Good Clinical Practice

• Good Clinical Practice (GCP)

  An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects
• Clinical trials

  • Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion (ADME) of an investigational product(s) with the object of ascertaining its safety and/or efficacy
• Purpose of GCP

  • Provide assurance that the rights, safety and well being of the study subjects are safeguarded; in keeping with the principles that have their origin in the Declaration of Helsinki
  • Ensure that data reported are credible and accurate
  • Ensure that all drug-related clinical trials conducted in Malaysia are in accordance highest international ethical and scientific standards while at the same time taking into consideration the national issues and local realities without compromising the standards
• Unethical clinical trials

  • The Monster Study (1939)
  • High Altitude experiment (1942)
  • Dachau hypothermia experiment (1941)
  • Syphilis Tuskegee Study (1932)
• Nuremberg code

  1947
• WHO and International conference on Harmonization (ICH)

  1970
• WHO developed Declaration of Helsinki

  1975
• ICH developed GCP

  1990
• Key topics in ICH GCP

  • Glossary
  • The Principles of ICH GCP
  • IRB/IEC
  • Investigator
  • Sponsor
  • Clinical Trial Protocol & Protocol Amendments
  • Investigator's Brochure
  • Essential Documents for the Conduct of a Clinical Trial
• Principles of ICH GCP

  • Trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and regulatory requirement(s)
  • Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks
  • The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society
  • The available non clinical and clinical information on an investigational product should be adequate to support the proposed clinical trial
  • Clinical trials should be scientifically sound, and described in a clear, detailed protocol
  • A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion
  • The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist
  • Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s)
  • Freely given informed consent should be obtained from every subject prior to clinical trial participation
  • All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification
  • The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s)
  • Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol
  • Systems with procedures that assure the quality of every aspect of the trial should be implemented