Standard Operating Procedure

Title: Temperature Logs and Equipment Maintenance records

 

CONTENTS

  1. Purpose
  2. Responsibilities
  3. Format

 

1.  Purpose

The purpose of this Standard Operating Procedure is to define the manner in which temperature logs and equipment maintenance and servicing logs are maintained.

 

2.  Responsibilities

It is the responsibility of a nominated member of the clinical research team to update and maintain an accurate ‘Temperature log and Equipment record Manual’.

 

3. Format

A temperature log and equipment record information should be maintained in an A4 ring binder.

-         The temperature log should be completed weekly. If the values fall outside of the required range on 3 consecutive occasions the cause should be investigated and the sponsor company should be notified (as a re supply of drugs may be necessary.

-         A list of all trial equipment and service history should be compiled and added to and deleted as necessary.