Google may be your friend.
I can't help with this subject, out of my experience but quick search turns up
https://clinicaltrials.gov/ProvidedDocs/91/NCT03282591/SAP_001.pdf
which has pretty extensive plan and example code to implement the plan.
https://www.pharmasug.org/proceedings/2019/ST/PharmaSUG-2019-ST-103.pdf
and others.
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