Clinical Data Management
What is Clinical Data Management?
Clinical Data Management (CDM) is a crucial element of clinical research focused on the gathering, validation, and management of the data gathered in clinical studies. Its main goal is to make sure that the information collected during clinical trials is complete, accurate and in compliance with international ethical and regulatory standards, such as Good Clinical Practice (GCP), ICH guidelines, and 21 CFR Part 11.
By implementing systematic processes like validation of data through a series of processes, including query management, and locking of databases, CDM safeguards the integrity and validity of data from clinical trials. The result of this process creates the basis for statistical analysis, submission to regulatory authorities and evidence-based medical decision making which ultimately aids in the approval and development of therapeutic products that are new and advancements in healthcare.
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About Clinical Data Management
This Clinic Data Management (CDM) program is designed to develop deep knowledge and practical skills on one of the important aspects of research in the fields of medicine and pharmaceuticals.
The program provides participants with the knowledge and skills required to handle and verify clinical data according to international regulations.Students will acquire a thorough knowledge of data collection methods and an eCRF (Electronic Case Report Form) design, data validation methods as well as query handling and closing procedures for databases. The emphasis is on ensuring accuracy of data as well as confidentiality, consistency, and accuracy throughout the entire lifecycle of a clinical trial.
When the course is completed, participants will be prepared to be able to understand the integrity and quality of data and contribute to documents for regulatory approval and play a crucial role in aiding clinical research activities and the approval process for drugs in worldwide healthcare.
Why Choose CatchU Academy
Industry-relevant curriculum
The course is specifically designed to meet global standards for pharmaceutical and clinical research and ensures that students learn real-world, work-ready skills.
Professional Faculty
Get to know experienced experts who share real-world knowledge from clinical research as well as the data management industries.
Praxis Training
Learn hands-on using the most advanced electronic Data Capture (EDC) tools, live projects and case-based lessons to get knowledge about CDM operations.
Support for Placement
Catchu Academy provides special help with placement and connects students with leading CROs and pharmaceutical firms, and research institutions to assist them in launching successful careers.
Flexible Learning Option
Choose from offline and online training options that are designed to meet various schedules and preferences for learning.
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Course Higlights
Comprehensive Learning
Gain a complete understanding of the clinical data management process, from study setup and data collection to database lock and archiving.
Regulatory & Ethical Standards
Learn key global guidelines such as ICH-GCP, 21 CFR Part 11, and data integrity principles to ensure compliance in every phase of a clinical trial.
Hands-On Practical Training
Get practical exposure to Electronic Data Capture (EDC) systems, eCRF design, data validation, and query management used in real-world studies.
Data Quality & Accuracy
Master essential skills in data cleaning, medical coding (MedDRA, WHO-DD), and quality control to ensure reliable and compliant clinical data
Advanced Technologies
Explore emerging trends in AI, machine learning, and automation transforming modern clinical data management practices.
Career-Focused Approach
Prepare for roles like Clinical Data Manager, Data Coordinator, or CDM Associate in CROs, pharmaceutical companies, and healthcare research organizations.
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Course Modules
1 . Introduction to Clinical Data Management
This module provides a foundational overview of clinical research and highlights the critical role of clinical data management in maintaining data quality and integrity across all stages of a clinical trial.
Key Topics:
- Overview of Clinical Research and the Drug Development Process
- Role and Importance of Clinical Data Management (CDM) in Clinical Trials
- Regulatory Guidelines: Good Clinical Practice (GCP) and 21 CFR Part 11
Key Terminology: eCRF (Electronic Case Report Form), EDC (Electronic Data Capture), and Data Queries
2 .Clinical Study Startup
Students learn how to set up and manage the early phases of a clinical study by converting study protocols into practical data collection systems.
Key Topics:
- Protocol Review and identification of key data points
- eCRF Design Principles for accurate and efficient data collection
- Database Development with edit checks and validation rules
User Acceptance Testing (UAT) prior to study initiation
3 .Data Collection and Management
This module focuses on the process of collecting, validating, and maintaining high-quality clinical data using advanced data management tools.
Key Topics:
- Electronic Data Capture (EDC) Systems and Source Data Verification
- Data Validation and Cleaning techniques for discrepancy resolution
- Medical Coding using MedDRA and WHO-DD dictionaries
Data Reconciliation between laboratory, safety, and trial datasets
5 .Quality Control and Auditing
Students gain knowledge of quality assurance and audit practices that uphold the credibility and regulatory compliance of clinical data.
Key Topics:
- Quality Control Measures and Data Review Procedures
- Audit Preparation and Execution (internal and external)
Risk-Based Monitoring (RBM) strategies in clinical trials
5 .Study Closeout
This module outlines the procedures for finalizing a clinical trial database and ensuring all data meets regulatory standards before analysis.
Key Topics:
- Final Data Review and Cleaning before database lock
- Database Lock and Documentation procedures
Archiving and Data Retention as per global regulatory guidelines
6.Advanced Topics and Emerging Trends
The final module explores evolving practices and technologies shaping the future of clinical data management.
Key Topics:
- CDM in Phase I–IV Clinical Trials
- Basics of Biostatistics and Data Analysis Applications
- Artificial Intelligence (AI), Machine Learning (ML), and Automation in Data Management
Frequently Asked Questions
Graduates in life sciences, pharmacy, nursing, biotechnology are eligible to join the course.
You’ll learn data collection, validation, query management and regulatory compliance using industry-standard tools.
Yes, the program is designed for both beginners and professionals seeking to enter the clinical research field.
You can work as a Clinical Data Coordinator, Data Analyst, CDM Associate, or Quality Specialist in pharma and CRO companies.
Yes, Catchu Academy offers dedicated placement assistance with connections to leading pharmaceutical companies and CROs.
Yes, Catchu Academy offers both online and classroom learning options for flexible study.
The course duration varies by program type but typically ranges from 2to 3 months.
You’ll earn a recognized certificate- ISO27001:2022 in Clinical Data Management that enhances your professional credibility and job readiness.