From 81d8d6ec61e040ecf6b215d48cad66d849de10d1 Mon Sep 17 00:00:00 2001 From: Joel Laxamana <95468392+laxamanaj@users.noreply.github.com> Date: Thu, 16 May 2024 09:49:28 -0700 Subject: [PATCH] Updated timelines for pilot 3 resubmission (#111) --- pilot3.qmd | 79 ++++++++++++++++++++++++++++-------------------------- 1 file changed, 41 insertions(+), 38 deletions(-) diff --git a/pilot3.qmd b/pilot3.qmd index daaeaf0..0e5b8b2 100644 --- a/pilot3.qmd +++ b/pilot3.qmd @@ -4,61 +4,64 @@ title: "R Submission Pilot 3" **Goals**: -- Expand on the work done in [Submission Pilot 1](pilot1.qmd), by now utilizing R to generate ADaM datasets. -- Deliver a publicly accessible R-based Submission to the FDA +- Expand on the work done in [Submission Pilot 1](pilot1.qmd), by now utilizing R to generate ADaM datasets. +- Deliver a publicly accessible R-based Submission to the FDA +**Key evaluation aspects**: -**Key evaluation aspects**: - -- For Submitter - - Generation of a reproducible R environment with a proprietary R package from git and open source R packages using `{renv}` - - Preparation of R-based submission materials -- For FDA Staff - - Reproduce analysis results by reproducing the R environment and retrieving both proprietary & open source packages +- For Submitter + - Generation of a reproducible R environment with a proprietary R package from git and open source R packages using `{renv}` + - Preparation of R-based submission materials +- For FDA Staff + - Reproduce analysis results by reproducing the R environment and retrieving both proprietary & open source packages -**Timeline**: Submitted to FDA on August 28th, 2023 +**Timeline**: + +- Submitted to FDA on August 28th, 2023 +- Feedback from FDA on February 2nd, 2024 (See feedback [here](https://rconsortium.github.io/submissions-wg/minutes/2024-02-02/)) +- Re-submitted to FDA on April 19th, 2024 **Data and analysis scope**: - -- ADaMs created using R (SDTM `.xpt` sourced from the CDISC Pilot study) -- TLFs created using R (ADaMs `.xpt` sourced from the ADaMs generated in R by the Pilot 3 team) + +- ADaMs created using R (SDTM `.xpt` sourced from the CDISC Pilot study) +- TLFs created using R (ADaMs `.xpt` sourced from the ADaMs generated in R by the Pilot 3 team) **Links**: [R Submission Pilot 3 Development Repo](https://github.com/RConsortium/submissions-pilot3-adam) -- Development area for Pilot 3 Team -- See Closed Issues discussion for how we worked -- See [Wiki](https://github.com/RConsortium/submissions-pilot3-adam/wiki) for Common Issues we ran into and QC Findings we encountered when comparing the ADaMs generated in the CDISC Pilot study. -- We made use of a [GitHub Project Board](https://docs.github.com/en/issues/planning-and-tracking-with-projects/learning-about-projects/about-projects) (Kanban Style Board) to drive development. +- Development area for Pilot 3 Team +- See Closed Issues discussion for how we worked +- See [Wiki](https://github.com/RConsortium/submissions-pilot3-adam/wiki) for Common Issues we ran into and QC Findings we encountered when comparing the ADaMs generated in the CDISC Pilot study. +- We made use of a [GitHub Project Board](https://docs.github.com/en/issues/planning-and-tracking-with-projects/learning-about-projects/about-projects) (Kanban Style Board) to drive development. [R Submission Pilot 3 eCTD Submission Package to FDA](https://github.com/RConsortium/submissions-pilot3-adam-to-fda) -- Materials submitted to the FDA following eCTD standards +- Materials submitted to the FDA following eCTD standards [R Submission Pilot 3 Website](https://rconsortium.github.io/submissions-pilot3-adam/main/) -- Breakdown of the Github repositories and files used for analysis development, e-submission and proprietary Pilot 3 R Package -- Renderings of ADaMs, TLFs, ADRG and Cover Letter -- Discussions at Conferences and feedback from FDA +- Breakdown of the Github repositories and files used for analysis development, e-submission and proprietary Pilot 3 R Package +- Renderings of ADaMs, TLFs, ADRG and Cover Letter +- Discussions at Conferences and feedback from FDA -**Key team members**: +**Key team members**: Developer team: -- Joel Laxamana-Roche -- Thomas Neitmann-Denali -- Phanikumar Tata-Syneos -- Robert Devine-J&J -- Steven Haesendonckx-J&J -- Lei Zhao-Roche -- Nicole Jones-Denali -- Kangjie Zhang-Bayer -- Benjamin Straub-GSK -- Declan Hodges-GSK -- Bingjun Wang - Merck - -FDA Staff: - -- Paul Schuette -- Hye Soo Cho \ No newline at end of file +- Joel Laxamana-Roche +- Thomas Neitmann-Denali +- Phanikumar Tata-Syneos +- Robert Devine-J&J +- Steven Haesendonckx-J&J +- Lei Zhao-Roche +- Nicole Jones-Denali +- Kangjie Zhang-Bayer +- Benjamin Straub-GSK +- Declan Hodges-GSK +- Bingjun Wang - Merck + +FDA Staff: + +- Paul Schuette\ +- Hye Soo Cho