Category:
Data Management |
Duration: 3 Weeks / 80 Hours |
Data Entry, Query Management & Discrepancy Resolution
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..
SIP – Self-Paced Online with Support
- Course Duration: 3 weeks (80 hours)
- Format: Self-Paced Online with Support (narrated lessons, readings, quizzes, and role-based tasks).
By completing this program, learners will::
- Understand the workflow of data entry from CRFs/eCRFs into EDC systems.
- Learn how to perform accurate and consistent data entry.
- Explore query management processes – system-generated vs. manual queries.
- Understand types of discrepancies (missing data, out-of-range values, inconsistencies).
- Learn the discrepancy resolution cycle between data managers, CRAs, and sites.
- Gain exposure to EDC tools (Medidata Rave, Oracle InForm, Veeva EDC).
- Apply regulatory and GCP principles to ensure compliance.
- Practice case scenarios of query generation and resolution.
This course is ideal for:
- Clinical Data Assistants (CDAs) handling EDC entries.
- Clinical Research Coordinators (CRCs) and site staff responsible for CRFs/eCRFs.
- Clinical Data Managers managing data validation workflows.
- Career changers entering pharma/CRO data management functions.
This program is ideal for:
- Gain practical knowledge in clinical trial data entry and query handling.
- Develop skills in discrepancy identification and resolution.
- Be prepared to work confidently with EDC systems.
- Strengthen employability for roles in clinical data management and trial operations.
This program is aligned with:
- Clinical Data Assistant (CDA)
- Data Management Associate
- Query Management Specialist
- Clinical Data Coordinator
- Clinical Data Manager (entry-level progression)
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 |
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.