Unlock the Power of Clinical Data with CDISC Certification: Enhance Your Career in Clinical Research with Encode-IT

The Clinical Data Interchange Standards Consortium (CDISC) is a globally recognized organization
that defines data standards for clinical trials and research. These standards ensure consistency,
accuracy, and interoperability of clinical data, making it easier to analyze and share information
across the healthcare and pharmaceutical sectors. With the growing importance of standardized
data in clinical research, proficiency in CDISC standards is a valuable skill for professionals in the
clinical research field.

The CDISC Course at Encode-IT is designed to equip you with the essential knowledge and skills to
work with CDISC standards, including SDTM (Study Data Tabulation Model), ADaM (Analysis Data
Model), and other related frameworks. By the end of this course, you will be able to organize,
standardize, and analyze clinical trial data in line with industry standards, facilitating smooth
regulatory submissions and efficient data management.

This course is ideal for clinical data managers, statisticians, clinical researchers, and anyone involved
in clinical trials or regulatory submissions who wants to gain expertise in CDISC standards and
enhance their career in clinical research.

Salary Prospects in India:
In India, professionals proficient in CDISC standards are highly sought after in the pharmaceutical,
biotechnology, and clinical research industries. A skilled professional in CDISC can expect to earn
anywhere between ₹6 to ₹15 lakhs annually, depending on experience, role, and location. Senior
roles, such as Clinical Data Manager or Lead Statisticians working with CDISC data standards, can
command salaries exceeding ₹20 lakhs annually. As clinical research organizations (CROs) and
pharmaceutical companies increasingly adopt CDISC standards for regulatory submissions, the
demand for certified professionals in this field continues to grow, providing ample career
opportunities and competitive compensation packages.

Placement Assistance & Certification:
At Encode-IT, we offer Placement Assistance to support your career transition or advancement. Our
placement services include resume building, mock interviews, job referrals to leading CROs and
pharmaceutical companies, and career guidance.
Upon successful completion of the CDISC Course, you will receive a Certificate of Completion from
Encode-IT, validating your proficiency in CDISC standards and enhancing your profile in the clinical
research industry.

Course Curriculum:

Module 1: Introduction to CDISC Standards
 Overview of CDISC and its Role in Clinical Research
 Key CDISC Standards: SDTM, ADaM, SEND, and ODM
 The Importance of Standardization in Clinical Trials
 Regulatory Requirements and Global Adoption of CDISC Standards

 Introduction to the CDISC Toolkit and Resources

Module 2: Understanding the Study Data Tabulation Model (SDTM)
 Introduction to SDTM and Its Structure
 CDISC SDTM Domains: Definition and Usage
 Mapping Clinical Trial Data to SDTM Domains
 Variables in SDTM: Data Types, Controlled Terminology, and Standards
 SDTM Implementation Guide: Best Practices and Guidelines

Module 3: Creating SDTM Datasets
 Data Collection in Clinical Trials and Conversion to SDTM Format
 How to Structure and Tabulate Raw Data into SDTM
 Working with SDTM datasets: Variable Transformation, Data Mapping, and Annotation
 SDTM Documentation: Define.XML and other metadata standards
 Handling Missing Data, Derivation Rules, and Data Consistency in SDTM

Module 4: Introduction to the Analysis Data Model (ADaM)
 Overview of ADaM and Its Role in Statistical Analysis
 ADaM Dataset Structure and Variables
 ADaM vs SDTM: Key Differences and Relationship
 Creating ADaM Datasets from SDTM Data
 ADaM Documentation: Define.XML for ADaM

Module 5: ADaM Dataset Creation and Transformation
 How to Derive Analysis Data Sets from SDTM
 Standard Variables in ADaM: Analysis and Derived Variables
 Best Practices for Analysis and Statistical Data Preparation
 ADaM Data Transformation Techniques for Analysis
 Case Studies: Deriving Key Variables for Statistical Analysis

Module 6: SEND: Standard for Exchange of Nonclinical Data
 Overview of SEND and Its Importance in Nonclinical Data
 SEND Datasets and Domains
 Mapping Nonclinical Data to SEND Standards
 Regulatory Considerations for Nonclinical Data Submission
 Case Study: Implementing SEND in Nonclinical Research

Module 7: CDISC Metadata and Define.XML
 Introduction to Define.XML and its Role in Clinical Data Submission
 Creating and Documenting Define.XML Files
 Metadata Standards for Clinical Trials Data
 CDISC Controlled Terminology and How to Implement It
 Validation and Quality Control of Metadata Files

Module 8: CDISC in Regulatory Submissions
 CDISC Standards for Regulatory Submissions to the FDA, EMA, and Other Agencies
 The Role of CDISC in Streamlining Regulatory Review Processes
 Understanding the Data Submission Lifecycle: From Data Collection to Submission
 Case Study: Regulatory Submission Using CDISC Standards
 Preparing Data for Submission to Regulatory Authorities (eCTD, SDTM, ADaM)

Module 9: Clinical Data Management and CDISC
 Data Collection, Monitoring, and Management in Clinical Trials
 Tools and Technologies Used for CDISC Data Management
 Best Practices in Clinical Data Management with CDISC
 Working with Electronic Data Capture (EDC) Systems
 Validating and Cleaning Data for CDISC Standards Compliance

Module 10: Final Project and Certification Exam
 Final Project: Implementing a Clinical Trial Dataset Using SDTM and ADaM
 Mapping Clinical Trial Data from Raw Data to SDTM and ADaM
 Project Evaluation: Demonstrating Your Skills in CDISC Standards
 Certification Exam: Comprehensive Test on CDISC Standards and Implementation
 Certification of Completion from Encode-IT and Placement Assistance

Key Features of the Course:
 Tools & Platforms: SAS, CDISC Toolkit, Define.XML, SDTM, ADaM, SEND

 Real-World Projects: Hands-on experience with SDTM, ADaM dataset creation, and data
mapping

 Certification & Placement Support: Encode-IT certification and job placement assistance to
accelerate your career

 Expert Instructors: Learn from professionals with deep expertise in clinical data
management and CDISC standards

 Career Advancement: Master CDISC standards to unlock career opportunities in clinical
research, regulatory affairs, and data management

By completing the CDISC Course at Encode-IT, you will gain the expertise needed to effectively
manage clinical trial data, ensuring compliance with global standards and improving the efficiency of
regulatory submissions. You’ll be well-positioned to contribute to the success of clinical trials,
helping pharmaceutical companies and CROs deliver safe, effective treatments to the market.