Certificate Course in CDISC – SDTM

Step-by-step practical learning on mapping using SDTM model and ADaM model

  • Total Hours: 300; 100 hours of learning content plus 100 hours of practicals and 75 hours of assessments
  • Learn from established experts with 12+ yrs of industry experience

Course Description

SDTM (Study Data Tabulation Model) describes a normal framework for human clinical trial (study) information tabulations and non-clinical study information tabulations to be presented to a regulatory agency such as the Food and Drug Administration of the United States (FDA) as part of a product request. The Clinical Data Interchange Standards Consortium (CDISC) Submission Data Standards Team describes SDTM.

The Certificate Course in CDISC – SDTM/ADaM from Clinosol Research Pvt. Ltd. has been designed to provide the students with data mapping knowledge to start a career in data mapping team.

  • What Will You Learn?
  • Who Can Learn?

At the completion of the course you will have hands-on experience on;

Special-Purpose Domains:

  • Comments (CO)
  • Demographics (DM)
  • Subject Elements (SE)
  • Subject Visits (SV)

Interventions General Observation Class:

  • Concomitant Medications (CM)
  • Exposure as Collected (EC)
  • Exposure (EX)
  • Substance Use (SU)
  • Procedures (PR)

Events General Observation Class:

  • Adverse Events (AE)
  • Clinical Events (CE)
  • Disposition (DS)
  • Protocol Deviations (DV)
  • Medical History (MH)
  • Healthcare Encounters (HO)

Findings General Observation Class:

  • Drug Accountability (DA)
  • Death Details (DD)
  • ECG Test Results (EG)
  • Inclusion/Exclusion Criterion Not Met (IE)
  • Immunogenicity Specimen Assessments (IS)
  • Laboratory Test Results (LB)
  • Microbiology Specimen (MB)
  • Microscopic Findings (MI)
  • Morphology (MO)
  • Microbiology Susceptibility Test (MS)
  • PK Concentrations (PC)
  • PK Parameters (PP)
  • Physical Examination (PE)
  • Questionnaires (QS)
  • Reproductive System Findings (RP)
  • Disease Response (RS)
  • Subject Characteristics (SC)
  • Subject Status (SS)
  • Tumor Identification (TU)
  • Tumor Results (TR)
  • Vital Signs (VS)

Findings About:

  • Findings About Events or Interventions (FA)
  • Skin Response (SR)
  • Trial Design Domains:
  • Trial Arms (TA)
  • Trial Disease Assessment (TD)
  • Trial Elements (TE)
  • Trial Visits (TV)
  • Trial Inclusion/Exclusion Criteria (TI)
  • Trial Summary (TS)

Special-Purpose Relationship Datasets:

  • Supplemental Qualifiers - SUPPQUAL
  • Relate Records - RELREC

ADaM defines dataset and metadata standards that support:

  • efficient generation, replication, and review of clinical trial statistical analyses, and
  • traceability among analysis results, analysis data, and data represented in the Study Data Tabulation Model (SDTM).​
  • ADaM is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan).
  • Graduates and postgraduates from pharmacy such as M. Pharmacy (Pharmacology)
  • MBBS
  • BDS
  • BHMS
  • BAMS
  • Pharm. D, B. Sc.
  • M.Sc. (from life sciences and statistics background)

Other Course Options: This course can be taken in combination with other courses like Clinical Research, Clinical Data Management, and Clinical SAS

On successfully completing all the learning modules, you will be awarded the,
Certificate in CDISC – SDTM/ADaM’ certification.

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