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Courses

Clinical Research

Protocol &Study Design basics
  • Protocol objectives, endpoints, inclusion/exclusion criteria
  • Study phases (I–IV), randomisation, blinding, control groups
  • Ethical approval (IRB/IEC) and informed consent
Clinical Trial Operations
  • Site initiation, subject recruitment, screening, enrolment, follow-up
  • Visit schedules, CRF/EDC completion, source documentation
  • Trial conduct support: deviations, amendments, participant retention
Data Management in Clinical Research
  • Data collection standards, CRF design and annotations
  • Query management, data cleaning, data reconciliation
  • Database lock activities and data quality checks
Regulatory &Compliance
  • ICH-GCP principles, patient safety and confidentiality
  • 21 CFR Part 11 awareness (electronic records/signatures)
  • Inspection/audit readiness documentation
Safety Management (Pharmacovigilance basics)
  • AE/SAE collection and reporting timelines awareness
  • MedDRA coding concepts, seriousness/severity/causality basics
  • Safety listings and reconciliation with clinical database
Clinical Reporting
  • CSR basics: structure, key sections, appendices
  • Support for ISS/ISE and annual report deliverables
  • Traceability from data to tables/figures to narrative conclusions
Tools & documentation habits
  • SOP adherence, version control practices, issue tracking logs
  • Clear documentation: meeting notes, reviewer checklists, audit trails
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Statistical Programming

CDISC Standards Implementation
  • CDASH/SDTM/ADaM mapping, dataset build, and QC
  • Controlled terminology checks, metadata consistency, traceability (Raw → SDTM → ADaM)
Dataset Programming
  • SDTM domain programming (e.g., DM, AE, CM, LB, VS, EX, DS)
  • ADaM dataset programming (e.g., ADSL, ADAE, ADLB, ADVS)
  • Derivations: baseline, change from baseline, visit/windowing, flags, imputations (per SAP)
TLF Programming (Tables, Listings, Figures)
  • Safety/efficacy TLF generation aligned with SAP and shells
  • Complex outputs: shift tables, exposure summaries, disposition, demographics
  • Figures (where applicable): KM plots, forest plots, trend/spaghetti plots
  • Output formats: RTF/PDF, titles/footnotes, pagination, consistency checks
Safety Management (Pharmacovigilance basics)
  • AE/SAE collection and reporting timelines awareness
  • MedDRA coding concepts, seriousness/severity/causality basics
  • Safety listings and reconciliation with clinical database
Clinical Reporting
  • CSR basics: structure, key sections, appendices
  • Support for ISS/ISE and annual report deliverables
  • Traceability from data to tables/figures to narrative conclusions
Tools & documentation habits
  • SOP adherence, version control practices, issue tracking logs
  • Clear documentation: meeting notes, reviewer checklists, audit trails
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+91 62933 37999

contact@e-stats.in

8th Floor, G block, Gopalan Global Axis, near Satya Sai Hospital Metro Station, Bengaluru

Copyright © 2025 e-stats  All Rights Reserved.