100% satisfaction guarantee Immediately available after payment Both online and in PDF No strings attached
logo-home
ACRP CP Exam Review 2024 – 2025 (Complete Solution) $9.69   Add to cart

Exam (elaborations)

ACRP CP Exam Review 2024 – 2025 (Complete Solution)

 4 views  0 purchase
  • Course
  • ACRP CP
  • Institution
  • ACRP CP

ACRP CP Exam Review 2024 – 2025 (Complete Solution)

Preview 2 out of 11  pages

  • August 24, 2024
  • 11
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers
  • ACRP CP
  • ACRP CP
avatar-seller
Futurenurses
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

The benefits of buying summaries with Stuvia:

Guaranteed quality through customer reviews

Guaranteed quality through customer reviews

Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.

Quick and easy check-out

Quick and easy check-out

You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.

Focus on what matters

Focus on what matters

Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!

Frequently asked questions

What do I get when I buy this document?

You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.

Satisfaction guarantee: how does it work?

Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.

Who am I buying these notes from?

Stuvia is a marketplace, so you are not buying this document from us, but from seller Futurenurses. Stuvia facilitates payment to the seller.

Will I be stuck with a subscription?

No, you only buy these notes for $9.69. You're not tied to anything after your purchase.

Can Stuvia be trusted?

4.6 stars on Google & Trustpilot (+1000 reviews)

84146 documents were sold in the last 30 days

Founded in 2010, the go-to place to buy study notes for 14 years now

Start selling
$9.69
  • (0)
  Add to cart