SOP Guide for Pharma

BA-BE Studies: SOP for Reconciliation of Clinical Sample Volumes – V 2.0

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BA-BE Studies: SOP for Reconciliation of Clinical Sample Volumes – V 2.0

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.
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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

  1. Prepare Sample Collection Labels with Volunteer ID, Study Code, and Timepoint (e.g., VOL110-001 / 0hr / BE-2025).
  2. Pre-fill Annexure-1: Sample Collection Register with scheduled timepoints.

5.2 Sample Collection and Labeling

  1. Collect blood samples as per the approved study protocol.
  2. Label tubes immediately at bedside using waterproof marker or pre-printed barcode.
  3. Document volume collected (e.g., 4 mL) in Annexure-2: Sample Volume Tracking Sheet.

5.3 Sample Transfer and Centrifugation

  1. Transport samples in temperature-controlled sample carriers to processing lab within 30 minutes.
  2. After centrifugation, separate plasma and record plasma volume obtained (e.g., 2.8 mL).
  3. Note plasma volume in reconciliation log against each subject and timepoint.

5.4 Sample Volume Reconciliation

  1. Match collected vs. expected samples for each timepoint using Annexure-3: Reconciliation Log.
  2. Any missing, broken, clotted, or hemolyzed samples must be documented with reason and PI notified.
  3. Sign and date reconciliation form by CRC and verified by QA or designee.
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5.5 Handling Discrepancies

  1. Classify discrepancies as minor (e.g., label smudge) or major (e.g., lost or untraceable sample).
  2. Document in Annexure-4: Sample Discrepancy and CAPA Log.
  3. CAPA to be initiated and signed by PI and QA.

5.6 Storage and Handover

  1. Transfer reconciled and aliquoted plasma to storage (-20°C or -70°C) based on protocol requirements.
  2. 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

  1. Sample Collection Register – Annexure-1
  2. Sample Volume Tracking Sheet – Annexure-2
  3. Sample Reconciliation Log – Annexure-3
  4. Sample Discrepancy and CAPA Log – Annexure-4
  5. 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
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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
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