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
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
Video: Key Players in Clinical Trials
Resources
Video: Initiation Visit
Video: Source Documents and CRFs
Video: Protocol NonAdherence
Video: Study Visits
Trial Management II
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
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
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
Questionnaire: Your Demographic Information
Print Your Course Certificate