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Introduction to GCPIntroduction to GCP

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OutlineOutline

Definition and scopeDefinition and scopePurpose of clinical researchPurpose of clinical researchEvolution of GCPEvolution of GCPPlayers in GCPPlayers in GCPChecklists of playersChecklists of players

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GCP = Good Clinical GCP = Good Clinical ResearchResearch PracticePractice

Purpose of GCPPurpose of GCPTo protect the To protect the rightsrights of research subjects of research subjects

(volunteers or patients)(volunteers or patients)To ensure To ensure credibilitycredibility of the data of the data

GCP is applicable toGCP is applicable toProphylactic, diagnostic and therapeutic Prophylactic, diagnostic and therapeutic

trialstrialsDrugs, devices and proceduresDrugs, devices and proceduresEpidemiological studiesEpidemiological studies

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The purpose of clinical research is to create knowledge needed to improve health care. Without such knowledge, action for health care may be impossible, wasteful, expensive or harmful because it will have no logical or empirical basis.

- IUTALD, 2001

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EvolutionEvolution

Nuremberg Code, 1947Nuremberg Code, 1947Declaration of Helsinki, 1964 Declaration of Helsinki, 1964 → → 20012001 ICH GCP guidelines, 1996ICH GCP guidelines, 1996Ethical Guidelines for Biomedical Ethical Guidelines for Biomedical

Research in Human Subjects (ICMR), Research in Human Subjects (ICMR), 20002000

GCP Guidelines, CDSCO, New Delhi, GCP Guidelines, CDSCO, New Delhi, 20012001

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Players in Clinical ResearchPlayers in Clinical Research

InvestigatorsInvestigatorsSponsorsSponsorsRegulatory agencyRegulatory agencyEthics CommitteeEthics Committee

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Investigator’s checklist - 1Investigator’s checklist - 1

Interest, expertise, time and facilitiesInterest, expertise, time and facilities Interaction with sponsorInteraction with sponsor

Protocol, CRF, PIS and ICFProtocol, CRF, PIS and ICFFinancial grantFinancial grantPublication policyPublication policy

Interaction with ethics committeeInteraction with ethics committeePresentation and defense of protocolPresentation and defense of protocolCompliance with conditions of approvalCompliance with conditions of approval

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Investigator’s checklist - 2Investigator’s checklist - 2

ImplementationImplementationOrganizing, briefing and supervising the Organizing, briefing and supervising the

teamteamFacilitating informed consent processFacilitating informed consent processCompleting and signing CRFsCompleting and signing CRFsReporting SAEReporting SAEInteracting with monitorInteracting with monitorReviewing and approving final reportReviewing and approving final reportArchiving source documentsArchiving source documentsPreparing for audit and/or inspectionPreparing for audit and/or inspection

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Sponsor’s checklist - 1Sponsor’s checklist - 1

Scientific, regulatory and ethical Scientific, regulatory and ethical basis of the protocol, PIS and ICFbasis of the protocol, PIS and ICF

Investigator’s qualifications, training Investigator’s qualifications, training and experienceand experience

Regulatory and ethical approvalsRegulatory and ethical approvalsPublication policyPublication policyQuality of trial suppliesQuality of trial supplies Initiation, monitoring and auditInitiation, monitoring and audit

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Sponsor’s checklist - 2Sponsor’s checklist - 2

Data management and analysisData management and analysisDrafting of study reportDrafting of study reportPreparation for inspectionPreparation for inspectionArchives of source documentsArchives of source documents

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Regulator’s checklistRegulator’s checklist

Periodic review of current regulations Periodic review of current regulations from scientific and ethical anglesfrom scientific and ethical angles

Advance consultation to sponsors on Advance consultation to sponsors on protocolsprotocolsEfficacy and safety criteriaEfficacy and safety criteriaComparator productComparator product

Advisory panels for review of Advisory panels for review of applications and decision makingapplications and decision making

Inspection of investigational centersInspection of investigational centers

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Ethics Committee’s checklist - Ethics Committee’s checklist - 11

Need for trialNeed for trialScientific aspects of protocol with Scientific aspects of protocol with

ethical implicationsethical implicationsParticipantsParticipants

NumberNumberHealthy volunteers or patientsHealthy volunteers or patientsVulnerable personsVulnerable persons

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Ethics Committee’s checklist - Ethics Committee’s checklist - 22

TreatmentTreatmentWithdrawal of current treatmentWithdrawal of current treatmentAssignment of placeboAssignment of placeboDosage and routeDosage and route

Assessment of responseAssessment of responseNature and frequencyNature and frequencyInvasive or non-invasiveInvasive or non-invasiveTotal blood drawnTotal blood drawn

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Ethics Committee’s checklist - Ethics Committee’s checklist - 33

Ethical aspects of protocolEthical aspects of protocolInformation and consent formInformation and consent form

Content and languageContent and languageRisks and benefitsRisks and benefitsCompensation or other paymentsCompensation or other paymentsInsurance for study-related injuryInsurance for study-related injuryTreatment after studyTreatment after study

Regulatory approvalRegulatory approval

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Resourcefulness

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Thank you!Thank you!