Standard Operating Procedure for Monitoring Vital Signs During Clinical Phase in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/065/2025 |
| Supersedes | SOP/BA-BE/065/2022 |
| 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 standard procedure for monitoring, recording, and responding to vital sign assessments of study participants during the clinical phase of Bioavailability/Bioequivalence (BA/BE) studies, ensuring safety and compliance with protocol and regulatory guidelines.
2. Scope
This SOP applies to the monitoring of vital signs including blood pressure, heart rate, respiratory rate, and body temperature for all study subjects during check-in, pre-dose, post-dose, and throughout the clinical stay as defined in the study protocol.
3. Responsibilities
- Ward Nurse/Paramedical Staff: Perform and document vital signs as per schedule using calibrated equipment.
- Clinical Research Coordinator (CRC): Ensures accuracy of logs and alerts medical staff in case of abnormal readings.
- Investigator/Sub-Investigator: Reviews abnormalities, initiates clinical action, and documents assessments.
4. Accountability
The Principal Investigator is accountable for ensuring that vital sign monitoring is performed as per protocol and deviations are addressed appropriately.
5. Procedure
5.1 Equipment Preparation and Calibration
- Use validated and calibrated digital sphygmomanometer, thermometer, and pulse oximeter.
- Ensure availability of backup equipment and calibration records.
5.2 Monitoring Schedule
- Record vital signs at the following time points:
- On check-in
- Within 1 hour pre-dose
- At defined intervals post-dose (e.g., 0.5h, 1h, 2h, 4h, 8h)
- Prior to discharge or exit
- Document timing and readings in Annexure-1: Vital Signs Monitoring Log.
5.3 Parameters to be Recorded
- Blood Pressure (mmHg) – Systolic and Diastolic
- Heart Rate (bpm)
- Respiratory Rate (breaths per minute)
- Body Temperature (°C) – Oral or Tympanic
- SpO2 (if applicable)
5.4 Handling Abnormal Results
- Any deviation outside the protocol-defined acceptable range should be:
- Immediately reported to the Investigator
- Re-checked and confirmed
- Documented in Annexure-2: Vital Signs Deviation Log
- PI may delay or cancel dosing if significant abnormality is confirmed.
5.5 Post-Monitoring Review
- Investigator to review all vital sign logs before and after dosing.
- Ensure that records are filed in the source documents and eTMF.
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- PI: Principal Investigator
- CRC: Clinical Research Coordinator
- SpO2: Peripheral Oxygen Saturation
7. Documents
- Vital Signs Monitoring Log – Annexure-1
- Vital Signs Deviation Log – Annexure-2
8. References
- ICH E6(R2) – Good Clinical Practice
- Study Protocol
- Clinical Trial Site SOP Manual
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Vital Signs Monitoring Log
| Subject ID | Timepoint | BP (mmHg) | HR (bpm) | RR | Temp (°C) | SpO2 | Initials |
|---|---|---|---|---|---|---|---|
| VOL-065 | Pre-dose | 118/76 | 72 | 16 | 36.8 | 98% | R. Pawar |
Annexure-2: Vital Signs Deviation Log
| Subject ID | Timepoint | Deviation | Action Taken | Reviewed By |
|---|---|---|---|---|
| VOL-065X | Pre-dose | BP 150/100 | Dosing deferred | Dr. Arvind Shah |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 14/01/2022 | 1.0 | Initial release | Study Implementation | QA Head |
| 17/04/2025 | 2.0 | Added SpO2 monitoring and deviation tracking | Protocol update | QA Head |