Good Clinical Practices | JindalChest Clinic

Good Clinical Practice (GCP) is an international set of guidelines that ensures reliable results and patient protection in clinical trials, covering design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. This presentation gives an overview on "Good clinical practice" including fundamental principles, ethics and safety, data handling, etc. For more information, please contact us: 9779030507.

1. Good Clinical Practices

2. 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.

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

4. 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

5. 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

6. Ethical and Safety Considerations: Principles Essentiality Voluntariness, informed consent and community agreement Non-exploitation Privacy and confidentiality Precaution and risk minimization Professional competence

7. Ethics & Safety…. Accountability and transparency Maximization of the public interest and distributive justice Institutional arrangement Public domain Totality of responsibility Compliance

8. 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

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

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