principles of gcp - sponsor

8/8/2019 Principles of GCP - Sponsor

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To ensure that the rights and welfare of trialsubjects are being protectedTo ensure that the Investigator and study staffare fully informedTo ensure the sites adherence to the protocol,guidelines and regulations (e.g. monitoring)


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To submit all required amendments (e.g.regulatory authorities, investigators, etc)To ensure integrity of scientific data; ensurethat the data is credible, verifiable and accurate(e.g. source data verification)


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S ponsor Responsibilities (continued):Monitoring

IRB/IBC Responsibilities


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The act of overseeing the progress of a clinical trial,and of ensuring that it is conducted, recorded, andreported in accordance with the protocol, StandardOperating Procedures (SOPs), Good Clinical Practice(GCP), and the applicable regulatory requirement(s).


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The purposes of trial monitoring are to verify that:the rights and well-being of human subjects areprotected.the reported trial data are accurate, complete, andverifiable from source documents.the conduct of the trial is in compliance with thecurrently approved protocol/amendment(s), with GCP,and with the applicable regulatory requirement(s).


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Verify that :the investigator has adequate qualificationsresources remain adequate throughout the trial period, thatfacilities, including laboratories, equipment, and staff, areadequate to safely and properly conduct the trial and remainadequate throughout the trial periodsites are monitored per scheduledraft monitoring visit reports are submitted, reviewed andfinalized in a timely fashion


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Verify that the Clinical Trial Material(s): Are stored at the appropriate conditionsSupply is sufficient throughout the trial.

Is/are supplied only to subjects who are eligible to receive it and at theprotocol specified dose(s).That subjects are provided with necessary instruction on properlyusing, handling, storing, and returning the Clinical Trial Material(s).That the receipt, use, and return of the Clinical Trial Material(s) at thetrial sites are controlled and documented adequately.That the disposition of unused Clinical Trial Material(s) at the trial sitescomplies with applicable regulatory requirement(s) and is inaccordance with the sponsor.


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P urpose: to ensure the reported trial data are accurate,complete and verifiable from source documentsS ource documents: CRFs, labs, scans

DatabaseTables and graphsFinal S tudy Report


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S ponsor Warning Letter Example


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What is an Institutional Review Board (IRB)?an IRB is an appropriately constituted group that has been formally designated toreview and monitor biomedical research involving human subjectsan IRB has the authority to approve, require modifications in (to secure approval),or disapprove researchan IRB review serves an important role in the protection of the rights and welfareof human research subjects

What is an Institutional Biosafety Committee (IBC)?established under the NIH Guidelines for Research Involving Recombinant DNAMolecules to provide local review and oversight of nearly all forms of researchutilizing recombinant DNA


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P rotocol/AmendmentInvestigators BrochureInformed Consent

1572P rincipal Investigator CV and medical licenseFinancial DisclosureS afety ReportsContinuing Review/Yearly Renewal

Deviation LogsRecruitment MaterialsCV and medical licensure of subinvestigators (or anyone obtaining consent)


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P rotocol/Amendment ApprovalsApproved Informed Consents

1572sP rincipal Investigator CVs and medical licensesAny Additional Requested Information


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principles of gcp - sponsor

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