Releases · RConsortium/submissions-pilot3-adam

Updates done for re-submission on April 19th, 2024.
Final materials submitted to the FDA-eCTD portal can be found here - https://github.com/RConsortium/submissions-pilot3-adam-to-fda/releases/tag/v2.0.0

What's Changed

Update Latest News section of the Pilot3 Website to include the Pharm… by @robertdevine in #154
FDA Feedback: Closes #152 Derive LOCF only considering ANL01FL=Y by @kaz462 in #146
Remove stray newline between bullet 2 and bullet 3 in the Latest News section of the README by @robertdevine in #157
Add Statistical Software Clarifying Statement to the Pilot3 Website homepage. by @robertdevine in #160
Pilot3 Website Update with link to R Consortium March 2024 Meeting Minutes by @robertdevine in #164
Pilot3 Website - Latest News Update - PharmaSUG May 2024 Baltimore by @robertdevine in #166
168 - namespace update by @SHAESEN2 in #169
156 adrg update fda feedback by @laxamanaj in #162
Closes #170 Clean up: Removes adrg_image folder, old spec references, duplicate image, website update by @bms63 in #171
Align lock file for .zip Installation Instructions, general cleanup by @robertdevine in #172
updated adrg, updated renv.lock to remove pilot3utils and xportr inst… by @laxamanaj in #175
added response letter by @SHAESEN2 in #163
add p21 report by @kaz462 in #182
Tidying tlf-demographic.Rmd removing {pilot1wrappers} package dependency. by @robertdevine in #178
Tidying .Rbuildignore removing {pilot1wrappers} references by @robertdevine in #184

Full Changelog: v1.0.0...v2.0.0

Development Repo used for Initial submission of Pilot 3 RCRSWG.
This release takes a snapshot of the current Pilot 3 R-base development area at the time it was submitted on 28Aug2023. See announcement here : https://www.r-consortium.org/announcement/2023/09/11/first-publicly-available-r-based-submission-package-submitted-to-fda-pilot-3

Alternatively, I've created a PDF of the announcement, which can be seen here : https://github.com/RConsortium/submissions-pilot3-adam-to-fda/releases/tag/v1.0.0

Pilot 3 Team.

What's Changed

SDTM by @SHAESEN2 in #14
Update renv.lock file to use 2022-11-01 CRAN snapshot by @thomas-neitmann in #9
Setup CI pipelines by @bms63 in #18
envsetup implementation and project rename by @SHAESEN2 in #16
updating README with new snapshot information by @nicolekjones in #22
Update .Rprofile by @SHAESEN2 in #26
3 adlb shaesen2 by @SHAESEN2 in #34
Create program for ADADAS dataset by @kaz462 in #23
Create program for ADSL dataset by @SHAESEN2 in #27
Update _pkgdown.yml by @bms63 in #44
#35 Windows CI check by @bms63 in #36
Update README.md by @bms63 in #46
Closes #39 resolve adadas DTYPE=LOCF issue by @kaz462 in #40
Closes #45 replace format_* functions by @kaz462 in #49
DRAFT ADAE - 2 dev adae laxamanaj by @laxamanaj in #54
#58 Updated Description file to current team names. Updated snapshot… by @bms63 in #64
3 adlb by @nicolekjones in #47
adtte finalization by @SHAESEN2 in #21
QC script for ADTTE dataset. by @robertdevine in #66
Fix ADADAS issue by @thomas-neitmann in #71
Closes #67 ADaM re-run with updated RACEN codelist. by @DeclanHodges in #73
Closes #31 Updates to reproduce Efficacy TLF from pilot1. by @DeclanHodges in #63
removed arsenal and simplified comment code. by @laxamanaj in #74
Issue #69 by @SHAESEN2 in #75
Closes #77 update renv.lock by @DeclanHodges in #86
updated .xpts against updated spces and added DAYS as correct unit for ADURU. by @laxamanaj in #84
Updates to spec file 'Variables tab, Format column, ADTTE Dataset rows for SAS-compatible xportr_write in adtte.R by @robertdevine in #90
Close #78 LOCF #87 adsl format discrepancy by @kaz462 in #91
regenerate output for demographic by @wangben718 in #65
Analysis output km-plot pilot3 context updates, tidying by @robertdevine in #76
Closes #88 and #94: Replaced deprecated admiral functions in ADSL code by @DeclanHodges in #93
82 adlbc derivations by @nicolekjones in #92
Closes #98: align SAS rounding and update the calculation for ADSL.DURDIS by @kaz462 in #99
10 update define by @laxamanaj in #97
updated define per new excel specs. by @laxamanaj in #102
95 lockfile r v4.2.3 by @laxamanaj in #105
Closes 103: add SDTM p21 report by @kaz462 in #106
107 pilot3 package install by @laxamanaj in #108
Uploaded wiki pdf by @SHAESEN2 in #114
Closes #116: update path by @kaz462 in #117
Website fixes by @bms63 in #118
feat: new ADaM vignettes. reworked readme. by @bms63 in #119
feat: cover letter and adrg, hid code from tlfs by @bms63 in #120
fix: adam locs by @bms63 in #121
Website fixes by @bms63 in #122
chore: troubleshooting website by @bms63 in #123
Website fixes by @bms63 in #124
fix: header by @bms63 in #125
Closes #127: replace round_sas by round_half_up by @kaz462 in #128
fix: remove envsetup from files. new paths. record pilot3 by @bms63 in #129
59 report tlf by @laxamanaj in #110
Add Pilot3 Website Home Page Latest News Section by @robertdevine in #131
Revert to the lock file from the Pilot3 website publication. by @robertdevine in #132
Closes #135 Feedback from January 2024 Meeting by @bms63 in #136
Conflation of Pilot3 Issues #95, #135, #137, #138, and #139 per the discussion in the Issue #135 PR thread by @robertdevine in #140
Pilot3 website - (i)fix typo and (ii)tidying OL/UL in the What's on t… by @robertdevine in #143
Add website link to the February 2, 2024 R Consortium WG Meeting Minu… by @robertdevine in #147