Category:
Analytics and Reporting |
Duration: 8 Weeks / 120 Hours |
Tables, Listings, and Graphs
In clinical trials, the results of data analysis are communicated through Tables, Listings, and Graphs (TLGs), which form the backbone of clinical study reports (CSRs) and regulatory submissions. TLGs present statistical analyses in a clear, standardized format to support decision-making by sponsors, investigators, and regulatory authorities such as the FDA and EMA.
The TLGS program provides learners with practical knowledge of creating and validating TLG outputs using ADaM datasets. It is an essential training module for statistical programmers and biostatisticians aiming to deliver submission-ready reports that meet global regulatory expectations.
SIP – Self-Paced Online with Support
- Course Duration: 4 weeks (100 hours)
- Format: Self-Paced Online with Support (narrated lessons, readings, quizzes, and role-based tasks).
By completing this program, learners will:
- Understand the role of TLGs in clinical trial reporting and submissions.
- Learn how to generate Tables, Listings, and Graphs using ADaM datasets.
- Explore statistical concepts applied in TLG outputs (efficacy, safety, demographics).
- Gain hands-on practice in SAS procedures and programming for TLGs.
- Ensure traceability between SDTM → ADaM → TLGs.
- Apply validation and quality control techniques to TLGs.
- Review regulatory expectations for submission-ready reports.
- Work through case studies on CSR outputs and mock regulatory deliverables.
- Statistical Programmers / SAS Programmers preparing clinical trial outputs.
- Biostatisticians generating and validating statistical reports.
- Regulatory submission specialists contributing to CSR deliverables.
- Clinical data professionals advancing into statistical programming.
- Gain hands-on SAS programming skills for producing TLGs.
- Build confidence in delivering regulatory-compliant clinical trial outputs.
- Understand end-to-end traceability from raw data → SDTM → ADaM → TLGs.
- Be job-ready for advanced statistical programming roles in CROs and pharma.
- Strengthen employability for global submission projects.
- Statistical Programmer (TLG Specialist)
- Clinical Statistical Analyst
- Biostatistics Reporting Programmer
- Regulatory Submission Programmer
- Clinical Programming Lead
Modules | |
1. Introduction to TLGs in Clinical Research
2. Role of TLGs in Clinical Study Reports (CSRs) 3. Linking SDTM → ADaM → TLGs 4. SAS Programming for Tables (PROC REPORT, PROC TABULATE) 5. SAS Programming for Listings (PROC PRINT, PROC SQL) 6. SAS Programming for Graphs (PROC SGPLOT, PROC GPLOT, ODS Graphics) 7. Common Statistical Outputs (Efficacy, Safety, Demographics) 8. Validation & QC of TLG Outputs 9. Regulatory Submission Requirements for TLGs 10. Case Studies – Building End-to-End CSR Deliverables |
For more information, please call us at +91 8925971788 / +91 8977943100 (WhatsApp)or email qpdc@qtechelearncenter.com. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.