Reply To: Filing of Material Tranfer Agreement

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Eldin Rammell

Would 08.02.02 Central & Local Testing\Sample Documentation\Shipment Records be appropriate? This seems the most logical place to me. The only issue is that the “definition/purpose” is not strictly accurate, describing records related to “any one shipment”. I cannot see any other relevant filing location so my personal view is to file in 08.02.02 and update the description of the artifact along the lines of “To capture information related to the shipment of samples”.

An alternative approach for a future revision to the Reference Model (in the absence of a more obvious filing location in the model) might be 08.02.04 Central & Local Testing\Sample Documentation\Sample Import or Export Documentation and amend the artifact name and definition/purpose to cover any kind of record that is required to allow the shipment of samples (not just import/export). This could cover import/export documents but would then also cover MTAs and other shipment agreements or licenses.

Just a suggestion. How have others handled MTAs? What recommendation have the sub-artifact team made on this document?