Skip to content
New issue

Have a question about this project? Sign up for a free GitHub account to open an issue and contact its maintainers and the community.

By clicking “Sign up for GitHub”, you agree to our terms of service and privacy statement. We’ll occasionally send you account related emails.

Already on GitHub? Sign in to your account

RADEX: Update to be consistent with treatment arms. #16

Open
cicdguy opened this issue Aug 5, 2021 · 0 comments
Open

RADEX: Update to be consistent with treatment arms. #16

cicdguy opened this issue Aug 5, 2021 · 0 comments
Labels
enhancement New feature or request New sme SP3

Comments

@cicdguy
Copy link
Contributor

cicdguy commented Aug 5, 2021

Please update logic for ADEX starting with records where PARCAT1 = INDIVIDUAL. Currently subjects are randomly assigned to Drug A or Drug B (in PARCAT2) but instead the assigned drug should be consistent with ADSL. ARM.

The table below represents the metadata that should drive how the random data is generated. Feel free to rewrite or simplify current code as needed.

PARCAT2 Arms this drug applies to Single Dose (EXDOSE) Dosing Schedule
Drug X Arm A or Arm C 10mg Daily
Placebo Arm B 0mg Daily
Drug Y Arm C 50mg Every 7 days

Please also update AVISIT/AVISITN to be by CYCLE X (1, 2, 3,....). You can assume each cycle is 28 days. Note AVISTIT/AVISITN should not include SCREENING and BASELINE.

Please also add missing variables:

AVALC
ANL01FL

Please open up a PR once the randomization for PARCAT1 = INDIVIDUAL is ready. Then can move on to the PARCAT2 = OVERALL records.

Provenance:

Creator: anajens
@cicdguy cicdguy added enhancement New feature or request New SP3 labels Aug 5, 2021
@shajoezhu shajoezhu added the sme label Apr 29, 2022
Sign up for free to join this conversation on GitHub. Already have an account? Sign in to comment
Labels
enhancement New feature or request New sme SP3
Projects
None yet
Development

No branches or pull requests

2 participants