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  1. 1. Vulnerable Subjects Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.
  2. 2. Good Clinical Practice (GCP)  GCP is defined as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials or studies  GCP compliance provides public assurance that the rights, safety and well-being of human subjects involved in research are protected GCPGCP
  3. 3. Goals of GCP To protect the rights, safety and welfarerights, safety and welfare of humans participating in research To assure the quality, reliability and integrityquality, reliability and integrity of data collected To provide standards and guidelinesstandards and guidelines for the conduct of clinical research Good Clinical Practice = Ethics + Quality Data GCP
  4. 4. Foundations for the ethical conduct of clinical research  The Nuremberg CodeNuremberg Code (1947)  The Declaration of HelsinkiDeclaration of Helsinki (1964)  The Belmont ReportBelmont Report (1979)  International Conference on Harmonisation (ICH-GCP)  International Standards Organization 14155  Code of Federal Regulations
  5. 5. A Historical Perspective Nuremberg Code (1947) Voluntary participationVoluntary participation Informed ConsentInformed Consent Minimization of riskMinimization of risk Belmont Report (1979) Respect for PersonsRespect for Persons BeneficenceBeneficence JusticeJustice Declaration of Helsinki (1964) Well-being of subject takes precedenceWell-being of subject takes precedence Respect for personsRespect for persons Protection of subjects health and rightsProtection of subjects health and rights Special protection for vulnerable populationsSpecial protection for vulnerable populations
  6. 6. THE PRINCIPLES OF ICH GCP EthicsEthics: 1. Ethical conduct of clinical trials 2. Benefits justify risks 3. Rights, safety, and well-being of subjects prevail Protocol and science:Protocol and science: 4. Nonclinical and clinical information supports the trial 5. Compliance with a scientifically sound, detailed protocol GOODGOOD CLINICALCLINICAL PRACTICEPRACTICE
  7. 7. THE PRINCIPLES OF ICH GCP Responsibilities:Responsibilities: 6. IRB/IEC approval prior to initiation 7. Medical care/decisions by qualified physician 8. Each individual is qualified (education, training, experience) to perform his/her tasks Informed Consent:Informed Consent: 9. Freely given from every subject prior to participation
  8. 8. THE PRINCIPLES OF ICH GCP Data quality and integrity:Data quality and integrity: 10. Accurate reporting, interpretation, and verification 11. Protects confidentiality of records Investigational ProductsInvestigational Products 12. Conform to GMP’s and used per protocol Quality Control/Quality Assurance 13. Systems with procedures to ensure quality of every aspect of the trial EDC IPIP
  9. 9. THE PRINCIPLES OF ICH GCP  The rights, safety, and well-beingrights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.  The available nonclinical and clinical informationnonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.
  10. 10. THE PRINCIPLES OF ICH GCP  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/favorable opinion.
  11. 11. THE PRINCIPLES OF ICH GCP  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).
  12. 12. THE PRINCIPLES OF ICH GCP  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.
  13. 13. THE PRINCIPLES OF ICH GCP  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. Clinical Trial Drug