290 likes | 631 Views
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)
E N D
Introduction to GCP A S Nanivadekar
Outline • Definition and scope • Purpose of clinical research • Evolution of GCP • Players in GCP • Checklists of players A S Nanivadekar
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
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
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
Players in Clinical Research • Investigators • Sponsors • Regulatory agency • Ethics Committee A S Nanivadekar
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
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
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
Sponsor’s checklist - 2 • Data management and analysis • Drafting of study report • Preparation for inspection • Archives of source documents A S Nanivadekar
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
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
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
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
Resourcefulness A S Nanivadekar
Thank you! A S Nanivadekar