1 / 16

Introduction to GCP

Introduction to GCP. Outline. Definition and scope Purpose of clinical research Evolution of GCP Players in GCP Checklists of players. GCP = Good Clinical Research Practice Purpose of GCP To protect the rights of research subjects (volunteers or patients)

zeus-hawkins
Download Presentation

Introduction to GCP

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Introduction to GCP A S Nanivadekar

  2. Outline • Definition and scope • Purpose of clinical research • Evolution of GCP • Players in GCP • Checklists of players A S Nanivadekar

  3. 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 A S Nanivadekar

  4. 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 A S Nanivadekar

  5. 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 A S Nanivadekar

  6. Players in Clinical Research • Investigators • Sponsors • Regulatory agency • Ethics Committee A S Nanivadekar

  7. Investigator’s 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 A S Nanivadekar

  8. Investigator’s 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 A S Nanivadekar

  9. Sponsor’s checklist - 1 • Scientific, regulatory and ethical basis of the protocol, PIS and ICF • Investigator’s qualifications, training and experience • Regulatory and ethical approvals • Publication policy • Quality of trial supplies • Initiation, monitoring and audit A S Nanivadekar

  10. Sponsor’s checklist - 2 • Data management and analysis • Drafting of study report • Preparation for inspection • Archives of source documents A S Nanivadekar

  11. Regulator’s 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 A S Nanivadekar

  12. Ethics Committee’s checklist - 1 • Need for trial • Scientific aspects of protocol with ethical implications • Participants • Number • Healthy volunteers or patients • Vulnerable persons A S Nanivadekar

  13. Ethics Committee’s 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 A S Nanivadekar

  14. Ethics Committee’s 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 A S Nanivadekar

  15. Resourcefulness A S Nanivadekar

  16. Thank you! A S Nanivadekar

More Related