Releases: RConsortium/submissions-pilot3-adam-to-fda
Releases · RConsortium/submissions-pilot3-adam-to-fda
Pilot 3 Re-submission
- Submission to the FDA eCTD portal was done on April 19th, 2024.
- This is a resubmission.
What's Changed
- Closes #38 pilot3utils package zip file by @bms63 in #39
- Closes #40 update pilot3 programs for zip build+run with pilot3utils namespace and library reference by @laxamanaj in #41
- fix: footnote in tlf-efficacy.r by @bms63 in #42
Full Changelog: v1.0.0...v2.0.0
Initial Pilot 3 Submission received
This release takes a snapshot of the current Pilot 3 R-base Submission package 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 and attached it here for convenience.
Pilot 3 Team.
What's Changed
- Closes #6: add sdtm folder by @kaz462 in #7
- 8_restructure_directories@main: Restructued directories. by @DeclanHodges in #9
- 10_update_readme@main: Updated readme with pilot3 info. by @DeclanHodges in #11
- switched to relative path instead of /cloud/project/ by @laxamanaj in #14
- Update README.md to include SDTMs in folder structure by @laxamanaj in #16
- Copy script update to include defines, specs and renv.lock by @DeclanHodges in #18
- Updated directory tree in README by @DeclanHodges in #20
- Changed batch_copy script and renv.lock location to project directory by @DeclanHodges in #22
- Change directory structure to align with eCTD expectations by @DeclanHodges in #24
- Changed renv.lock to .txt in batch copy script by @DeclanHodges in #27
- Update README.md by @laxamanaj in #29
- Add PDF with Pilot3 Report TLFs. by @robertdevine in #31
- final cover letter and analysis results by @laxamanaj in #33
- docs: #30 entry for batch_copy file by @bms63 in #34
New Contributors
- @kaz462 made their first contribution in #7
- @DeclanHodges made their first contribution in #9
- @laxamanaj made their first contribution in #14
- @robertdevine made their first contribution in #31
- @bms63 made their first contribution in #34
Full Changelog: https://github.com/RConsortium/submissions-pilot3-adam-to-fda/commits/v1.0.0