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explore-eda / SilentNight-MT

A mock trial for In Home Assessment of Three Anti-Snoring Devices, a cross over study SRC-AI-SilentNight-10090 Version 3.0
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Create blank casebook for all CRFs by Visit #3

Open james-eda opened 9 months ago

james-eda commented 9 months ago

Next, we will annotate it (acrf.pdf)

james-eda commented 9 months ago

for one subject, for every visit, every crf, in order, in one pdf, without annotations filed in /doc

khsarvar commented 9 months ago

Done! Uploaded in OneDrive so far https://netorgft5511632.sharepoint.com/:b:/s/edaclinical.com/EXKTDwuehaVHlCC_lqunUg8B1nasCUkmR6jX7ph-vCTrXQ?e=hYDiXv

james-eda commented 9 months ago

Not quite - the goal is to be able to flip through the casebook, page by page, and imagine the subject experience. For example, the first form a subject will see is an informed consent form, then the inclusion/exclusion forms, and that is all before Visit 1!

khsarvar commented 9 months ago

Done! https://netorgft5511632.sharepoint.com/:b:/s/edaclinical.com/Ee6Dy1miLfFEtLBe9jkBn44BKdya0bIEr2Z1dYimBWvL5g?e=ag5t2f

james-eda commented 9 months ago

Ok, we will review this together. This represents all the data collected during the course of a trial, for a single subject.

Initial thoughts: If no table of contents, perhaps we need a title page when each visit begins with visit name and visit code. Also, I think a device information/exposure form will be collected for each visit where a new device is presented. Consider alongside the Visit Schedule in SAP