Standard Operating Procedure for Bed Allotment and Facility Assignment in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/079/2025 |
| Supersedes | SOP/BA-BE/079/2022 |
| 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 and unbiased process for bed allotment and facility assignment for healthy volunteers enrolled in Bioavailability/Bioequivalence (BA/BE) studies, ensuring regulatory compliance, safety, and operational efficiency.
2. Scope
This SOP is applicable to the clinical operations team, study coordinators, and data management team involved in assigning beds and facility locations (rooms, wards, collection bays) for subjects participating in BA/BE studies.
3. Responsibilities
- Clinical Research Coordinator (CRC): Prepares and verifies the bed allotment sheet based on randomization code.
- Volunteer Coordinator: Communicates assigned beds and escorts volunteers to their designated area.
- QA Personnel: Verifies proper documentation and randomization alignment during audits.
4. Accountability
The Principal Investigator is accountable for ensuring fair and documented allotment of beds and facilities, in line with the protocol and approved study documents.
5. Procedure
5.1 Pre-Study Preparations
- Designate total available beds based on ward layout and room capacity.
- Verify facility readiness (cleanliness, temperature, ventilation, bed tags, numbering).
- Assign unique bed IDs (e.g., R1-B01 for Room 1, Bed 01).
5.2 Bed Allotment Strategy
- Prepare a bed allotment sheet based on the randomization schedule approved in the protocol.
- Allotment must be blinded to volunteers to avoid bias.
- Maintain subject-wise facility assignment in Annexure-1: Bed Allotment Log.
5.3 Volunteer Communication
- On check-in, the volunteer coordinator shall:
- Verify the volunteer ID and randomization number
- Direct them to the assigned bed with proper labeling
- Escort and monitor volunteer placement to ensure correct location and time of occupancy.
5.4 Facility Use Documentation
- Document the facility used by each subject including:
- Bed number
- Room number
- Date/time of check-in and discharge
- Update Annexure-2: Facility Assignment Record daily.
5.5 Restrictions and Considerations
- Ensure gender-specific segregation where applicable.
- Account for emergency beds and isolation rooms, which should not be pre-assigned.
- Do not re-assign beds without documented reason and PI approval.
5.6 Post-Study Closeout
- After study phase completion:
- Review logs for consistency and completeness
- Maintain records with the TMF/eTMF
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- CRC: Clinical Research Coordinator
- TMF: Trial Master File
- PI: Principal Investigator
7. Documents
- Bed Allotment Log – Annexure-1
- Facility Assignment Record – Annexure-2
8. References
- ICH E6(R2) – Good Clinical Practice
- Schedule Y – Indian Drugs & Cosmetics Act
- Study Protocol and Randomization Sheet
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Bed Allotment Log
| Volunteer ID | Randomization No. | Room | Bed No. | Assigned By | Date |
|---|---|---|---|---|---|
| VOL-079 | R05 | Room-1 | R1-B03 | Sunita Reddy | 17/04/2025 |
Annexure-2: Facility Assignment Record
| Volunteer ID | Room No. | Bed ID | Check-in Time | Discharge Time | Remarks |
|---|---|---|---|---|---|
| VOL-079 | Room-1 | R1-B03 | 08:00 | 18:00 | Phase-1 |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 12/01/2022 | 1.0 | Initial Release | Standardization | QA Head |
| 17/04/2025 | 2.0 | Included randomization-based bed allotment and annexures | GCP Audit Preparedness | QA Head |