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Good Clinical Practice. A Review for OCRA US RAC Study Group September 2005 Ginger Clasby, MS Promedica International [email protected] 714-799-1617 x 25. GCP What It Is.

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good clinical practice

Good Clinical Practice

A Review for OCRA US RAC Study GroupSeptember 2005Ginger Clasby, MS Promedica [email protected] 714-799-1617 x 25

gcp what it is
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
gcp participating parties
GCPParticipating Parties
  • IRB/Ethics Committee
  • Investigators
  • Sponsor
  • Regulatory Authorities
gcp key documents
GCPKey Documents
  • Investigator Brochure
  • Study Protocol
  • Informed Consent Document
gcp principles
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
gcp principles1
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
gcp principles2
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
irb ec roles responsibilities
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
irb ec composition operations
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
irb ec composition operations1
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)
irb ec procedures
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
irb ec procedures1
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
irb ec procedures2
IRB/ECProcedures
  • Notify Investigator promptly of:
    • Study-related decisions
    • Reason for decisions
    • Procedures for appeal of decisions
irb ec required records
IRB/ECRequired Records
  • Relevant records maintained ≥ 3 yr after study completion
  • Records available for review by regulatory authorities
irb ec what is reviewed
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
irb ec when reviews occur
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
investigator roles responsibilities
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
investigator responsibilities appropriate qualifications
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
investigator responsibilities adequate resources
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
investigator responsibilities medical care
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
investigator responsibilities irb ec communications
Investigator ResponsibilitiesIRB/EC Communications
  • IRB/EC approval prior to study initiation
  • IRB/EC kept apprised of events & progress during study
investigator responsibilities protocol compliance
Investigator ResponsibilitiesProtocol 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
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
investigator responsibilities randomization procedures unmasking
Investigator ResponsibilitiesRandomization Procedures & Unmasking
  • Follow study randomization procedures
  • Unmask only in accordance with protocol
  • Document noncompliance or premature unmasking
investigator responsibilities subject informed consent
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
investigator responsibilities subject informed consent1
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
investigator responsibilities required records reports
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
investigator responsibilities required records reports1
Investigator ResponsibilitiesRequired Records & Reports
  • Source documentation
  • Data capture forms (study-specific)
  • Data clarification forms
  • Fully executed informed consent documents
investigator responsibilities required records reports2
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
sponsor roles responsibilities
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
sponsor roles responsibilities1
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
sponsor roles responsibilities2
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
sponsor roles responsibilities3
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
study protocol components
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
study protocol components1
Study ProtocolComponents
  • How data will be captured & maintained
  • Monitoring procedures
  • Proposed informed consent document
informed consent document components
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)
informed consent document components1
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
informed consent document components2
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
investigator brochure what it is
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

investigator brochure components
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
good clinical practice reference documents links
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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