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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

Good Clinical Practice

A Review for OCRA US RAC Study GroupSeptember 2005Ginger Clasby, MS Promedica Internationalgclasby@promedica-intl.com 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