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
- Follow protocol-defined water intake limits, typically:
- Allowed up to 1 hour before dosing
- Restricted for at least 1 hour post dosing
- Specify total volume permitted with drug administration (commonly 240 mL).
5.2 Subject Instruction
- Inform subjects of the exact timing and limits of water consumption during pre-study orientation.
- Provide written instructions as part of volunteer briefing materials.
5.3 Monitoring Water Intake
- Supervise and record all permitted water intake from 10 hours before dosing to 4 hours post dosing in Annexure-1: Water Intake Log.
- Mark timing and volume for each subject during:
- Fasting period
- Dosing
- Post-dose restriction and resumption
5.4 Water Provided at Dosing
- At the time of dosing, provide exact volume of water (as per protocol), usually 240 mL.
- Document in Annexure-2: Dosing Water Record.
5.5 Post-Dose Water Resumption
- Allow subjects to resume water intake after the restricted window has passed (e.g., after 1 hour post-dose).
- Resume with sips under supervision and monitor subject hydration status.
5.6 Deviation Handling
- If a subject violates the water restriction, inform the PI immediately.
- Document the deviation in Annexure-3: Water Intake Deviation Log and in protocol deviation report, if applicable.
- 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
- Water Intake Log – Annexure-1
- Dosing Water Record – Annexure-2
- 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 |