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

1. Install calibrated digital room thermometers or continuous data loggers in each sample collection area.
2. Place devices at an appropriate height, away from direct sunlight, doors, and air vents.
3. Ensure calibration certificate is valid and available (Annexure-1).

5.2 Monitoring Frequency

1. During study conduct, record room temperature:
   • Hourly during sample collection periods
   • Before initiation of sample collection and after completion
2. Use Annexure-2: Room Temperature Log Sheet for manual entries.

5.3 Temperature Limits and Alert Range

1. Acceptable temperature range: 20°C to 25°C ±2°C (unless specified by protocol).
2. 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)

1. Download electronic logs at the end of the study day or session.
2. Review for any temperature excursions and archive records in eTMF or site file.

5.5 Record Review and Archiving

1. QA team to review completed temperature logs weekly or at study close-out.
2. 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

1. Calibration Certificate – Annexure-1
2. Room Temperature Log Sheet – Annexure-2
3. 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