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“headline”: “SOP for Case Report Form (CRF) Completion and Review in Clinical Trials”,
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Standard Operating Procedure for CRF Completion and Review

Purpose

The purpose of this SOP is to define standardized procedures for the accurate completion, verification, and review of Case Report Forms (CRFs) in clinical trials. Proper CRF management ensures data integrity, compliance with regulatory requirements, and readiness for audits and inspections.

Scope

This SOP applies to investigators, study coordinators, CRAs, and sponsors responsible for completing and reviewing CRFs in both paper and electronic formats. It covers data entry, corrections, review, monitoring, and archiving of CRFs.

Responsibilities

• Principal Investigator (PI): Ensures CRFs are completed accurately, reviewed, and signed off.
• Study Coordinator: Records subject data in CRFs promptly and maintains CRF records in ISF.
• Clinical Research Associate (CRA): Verifies CRFs against source data during monitoring visits.
• Sponsor/CRO: Provides oversight, ensures CRF compliance, and manages electronic CRF systems.
• Quality Assurance Officer: Reviews CRF processes during audits and ensures inspection readiness.

Accountability

The PI is accountable for ensuring CRF accuracy and integrity. Sponsors are accountable for maintaining systems that comply with regulatory requirements.

Procedure

1. CRF Completion
Enter data into CRFs directly from source documents.
Ensure entries are complete, accurate, and contemporaneous with subject visits.
Use black ink for paper CRFs; electronic CRFs must maintain audit trails.

2. Corrections
Correct errors with a single line, initial, and date; avoid erasures or overwrites.
Electronic CRFs must log corrections with user ID and timestamp.

3. Review
PI reviews CRFs regularly and signs off completed forms.
Review should ensure consistency with source data and protocol requirements.

4. Monitoring
CRA verifies CRFs against source data during monitoring visits.
Discrepancies must be documented in Data Query Log (Annexure-1).

5. Archiving
Maintain CRFs in ISF/TMF for minimum of 15 years or as per local regulations.
Ensure records are secure, confidential, and accessible for regulatory inspection.

Abbreviations

• SOP: Standard Operating Procedure
• CRF: Case Report Form
• PI: Principal Investigator
• CRA: Clinical Research Associate
• CRO: Clinical Research Organization
• QA: Quality Assurance
• ISF: Investigator Site File
• TMF: Trial Master File
• ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available

Documents

1. Data Query Log (Annexure-1)
2. CRF Correction Log (Annexure-2)
3. CRF Review Checklist (Annexure-3)

References

• ICH E6(R2) – Good Clinical Practice
• US FDA – Clinical Data Submission Requirements
• EMA – Data Integrity and CRF Guidelines
• CDSCO – Clinical Data Management Rules
• WHO – Clinical Trial Data Recording Guidelines

Version: 1.0

Approval Section

Annexures

Annexure-1: Data Query Log

Annexure-2: CRF Correction Log

Annexure-3: CRF Review Checklist

Revision History

For more SOPs visit: Pharma SOP