section 02.01.07 Sample CRFs unique or master?

[Anonymous]

Hello,

I’m seeking guidance on the type of Sample CRF file we should put in the section 02.01.07. It’s not clear to me whether this file should only contain the unique forms in EDC, or if it should be the master file that contains all the forms and their visits in EDC.

Currently, our conventions wants the master file in 02.01.07 eTMF vault, however we are also required to provide the unique file in the submissions vault (which is crosslinked from our eTMF vault in same section 02.01.07.

Just wanted to see what guidance or what experiences other data managers have had for this particular section.

Thanks,
Richie

[Author]

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