INTRODUCTION TO CLINICAL DATA MANAGEMENT - Qtech-Sol offers Clinical Research / Trials, Pharmacovigilance, Drug Safety, Clinical Data Management, Clinical SAS Programming and Healthcare BA Training Programs
Category:
Data Management
 
Duration:
3 Weeks / 80 Hours
 
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Introduction to Clinical Data Management

Introduction – Clinical Data Management (CDM)

Clinical Data Management (CDM) is a critical function in clinical research, ensuring that trial data is accurate, reliable, and compliant with regulatory requirements. With the increasing complexity of clinical trials, CDM professionals play a central role in data collection, cleaning, validation, and preparation for analysis and regulatory submission.
The CDMI program provides a comprehensive introduction to CDM concepts, workflows, and tools, making it ideal for individuals entering the field of clinical research or transitioning into data-focused roles.

Course Name :  Introduction to Clinical Data Management
Course Code :  CDMI
Experience Level :  Entry-Level
Qualification :  Bachelor’s / Master’s in Life Sciences, Pharmacy, Nursing, Public Health, Statistics, or related fields
Student Category :  Recent Graduates, Clinical Research Professionals, Career Changers

Delivery Type

SIP – Self-Paced Online with Support

Duration & Delivery
  1. Course Duration: 3 weeks (80 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 role and importance of CDM in clinical trials.
  3. Learn about the clinical trial process and where CDM fits.
  4. Gain knowledge of case report forms (CRFs) and electronic data capture (EDC).
  5. Explore data cleaning, discrepancy management, and query handling.
  6. Understand database design and validation procedures.
  7. Learn about regulatory guidelines (ICH-GCP, 21 CFR Part 11, HIPAA) affecting CDM.
  8. Review real-world CDM workflows for trial data handling.
Who Should Take This Course

This course is ideal for:

  1. Life science graduates seeking entry into clinical research.
  2. Clinical research professionals transitioning into data management.
  3. Healthcare professionals looking to expand into CDM roles.
  4. Career changers entering the pharmaceutical/clinical trials domain.
Benefits & Outcomes

This program is ideal for:

  1. Build a strong foundation in clinical data collection, validation, and compliance.
  2. Gain exposure to EDC tools and real-world data workflows.
  3. Be job-ready for entry-level CDM positions in CROs, pharma, or research organizations.
  4. Establish a pathway toward advanced programs (SDTM, ADaM, TLGs, SAS programming).
Career Pathways: After completing this course.

This program is aligned with:

  1. Clinical Data Assistant (CDA)
  2. Clinical Data Coordinator
  3. Data Management Associate
  4. EDC Specialist
  5. Clinical Data Manager (entry-level progression)

Curriculum & Modules

Modules
1. Introduction to Clinical Research & Data Management

2. The Role of CDM in Clinical Trials

3. Case Report Forms (CRFs) – Paper & Electronic

4. Electronic Data Capture (EDC) Systems Overview

5. Data Entry, Validation, and Quality Control

6. Query Management & Discrepancy Resolution

7. Regulatory Standards & Guidelines for CDM (ICH, FDA, EMA)

8. Database Design, Testing & Lock Process

9. Coding Standards in CDM (MedDRA, WHO-DD)

10. Audit Trails & Data Integrity in CDM

11. Collaboration Between CDM, Biostatistics, and PV Teams

12. Career Pathways in Clinical Data Management
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.