Standard Operating Procedure for Blood Sample Collection Schedule Adherence in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/071/2025
Supersedes	SOP/BA-BE/071/2022
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 standardized process for ensuring accurate adherence to the blood sample collection schedule in Bioavailability/Bioequivalence (BA/BE) studies as per protocol-defined time points, maintaining sample integrity and study validity.

2. Scope

This SOP is applicable to all study personnel involved in the collection, documentation, and verification of blood samples during the pharmacokinetic (PK) phase of BA/BE studies.

3. Responsibilities

• Phlebotomist: Collects blood samples at exact scheduled time points and records collection time.
• Clinical Research Coordinator (CRC): Prepares subject-wise sampling schedule, verifies adherence, and manages deviations.
• Bioanalytical Liaison/Technician: Ensures samples are promptly transferred and logged post-collection.

4. Accountability

The Principal Investigator is accountable for ensuring that all blood sample collection adheres to the defined schedule and any deviations are assessed for their impact on pharmacokinetic evaluation.

5. Procedure

5.1 Pre-Study Preparation

1. Review the protocol-defined sampling time points (e.g., pre-dose, 0.25h, 0.5h, 1h, 2h, 4h, 6h, etc.).
2. Create a subject-specific sampling schedule using a time-and-event matrix, starting from the exact dose time (t=0).
3. Train phlebotomy team and provide access to stopwatches or synchronized digital clocks.

5.2 Sample Collection Timing

1. Initiate the stopwatch immediately upon dosing.
2. Collect each sample within the protocol-specified window, typically ±2 minutes for early time points (≤1h) and ±5 minutes for later points.
3. Document:
   • Scheduled time
   • Actual collection time
   • Time deviation (if any)
   • Initials of phlebotomist
4. Use Annexure-1: Blood Sampling Time Log to capture entries.

5.3 Sample Labeling and Verification

1. Label samples immediately with:
   • Subject ID
   • Study period
   • Scheduled and actual time point
2. Have CRC double-check label accuracy before placing in racks.

5.4 Deviation Management

1. If a sample is delayed beyond the acceptable time window:
   • Record the reason in Annexure-2: Sampling Deviation Log
   • Inform the Investigator for impact assessment
   • Tag such samples as ‘Protocol Deviation’ in CRF

5.5 Backup and Contingency

1. Maintain trained backup staff for sample collection and time monitoring.
2. Have spare tubes, labels, and cold chain tools available in the sampling area.

5.6 Monitoring and Quality Control

1. QA personnel shall periodically review time logs and sample labeling.
2. Discrepancies between logs and CRFs must be reconciled and signed by the CRC and PI.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• CRC: Clinical Research Coordinator
• PI: Principal Investigator
• CRF: Case Report Form

7. Documents

1. Blood Sampling Time Log – Annexure-1
2. Sampling Deviation Log – Annexure-2

8. References

• ICH E6(R2) – Good Clinical Practice
• US FDA Guidance on 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: Blood Sampling Time Log

Subject ID	Scheduled Time	Actual Time	Time Deviation	Phlebotomist
VOL-071	08:00	08:01	+1 min	Sunita Reddy

Annexure-2: Sampling Deviation Log

Subject ID	Time Point	Deviation	Reason	Notified To
VOL-071X	2h	+7 min	Needle replacement delay	Dr. Arvind Shah

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
15/01/2022	1.0	Initial release	Protocol compliance	QA Head
17/04/2025	2.0	Included deviation management and annexures	Audit requirement	QA Head