CERTIFICATE PROGRAM

Clinical Trials Management

Final Application Deadline:

Program Begins:

Ethics Education Courses

Curriculum

This program features blended learning  comprising of a two-day workshop (face to face or virtual) and 4 weeks of eLearning.

Over the course of  five weeks, participants participate in the following topics:

Introduction to Good Clinical Practice

Topics

  • Introduction to Good Clinical Practice
  • Roles and Responsibilities
  • Research and discovery stage and drug development
  • Regulatory submission and lifecycle concept

Resources

Video: International Conference on Harmonisation & GCP

Presentation: Good Clinical Practice Presentation Henry Silverman

Website: Introduction to Good Clinical Practice Global Health Training Centre

Activities

Lesson: Introduction to ICH

Trial Management I

Topics

  • Selecting and Initiating Study Sites
  • Study Protocol, Essential Documents,
  • PreStudy and Essential Documents

Resources

Video: Key Players in Clinical Trials

Video: Initiation Visit

Video: Source Documents and CRFs

Video: Study Visits

Trial Management II

Topics

  • Protocol Non-adherences
  • Quality control and assurances
  • Monitoring and closing clinical trials

Resources

Video: Quality Control & Assurance

Presentation: Quality Monitoring and Quality Assurance

Video: Protocol NonAdherence

Subject Management I: Recruitment and Informed Consent

Topics

  • Recruitment and Screening
  • Retention
  • Informed Consent

Resources

SCORM: Informed Consent

Presentation: Screening and Informed Consent

URL: The Process of Informed Consent

Subject Management II: Clinical Trial Safety

Topics

  • Participant Safety
  • Adverse Event Reporting
  • Incidental Findings
  • Data Safety Monitoring and Data Safety Monitoring Boards

Resources

Video: Safety in Clinical Trials AEs and DSMBs

Presentation: Monitoring Clinical Trials

Presentation: Adverse Events Tamer Hifnawy

Activities

Lesson: Monitoring for Safety

End of Course Activities

Feedback Activity

Post-test

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