Live Project Course Highlights – SAS Clinical Programming (SDTM | ADaM | TLFs)
Real-Time Industry Project Experience. End-to-End Clinical Submission. Connecting with server based on scheduled timelines and tasks.
- Description
- Curriculum
- FAQ
- Notice
- Reviews
Q1. What type of project will I be working on?
A: You’ll work on a real-world Oncology clinical trial project, modified to reflect the latest industry implementation standards (CDISC SDTM IG v3.4 & ADaM IG v1.3). It covers the full pipeline: raw data → SDTM → ADaM → TLFs → Submission.
Q2. Is the project based on real clinical trial data?
A: Yes. You will work with a de-identified, modified real clinical study, simulating a real CRO/Pharma working environment.
Q3. Is this project updated to the latest CDISC standards?
A: Absolutely. The entire project is designed using SDTM IG v3.4, ADaM IG v1.3, and follows regulatory submission best practices used by FDA and PMDA.
Q4. What SDTM and ADaM domains are included in the project?
A: You will build and validate important domains such as:
SDTM: DM,SE,SV,CO, AE, DS,VS, LB, MH, CM, EG,EX, SUPPQUAL, RELREC
ADaM: ADSL, ADAE, ADCM,ADDS,ADLB, ADVS, ADTTE (Time to Event for Oncology) .The order of the domains will be changed or introduced
SDTM: DM,SE,SV,CO, AE, DS,VS, LB, MH, CM, EG,EX, SUPPQUAL, RELREC
ADaM: ADSL, ADAE, ADCM,ADDS,ADLB, ADVS, ADTTE (Time to Event for Oncology) .The order of the domains will be changed or introduced
Q5. Do we get hands-on experience with TLFs?
A: Yes. You will create Tables (Demographics, AE Summaries, Lab Shifts), Listings, and Figures (KM Curves, Boxplots) from ADaM datasets, including shell design and validation.
Q6. Will the project be done using a SAS server environment?
A: Yes. You’ll get access to a remote server to simulate a real-time CRO/Pharma environment, ideal for multi-user programming and validation workflows.
Q7. Will we be using Pinnacle 21 for validation?
A: Yes. You’ll perform SDTM and ADaM validations using Pinnacle 21 Community Edition, just like in actual FDA submissions.
Q8. Will we work with Define.xml and Reviewer’s Guides?
A: Yes. You’ll learn to create Define.xml v2.1, SDRG (Study Data Reviewer’s Guide), and ADRG (Analysis Data Reviewer’s Guide) as part of the final submission package.
Q9. Will there be any documentation or specs provided?
A: Yes. You’ll receive:
Annotated CRFs
SDTM & ADaM specifications
SAP extracts
Shells for TLFs
Project flow diagrams
Validation reports
Annotated CRFs
SDTM & ADaM specifications
SAP extracts
Shells for TLFs
Project flow diagrams
Validation reports
Q10. Will I be guided step-by-step through the project?
A: Yes. You will receive mentor-led step-by-step guidance, live discussions, doubt clearing sessions, and project walkthroughs with explanation of logic and derivations.
Q11. Is this project useful for interviews?
A: Definitely. You’ll receive interview-focused documentation and guidance on how to explain your role in the project. This project will be a key asset on your resume and in technical rounds.
Q12. Will I get a certificate for completing the project?
A: Yes. You’ll receive a Live Project Completion Certificate, which can be added to your resume, LinkedIn profile, and portfolio.
Q14. Do you offer job placement after the project?
A: Yes, we offer a Guaranteed Job Placement Opportunity for eligible students who complete the full project, submit assignments, and clear internal evaluations. You’ll also receive mock interview support and resume building.
Q15. Can I add this project to my resume and LinkedIn?
A: Absolutely! This project is interview-ready and portfolio-friendly. We’ll guide you on how to present it in your resume and LinkedIn professionally.
Subject: SAS Clinical Live Project Enrollment – Reminder
Dear project members,
This is to inform you that the Live Clinical Project (SDTM | ADaM | TLFs – Oncology Study) will begin on every 45 days. This real-time project will provide hands-on experience aligned with the latest CDISC standards and regulatory expectations.
✅ Last date for enrollment:
✅ Project Mode: Online – Server-Based Environment
✅ Includes: SDTM, ADaM, TLFs, Define.xml, Validation, Interview Prep
✅ Certificate: Issued upon successful completion
✅ Job Placement: Based on performance & eligibility
📍 Please ensure your registration by mailing
info@nova8labs.com
Best regards,
[Nova8Labs Team]
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