Standard Operating Procedure for Scheduling of Pre-Dose Fasting Period in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/058/2025 |
| Supersedes | SOP/BA-BE/058/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To establish a standard procedure for scheduling and enforcing the pre-dose fasting period for study participants in Bioavailability/Bioequivalence (BA/BE) studies to ensure valid pharmacokinetic evaluations and adherence to protocol.
2. Scope
This SOP applies to all BA/BE clinical studies conducted at the facility where fasting prior to dosing is a protocol-mandated requirement. It covers subject instructions, meal restrictions, monitoring, and documentation procedures.
3. Responsibilities
- Clinical Research Coordinator (CRC): Communicates fasting instructions, schedules last meal, and ensures volunteer compliance.
- Ward In-charge/Nurse: Monitors and documents fasting start time and confirms adherence at dosing.
- Principal Investigator (PI): Approves pre-dose readiness and confirms protocol compliance.
See also BA-BE Studies: SOP for Review of Bioequivalence Waiver Justifications (BCS Class I) - V 2.0
4. Accountability
The Study PI is accountable for ensuring that all enrolled subjects have completed the required fasting period prior to dosing, as defined by the study protocol.
5. Procedure
5.1 Determination of Fasting Period
- Refer to the clinical protocol to confirm the exact fasting requirement (e.g., 10 hours overnight fasting).
- Document the protocol-specified fasting duration in Annexure-1: Fasting Period Reference Sheet.
5.2 Scheduling Last Meal
- Arrange a light standardized dinner for all volunteers as per protocol (generally low-fat, <30% calories from fat).
- Serve dinner at a scheduled time (e.g., 8:00 PM) and document meal composition in Annexure-2: Pre-Dose Meal Record.
5.3 Initiation of Fasting
- Confirm start time of fasting for each subject immediately after last meal intake (e.g., 8:30 PM).
- Restrict food, beverages (except water), chewing gum, and tobacco post fasting initiation.
- Water is permitted as per protocol (e.g., up to 1 hour prior to dosing).
5.4 Fasting Monitoring
- Assign nursing staff to monitor and document compliance in Annexure-3: Fasting Monitoring Log.
- Check with subjects for any fasting violations (e.g., consumption of food or restricted items).
5.5 Confirmation Prior to Dosing
- Before dosing, reconfirm fasting duration for each subject (must be equal to or more than protocol requirement).
- Investigators or Sub-Investigators to verify and sign Annexure-4: Fasting Compliance Declaration.
5.6 Non-Compliance Handling
- Document any deviation from fasting requirements.
- Inform PI for decision on subject inclusion or replacement.
- Record the incident in the protocol deviation log if required.
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- PI: Principal Investigator
- CRC: Clinical Research Coordinator
7. Documents
- Fasting Period Reference Sheet – Annexure-1
- Pre-Dose Meal Record – Annexure-2
- Fasting Monitoring Log – Annexure-3
- Fasting Compliance Declaration – Annexure-4
8. References
- ICH E6(R2) – Good Clinical Practice
- CDSCO Guidelines for BA/BE Studies
- 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: Fasting Period Reference Sheet
| Study Code | Fasting Requirement | Reference (Protocol Section) |
|---|---|---|
| BE2025-058 | 10 hours | Section 5.1 |
Annexure-2: Pre-Dose Meal Record
| Subject ID | Meal Type | Meal Time | Supervised By |
|---|---|---|---|
| VOL-058 | Standard Low-Fat | 20:00 | Sunita Reddy |
Annexure-3: Fasting Monitoring Log
| Subject ID | Fasting Start Time | Monitoring Interval | Compliance Noted | Initials |
|---|---|---|---|---|
| VOL-058 | 20:30 | Every 2 hrs | Yes | R. Pawar |
Annexure-4: Fasting Compliance Declaration
| Subject ID | Fasting Duration | Fit for Dosing | Verified By (Investigator) | Date |
|---|---|---|---|---|
| VOL-058 | 10 hrs | Yes | Dr. Arvind Shah | 17/04/2025 |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 15/01/2022 | 1.0 | Initial release | Protocol implementation | QA Head |
| 17/04/2025 | 2.0 | Detailed monitoring and annexures added | Operational clarity | QA Head |