Standard Operating Procedure for Water Intake Restrictions and Management in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/062/2025
Supersedes	SOP/BA-BE/062/2022
Page No.	Page 1 of 9
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To define a standardized procedure for controlling and documenting water intake before and after the administration of study drug in Bioavailability/Bioequivalence (BA/BE) studies, in alignment with regulatory requirements and clinical protocols.

2. Scope

This SOP applies to all BA/BE clinical studies where water restriction before and after dosing is mandated. It includes subject instruction, monitoring, and deviation handling related to water intake.

3. Responsibilities

• Clinical Research Coordinator (CRC): Informs subjects of water restrictions and records permitted intake periods.
• Ward Nurse: Monitors compliance with water intake timing and quantity.
• Investigator/Sub-Investigator: Reviews compliance before dosing and evaluates deviations.

4. Accountability

The Principal Investigator is accountable for ensuring water intake is regulated according to the protocol and that all deviations are properly documented and reviewed.

5. Procedure

5.1 Water Restriction Guidelines

1. Follow protocol-defined water intake limits, typically:
   • Allowed up to 1 hour before dosing
   • Restricted for at least 1 hour post dosing
2. Specify total volume permitted with drug administration (commonly 240 mL).

5.2 Subject Instruction

1. Inform subjects of the exact timing and limits of water consumption during pre-study orientation.
2. Provide written instructions as part of volunteer briefing materials.

5.3 Monitoring Water Intake

1. Supervise and record all permitted water intake from 10 hours before dosing to 4 hours post dosing in Annexure-1: Water Intake Log.
2. Mark timing and volume for each subject during:
   • Fasting period
   • Dosing
   • Post-dose restriction and resumption

5.4 Water Provided at Dosing

1. At the time of dosing, provide exact volume of water (as per protocol), usually 240 mL.
2. Document in Annexure-2: Dosing Water Record.

5.5 Post-Dose Water Resumption

1. Allow subjects to resume water intake after the restricted window has passed (e.g., after 1 hour post-dose).
2. Resume with sips under supervision and monitor subject hydration status.

5.6 Deviation Handling

1. If a subject violates the water restriction, inform the PI immediately.
2. Document the deviation in Annexure-3: Water Intake Deviation Log and in protocol deviation report, if applicable.
3. Decision regarding dosing continuation or withdrawal shall be taken by the PI.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• PI: Principal Investigator
• CRC: Clinical Research Coordinator

7. Documents

1. Water Intake Log – Annexure-1
2. Dosing Water Record – Annexure-2
3. Water Intake Deviation Log – Annexure-3

8. References

• US FDA Guidance on Conduct of Fed and Fasted Bioavailability Studies
• ICH E6(R2) – Good Clinical Practice
• Study Protocol

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Water Intake Log

Subject ID	Time	Volume (mL)	Phase	Remarks
VOL-062	06:00	150	Pre-dose	Allowed

Annexure-2: Dosing Water Record

Subject ID	Dosing Time	Water Volume (mL)	Administered By	Remarks
VOL-062	07:00	240	Dr. Sunita Reddy	As per protocol

Annexure-3: Water Intake Deviation Log

Subject ID	Deviation	Time	Action Taken	Investigator
VOL-062X	Drank water 20 min before dose	06:40	Excluded	Dr. Arvind Shah

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
15/01/2022	1.0	Initial version	Regulatory alignment	QA Head
17/04/2025	2.0	Included annexures and deviation management process	Audit recommendations	QA Head