Training Modules
- Introduction to Drug Lifecycle Safety Management
- Clinical study protocol review and Clinical Safety Assessments
- Subject inclusion and exclusion criteria, study procedures and designs
- Compliance with protocols during clinical studies
- Clinical Research Regulations, Legislations, Ethics and Good Clinical Practices (GCP)
- Informed consent form review, virtual Inform consent process and assessments
- Subject visits scheduling processes as specified in protocol and Manual of schedule
- Transcribing of source documents into EDCs and resolving fired queries
- Data reporting standards for Adverse Events, Adverse Drugs Reactions to Institutional Review Board, Regulatory Bodies, and the Study sponsors.
- Source documents, patient binders, ISF, regulatory binders and drug accountability logs readiness and maintenance.
- Site staff training processes, delegation processes and general organization.
- Gross overview of site staff's GCP certificates, CVs, Licenses and PI's 1572 forms etc
- Clinical Data Acquisition and Data Management.
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