CDISC STANDARDS – OVERVIEW - Qtech-Sol offers Clinical Research / Trials, Pharmacovigilance, Drug Safety, Clinical Data Management, Clinical SAS Programming and Healthcare BA Training Programs
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Duration:
4 Weeks / 100 Hours
 
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CDISC Standards – Overview

Introduction – CDISC Standards

In today’s regulatory environment, data standardization is mandatory for clinical trial submissions. The Clinical Data Interchange Standards Consortium (CDISC) defines global data standards (SDTM, ADaM, SEND, ODM, Define.xml, etc.) that enable consistent data collection, exchange, and regulatory review.
The CDIS program introduces learners to the core principles, models, and implementation frameworks of CDISC standards. It provides the foundation needed to understand how raw trial data is transformed into submission-ready datasets that meet FDA, EMA, and PMDA requirements.

Course Name :  CDISC Standards – Overview
Course Code :  CDISC
Experience Level :  Entry to Intermediate
Qualification :  Bachelor’s / Master’s in Life Sciences, Statistics, Computer Science, or related fields
Student Category :  : Clinical Data Managers, SAS Programmers, Biostatisticians, Regulatory Affairs Professionals, Career Changers entering Data Standards

Delivery Type

SIP – Self-Paced Online with Support

Duration & Delivery
  1. Course Duration: 4 weeks (100 hours)
  2. Format: Self-Paced Online with Support (narrated lessons, readings, quizzes, and role-based tasks).
Key Learning Objectives

   By completing this program, learners will:

  2. Understand the importance of CDISC standards in clinical research and submissions.
  3. Learn about the different CDISC models: SDTM, ADaM, SEND, ODM, Define.xml, and Controlled Terminology.
  4. Explore how data flows from study setup to regulatory submission.
  5. Recognize the roles of FDA, EMA, PMDA in enforcing CDISC compliance.
  6. Gain insight into traceability and data integration across models.
  7. Review real-world case studies where CDISC improved submission efficiency.
Who Should Take This Course
  1. Clinical Data Managers standardizing trial datasets.
  2. Statistical Programmers working on SDTM and ADaM.
  3. Biostatisticians preparing regulatory submissions.
  4. Regulatory affairs specialists overseeing CDISC compliance.
  5. Career changers with data or life science backgrounds entering clinical programming.
Benefits & Outcomes
  1. Gain foundational knowledge of CDISC standards and their regulatory importance.
  2. Build readiness for advanced programs (SDTM, ADaM, TLGs).
  3. Understand how CDISC improves data quality, integrity, and submission efficiency.
  4. Be prepared for roles in clinical programming, data management, and regulatory compliance.
Career Pathways: After completing this course.
  1. Clinical Data Standards Associate
  2. CDISC Compliance Specialist
  3. SDTM / ADaM Programmer
  4. Regulatory Data Submission Analyst
  5. Clinical Data Manager

Curriculum & Modules

Modules
1. Introduction to CDISC and Its Global Role

2. Regulatory Requirements for CDISC Compliance (FDA, EMA, PMDA)

3. SDTM – Study Data Tabulation Model Overview

4. ADaM – Analysis Data Model Overview

5. SEND – Standard for Exchange of Nonclinical Data

6. ODM – Operational Data Model for Data Exchange

7. Define.xml – Metadata for Submissions

8. Controlled Terminology in CDISC

9. Data Flow: Raw Data → SDTM → ADaM → TLGs

10. Tools & Validation for CDISC Compliance (Pinnacle 21, OpenCDISC)

11. Case Studies – CDISC in Action

12. Future Trends: AI & Automation in CDISC Standards
Getting in Touch:

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.