[Janet Wright]

Thank you very much for the prompt reply, Karen!

A follow-up question… If you are scanning an entire TMF: is there any guidance on whether you should mark as certified each file individually, or if you can have a blanket certification that would cover the entire process or batches? For example, if your transfer plan describes the scanning and the initial and second QCs, would it be acceptable to have a single sign off at the end?

Thank you again!

[Author]

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