Protocol for Blood Sample Collection in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the collection, handling, and processing of pharmacokinetic (PK) blood samples in Bioavailability (BA) and Bioequivalence (BE) studies conducted in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in the planning, collection, handling, and analysis of PK blood samples, including Clinical Research Associates (CRAs), Study Nurses, Laboratory Personnel, and Data Managers.

Responsibilities

• The Study Coordinator is responsible for coordinating PK sample collection activities and ensuring compliance with the study protocol and regulatory requirements.
• The Study Nurse or Phlebotomist is responsible for collecting blood samples from study participants according to the specified sampling schedule and procedures.
• The Laboratory Personnel are responsible for processing and analyzing PK blood samples, including sample storage, centrifugation, and analysis techniques.

Procedure

1. Develop a PK sampling plan detailing the timing, frequency, and volume of blood samples to be collected based on the study protocol and pharmacokinetic objectives.
2. Train study personnel involved in sample collection on proper phlebotomy techniques, sample handling, and documentation procedures.
3. Coordinate with study participants to schedule PK sampling visits and provide clear instructions on fasting requirements, medication restrictions, and other relevant instructions.
4. Collect blood samples using aseptic techniques and appropriate collection devices, ensuring correct labeling and documentation of sample collection times.
5. Process blood samples promptly according to the study protocol, including centrifugation, aliquoting, and storage at specified temperatures.
6. Transfer processed samples to the laboratory for analysis, maintaining appropriate chain of custody and documentation throughout the process.
7. Analyze PK blood samples using validated analytical methods and instruments, ensuring accuracy, precision, and reliability of results.
8. Document all PK sample collection, handling, and analysis activities in the study records, including any deviations or incidents encountered.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence
• PK – Pharmacokinetic
• CRA – Clinical Research Associate

Documents

• PK Sampling Plan
• Phlebotomy Training Records
• Sample Collection Log
• Sample Analysis Reports

Reference

International Conference on Harmonisation (ICH) E6 Good Clinical Practice guidelines and relevant regulatory requirements for bioanalytical method validation and sample handling.

SOP Version

Version 1.0