DATA ENTRY, QUERY MANAGEMENT & DISCREPANCY RESOLUTION - 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
 

Data Entry, Query Management & Discrepancy Resolution

Introduction – Data Entry & Query Management

High-quality data is the cornerstone of every successful clinical trial. Data entry, query management, and discrepancy resolution are critical processes in Clinical Data Management (CDM) to ensure accuracy, compliance, and regulatory readiness.
The DAEN program introduces learners to the end-to-end process of clinical trial data handling — from entering CRF/eCRF data into Electronic Data Capture (EDC) systems, to managing system-generated queries, and resolving discrepancies with investigators and site staff. This program prepares learners for entry and mid-level CDM roles, where data accuracy and timely resolution of queries are vital..

Course Name :  Data Entry, Query Management & Discrepancy Resolution
Course Code :  DAEN
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::

  1. Understand the workflow of data entry from CRFs/eCRFs into EDC systems.
  2. Learn how to perform accurate and consistent data entry.
  3. Explore query management processes – system-generated vs. manual queries.
  4. Understand types of discrepancies (missing data, out-of-range values, inconsistencies).
  5. Learn the discrepancy resolution cycle between data managers, CRAs, and sites.
  6. Gain exposure to EDC tools (Medidata Rave, Oracle InForm, Veeva EDC).
  7. Apply regulatory and GCP principles to ensure compliance.
  8. Practice case scenarios of query generation and resolution.
Who Should Take This Course

This course is ideal for:

  1. Clinical Data Assistants (CDAs) handling EDC entries.
  2. Clinical Research Coordinators (CRCs) and site staff responsible for CRFs/eCRFs.
  3. Clinical Data Managers managing data validation workflows.
  4. Career changers entering pharma/CRO data management functions.
Benefits & Outcomes

This program is ideal for:

  1. Gain practical knowledge in clinical trial data entry and query handling.
  2. Develop skills in discrepancy identification and resolution.
  3. Be prepared to work confidently with EDC systems.
  4. Strengthen employability for roles in clinical data management and trial operations.
Career Pathways: After completing this course.

This program is aligned with:

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

Curriculum & Modules

Modules
1. Introduction to Data Entry in Clinical Trials

2. CRF/eCRF Data Flow into EDC Systems

3. Best Practices for Accurate Data Entry

4. Introduction to Queries – Types & Triggers

5. System-Generated vs. Manual Queries

6. Discrepancy Management & Resolution Workflow

7. Site Collaboration for Query Clarifications

8. Regulatory Expectations (ICH-GCP, 21 CFR Part 11, HIPAA)

9. Case Studies – Handling Queries & Resolving Discrepancies

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.