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RConsortium / rtrs-wg

R Tables for Regulatory Submissions Working Group
https://rconsortium.github.io/rtrs-wg/
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Chapter on Literature: Collect References #4

Open kaneplusplus opened 3 years ago

kaneplusplus commented 3 years ago

also see all the references in the current paper

Mike Stackhouse to Everyone (12:09 PM)

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

Mike Stackhouse to Everyone (12:11 PM)

Base R on 21 CFR Part 11: https://www.r-project.org/doc/R-FDA.pdf

RStudio/tidyverse/shiny/gt/markdown/etc. similar documents - so all are aware: https://rstudio.com/solutions/pharma/ Way down aCollectt the bottom.

Mike Stackhouse to Everyone (12:19 PM)

Some PHUSE white papers on standard tables:

https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Standard+Analyses+and+Code+Sharing/Analyses+and+Displays+Associated+with+Adverse+Events+Focus+on+Adverse+Events+in+Phase+2-4+Clinical+Trials+and+Integrated+Summary.pdf Mike Stackhouse to Everyone (12:19 PM)

https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Standard+Analyses+and+Code+Sharing/Analyses+%26+Displays+Associated+with+Outliers+or+Shifts+from+Normal+To+Abnormal+Focus+on+Vital+Signes+%26+Electrocardiogram+%26+Laboratory+Analyte+Measurements+in+Phase+2-4+Clinical+Trials+and+Integrated+Summary.pdf Mike Stackhouse to Everyone (12:19 PM)

https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Standard+Analyses+and+Code+Sharing/Analyses+%26+Displays+Associated+with+Measures+of+Central+Tendency-+Focus+on+Vital+Sign,+Electrocardiogram+%26+Laboratory+Analyte+Measurements+in+Phase+2-4+Clinical+Trials+and+Integrated+Submissions.pdf Mike Stackhouse to Everyone (12:20 PM)

https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Standard+Analyses+and+Code+Sharing/Analyses+%26+Displays+Associated+with+Demographics,+Disposition+and+Medication+in+Phase+2-4+Clinical+Trials+and+Integrated+Summary+Documents.pdf

Mike Stackhouse to Everyone (12:29 PM)

https://atorus-research.github.io/pharmaRTF/

Mike Stackhouse to Everyone (12:35 PM) Collect Publicly available set of trial data: https://github.com/phuse-org/phuse-scripts/blob/master/data/sdtm/TDF_SDTM_v1.0%20.zip

https://github.com/phuse-org/phuse-scripts/blob/master/data/adam/TDF_ADaM_v1.0.zip

Mike Stackhouse to Everyone (12:38 PM)

https://github.com/atorus-research/CDISC_pilot_replication

ClaudiaNie commented 2 years ago

I am not sure if this reference is hidden somewhere in this long list, but in any case should be a good reference to have a full list of required outputs for a FDA submission : image