This repository contains SAS programs developed for generating TLF outputs in clinical trials.
Each program is designed for a specific reporting component such as safety listings, demographic summaries, and adverse event tables.
| File Name | Description |
|---|---|
| Listing task 1.sas | Generates subject-level listing outputs for review. |
| Safety Population - demographics.sas | Creates demographic summary tables for the Safety Population. |
| Table_14.3.2.4_TRTEMFL_AE_BySOC_PT_Severity.sas | Produces AE summary tables by System Organ Class (SOC), Preferred Term (PT), and severity. |
The programs demonstrate:
- SDTM to ADaM mapping and derivations.
- Safety and efficacy data summarization.
- Generation of regulatory-compliant tables and listings.
- SAS version: 9.4 or above
- Input datasets: SDTM/ADaM domains (e.g., DM, AE, LB)
- Output format:
.rtf/.lst/.xlsx(as applicable)
| Output Type | Example |
|---|---|
| Listing | Subject-level AE Listing |
| Table | AE Summary by SOC and Severity |
| Figure | (Optional) Can include graphical summaries if extended |
Siva M
Clinical SAS Programmer | TLF Development | ADaM/SDTM Implementation
For feedback, suggestions, or collaboration:
๐ GitHub Profile
This project is open-source and can be used for learning and non-commercial purposes.