Procedure for Administering Investigational Products in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the safe and accurate administration of study drugs or investigational products in Bioavailability (BA) and Bioequivalence (BE) studies conducted in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in the administration of study drugs or investigational products to study participants, including Principal Investigators, Study Coordinators, Nurses, and Clinical Research Associates.

Responsibilities

• The Principal Investigator (PI) or Study Coordinator is responsible for ensuring that study drugs are administered according to the study protocol and applicable regulatory requirements.
• The Study Team members responsible for drug administration must be appropriately trained and competent in administering study drugs and documenting administration details.
• The Pharmacy or Investigational Drug Service is responsible for preparing study drugs for administration according to the study protocol and dispensing procedures.

Procedure

1. Review the study protocol and participant’s medical history to confirm eligibility and dosing requirements.
2. Prepare study drugs for administration according to the study protocol and pharmacy procedures, ensuring accuracy and sterility.
3. Administer study drugs to participants according to the prescribed dosing regimen, route of administration, and timing specified in the protocol.
4. Document all drug administrations accurately and promptly in the participant’s medical records or designated study documents.
5. Monitor participants for any adverse reactions or events following drug administration and take appropriate action as needed.
6. Ensure that participants receive clear instructions on any additional requirements or restrictions related to drug administration, such as fasting or dietary restrictions.
7. Dispose of any unused or expired study drugs according to pharmacy or sponsor instructions and regulatory requirements.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence
• PI – Principal Investigator

Documents

• Participant Medical Records
• Drug Administration Log
• Adverse Event Reporting Forms
• Drug Accountability Records

Reference

Good Clinical Practice guidelines (ICH E6) and relevant regulatory requirements for drug administration in clinical trials.

SOP Version

Version 1.0