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Admission on going

Clinical SAS Programming Course

( Pre-requisite: Knowledge of Base & Advance SAS Programming)

  • Clinical trial process and essential documents
  • Protocol | Raw CRF | SDTM IG Guide | SAP | SOP’s | CT | Study grid | etc…

  • Describe the clinical research process (phases, key roles, key organizations).
  •  Interpret a Statistical Analysis Plan.
  •  Derive programming requirements from an SAP and an annotated Case Report Form.
  •  Describe regulatory requirements (principles of 21 CFR Part 11, International
    Conference on Harmonization, Good Clinical Practices).
The SDTM Standard Domain Models

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)
• Disposition (DS)
• Medical History (MH)

Implementing ADaM with Base SAS ADaM Tools
  • ISO 8601 Date and DateTime Conversions
  •  Merging in Supplemental Qualifiers
    ADSL – The Subject-Level Dataset
  • The ADaM Basic Data Structure (BDS)
  • ADAE – Adverse Event Analysis Datasets
  •  ADTTE – The Time-to-Event Analysis Dataset
Clinical trials process
  • Accessing, managing and transforming clinical trials data.
  •  Statistical procedures and macro programming.
  • Reporting clinical trials results.
  •  Validating clinical trial data reporting.
Findings General Observation Class

• Drug Accountability (DA)
• Death Details (DD)
• ECG Test Results (EG)
• Inclusion/Exclusion Criterion Not Met (IE)
• Laboratory Test Results (LB)
• Physical Examination (PE)
• Vital Signs (VS)

Oncology Domains

• Tumor Identification (TU)
• Tumor Results (TR)
• Disease Response (RS)

  • Statistical procedures and macro programming
  • Accessing, managing and transforming clinical trial data.
  • Reporting Clinical trials results
  • Validating Clinical data reporting

Our Students Work at Renowned Companies & Startups

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