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GCP
  • bestseller
  • 12 Courses
  • 110 Students
  • All Levels

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording..

  • 500
  • (4.5)
  • (11 ratings)
What you will learn
  • INTRODUCTION GLOSSARY THE PRINCIPLES OF ICH GCP
  • INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC) Responsibilities Composition, Functions, and Operat...
  • INVESTIGATOR Investigator’s Qualifications and Agreements Adequate Resources Medical Care of Trial Subjects Communi...
  • SPONSOR Quality Management Quality Assurance and Quality Control Contract Research Organization (CRO) Expertise Tr...
  • Investigator Selection Allocation of Responsibilities Compensation to Subjects and Investigators Financing Notifi...
  • Monitoring Purpose Selection and Qualifications of Monitors Extent and Nature of Monitoring Monitor's Responsibiliti...
  • Audit Purpose Selection and Qualification of Auditors Auditing Procedures Noncompliance Premature Termination or S...
  • Clinical Trial/Study Reports Multicenter Trials
  • CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S) Trial Design Selection and Withdrawal of Subjects Treatment of Subj...
  • INVESTIGATOR'SBROCHURE Introduction General Considerations Title Page Confidentiality Statement Contents of the Inv...