CERTIFICATE PROGRAM

Clinical Trials Management

Final Application Deadline:

Program Begins:

Ethics Education Courses

Curriculum

This program features a blended learning model comprising live workshops, self-paced on-demand sessions and live webinars.

Over the course of  five weeks, participants will:

Introduction to Good Clinical Practice

Intro

SCORM: Introduction to Best Clinical Practices: GCP and Roles and Responsibilities

Resources

Video: International Conference on Harmonisation & GCP

Presentation: Good Clinical Practice Presentation Henry Silverman

URL: Introduction to Good Clinical Practice Global Health Training Centre

Activities

Lesson: Introduction to ICH

Trial Management I

Intro

Video: Key Players in Clinical Trials

Resources

Video: Initiation Visit

Video: Source Documents and CRFs

Video: Protocol NonAdherence

Video: Study Visits

Trial Management II

Intro

Video: Quality Control & Assurance

Resources

Video: Study Protocol, Essential Documents, Recruitment

Presentation: PreStudy and Essential Documents

Presentation: Quality Monitoring and Quality Assurance

Subject Management I Recruitment and Informed Consent

Recruitment

Video: Recruitment and Retention

Informed Consent

SCORM: Informed Consent

Presentation: Screening and Informed Consent

URL: The Process of Informed Consent

Subject Management II Monitoring Clinical Trials

Introduction

SCORM: Participant Safety & AE Reporting

Resources

Video: Safety in Clinical Trials AEs and DSMBs

Presentation: Safety in Clinical Trials

Presentation: Monitoring Clinical Trials

Presentation: Adverse Events Tamer

Presentation: DSMB Henry Silverman

Activities

Lesson: Monitoring for Safety

End of Course Activities

Feedback Activity

Questionnaire: Your Demographic Information

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