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Clinical Trial Informatics & eCRF Design (CDISC SDTM/ADaM) | eCRF→SDTM→ADaM→TLFs

NTHRYS >> Services >> Academic Services >> Training Programs >> Bioinformatics Training >> Clinical & Translational Bioinformatics / Precision Medicine >> Clinical Trial Informatics & eCRF Design (CDISC SDTM/ADaM) | eCRF→SDTM→ADaM→TLFs

Clinical Trial Informatics & eCRF Design (CDISC SDTM/ADaM) — Hands-on

Build audit-ready clinical data pipelines from protocol to analysis. This hands-on module covers eCRF design and EDC configuration, CDISC SDTM domain mapping, ADaM analysis dataset creation, metadata/traceability (define.xml, aCRF) , edit checks and data queries, TLF shells, and governance aligned to 21 CFR Part 11 and GCP.

Clinical Trial Informatics & eCRF Design (CDISC SDTM/ADaM)
Help Desk · WhatsApp
Session 1
Fee: Rs 20120
Protocol → eCRF & EDC Foundations
  • From endpoints to forms
    • objective/endpoint mapping schedule of assessments visit structure
  • EDC & eCRF design
    • form libraries & coding edit checks & queries roles & audit trails
  • Coding & dictionaries (overview)
    • MedDRA/WHO-DD units/controlled terms concomitant meds, AEs
Session 2
Fee: Rs 24320
CDISC SDTM Domains & Mapping
  • SDTM essentials
    • IG/CT/ODM (high-level) DM, AE, EX, VS, LB findings/events/interventions
  • Mapping from eCRF to SDTM
    • value-level metadata supplemental qualifiers relrec & identifiers
  • QC & conformance checks
    • validator tools spec tables derivation logs
Session 3
Fee: Rs 28520
ADaM Datasets, Traceability & TLFs
  • ADaM structures
    • ADSL, ADAE, ADVS, ADLB BDS/ADTTE param/aval framework
  • Traceability & metadata
    • from SDTM to ADaM analysis flags & derivations programming specs
  • TLF shells & outputs
    • tables/listings/figures safety/efficacy endpoints reproducible runs
Session 4
Fee: Rs 34120
Validation, define.xml & Compliance
  • Submission package & metadata
    • define.xml & aCRF reviewer guides ADM/SDRG/ADRG notes
  • Validation & governance
    • conformance checks change control & SOPs issue management
  • Regulatory readiness (overview)
    • 21 CFR Part 11 GCP & audit trails privacy & security


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