TMF RM 3.3

[Maria Pedko]

Dear colleagues,

I have some questions regarding document assignment in the correct version of TMF RM. Your help is very much appreciated 😊.

1) Material Transfer Agreement (Required for all instances where biological samples will be exported out of the country. An agreement between the provider and the recipient (Central Laboratory) of all the biological samples collected during the study that stipulates what will be done with said samples during and after the study conduct)

In our company we keep this agreement under “08.02.04 Sample Import or Export Documentation”. In accordance with 3.3. it should go to Regulatory “03.02.02 Import or Export Documentation”. Would you please confirm that Regulatory is the correct section for an agreement with Central Lab?
2) Package Insert is now mentioned in two artifacts “02.01.11 Marketed Product Material” and “06.01.02 IP Instructions for Handling”. Would you please confirm what is the difference?

Thank you a lot for your help,
Best regards,
Maria Pedko, Document Manager, PSI CRO

[Karen Williams]

The package insert includes details and directions that health care providers need to prescribe a drug properly, including approved uses for the drug, contraindications, potential adverse reactions, available formulations, and dosage, and how to administer the drug.

IP Instructions: storage and dispensing of IP. Instruction on return of unused IP; Establishing Quality control for IP. The procedures should address adequate and safe receipt, handling, storage, dispensing, retrieval of unused product from subjects, and return of unused investigational product(s) to the sponsor (or alternative disposition if authorized by the sponsor and in compliance with the applicable regulatory requirement(s))

both are part of the IP process but two separate processes and are filed separately

[Author]

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