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“headline”: “SOP for Data Transcription from Source to Case Report Form (CRF) in Clinical Trials”,
“description”: “This SOP outlines the process for accurate transcription of data from source documents to CRFs, ensuring compliance with ALCOA+ principles, ICH GCP, FDA, EMA, CDSCO, and WHO guidelines for clinical trial data integrity.”,
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Published on 21/12/2025
Standard Operating Procedure for Data Transcription from Source to CRF
| Department | Clinical Research |
| SOP No. | CR/DATA/051/2025 |
| Supersedes | NA |
| Page No. | 1 of 22 |
| Issue Date | 26/08/2025 |
| Effective Date | 01/09/2025 |
| Review Date | 01/09/2026 |
Purpose
The purpose of this SOP is to establish standardized procedures for transcribing data from source documents to
Scope
This SOP applies to investigators, study coordinators, data entry personnel, and monitors involved in clinical trials. It covers transcription from both paper and electronic source documents into CRFs (paper or electronic).
Responsibilities
- Principal Investigator (PI): Ensures CRF entries accurately reflect source data and signs off on completed CRFs.
- Study Coordinator: Transcribes data promptly, accurately, and contemporaneously from source documents to CRFs.
- CRA/Monitor: Verifies accuracy of transcription through Source Data Verification (SDV).
- Sponsor/CRO: Provides oversight, training, and ensures compliance with data transcription standards.
- QA Officer: Audits data transcription processes for regulatory compliance.
Accountability
The PI is accountable for accuracy and completeness of all CRF data transcribed from source documents. Sponsors are accountable for providing systems that ensure secure and compliant data transcription.
Procedure
1. Preparation
Ensure source documents are complete, legible, and signed/dated by authorized personnel.
Prepare CRFs for data entry (paper or electronic system access).
2. Data Transcription
Transcribe data directly from source documents without omission.
Enter data contemporaneously at the time of observation or as soon as possible thereafter.
For electronic CRFs, ensure system audit trails record user ID, date, and time of entry.
3. Corrections
Paper CRFs: Correct errors with a single line, initials, and date. Do not use erasers or overwrites.
Electronic CRFs: Corrections must be logged automatically in the audit trail.
4. Verification
CRA verifies accuracy of transcription during monitoring visits using SDV.
Discrepancies must be documented in Data Discrepancy Log (Annexure-1).
5. Quality Checks
Perform periodic internal quality checks on data transcription.
Ensure entries meet ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available.
6. Archiving
Store CRFs and related logs in ISF/TMF as per regulatory requirements (minimum 15 years or region-specific rules).
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
- SDV: Source Data Verification
- ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available
Documents
- Data Discrepancy Log (Annexure-1)
- CRF Transcription Checklist (Annexure-2)
- CRF Verification Log (Annexure-3)
References
- ICH E6(R2) – Good Clinical Practice
- US FDA – Clinical Data Submission Guidelines
- EMA – Data Integrity Standards
- CDSCO – Data Entry and Documentation Rules
- WHO – Data Recording 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: Data Discrepancy Log
| Date | Subject ID | CRF Page | Discrepancy Description | Resolution | Resolved By |
|---|---|---|---|---|---|
| 12/09/2025 | CT2025-SITE01-151 | Page 22 | Height recorded as 1700 cm instead of 170 cm | Corrected | Study Coordinator |
Annexure-2: CRF Transcription Checklist
| Checklist Item | Status | Remarks |
|---|---|---|
| All source data transcribed | Yes | Verified |
| Corrections logged | Yes | Compliant |
Annexure-3: CRF Verification Log
| Date | CRF Page | Verified Against Source | Discrepancy | Verified By |
|---|---|---|---|---|
| 15/09/2025 | Page 24 | Yes | No | 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 |
For more SOPs visit: Pharma SOP