CASE REPORT FORM (CRF) / ECRF BASICS - 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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Case Report Form (CRF) / eCRF Basics

Introduction – CRF & eCRF in Clinical Trials

The Case Report Form (CRF), whether paper-based or electronic (eCRF), is the primary tool for capturing clinical trial data. Accurate CRF design and data entry are essential to ensure the integrity, quality, and compliance of trial outcomes.
The ECRF program provides learners with an overview of CRF/eCRF structure, design principles, and usage in clinical trials. It introduces how CRFs support data collection, how eCRFs integrate with Electronic Data Capture (EDC) systems, and the role of Clinical Data Management (CDM) professionals in ensuring data accuracy and reliability.

Course Name :  Case Report Form (CRF) / eCRF Basics
Course Code :  ECRF
Experience Level :  Entry-Level
Qualification :  Bachelor’s / Master’s in Life Sciences, Pharmacy, Nursing, Public Health, or related disciplines
Student Category :  Clinical Research Associates, Clinical Data Managers, Research Coordinators, 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 of CRFs/eCRFs in clinical research.
  3. Learn the differences between paper CRFs and electronic CRFs (eCRFs).
  4. Explore principles of CRF design for accurate and compliant data capture.
  5. Understand the workflow of data collection using CRFs in clinical trials.
  6. Gain insights into eCRF integration with EDC systems.
  7. Learn about query management, discrepancy handling, and data validation linked to CRFs.
  8. Review regulatory considerations (ICH-GCP, 21 CFR Part 11, HIPAA).
Who Should Take This Course

This course is ideal for:

  1. Clinical Data Management trainees learning data capture basics.
  2. Clinical Research Coordinators (CRCs) and CTAs working on site-level CRF completion.
  3. Clinical Research Associates (CRAs) monitoring CRF/eCRF entries.
  4. Healthcare professionals moving into clinical research.
  5. Career changers looking to enter CROs or pharma roles in data management.
Benefits & Outcomes

This program is ideal for:

  1. Build foundational skills in CRF/eCRF design and usage.
  2. Learn how CRFs impact data quality, integrity, and compliance.
  3. Be job-ready for entry-level CDM and clinical research roles.
  4. Establish a pathway to advanced CDM training (CDMI, SDTM, ADaM).
Career Pathways: After completing this course.

This program is aligned with:

  1. Clinical Data Assistant (CDA)
  2. Clinical Research Coordinator (CRC)
  3. Clinical Trial Assistant (CTA)
  4. Data Management Associate
  5. EDC/CRF Specialist

Curriculum & Modules

Modules
1. Introduction to CRFs in Clinical Trials

2. Paper CRFs vs. Electronic CRFs – Key Differences

3. Principles of CRF/eCRF Design

4. Data Collection Workflow Using CRFs

5. eCRFs and EDC Systems (Overview of Medidata Rave, Inform, etc.)

6. Query Management & Discrepancy Resolution in CRFs

7. Regulatory Considerations for CRF/eCRF Use (ICH, FDA, EMA)

8. Case Studies – Good vs. Poor CRF Design
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.