Good Clinical Practices And Regulatory Compliance Questions With Clear - Cut Solutions

Good Clinical Practices And Regulatory Compliance -
x x x x x x



Questions With Clear-Cut Solutions
x x x x




Drugx&xBiologicxversusxMedicalxDevicexRegulationsx–
x RIGHTxANSxdifferencesxbetweenxthexregulationsxgoverningxdrugsx&xbiologicsxcomparedxt
oxmedicalxdevices.


EntitiesxResponsiblexforxGCPxCompliancex–
x RIGHTxANSxorganizationsxorxindividualsxaccountablexforxadheringxtoxGoodxClinicalxPracti
ces.


LinksxbetweenxICHxGCPxE6xandx21CFRx312/812x–
x RIGHTxANSxconnectionsxorxrelationshipsxbetweenxICHxGoodxClinicalxPracticexE6xandx21x
CodexofxFederalxRegulationsxPartsx312xandx812.


ObjectivexofxGoodxClinicalxPracticesx(GCP)x–
x RIGHTxANSxthexpurposexorxgoalxofxGCPxandxhowxadherencexisxenforcedxthroughxStandar
dxOperatingxProceduresx(sops).


RegulatoryxInformationxSheetsx–
x RIGHTxANSxdocumentsxcontainingxregulatoryxinformationxrelatedxtoxthextopic.


InstitutionalxReviewxBoardx–
x RIGHTxANSxaxboardxresponsiblexforxreviewingxandxapprovingxclinicalxresearchxprotocolsxt
oxensurexsubjectxsafetyxandxcompliancexwithxregulations.


ICHxGCPxE6xR2x–
x RIGHTxANSxaxguidelinexoutliningxthexresponsibilitiesxofxallxpartiesxinvolvedxinxclinicalxinves
tigations,xnotxaxlegalxdocumentxbutxaxtoolxforxinterpretingxFDAxregulations.

, InvestigatorxSitex–
x RIGHTxANSxlocationxwherexclinicalxresearchxisxconducted,xresponsiblexforxsafetyxreviews,
x dataxcollection,xandxotherxactivities.


DataxManagementx–
x RIGHTxANSxprocessxofxmaintainingxdatabases,xreviewingxdata,xandxensuringxdataxquality
x inxclinicalxtrials.


GCPxParadigmx–
x RIGHTxANSxthexoverallxframeworkxorxmodelxofxGoodxClinicalxPracticesxincludingxFDAxgui
delines,xICHxGCPxguidelines,xandxotherxdirectives.


AuditxTrailx–
x RIGHTxANSxaxdocumentedxhistoryxofxactivitiesxinxaxclinicalxtrialxtoxensurexdataxintegrityxan
dxcompliance.


SourcesxofxGCPx–
x RIGHTxANSxvariousxoriginsxofxGoodxClinicalxPracticesxincludingxFDAxregulations,xICHxGC
Pxguidelines,xandxEUxregulations.


FDAxRegulationsx(21xCFR)x–
x RIGHTxANSxregulationsxestablishedxbyxthexFDAxtoxgovernxclinicalxresearchxofxmedicinalxp
roducts.


ISOx–
x RIGHTxANSxinternationalxOrganizationxforxStandardization,xwhichxmayxprovidexstandards
x relevantxtoxclinicalxresearch.


Sponsor/CROxsopsx-
x RIGHTxANSxstandardxOperatingxProceduresxspecificxtoxsponsorsxorxContractxResearchx
Organizationsx(cros)xinxclinicalxtrials.