Categorizations of Analyses and Outputs

[ASL-rmarshall]

As described in PBI #30 , there is a need for categorization of analyses and outputs. Please use this discussion for questions and posting use cases.

[bhavinbusa]

From Dante: Another use case is to support internal review and validation of output and docs - Based on the example category of Top-line/result (or not), to ensure certain validation artifacts exist and are not "stale", based on prior data snapshots, etc.

[dditomma]

ICH E3 CSR structure:
https://database.ich.org/sites/default/files/E3_Guideline.pdf
Ability to categorize and organize outputs into documents with specific structures, like ICH E3 CSR structure.
Other defined structures exist, as others noted: ISS, ISE, and BIMO categories

So reports could fit into different document structures, according to

• category, and
• (possibly) order within category
  with some categories and groups of categories being pre-defined by industry standard/convention.

[dditomma]

Select outputs assembled into doc structures like noted above may be used directly within report body, sometimes called "in text" tables, which could be another category / use case