data. These steps ensure accuracy, consistency, and regulatory compliance, supporting reliable statistical analysis and reporting.

Scope

This SOP applies to data managers, statisticians, investigators, CROs, and sponsors involved in clinical trial data management. It covers adverse event coding, concomitant medication coding, data cleaning, discrepancy resolution, and quality assurance of clinical trial datasets.

Responsibilities

• Data Manager: Ensures proper data coding, cleaning, and execution of quality checks.
• Investigator: Reviews coded data for accuracy and medical appropriateness.
• CRA/Monitor: Verifies transcription accuracy during monitoring visits.
• Sponsor/CRO: Provides oversight and ensures regulatory compliance in data management processes.
• QA Officer: Audits data coding and cleaning processes for adherence to SOPs and global standards.

Accountability

The Data Manager is accountable for implementing coding, cleaning, and quality checks, while the sponsor ensures compliance with regulatory expectations and inspection readiness.

Procedure

1. Data Coding
Use standardized dictionaries (e.g., MedDRA for adverse events, WHO-DD for medications).
Code terms consistently across datasets.
Document coding decisions in Coding Log (Annexure-1).

2. Data Cleaning
Identify discrepancies such as missing data, inconsistent entries, or out-of-range values.
Generate and resolve data queries as per SOP for Data Query Management.
Document resolutions in Data Cleaning Log (Annexure-2).

3. Quality Checks
Perform routine quality checks (logic checks, cross-variable checks, range checks).
Verify completeness and accuracy of CRFs against source documents.
Maintain audit trail of all checks in Quality Check Log (Annexure-3).

4. Review and Approval
Data manager reviews cleaned datasets before database lock.
PI reviews medically coded terms for accuracy.
Sponsor signs off final data prior to submission.

5. Archiving
Archive coding dictionaries, logs, and final datasets in TMF.
Retain records for a minimum of 15 years or as per local requirements.

Abbreviations

• SOP: Standard Operating Procedure
• CRF: Case Report Form
• CRA: Clinical Research Associate
• CRO: Clinical Research Organization
• QA: Quality Assurance
• TMF: Trial Master File
• MedDRA: Medical Dictionary for Regulatory Activities
• WHO-DD: World Health Organization Drug Dictionary

Documents

1. Coding Log (Annexure-1)
2. Data Cleaning Log (Annexure-2)
3. Quality Check Log (Annexure-3)

References

• ICH E6(R2) – Good Clinical Practice
• US FDA – Data Management and Coding Guidance
• EMA – Data Integrity Standards
• CDSCO – Clinical Data Management Guidelines
• WHO – Data Quality Management in Clinical Research

Version: 1.0

Approval Section

Prepared By	Rajesh Kumar, Clinical Data Manager
Checked By	Sunita Reddy, QA Officer
Approved By	Dr. Anil Sharma, Principal Investigator

Annexures

Annexure-1: Coding Log

Date	Variable	Coding Dictionary	Code Assigned	Reviewed By
12/09/2025	Adverse Event – Headache	MedDRA v25.0	10019211	Data Manager

Annexure-2: Data Cleaning Log

Date	Subject ID	Discrepancy	Resolution	Resolved By
13/09/2025	CT2025-SITE01-171	Missing lab value	Updated	Study Coordinator

Annexure-3: Quality Check Log

Date	Check Performed	Result	Corrective Action	Verified By
15/09/2025	Out-of-range check	Value corrected	Updated CRF	CRA

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
26/08/2025	00	Initial version	New SOP creation	Head, Clinical Research

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