Clinical Data Management

Clinical Data Management (CDM)

Introduction

At SRC, we are committed to excellence in Clinical Data Management (CDM) training. Our innovative approach equips students with practical skills and theoretical knowledge, ensuring they are job-ready to meet the demands of the clinical research industry.

What We Teach

Our Clinical Data Management (CDM) certification course is a two-month program designed to provide students with an in-depth understanding of essential CDM concepts and practices. Key modules include:

  • Clinical Data Management
    Learn the fundamentals of CDM, including its importance in clinical research, the lifecycle of clinical trial data, and the role of data integrity in ensuring reliable trial outcomes.

  • Process Flow
    Understand the workflow in clinical data management, from data collection to database lock, including quality control processes and regulatory compliance.

  • CDM Systems
    Gain hands-on experience with industry-standard CDM tools such as Oracle Clinical, Rave, eClinical Suite, Clintrial, and Macro. These tools streamline data collection, validation, and analysis for large and complex clinical trials.

  • Creating Standards
    Explore the importance of standardization in clinical data management, focusing on data formatting, coding, and compliance with global regulatory standards, including 21 CFR Part 11.

Learning Objectives

Students will gain practical experience with EDC (Electronic Data Capture) systems and cover critical topics such as:

  • Clinical Research Process

  • Database Design

  • Data Validation

  • 21 CFR Part 11 Compliance

FAQs

Why is Clinical Data Management (CDM) crucial in clinical research?
CDM ensures the generation of high-quality, reliable, and statistically sound data essential for drug development while maintaining data integrity throughout clinical trials.

What tools are used in Clinical Data Management?
Tools include Oracle Clinical, Rave, and eClinical Suite. SRC provides real-time access to these systems.

Is Clinical Data Management a good career?
Yes, CDM offers significant growth opportunities as the demand for skilled professionals increases.

What is the scope of job opportunities in Clinical Data Management?
Job roles include Clinical Data Manager, Clinical Data Analyst, and Quality Assurance Specialist, among others.

Who is eligible?
Graduates and postgraduates in life sciences, pharmacy, and medical fields are eligible.

Is an internship provided?
Yes, a two-month internship is provided to enhance practical skills.

Is there placement support?
SRC offers 100% placement support, ensuring successful course graduates secure roles in top clinical research organizations.