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    Good Clinical Practice

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    Krishna Kishore
    Good Clinical Practice (GCP) is an international quality standard for clinical research that outlines ethical and scientific standards for designing, conducting, recording, and reporting trials involving human subjects. Key parties in GCP-compliant trials include investigators, sponsors, institutional review boards/ethics committees, and regulatory authorities. GCP establishes principles like prioritizing subject safety, obtaining informed consent, and ensuring qualified investigators properly conduct trials according to approved protocols and applicable regulations.

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    Good Clinical Practice

    Uploaded by

    Krishna Kishore
    189 views41 pages
    Good Clinical Practice (GCP) is an international quality standard for clinical research that outlines ethical and scientific standards for designing, conducting, recording, and reporting trials involving human subjects. Key parties in GCP-compliant trials include investigators, sponsors, institutional review boards/ethics committees, and regulatory authorities. GCP establishes principles like prioritizing subject safety, obtaining informed consent, and ensuring qualified investigators properly conduct trials according to approved protocols and applicable regulations.

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    Good Clinical Practice (GCP) is an international quality standard for clinical research that outlines ethical and scientific standards for designing, conducting, recording, and reporting trials involving human subjects. Key parties in GCP-compliant trials include investigators, sponsors, institutional review boards/ethics committees, and regulatory authorities. GCP establishes principles like prioritizing subject safety, obtaining informed consent, and ensuring qualified investigators properly conduct trials according to approved protocols and applicable regulations.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    189 views41 pages

    Good Clinical Practice

    Uploaded by

    Krishna Kishore
    Good Clinical Practice (GCP) is an international quality standard for clinical research that outlines ethical and scientific standards for designing, conducting, recording, and reporting trials involving human subjects. Key parties in GCP-compliant trials include investigators, sponsors, institutional review boards/ethics committees, and regulatory authorities. GCP establishes principles like prioritizing subject safety, obtaining informed consent, and ensuring qualified investigators properly conduct trials according to approved protocols and applicable regulations.

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    of 41

    Good Clinical Practice

    Overview Of Good Clinical Practice

    GCP What It Is
    An international ethical & scientific quality standard for designing, conducting, recording & reporting human clinical studies
    EU Japan US

    Applies to registration studies that may have an impact on safety & welfare of human subjects

    GCP Participating Parties


    IRB/Ethics Committee Investigators Sponsor Regulatory Authorities

    GCP Key Documents


    Investigator Brochure Study Protocol Informed Consent Document

    GCP Principles
    1. Studies in accordance with Declaration of Helsinki; consistent with GCP & applicable regulatory requirements Studies initiated & continued only if anticipated benefits outweigh risks Rights, safety & welfare of human subjects take priority over interests of science & society Available non-clinical & clinical info on product adequate to support study

    2. 3. 4.

    GCP Principles
    5. Studies scientifically sound; described in clear, detailed protocol 6. Study in compliance with IRB/EC approved protocol 7. Medical care given to subjects is the responsibility of qualified medical professional(s) 8. Individuals conducting studies qualified by education, training & experience 9. Freely given informed consent obtained from every subject prior to study participation

    GCP Principles
    10. Study information recorded, handled & stored to allow accurate reporting, interpretation & verification 11. Confidentiality of subject records protected in accordance with applicable regulatory requirements 12. Investigational products manufactured, handled & stored in accordance with GCP & used in accordance with approved protocol 13. Systems/procedures implemented to assure quality of study

    IRB/EC Roles & Responsibilities


    To safeguard study subjects rights & welfare by: Evaluation/disposition of study proposal Evaluation of proposed subject consent materials Evaluation of emergency use consent methodology Evaluation of investigator qualifications Ongoing review of study progress (at least yearly) Evaluation of proposed subject compensation plans

    IRB/EC Composition & Operations


    Membership has qualifications & experience to evaluate science, medical aspects & ethics of proposed study
    5 members 1 member whose primary interest in nonscientific 1 member independent of institution or study site

    Written SOPs & records Decisions rendered at announced meetings with quorum in attendance

    IRB/EC Composition & Operations


    Only members participating in review should vote Investigator may provide info on study, but should not be involved in review or vote Nonmembers with expertise in special areas may be invited to assist with review (but cannot vote)

    IRB/EC Procedures
    Document group membership & qualifications Schedule meetings & notify members Conduct initial & ongoing review of studies Determine ongoing review frequency Provide expedited review of minor study changes, in accordance with regulatory requirements Specify that no subject should be enrolled in study prior to IRB/EC approval

    IRB/EC Procedures
    Specify that no deviations from protocol should be initiated without prior IRB/EC approval
    Emergency situations require immediate notification of IRB/EC after the fact

    Specify that Investigator should promptly report:


    Protocol deviations Changes increasing subject risk or study procedures Serious and unexpected adverse events

    IRB/EC Procedures
    Notify Investigator promptly of:
    Study-related decisions Reason for decisions Procedures for appeal of decisions

    IRB/EC Required Records


    Relevant records maintained 3 yr after study completion Records available for review by regulatory authorities

    IRB/EC What is Reviewed


    Investigator Brochure or Report of Prior Investigations Study protocol & amendments Investigator qualifications Informed consent documents, including subject recruiting tools Other written information provided to subjects Subject compensation plans Adverse events Protocol deviations

    IRB/EC When Reviews Occur


    Prior to study initiation at site At least yearly during study During study, as necessitated by: Changes in protocol, consent documents, etc. Changes in study investigator Reports of serious or unanticipated device-related adverse events At study completion or termination

    Investigator Roles & Responsibilities


    Qualified to conduct study Have adequate resources to conduct study Provide medical care to study subjects Regular communication with IRB/EC reviewing study Compliance with study protocol Maintenance of investigational product accountability Compliance with study randomization & unmasking procedures Provide informed consent to study subjects

    Investigator Responsibilities Appropriate Qualifications


    Training & experience demonstrated via:
    Medical license CV Specialized study training GCP training

    If study responsibilities delegated, need a list of qualified persons to whom responsibilities are delegated

    Investigator Responsibilities Adequate Resources


    Suitable staff & good methods for keeping them apprised Suitable facilities Appropriate patient population
    Access to disease or condition Volume of patients with disease or condition

    Investigator Responsibilities Medical Care


    Make medical decisions regarding patient treatment Adequate care for study-related adverse events Diligence in ascertaining reason(s) for subject withdrawals from study

    Investigator Responsibilities IRB/EC Communications


    IRB/EC approval prior to study initiation IRB/EC kept apprised of events & progress during study

    Investigator Responsibilities Protocol Compliance


    Conduct study in accordance with protocol May not deviate from protocol without Sponsor/IRB approval Document deviations from protocol

    Investigator Responsibilities Investigational Product Accountability


    Maintain accountability at study site Document product receipt & disposition Maintain product in a secure area Use product only in accordance with protocol Disallow use of product by anyone not registered with study

    Investigator Responsibilities Randomization Procedures & Unmasking


    Follow study randomization procedures Unmask only in accordance with protocol Document noncompliance or premature unmasking

    Investigator Responsibilities Subject Informed Consent


    Comply with regulatory requirements Update consent documents as necessary Inform subject that study involves investigational product May not coerce subject to participate May not waive subjects legal rights Keep subject informed of new information regarding study

    Investigator Responsibilities Subject Informed Consent


    Provide informed consent in understandable language Give subject the chance to ask questions If subject cant read, need impartial witness If subject is disadvantaged, need legally authorized witness Get subject consent in writing prior to initiation of study procedures Give subject a copy of signed consent document

    Investigator Responsibilities Required Records & Reports


    Essential regulatory document file(s)
    Protocol & amendments Approved informed consent documents Product accountability documentation Investigator qualifications & agreements IRB correspondence Study delegation list Subject screening/enrollment logs Study monitoring reports Calibration/maintenance logs Memos to file

    Investigator Responsibilities Required Records & Reports


    Source documentation Data capture forms (study-specific) Data clarification forms Fully executed informed consent documents

    Investigator Responsibilities Required Records & Reports


    Written periodic status reports to IRB/EC Written reports of protocol deviations to Sponsor & IRB/EC Serious or unanticipated product-related adverse events to Sponsor & IRB/EC Notification of study suspension or termination to IRB/EC Final study report to IRB/EC Retain 2 yr

    Sponsor Roles & Responsibilities


    Study quality assurance Appropriately qualified medical personnel to advise on study Utilization of qualified personnel in study design & operations Study management, data handling & record keeping Investigator selection & training Definition/allocation of study responsibilities

    Sponsor Roles & Responsibilities


    Facilitation of communications between Investigators Study compensation (investigators and/or subjects) & financing Regulatory authority notification/submission Confirmation of IRB/EC review/approval Investigational product information Investigational product manufacturing, packaging, labeling & coding Investigational product supply & handling

    Sponsor Roles & Responsibilities


    Record access Ongoing safety evaluation & reporting Serious/unanticipated adverse event reporting Study monitoring Study noncompliance procedures Study termination or suspension notification Study reports

    Sponsor Roles & Responsibilities


    Sponsor may transfer responsibilities to CRO Transfer must be documented in writing Sponsor still has ultimate responsibility for study quality and data integrity

    Study Protocol Components


    General administrative info Background Study purpose & objectives Study design Subject eligibility requirements How subjects will be treated How safety & efficacy will be assessed Sample size justification & statistical analysis methods

    Study Protocol Components


    How data will be captured & maintained Monitoring procedures Proposed informed consent document

    Informed Consent Document Components


    Statement that study involves research & product experimental (if applicable) Study purpose Number of expected study subjects to be enrolled Study treatment(s) & probability for random assignment Study exams & procedures for duration of trial Subjects responsibilities Foreseeable risks to subject (embryo, fetus, nursing infant)

    Informed Consent Document Components


    Expected benefits Alternatives procedures or therapies & associated risk/benefit Compensation available in event of study-related injury or sickness Anticipated payments to subject for study participation Anticipated expenses to subject for study participation Statement that participation is voluntary

    Informed Consent Document Components


    Description of extent to which confidentiality can be assured Commitment to keep subject apprised on new information that may affect subjects willingness to participate in study Contact info for questions re: subject rights; trialrelated adverse events Circumstances under which subjects participation may be terminated

    Investigator Brochure What It Is


    A compilation of clinical & non-clinical data on the product that is relevant to the products study in humans

    Necessary for Investigator & IRB/EC review to assess the risks/benefits associated with study

    Investigator Brochure Components


    Product formulation summary Introduction/background info regarding product & investigational plan Investigational product physical, chemical & pharmaceutical properties & formulation Non-clinical studies Human clinical studies Summary of data & guidance for Investigator

    Good Clinical Practice Reference Documents & Links


    ICH - E6: Guideline for Good Clinical Practice 21 CFR 50 - Informed Consent 21 CFR 56 - Institutional Review Board

    http://www.ich.org/cache/compo/276-254-1.html http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrs earch.cfm

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