Introduction to GCP

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Introduction to GCP
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Outline

• Definition and scope
• Purpose of clinical research
• Evolution of GCP
• Players in GCP
• Checklists of players

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• GCP Good Clinical Research Practice
• Purpose of GCP
• To protect the rights of research subjects
  (volunteers or patients)
• To ensure credibility of the data
• GCP is applicable to
• Prophylactic, diagnostic and therapeutic trials
• Drugs, devices and procedures
• Epidemiological studies

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The purpose of clinical research is to create
knowledge needed to improve health care. Without
such knowledge, action for health care may be
impossible, wasteful, expensive or harmful
because it will have no logical or empirical
basis. - IUTALD, 2001
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Evolution

• Nuremberg Code, 1947
• Declaration of Helsinki, 1964 ? 2001
• ICH GCP guidelines, 1996
• Ethical Guidelines for Biomedical Research in
  Human Subjects (ICMR), 2000
• GCP Guidelines, CDSCO, New Delhi, 2001

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Players in Clinical Research

• Investigators
• Sponsors
• Regulatory agency
• Ethics Committee

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Investigators checklist - 1

• Interest, expertise, time and facilities
• Interaction with sponsor
• Protocol, CRF, PIS and ICF
• Financial grant
• Publication policy
• Interaction with ethics committee
• Presentation and defense of protocol
• Compliance with conditions of approval

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Investigators checklist - 2

• Implementation
• Organizing, briefing and supervising the team
• Facilitating informed consent process
• Completing and signing CRFs
• Reporting SAE
• Interacting with monitor
• Reviewing and approving final report
• Archiving source documents
• Preparing for audit and/or inspection

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Sponsors checklist - 1

• Scientific, regulatory and ethical basis of the
  protocol, PIS and ICF
• Investigators qualifications, training and
  experience
• Regulatory and ethical approvals
• Publication policy
• Quality of trial supplies
• Initiation, monitoring and audit

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Sponsors checklist - 2

• Data management and analysis
• Drafting of study report
• Preparation for inspection
• Archives of source documents

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Regulators checklist

• Periodic review of current regulations from
  scientific and ethical angles
• Advance consultation to sponsors on protocols
• Efficacy and safety criteria
• Comparator product
• Advisory panels for review of applications and
  decision making
• Inspection of investigational centers

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Ethics Committees checklist - 1

• Need for trial
• Scientific aspects of protocol with ethical
  implications
• Participants
• Number
• Healthy volunteers or patients
• Vulnerable persons

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Ethics Committees checklist - 2

• Treatment
• Withdrawal of current treatment
• Assignment of placebo
• Dosage and route
• Assessment of response
• Nature and frequency
• Invasive or non-invasive
• Total blood drawn

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Ethics Committees checklist - 3

• Ethical aspects of protocol
• Information and consent form
• Content and language
• Risks and benefits
• Compensation or other payments
• Insurance for study-related injury
• Treatment after study
• Regulatory approval

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Resourcefulness
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Thank you!