Post-Use Investigational Product Inspection

[Dennis Hannigan]

The company receives post-use investigational product for inspection and analytical testing. Should the records associated with the returned post-use IP be in Section 08? Some think these are IP Returns falling under Section 06 because they are not blood or similar specimens for analysis.
Dennis

[Janna Gonzalez]

Hi Dennis,
What zone are you looking at for Section 08?
Janna

[Janna Gonzalez]

06 IP and Trial Supplies 06.01 IP Documentation 06.01.10 IP Return Documentation To record details of returns to/from a distribution center, depot and/or trial site. Examples include courier documentation and packing/ inventory listing. “Acknowledgement of Return
IP Return Documentation
IP Return Form

Non-IP-
06 IP and Trial Supplies 06.05 Non-IP Documentation 06.05.03 Non-IP Return Documentation To inventory the returns of certain non-IP supplies needed to fulfill the trial protocol requirements to a distribution center, depot and/or site. Examples include courier documentation and packing/ inventory listing. “Acknowledgement of Return
Non-IP Return Documentation
Non-IP Return Form”

Please follow your SOP.
hope this helps!
Janna

[Janna Gonzalez]

Example for Non-IP Documents,
Non IP Example of documents (if applicable)
Study Supplies Log
Subject Accountability Log
Other Site Logs

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