Standard Operating Procedure for Reconciliation of Clinical Sample Volumes in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/110/2025 |
| Supersedes | SOP/BA-BE/110/2022 |
| 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 systematic procedure for reconciling the clinical samples collected during Bioavailability/Bioequivalence (BA/BE) studies to ensure sample traceability, prevent loss or misidentification, and maintain integrity of the study.
2. Scope
This SOP applies to all clinical and sample handling staff responsible for collection, labeling, transfer, processing, storage, and reconciliation of clinical samples (e.g., blood, plasma) during BA/BE trials.
3. Responsibilities
- Clinical Research Coordinator (CRC): Ensures samples are labeled correctly and reconciled after each collection timepoint.
- Sample Processing Technician: Checks volumes post-centrifugation and maintains reconciliation records.
- QA Officer: Verifies completeness and traceability of sample records during audits and inspections.
- Principal Investigator (PI): Reviews discrepancies and approves CAPA where applicable.
4. Accountability
The Head of Clinical Operations and PI are accountable for ensuring that clinical samples are accurately reconciled, documented, and traceable from collection to analysis or disposal.
5. Procedure
5.1 Pre-Sample Collection Preparation
- Prepare Sample Collection Labels with Volunteer ID, Study Code, and Timepoint (e.g., VOL110-001 / 0hr / BE-2025).
- Pre-fill Annexure-1: Sample Collection Register with scheduled timepoints.
5.2 Sample Collection and Labeling
- Collect blood samples as per the approved study protocol.
- Label tubes immediately at bedside using waterproof marker or pre-printed barcode.
- Document volume collected (e.g., 4 mL) in Annexure-2: Sample Volume Tracking Sheet.
5.3 Sample Transfer and Centrifugation
- Transport samples in temperature-controlled sample carriers to processing lab within 30 minutes.
- After centrifugation, separate plasma and record plasma volume obtained (e.g., 2.8 mL).
- Note plasma volume in reconciliation log against each subject and timepoint.
5.4 Sample Volume Reconciliation
- Match collected vs. expected samples for each timepoint using Annexure-3: Reconciliation Log.
- Any missing, broken, clotted, or hemolyzed samples must be documented with reason and PI notified.
- Sign and date reconciliation form by CRC and verified by QA or designee.
5.5 Handling Discrepancies
- Classify discrepancies as minor (e.g., label smudge) or major (e.g., lost or untraceable sample).
- Document in Annexure-4: Sample Discrepancy and CAPA Log.
- CAPA to be initiated and signed by PI and QA.
5.6 Storage and Handover
- Transfer reconciled and aliquoted plasma to storage (-20°C or -70°C) based on protocol requirements.
- Use Annexure-5: Storage Box Inventory Sheet to document box number, position, and volume.
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- CRC: Clinical Research Coordinator
- PI: Principal Investigator
- CAPA: Corrective and Preventive Action
7. Documents
- Sample Collection Register – Annexure-1
- Sample Volume Tracking Sheet – Annexure-2
- Sample Reconciliation Log – Annexure-3
- Sample Discrepancy and CAPA Log – Annexure-4
- Storage Box Inventory Sheet – Annexure-5
8. References
- ICH E6(R2) – Good Clinical Practice
- Schedule Y – Drugs and Cosmetics Rules
- Sponsor Protocol and Sample Handling Guidelines
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Sample Collection Register
| Volunteer ID | Timepoint | Date | Collected By | Signature |
|---|---|---|---|---|
| VOL-110-002 | 0 hr | 17/04/2025 | Rajesh Kumar | Signed |
Annexure-2: Sample Volume Tracking Sheet
| Volunteer ID | Timepoint | Blood Volume (mL) | Plasma Volume (mL) | Recorded By |
|---|---|---|---|---|
| VOL-110-002 | 0 hr | 4 | 2.7 | Sunita Reddy |
Annexure-3: Sample Reconciliation Log
| Volunteer ID | Timepoint | Status | Remarks | Verified By |
|---|---|---|---|---|
| VOL-110-002 | 0 hr | Complete | NA | QA Officer |
Annexure-4: Sample Discrepancy and CAPA Log
| Date | Volunteer ID | Issue | CAPA | Approved By |
|---|---|---|---|---|
| 17/04/2025 | VOL-110-005 | Clotted sample | Staff retraining | PI |
Annexure-5: Storage Box Inventory Sheet
| Box No. | Volunteer ID | Timepoint | Position | Volume |
|---|---|---|---|---|
| Box-03 | VOL-110-002 | 0 hr | A1 | 2.7 mL |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 10/01/2022 | 1.0 | Initial SOP | Study Requirement | QA Head |
| 17/04/2025 | 2.0 | Added discrepancy log and detailed reconciliation steps | Audit Observation | QA Head |