FUNDAMENTALS OF DATA VALIDATION & EDIT CHECKS - 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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Fundamentals of Data Validation & Edit Checks

Introduction – Data Validation & Edit Checks

In clinical trials, data quality is non-negotiable. Clinical Data Management (CDM) teams are responsible for ensuring that data collected via Case Report Forms (CRFs/eCRFs) is accurate, consistent, and compliant with regulatory requirements. This is achieved through data validation and edit checks, which identify discrepancies, missing information, or outliers before the database is locked for analysis.
The EDCK program provides learners with a solid foundation in data validation principles and edit check implementation, preparing them for real-world CDM roles where data integrity is a top priority.

Course Name :  Fundamentals of Data Validation & Edit Checks
Course Code :  EDCK
Experience Level :  Entry to Intermediate
Qualification :  Bachelor’s / Master’s in Life Sciences, Pharmacy, Nursing, Public Health, Statistics, or related fields
Student Category :  Clinical Data Managers, Data Coordinators, 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 importance of data validation in clinical trials.
  3. Learn how edit checks improve data accuracy and consistency.
  4. Explore types of edit checks: range checks, consistency checks, mandatory fields, and cross-form checks.
  5. Gain insights into query generation, discrepancy management, and resolution.
  6. Review examples of edit checks in EDC systems (Medidata Rave, Oracle InForm, etc.).
  7. Learn how data validation supports regulatory compliance (ICH-GCP, 21 CFR Part 11, HIPAA).
  8. Practice real-world scenarios for identifying and resolving data issues.
Who Should Take This Course

This course is ideal for:

  1. Clinical Data Management trainees learning data quality fundamentals.
  2. Clinical Research Coordinators (CRCs/CTAs) involved in CRF/eCRF completion.
  3. Entry-level data managers preparing for edit check design roles.
  4. Career changers entering pharma/CRO data management functions.
Benefits & Outcomes

This program is ideal for:

  1. Gain practical knowledge of data validation and edit checks.
  2. Learn to identify, document, and resolve data discrepancies.
  3. Improve readiness for audit and inspection scenarios.
  4. Build career progression toward advanced CDM roles and regulatory programming.
Career Pathways: After completing this course.

This program is aligned with:

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

Curriculum & Modules

Modules
1. Introduction to Data Validation in Clinical Research

2. Role of Edit Checks in Data Quality Assurance

3. Types of Edit Checks: Range, Consistency, Cross-Form, Missing Data

4. Designing Edit Checks for CRFs/eCRFs

5. Query Generation & Discrepancy Resolution Process

6. Edit Checks in EDC Systems (Medidata Rave, Oracle InForm, etc.)

7. Regulatory Standards & Compliance in Data Validation

8. Case Studies – Designing and Applying Edit Checks
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.