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_pkgdown.yml
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url: https://rconsortium.github.io/submissions-pilot3-adam
template:
bootstrap: 5
params:
bootswatch: flatly
search:
exclude: ["news/index.html"]
news:
cran_dates: true
navbar:
structure:
left: [project, articles, conferences, feedback]
right: [slack, github]
components:
slack:
icon: fa-slack
href: https://pharmaverse.slack.com/archives/C030EB2M4GM
aria-label: slack
github:
icon: fa-github
href: https://github.com/RConsortium/submissions-pilot3-adam
aria-label: github
project:
text: Project Background/Setup
menu:
- text: Project Background
href: articles/project_background.html
- text: Project Setup
href: articles/project_setup.html
- text: Statistical Software Clarifying Statement
href: articles/statistical-software-clarifying-statement.html
articles:
text: Deliverables
menu:
- text: -------
- text: "Cover Letter"
href: articles/cover-letter.html
- text: -------
- text: "Displays"
- text: Summary of Demographic and Baseline Characteristics
href: articles/tlf-demographic.html
- text: Efficacy Tables
href: articles/tlf-efficacy.html
- text: Kaplan-Meier Plot for Time to First Dermatologic Event
href: articles/tlf-kmplot.html
- text: ADAS Cog Change from Baseline to Week 24 - LOCF
href: articles/tlf-primary.html
- text: -------
- text: "Datasets and ADRG"
- text: ADSL - Subject Level Analysis
href: articles/adam-adsl.html
- text: ADAE - Adverse Event Analysis
href: articles/adam-adae.html
- text: ADLBC - Laboratory Results Chemistry Analysis
href: articles/adam-adlbc.html
- text: ADTTE - AE Time to 1st Derm. Event Analysis
href: articles/adam-adtte.html
- text: ADADAS - ADS-COG Analysis
href: articles/adam-adadas.html
- text: ADRG - Analysis Data Reviewers Guide
href: articles/adrg_website.html
conferences:
text: Conferences
menu:
- text: PHUSE SDE London
href: articles/conf_phuse_sde_london.html
- text: PHARMA SUG Baltimore
href: articles/conf_pharma_sug_baltimore.html
feedback:
text: WG Minutes and Regulatory Feedback
menu:
- text: -------
- text: "R Consortium WG Meeting Minutes"
- text: August 2024
href: https://rconsortium.github.io/submissions-wg/minutes/2024-08-02/
- text: June 2024
href: https://rconsortium.github.io/submissions-wg/minutes/2024-06-07/
- text: May 2024
href: https://rconsortium.github.io/submissions-wg/minutes/2024-05-03/
- text: April 2024
href: https://rconsortium.github.io/submissions-wg/minutes/2024-04-05/Index.html
- text: March 2024
href: https://rconsortium.github.io/submissions-wg/minutes/2024-03-01/
- text: February 2024
href: https://rconsortium.github.io/submissions-wg/minutes/2024-02-02/
- text: January 2024
href: https://rconsortium.github.io/submissions-wg/minutes/2024-01-05/
- text: December 2023
href: https://rconsortium.github.io/submissions-wg/minutes/2023-12-01/
- text: November 2023
href: https://rconsortium.github.io/submissions-wg/minutes/2023-11-03/
- text: October 2023
href: https://rconsortium.github.io/submissions-wg/minutes/2023-10-06/
- text: -------
- text: "Pilot 3 Submission Issues Compilation"
- text: January 2024 FDA Feedback Summary
href: articles/feedback_jan2024.html
- text: -------
- text: "Pilot 3 Successfully Reviewed by FDA CDER"
- text: FDA Response Letter
href: https://github.com/RConsortium/submissions-wg/blob/main/_Documents/Summary_R_Pilot3_Submission.pdf
- text: Pilot 3 Successfully Reviewed by FDA
href: https://www.r-consortium.org/blog/2024/08/26/news-from-r-submissions-working-group-pilot-3-successfully-reviewed-by-fda