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“headline”: “SOP for QT/QTc (ICH E14) Signal Management”,
“description”: “This SOP describes the procedures for monitoring and managing QT/QTc signals in clinical trials in compliance with ICH E14. It covers ECG monitoring, data collection, signal detection, and regulatory reporting to ensure participant safety and regulatory compliance.”,
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Published on 22/12/2025
Standard Operating Procedure for QT/QTc (ICH E14) Signal Management
| SOP No. | CR/OPS/159/2025 |
| Supersedes | NA |
| Page No. | X of Y |
| Issue Date | 26/08/2025 |
| Effective Date | 01/09/2025 |
| Review Date | 01/09/2026 |
Purpose
The purpose of this SOP is to define processes for managing QT/QTc signals in clinical trials in alignment with ICH E14. QT prolongation poses
Scope
This SOP applies to sponsors, CROs, investigators, pharmacovigilance (PV) staff, data managers, and QA staff engaged in cardiac safety monitoring during clinical trials. It covers ECG data collection, analysis, signal management, regulatory submissions, and archiving.
Responsibilities
- Sponsor: Ensures trial protocols include cardiac safety monitoring per ICH E14.
- CRO: Coordinates ECG collection, transmission, and data management.
- Investigator: Performs ECGs and documents QT/QTc abnormalities.
- PV Department: Monitors for cardiac signals and reports SAEs to regulators.
- QA: Audits ECG and cardiac safety processes for compliance.
Accountability
The Sponsor’s Head of Pharmacovigilance and Biostatistics is accountable for ensuring adherence to ICH E14 cardiac safety requirements and proper QT/QTc signal management.
Procedure
1. ECG Data Collection
1.1 Collect baseline and follow-up ECGs per protocol.
1.2 Use standardized equipment validated for QT/QTc assessment.
1.3 Record in ECG Collection Log (Annexure-1).
2. Data Handling and Analysis
2.1 Transfer ECG data to central lab or validated system.
2.2 Biostatisticians analyze QT/QTc intervals using validated methods.
2.3 Document in ECG Data Handling Log (Annexure-2).
3. Signal Detection
3.1 Identify potential QT prolongation signals (e.g., >450ms in males, >470ms in females).
3.2 Escalate findings to PV and Data Safety Monitoring Board (DSMB).
3.3 Record in Signal Detection Log (Annexure-3).
4. Regulatory Reporting
4.1 Report QT/QTc-related SAEs and SUSARs to regulators.
4.2 Submit safety updates in DSUR and CSR.
4.3 Document in Regulatory Reporting Log (Annexure-4).
5. Risk Mitigation
5.1 Implement dose adjustment, treatment discontinuation, or subject withdrawal as required.
5.2 Ensure subject safety measures are recorded in Risk Mitigation Log (Annexure-5).
6. Archiving
6.1 Archive ECG data, analysis reports, and regulatory submissions in TMF.
6.2 Record archiving details in ECG Archiving Log (Annexure-6).
Abbreviations
- SOP: Standard Operating Procedure
- ECG: Electrocardiogram
- QT/QTc: Corrected QT Interval
- PV: Pharmacovigilance
- SAE: Serious Adverse Event
- SUSAR: Suspected Unexpected Serious Adverse Reaction
- DSMB: Data Safety Monitoring Board
- CSR: Clinical Study Report
- DSUR: Development Safety Update Report
- CRO: Contract Research Organization
- QA: Quality Assurance
- TMF: Trial Master File
Documents
- ECG Collection Log (Annexure-1)
- ECG Data Handling Log (Annexure-2)
- Signal Detection Log (Annexure-3)
- Regulatory Reporting Log (Annexure-4)
- Risk Mitigation Log (Annexure-5)
- ECG Archiving Log (Annexure-6)
References
- ICH E14 – Clinical Evaluation of QT/QTc Interval Prolongation
- ICH GCP Guidelines
- FDA Guidance – Clinical Evaluation of QT/QTc Interval Prolongation
Version: 1.0
Approval Section
| Prepared By | Ravi Kumar, PV Specialist |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, Head Clinical Operations |
Annexures
Annexure-1: ECG Collection Log
| Date | Subject ID | ECG Performed By | Result | Status |
|---|---|---|---|---|
| 01/09/2025 | SUB-701 | Site Nurse | Normal | Completed |
Annexure-2: ECG Data Handling Log
| Date | Batch ID | Transferred By | Verified By | Status |
|---|---|---|---|---|
| 02/09/2025 | ECG-BATCH-01 | Site Staff | Data Manager | Verified |
Annexure-3: Signal Detection Log
| Date | Subject ID | QTc Interval | Detected By | Status |
|---|---|---|---|---|
| 04/09/2025 | SUB-701 | 480ms | PV Officer | Escalated |
Annexure-4: Regulatory Reporting Log
| Date | Event | Reported To | Reported By | Status |
|---|---|---|---|---|
| 05/09/2025 | QTc Prolongation | EMA/FDA | PV Specialist | Submitted |
Annexure-5: Risk Mitigation Log
| Date | Subject ID | Action Taken | Responsible | Status |
|---|---|---|---|---|
| 06/09/2025 | SUB-701 | Dose Reduced | Investigator | Implemented |
Annexure-6: ECG Archiving Log
| Date | Document | Archived By | Location | Status |
|---|---|---|---|---|
| 10/09/2025 | ECG Reports Batch-01 | QA | TMF | Archived |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 26/08/2025 | 00 | Initial version | New SOP creation | Head Clinical Operations |
For more SOPs visit: Pharma SOP