BASICS OF CLINICAL TRIAL PHASES & ROLE OF CDM - 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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Basics of Clinical Trial Phases & Role of CDM

Introduction – Basics of Clinical Trial Phases & Role of CDM

Clinical trials progress through distinct phases (I–IV), each designed to answer critical questions about a drug’s safety, efficacy, and long-term impact. At every stage, Clinical Data Management (CDM) plays a pivotal role in ensuring that data is collected accurately, cleaned systematically, and prepared for meaningful analysis.
The CTPH program introduces learners to the basics of clinical trial phases and provides an overview of how CDM supports each stage of the drug development lifecycle. It is designed as a foundation-level course for those entering clinical research, data management, or pharmacovigilance careers.

Course Name :  Basics of Clinical Trial Phases & Role of CDM
Course Code :  CTPH
Experience Level :  Entry-Level
Qualification :  Bachelor’s / Master’s in Life Sciences, Pharmacy, Nursing, Public Health, or related sciences
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 purpose and design of each clinical trial phase (I–IV).
  3. Learn the regulatory and ethical requirements guiding trial conduct.
  4. Gain insights into the data lifecycle from collection to submission.
  5. Recognize the role of CDM in clinical trials, including CRF design, EDC setup, and data validation.
  6. Explore how CDM ensures data integrity, compliance, and readiness for regulatory review.
  7. Review examples of CDM tasks across trial phases (queries, coding, discrepancy management, database lock).
Who Should Take This Course

This course is ideal for:

  1. Entry-level life science graduates preparing for clinical research or CDM roles.
  2. Clinical trial staff (CRCs, CTAs) seeking to understand CDM’s role in trials.
  3. Healthcare professionals transitioning into research and data management.
  4. Career changers looking to enter pharma or CRO environments.
Benefits & Outcomes

This program is ideal for:

  1. Build a strong foundation in clinical trial phases and CDM functions.
  2. Learn how CDM contributes to regulatory compliance and data quality.
  3. Be prepared for entry-level roles such as Clinical Data Assistant or Coordinator.
  4. Gain clarity on career progression into advanced CDM and SAS programming roles.
Career Pathways: After completing this course.

This program is aligned with:

  1. Clinical Data Assistant (CDA)
  2. Clinical Trial Assistant (CTA)
  3. Data Management Coordinator
  4. Clinical Research Coordinator (CRC)
  5. Entry-Level Data Manager

Curriculum & Modules

Modules
1. Introduction to Clinical Trials & Drug Development Lifecycle

2. Overview of Clinical Trial Phases (I–IV)

3. Regulatory Guidelines (ICH-GCP, FDA, EMA)

4. Data Flow in Clinical Trials – Source → CRF → EDC → Database

5. Role of CDM in Phase I Trials (Safety & Tolerability)

6. Role of CDM in Phase II Trials (Efficacy & Dose-Finding)

7. Role of CDM in Phase III Trials (Large-Scale Validation)

8. Role of CDM in Phase IV/Post-Marketing Surveillance

9. CDM Deliverables Across Phases (Queries, Reports, Data Lock)

10. Case Studies – CDM Contributions to Trial Outcomes
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.