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ICH Good Clinical Practice

Course Details:
Category: Clinical Duration:
30 minutes
Target Audience: Clinical Research Staff
Course Overview: The World Health Organization's (WHO) 2002 Handbook for Good Clinical Research Practice (GCP) states that in order to establish the safety and effectiveness of specific health and medical products and practices, it is necessary to carry out clinical research. GCP should be applied in a pragmatic manner, taking into account the needs and requirements of the community within which the research is being carried out.

Objectives include:

  • The 13 Principles of Good Clinical Practice

  • Key Roles of the GCP

  • GCP Investigator Responsibilities

  • Participant Informed Consent Process

  • GCP Guidelines

  • Randomization, Blinding, Unblinding Procedures

  • Study Protocol Compliance

  • Investigator Qualification and Agreements

  • Records and Reports Management

  • Safety Reporting

  • Ensuring Adequate Resources

  • Premature Termination or Suspension of a Trial