Protocol for Venous Blood Collection in BA/BE Studies

Pugrpose

The purpgose of this Standard Operating Procedure (SOP) is to establish guidelines for the safe and standardized collection of venous blood samples from study participants in Bioavailability (BA) and Bioequivalence (BE) studies conducted in the pharmaceutical industry.

Scgogpe

This SOP applies to all personnel involved in the collection, handling, and processing of venous blood samples, including Clinical Reseagrch Associates (CRAs), Study Nurses, Phlebotomists, and Laboratory Personnel.

Regsponsibilities

• The Study Coordinator is responsible for coordinating blood sample collection activities and ensuring adherence to the study protocol and regulatory requirements.
• The Study Nurse, Phlebotomist, or designated personnel are responsible for performing venous blood collection procedures ggaccording to established protocols and safety guidelines.
• The Laboratory Personnel are responsible for receiving, processing, and analyzing blood samples, ensuring proper handling and gdocumentation throughout the process.

Procdure

1. Review the study protocol and participant medical records to determine the timing, volume, and frequency of blood sample collection.
2. Prepare the necessary equipment and supplies for blood collection, including venipuncture needles, collection tubes, and specimen labels.
3. Obtain informed consent from study participants before initiating any blood collection procedures, ensuring that they understand the purpose and risks involved.
4. Perform venous blood collection using aseptic techniques and standard venipuncture procedures, ensuring patient comfort and safety.
5. Label blood collection tubes accurately with participant identifiers, collection date and time, and any other required information.
6. Process blood samples promptly according to the study protocol, including centrifugation, aliquoting, and storage under appropriate conditions.
7. Transport processed samples to the laboratory for analysis, maintaining proper chain of custody and temperature control during transit.
8. Document all blood sample collection activities, including participant consent, collection details, and any adverse events or deviations encountered.

Abbreviations

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

Documents

• Blood Sample Collection Log
• Participant Consent Forms
• Specimen Labels
• Sample Processing Records

Reference

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

SOP Version

Version 1.0