Standard Operating Procedure
Title: Temperature Logs and Equipment Maintenance records
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.
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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.
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A list of all trial equipment and
service history should be compiled and added to and deleted as necessary.