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.
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
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”