Last updated Sat, 02-May-2026

Outcomes:

• Explain all 5 phases of drug development and describe the specific CDM activities and deliverables at each stage
• Write and interpret a Data Management Plan (DMP) — the master governing document for clinical trial data
• Design and interpret edit checks (validation rules) for range, consistency, and completeness errors in clinical data
• Perform medical coding using MedDRA (adverse events) and WHO Drug Dictionary (medications)
• Apply CDISC standards: understand CDASH, map CRF data to SDTM domains, and interpret ADaM dataset structures
• Apply CDISC standards: understand CDASH, map CRF data to SDTM domains, and interpret ADaM dataset structures
• Design a well-structured Case Report Form (CRF) that aligns with protocol requirements and CDASH standards
• Navigate and operate Electronic Data Capture (EDC) systems including Medidata Rave and Oracle Clinical
• Manage the complete query lifecycle — from auto-query generation to site response, resolution, and SLA tracking
• Manage the complete query lifecycle — from auto-query generation to site response, resolution, and SLA tracking
• Lead a database lock process — completing the pre-lock checklist and coordinating across CDM, biostatistics, and medical teams
• Describe post-marketing CDM activities including Phase IV trials, PSUR reports, and Risk Management Plans

Last updated Tue, 02-Jun-2026

Outcomes:

• ✓ Explain the complete new drug discovery and development process from preclinical to post-marketing surveillance
• ✓ Distinguish between Phase 0, I, II, III, and IV clinical trials and describe the purpose and typical sample size of each phase
• ✓ Interpret and prepare regulatory dossiers including INDA/IMPD, NDA/MAA, ANDA, and BLA using CTD module structure
• ✓ Apply ICH E6 GCP principles and identify the responsibilities of Sponsors, Investigators, CRAs, CRCs, and IRB/IEC members
• ✓ Evaluate clinical trial study designs including RCTs (parallel and crossover), observational designs, and decentralized trial models
• ✓ Describe ethical frameworks — Nuremberg Code, Declaration of Helsinki, Belmont Report, CIOMS, and the Common Rule — and apply them to trial scenarios
• ✓ Understand blinding techniques (single, double, triple-blind), allocation concealment, dummy techniques, placebo use, and sources of bias
• ✓ Correctly use and explain 60+ essential clinical research terminologies used in the pharmaceutical and CRO industry
• ✓ Describe the components and purpose of Trial Master Files (TMF/eTMF), Informed Consent Forms (ICF), and Case Report Forms (CRF)
• ✓ Apply epidemiological concepts — incidence, prevalence, epidemic, endemic, and pandemic — to understand public health and clinical research context
• ✓ Demonstrate readiness for entry-level roles in clinical research, regulatory affairs, pharmacovigilance, and the pharmaceutical industry

Last updated Thu, 30-Apr-2026

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Last updated Tue, 31-Mar-2026

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Last updated Tue, 02-Jun-2026

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Last updated Tue, 02-Jun-2026

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Last updated Tue, 02-Jun-2026

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Last updated Tue, 02-Jun-2026

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Last updated Tue, 02-Jun-2026

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Last updated Thu, 28-May-2026

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