Good Clinical Practices

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Good Clinical Practices
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Good Clinical Practices

• A set of guidelines for biomedical studies which
  encompass the
• Design
• Conduct
• Termination
• Audit
• Analysis
• Reporting and documentation
• of the studies involving human subjects.

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Fundamental Principles

1. The interest of science and society should never
   take precedence over considerations related to
   the well being of the study subject.
2. Studies are scientifically and ethically sound
   and the clinical properties of the pharmaceutical
   substances under investigation are properly
   documented.

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Pre-requisites

• Investigational Pharmaceutical Product
• Pre-clinical supporting data
• Protocol
• General information
• Objectives and justification
• Ethical considerations
• Study design
• Inclusion, Exclusion withdrawal of subjects
• Handling of the Product

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Protocol

• Assessment of efficacy
• Assessment of safety
• Statistics
• Data handling and management
• Quality control and assurance
• Finance and insurance
• Publication policy
• Evaluation
• Supplementaries and appendices

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Ethical and Safety Considerations Principles

• Essentiality
• Voluntariness, informed consent and community
  agreement
• Non-exploitation
• Privacy and confidentiality
• Precaution and risk minimization
• Professional competence

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Ethics Safety.

• Accountability and transparency
• Maximization of the public interest and
  distributive justice
• Institutional arrangement
• Public domain
• Totality of responsibility
• Compliance

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Multi centre Studies

• Assurance that the study will be planned and
  conducted according to GCPs
• Responsibility for
• Commencement and overall performance
• Supervision of data
• Monitoring of ADRs/AEs and policy matters
• Coordinating committee
• Ideally, the studies should begin and end
  simultaneously at all centres
• Facilitate communication between various sites
• Training to follow same protocols and systems

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Record-keeping and data handling

1. Documentation Detailed as per protocol
2. Corrections should not obscure the original
   entry. Correct data should be inserted with the
   reason for correction, date and initials.
3. Electronic data processing only by authorized
   person. Security and safeguards-important.
4. Language, which is clearly understood.
5. Responsibility of the investigator for lab
   values, normal reference ranges (etc).

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