Clinical Trial Batch Record Template
Batch Information
Product Name
Batch Number
Protocol Number
Date of Manufacture
Expiration Date
Lot Number(s)
Materials Used
Material Name
Lot Number
Quantity
Supplier
Manufacturing Steps
Step
Description
Performed By
Date/Time
In-Process Controls
Test/Check
Result
Performed By
Date/Time
Comments/Deviations
Review & Approval
Prepared By
Date
Reviewed By
Date
Approved By
Date