Protocol for Ensuring Environmental Health and Safety in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for maintaining environmental health and safety standards in clinical and laboratory settings involved in Bioavailability (BA) and Bioequivalence (BE) studies, ensuring the well-being of study personnel and compliance with regulatory requirements.

Scope

This SOP applies to all study personnel working in clinical and laboratory settings where BA/BE studies are conducted, including Investigators, Laboratory Technicians, Clinical Research Associates (CRAs), and Environmental Health and Safety Officers.

Responsibilities

The Investigator is responsible for ensuring that study facilities comply with environmental health and safety regulations, providing necessary resources and support to maintain a safe working environment.
The Laboratory Technician is responsible for following established safety procedures and protocols when handling hazardous materials, chemicals, or biological samples in the laboratory.
The Clinical Research Associate (CRA) is responsible for monitoring compliance with environmental health and safety guidelines during site visits, identifying potential hazards or safety risks, and ensuring corrective actions are taken.
The Environmental Health and Safety Officer is responsible for developing and implementing environmental health and safety policies, conducting risk assessments, providing training, and overseeing safety inspections and audits.

Procedure

Develop and implement environmental health and safety policies and procedures specific to BA/BE

studies, addressing potential hazards, risks, and emergency response protocols in both clinical and laboratory settings.

Provide comprehensive training to study personnel on environmental health and safety practices, including proper handling of hazardous materials, use of personal protective equipment (PPE), emergency procedures, and waste disposal protocols.

Conduct regular risk assessments and safety audits of study facilities, identifying potential hazards such as chemical spills, exposure to biological agents, electrical hazards, and ergonomic risks, and implementing controls to mitigate risks.

Ensure that all laboratory equipment and facilities meet safety standards and are properly maintained, calibrated, and inspected regularly to prevent accidents or equipment failures.

Establish procedures for the safe handling, storage, and disposal of hazardous materials, chemicals, and biological samples, in compliance with regulatory requirements and industry best practices.

Implement measures to control exposure to hazardous substances, including engineering controls, administrative controls, and personal protective equipment (PPE), to minimize risks to study personnel and ensure compliance with safety regulations.

Provide emergency response training to study personnel, including procedures for handling chemical spills, medical emergencies, fires, and evacuations, and ensure that emergency equipment and supplies are readily available and accessible.

Document all environmental health and safety activities, including risk assessments, safety training records, safety inspections, incident reports, and emergency response plans, for review and compliance purposes.

Review and update environmental health and safety policies and procedures regularly, incorporating feedback from study personnel, changes in regulations, and lessons learned from incidents or near misses, to continuously improve safety practices.

Abbreviations

SOP – Standard Operating Procedure
BA – Bioavailability
BE – Bioequivalence
PPE – Personal Protective Equipment
CRA – Clinical Research Associate

Documents

Environmental Health and Safety Policy
Safety Training Records
Risk Assessment Reports
Safety Inspection Logs
Incident and Accident Reports
Emergency Response Plan

Reference

Occupational Safety and Health Administration (OSHA) regulations, Environmental Protection Agency (EPA) guidelines, and relevant local, state, and national regulations pertaining to environmental health and safety in laboratory and clinical settings.

SOP Version

Version 1.0