Excel spec sheet template for input to P21 community?

Pinnacle 21 General
1

HI All,

I’m fairly new to CDISC programming (and also coming at this from the R side of things). Im’ trying to understand best practice for creating define.xml files. I understand one can either:

  1. Create define.xml once SDTM/ADaM datasets have been created, or
  2. Create define.xml early on - even before the study has started - based on the CRF.

The second option seems more appealing from a planning POV. To do this it seems you can create an Excel spec sheet for the various metadata components of SDTM/ADaM (separately), pre-populate manually, then input that to P21 community, and create the define.xml from there. If that’s the case, is there a template somewhere for the recommended structure of the Excel file (e.g. showing sheets required, their names, variables required in each sheet and their names)?

Thank you!

Paul

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