logo

GCP-R2

  • 4.5 Rating
  • (10 Reviews)
  • 47 User Enrolled

GCP-R2

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.

  • 4.5 Rating
  • (10 Reviews)
  • 47 User Enrolled
  • 500
Tags:
GCP



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...

Course Content

6 sections • 12 lectures • 09h 33m total length
RECORD
114min
MATERIAL
mb
Record
85min
Material
mb
Record
79min
Material
mb
Record
122min
Material
mb
Record
58min
Material
mb
Record
115min
Material
mb

Requirements

  • From Zero to Hero

Description

The objective of this ICH GCP guidance is to provide a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. 

The guidance was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries, and the World Health Organization. 

This guidance should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities. 

The principles established in this guidance may also be applied to other clinical investigations that may have an impact on the safety and well-being of human subjects.

Target Audience:

  • Pharmacists
  • Physicians
  • Scientists
  • Healthcare professionals
  • Investigators and Researchers
  • Employees involved in Clinical Research in Pharma companies, CROs
  • Students of health-related disciplines: Public Health, Faculty of science

Recently Added Courses

blog
Last Updated 30th May 2021
  • 52
  • 500
blog
Last Updated 26th May 2021
  • 69
  • 500
blog
Last Updated 30th May 2021
  • 47
  • 500
blog
Last Updated 30th May 2021
  • 4
  • 500
blog
Last Updated 30th May 2021
  • 7
  • 500

About the Instructor

instructor
About the Instructor

Student Feedback

4.5
Course Rating
96%  
78%  
96%