Standard Operating Procedure for Room Temperature Monitoring in Sample Collection Areas during BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/089/2025 |
| Supersedes | SOP/BA-BE/089/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To establish a standardized method for the monitoring, recording, and reviewing of ambient room temperature in sample collection areas during the conduct of Bioavailability/Bioequivalence (BA/BE) studies to maintain sample integrity and ensure protocol compliance.
2. Scope
This SOP applies to all clinical staff involved in biological sample collection, handling, and pre-processing in designated sample collection areas at clinical research facilities conducting BA/BE studies.
3. Responsibilities
- Clinical Research Coordinator (CRC): Ensures routine temperature monitoring and log maintenance.
- Study Nurse: Records temperature at defined intervals during study procedures.
- QA Officer: Periodically audits the temperature records and calibrations.
4. Accountability
The Site Operations Manager is accountable for ensuring that environmental monitoring is performed as per protocol and any deviations are promptly investigated and resolved.
5. Procedure
5.1 Equipment Setup
- Install calibrated digital room thermometers or continuous data loggers in each sample collection area.
- Place devices at an appropriate height, away from direct sunlight, doors, and air vents.
- Ensure calibration certificate is valid and available (Annexure-1).
5.2 Monitoring Frequency
- During study conduct, record room temperature:
- Hourly during sample collection periods
- Before initiation of sample collection and after completion
- Use Annexure-2: Room Temperature Log Sheet for manual entries.
5.3 Temperature Limits and Alert Range
- Acceptable temperature range: 20°C to 25°C ±2°C (unless specified by protocol).
- If temperature goes outside the specified range:
- Immediately inform the CRC and PI
- Document deviation in Annexure-3: Environmental Deviation Log
- Implement immediate corrective action such as adjusting HVAC or relocating samples
5.4 Data Logger Use (If Applicable)
- Download electronic logs at the end of the study day or session.
- Review for any temperature excursions and archive records in eTMF or site file.
5.5 Record Review and Archiving
- QA team to review completed temperature logs weekly or at study close-out.
- All temperature logs must be archived in the Trial Master File (TMF) for a minimum of 5 years.
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- CRC: Clinical Research Coordinator
- QA: Quality Assurance
- HVAC: Heating, Ventilation, and Air Conditioning
- TMF: Trial Master File
7. Documents
- Calibration Certificate – Annexure-1
- Room Temperature Log Sheet – Annexure-2
- Environmental Deviation Log – Annexure-3
8. References
- ICH E6(R2) – Good Clinical Practice
- Study Protocols for BA/BE Studies
- WHO Guidelines on Good Clinical Laboratory Practice (GCLP)
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Calibration Certificate
| Device ID | Last Calibration Date | Next Due Date | Calibrated By |
|---|---|---|---|
| THERMO-089 | 10/03/2025 | 10/03/2026 | Rajesh Instruments |
Annexure-2: Room Temperature Log Sheet
| Date | Time | Temperature (°C) | Recorded By | Remarks |
|---|---|---|---|---|
| 17/04/2025 | 08:00 | 23.1 | Nisha Verma | Within Range |
Annexure-3: Environmental Deviation Log
| Date | Time | Temperature Recorded | Deviation | Corrective Action | Reported To |
|---|---|---|---|---|---|
| 17/04/2025 | 13:00 | 27.5°C | Above limit | HVAC adjusted | CRC & QA |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 10/01/2022 | 1.0 | Initial Release | New SOP | QA Head |
| 17/04/2025 | 2.0 | Added Annexures and deviation handling section | Audit Observation | QA Head |