssbyswhichsassubjectsvoluntarilysconfirmsshissorsherswillingnessstosparticipatesinsas
particularstrial,saftershavingsbeensinformedsofsallsaspectssofsthestrialsthatsaresrelevantstosthes
subject'ssdecisionstosparticipate.sInformedsconsentsissdocumentedsbysmeanssofsaswritten,ssig
nedsandsdatedsinformedsconsentsform.
Inspections-
sThesactsbysasregulatorysauthority(ies)sofsconductingsansofficialsreviewsofsdocuments,sfaciliti
es,srecords,sandsanysothersresourcessthatsaresdeemedsbysthesauthority(ies)stosbesrelatedstost
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