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Good Clinical Practice

Good Clinical Practice. A Review for OCRA US RAC Study Group September 2005 Ginger Clasby, MS Promedica International gclasby@promedica-intl.com 714-799-1617 x 25. GCP What It Is.

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Good Clinical Practice

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  1. Good Clinical Practice A Review for OCRA US RAC Study GroupSeptember 2005Ginger Clasby, MS Promedica Internationalgclasby@promedica-intl.com 714-799-1617 x 25

  2. GCPWhat 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

  3. GCPParticipating Parties • IRB/Ethics Committee • Investigators • Sponsor • Regulatory Authorities

  4. GCPKey Documents • Investigator Brochure • Study Protocol • Informed Consent Document

  5. GCPPrinciples • 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

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

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

  8. IRB/ECRoles & 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

  9. IRB/ECComposition & 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

  10. IRB/ECComposition & 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)

  11. IRB/ECProcedures • 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

  12. IRB/ECProcedures • 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

  13. IRB/ECProcedures • Notify Investigator promptly of: • Study-related decisions • Reason for decisions • Procedures for appeal of decisions

  14. IRB/ECRequired Records • Relevant records maintained ≥ 3 yr after study completion • Records available for review by regulatory authorities

  15. IRB/ECWhat 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

  16. IRB/ECWhen 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

  17. InvestigatorRoles & 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

  18. Investigator ResponsibilitiesAppropriate 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

  19. Investigator ResponsibilitiesAdequate 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

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

  21. Investigator ResponsibilitiesIRB/EC Communications • IRB/EC approval prior to study initiation • IRB/EC kept apprised of events & progress during study

  22. Investigator ResponsibilitiesProtocol Compliance • Conduct study in accordance with protocol • May not deviate from protocol without Sponsor/IRB approval • Document deviations from protocol

  23. Investigator ResponsibilitiesInvestigational 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

  24. Investigator ResponsibilitiesRandomization Procedures & Unmasking • Follow study randomization procedures • Unmask only in accordance with protocol • Document noncompliance or premature unmasking

  25. Investigator ResponsibilitiesSubject 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 subject’s legal rights • Keep subject informed of new information regarding study

  26. Investigator ResponsibilitiesSubject Informed Consent • Provide informed consent in understandable language • Give subject the chance to ask questions • If subject can’t 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

  27. Investigator ResponsibilitiesRequired 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

  28. Investigator ResponsibilitiesRequired Records & Reports • Source documentation • Data capture forms (study-specific) • Data clarification forms • Fully executed informed consent documents

  29. Investigator ResponsibilitiesRequired 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

  30. SponsorRoles & 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

  31. SponsorRoles & 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

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

  33. SponsorRoles & Responsibilities • Sponsor may transfer responsibilities to CRO • Transfer must be documented in writing • Sponsor still has ultimate responsibility for study quality and data integrity

  34. Study ProtocolComponents • 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

  35. Study ProtocolComponents • How data will be captured & maintained • Monitoring procedures • Proposed informed consent document

  36. Informed Consent DocumentComponents • 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 • Subject’s responsibilities • Foreseeable risks to subject (embryo, fetus, nursing infant)

  37. Informed Consent DocumentComponents • 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

  38. Informed Consent DocumentComponents • Description of extent to which confidentiality can be assured • Commitment to keep subject apprised on new information that may affect subject’s willingness to participate in study • Contact info for questions re: subject rights; trial-related adverse events • Circumstances under which subject’s participation may be terminated

  39. Investigator BrochureWhat It Is A compilation of clinical & non-clinical data on the product that is relevant to the product’s study in humans Necessary for Investigator & IRB/EC review to assess the risks/benefits associated with study

  40. Investigator BrochureComponents 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

  41. Good Clinical PracticeReference 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/cfrsearch.cfm

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