Standard Operating Procedure for ECG Monitoring Before Dosing in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/056/2025 |
| Supersedes | SOP/BA-BE/056/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To define the procedure for conducting and documenting electrocardiogram (ECG) monitoring of healthy volunteers prior to dosing in Bioavailability/Bioequivalence (BA/BE) studies to evaluate cardiac health and ensure subject safety.
2. Scope
This SOP applies to all clinical research personnel involved in the pre-dose assessment of study participants through ECG monitoring as per protocol requirements.
3. Responsibilities
- Technician: Performs ECG using calibrated equipment, labels and stores the report.
- Investigator/Sub-Investigator: Reviews ECG, assesses for abnormalities, and determines subject eligibility.
- Clinical Research Coordinator: Ensures proper scheduling and documentation of ECG assessments.
4. Accountability
The Principal Investigator is accountable for verifying that ECG monitoring has been completed and subjects are fit for dosing based on cardiac status.
5. Procedure
5.1 Preparation
- Ensure the ECG machine is calibrated and functional.
- Explain the procedure to the subject and ensure privacy during ECG recording.
- Use a 12-lead ECG configuration unless otherwise specified in the protocol.
5.2 ECG Recording
- Ask the subject to lie down calmly for 5–10 minutes before recording.
- Clean skin area and apply electrodes as per standard 12-lead configuration.
- Record the ECG and ensure proper waveform quality.
- Label the ECG printout with:
- Subject ID
- Date and Time
- Investigator Initials
5.3 ECG Review
- The Investigator shall assess:
- Heart rate
- PR, QRS, QT, and QTc intervals
- Rhythm abnormalities (e.g., bradycardia, tachycardia)
- Evidence of conduction blocks, ST/T wave changes
- Record findings in Annexure-1: ECG Assessment Form.
- Mark subject as Fit or Unfit for dosing based on review.
5.4 Documentation
- Attach ECG report to the subject’s source documentation file.
- Record summary data in Annexure-2: ECG Summary Log.
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- ECG: Electrocardiogram
- PI: Principal Investigator
- QTc: Corrected QT Interval
7. Documents
- ECG Assessment Form – Annexure-1
- ECG Summary Log – Annexure-2
8. References
- ICH E6(R2) – Good Clinical Practice
- CDSCO BA/BE Study Guidelines
- Clinical Trial Protocol Requirements
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: ECG Assessment Form
| Subject ID | Date | HR | QTc | ECG Findings | Fit for Dosing? | Investigator |
|---|---|---|---|---|---|---|
| VOL-056 | 16/04/2025 | 72 | 408 ms | Normal sinus rhythm | Yes | Dr. Arvind Shah |
Annexure-2: ECG Summary Log
| Date | Subject ID | ECG Status | Remarks |
|---|---|---|---|
| 16/04/2025 | VOL-056 | Normal | Eligible for dosing |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 15/01/2022 | 1.0 | Initial release | Regulatory requirement | QA Head |
| 17/04/2025 | 2.0 | Updated with QTc and ECG criteria | Protocol harmonization | QA Head |