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