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Good Clinical Practice

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Good Clinical Practice A Review for OCRA US RAC Study Group September 2005 Ginger Clasby, MS Promedica International gclasby_at_promedica-intl.com 714-799-1617 x 25 – PowerPoint PPT presentation

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Title: Good Clinical Practice


1
Good Clinical Practice
A Review for OCRA US RAC Study Group September
2005 Ginger Clasby, MS Promedica
International gclasby_at_promedica-intl.com 714-7
99-1617 x 25
2
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

3
GCP Participating Parties
  • IRB/Ethics Committee
  • Investigators
  • Sponsor
  • Regulatory Authorities

4
GCP Key Documents
  • Investigator Brochure
  • Study Protocol
  • Informed Consent Document

5
GCP Principles
  1. Studies in accordance with Declaration of
    Helsinki consistent with GCP applicable
    regulatory requirements
  2. Studies initiated continued only if anticipated
    benefits outweigh risks
  3. Rights, safety welfare of human subjects take
    priority over interests of science society
  4. Available non-clinical clinical info on product
    adequate to support study

6
GCP Principles
  • 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
GCP Principles
  1. Study information recorded, handled stored to
    allow accurate reporting, interpretation
    verification
  2. Confidentiality of subject records protected in
    accordance with applicable regulatory
    requirements
  3. Investigational products manufactured, handled
    stored in accordance with GCP used in
    accordance with approved protocol
  4. Systems/procedures implemented to assure quality
    of study

8
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

9
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

10
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)

11
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

12
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

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

14
IRB/EC Required Records
  • Relevant records maintained 3 yr after study
    completion
  • Records available for review by regulatory
    authorities

15
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

16
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

17
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

18
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

19
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

20
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

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

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

23
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

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

25
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

26
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

27
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

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

29
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

30
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

31
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

32
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

33
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

34
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

35
Study Protocol Components
  • How data will be captured maintained
  • Monitoring procedures
  • Proposed informed consent document

36
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)

37
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

38
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
    trial-related adverse events
  • Circumstances under which subjects participation
    may be terminated

39
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

40
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

41
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/cfrsearch.cfm
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