Master Clinical Data Analysis with Encode-IT’s ADaM Online Course

Clinical data analysis plays a crucial role in ensuring the accuracy and integrity of clinical trials and
regulatory submissions. ADaM (Analysis Data Model) is a critical tool used for transforming raw
clinical data into datasets that meet regulatory standards, enabling meaningful insights into clinical
trials. Encode-IT’s ADaM Online Course is designed to provide you with in-depth knowledge and
hands-on experience in the world of clinical data analysis, with a specific focus on ADaM.

Through this comprehensive course, you will learn the essential skills required to create analysis
datasets, apply industry standards, and understand the nuances of regulatory submissions. Whether
you are aiming for a career in clinical research, data analysis, or biostatistics, this course will equip
you with the practical skills and expertise needed to excel in the field.

Salary Prospects in India:
The clinical research and data analytics sectors are experiencing significant growth in India, driven by
the demand for skilled professionals who are proficient in industry standards like ADaM. On average,
Clinical Data Analysts in India earn between ₹5 to ₹8 lakhs per annum. Professionals who specialize
in ADaM and clinical data modeling often earn higher salaries, ranging from ₹10 to ₹15 lakhs
annually, depending on their expertise and experience. The demand for ADaM professionals is
expected to rise as clinical trials become increasingly complex and data-driven.

By completing this course from Encode-IT, you will be well-positioned to tap into this growing job
market, opening the door to rewarding and well-compensated career opportunities in clinical data
analysis.

Placement Assistance & Certification:
At Encode-IT, we believe in not only providing knowledge but also ensuring that our students are
ready to take the next step in their careers. Our Placement Assistance program connects you with
leading companies in the clinical research and data analytics fields. We offer personalized support in
resume building, interview preparation, and job placement, ensuring you are prepared for your next
career move.

Upon successful completion of the ADaM course, you will receive a Certificate of Completion from
Encode-IT, which is recognized in the industry. This certification will validate your proficiency in
ADaM and clinical data analysis, helping you stand out in the competitive job market.

Course Curriculum:

Module 1: Introduction to ADaM and Clinical Data Analysis
 What is ADaM? Overview and Key Concepts
 Role of ADaM in Clinical Trials and Regulatory Submissions
 Introduction to SAS Programming for ADaM
 Understanding Clinical Trial Data and Key Variables

Module 2: Data Structures and Components of ADaM
 Overview of ADaM Data Models (ADaM Datasets and Formats)

 Mapping Raw Clinical Data to ADaM Structure
 Standard Variables in ADaM: eVars, Props, and Events
 Handling Demographic, Efficacy, and Safety Data

Module 3: Creating ADaM Datasets
 Step-by-Step Guide to Creating ADaM Datasets
 Using Derived Variables to Transform Raw Data
 Defining Analysis Datasets for Clinical Reporting
 Handling Complex Data Structures and Relationships

Module 4: ADaM Standards and Compliance
 Overview of ADaM Standards: CDISC and FDA Guidelines
 Ensuring Compliance with Regulatory Requirements
 Best Practices for ADaM Dataset Creation and Documentation
 Case Studies of Regulatory Submissions Using ADaM

Module 5: Advanced ADaM Techniques
 Creating Advanced ADaM Datasets: ADAE, ADVS, and ADLB
 Working with Complex Data: Analyzing Adverse Events, Lab Results, and Vital Signs
 Using ADaM for Safety and Efficacy Analysis
 Preparing ADaM Datasets for Final Reporting

Module 6: ADaM Data Validation and Quality Assurance
 Validating ADaM Datasets for Accuracy and Consistency
 Handling Data Quality Issues and Anomalies
 Data Cleaning Techniques and Strategies
 Ensuring Data Completeness and Integrity for Regulatory Submission

Module 7: Statistical Analysis and Reporting with ADaM
 Using ADaM Data for Statistical Analysis
 Analyzing Clinical Trial Data: Safety and Efficacy Metrics
 Generating Summary Tables and Statistical Outputs
 Reporting Results: Key Findings from ADaM Datasets

Module 8: Career Development in Clinical Data Analysis
 Job Roles in Clinical Data Analysis: Clinical Data Manager, Biostatistician, and SAS
Programmer

 Career Pathways in Clinical Research and Data Analytics
 Networking and Building Your Professional Profile
 Resume Building and Job Interview Preparation

Module 9: Final Project and Certification Exam
 Final Project: Creating and Validating ADaM Datasets for a Clinical Trial
 Project Evaluation: Showcasing Your ADaM Skills
 Final Exam: Comprehensive Test on ADaM Concepts and Techniques
 Certification of Completion from Encode-IT and Job Placement Assistance

Key Features of the Course:
 Tools & Platforms: SAS Programming, ADaM Standards, CDISC, FDA Guidelines
 Real-World Projects: Hands-on projects focused on creating and validating ADaM datasets
 Certification & Placement Support: Encode-IT certification and job placement assistance to
help you advance in your career
 Expert Instructors: Learn from professionals with extensive experience in clinical research
and data analysis
 Career Advancement: Acquire the skills needed to pursue high-demand roles in clinical data
analysis, clinical research, and biostatistics

By completing the ADaM training at Encode-IT, you will gain the skills required to manage clinical
data effectively, apply ADaM standards in real-world clinical trials, and prepare for regulatory
submissions with confidence. This course will prepare you for a successful career in clinical data
analysis, making you a valuable asset in the clinical research industry.