Create Shell for SAP Appendix

[james-eda]

• [ ] Finalize ToC (every table is followed by a listing, every SDTM domain has a listing)

[khsarvar]

Screenshots collected in OneNote Result page? As PDF?

[james-eda]

• [x] In the appendix of the SAP, below each title for each expected analysis report, include an empty table.
• [x] The section in the appendix should start on its own page.

Later, these pages will be selected from the SAP, printed separately as PDFs, and annotated.

[khsarvar]

Ok! Should those shells be created using Word tables, or is it just screenshots?

[james-eda]

Officially, Word tables (I prefer to copy from OneNote)

[khsarvar]

Done! Available in OneDrive: https://netorgft5511632.sharepoint.com/:w:/s/edaclinical.com/EZdFO91hYmFDuztAeQDk6r0Bwyd402kSqAEgp4fNHRKFbA?e=U7Tnsa

[james-eda]

Looks very good! Copying from OneNote allows us to resize the length and width of the table in Word very easily - nice!

I separated SAP from Shells to enable landscape mode for Shells. I also added a Table of Contents. Shells may be updated as we develop the output (for example, we may add footnotes for clarification, update titles or numbering, and annotate).

For now, I added a few action items in the comments section so that we can consider this done (titles, numbers, bold labels).

https://netorgft5511632.sharepoint.com/:w:/s/edaclinical.com/ETTooNlbO_hDnUFRo9ZlxekBumOn20rC66jViwkvgb5p8g?e=oJA1E0

[khsarvar]

Added numbering for each shell, modified some of the shells like adverse events and etc.

[james-eda]

@khsarvar Updated content - see table of contents. I have to

• [ ] transpose rows to Met, Not Met, Total for some tables.

Please complete Report Generation Checklist at the end of the SAP. It is "a checklist of recommended items to include in a statistical analysis plan. Some of these are specific to clinical trials (based on this JAMA paper) and some are other are specific to observational studies (based on STROBE/RECORD guidelines), so every item will not be necessary for every project. [...]. This checklist was developed using the CONSORT 2010 Checklist."

I also added some comments to the shell.

Based on your findings, we will have to update the list of To-Do's req'd to finalize this deliverable and extract the table of contents for our QC plan

[khsarvar]

Regarding the checklist:

1, 2. I added a couple more listings, but I am not sure what else to add.

3. Not sure what shells would need Population Set Criteria (e.g., SAFFL) and Timing Criteria (e.g., APERIOD)