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https://r4csr.org/tlf-population.html - 2023-07-09T06:49:03.146Z + 2023-07-29T15:04:50.321Z https://r4csr.org/tlf-baseline.html - 2023-07-09T06:49:03.162Z + 2023-07-29T15:04:50.333Z https://r4csr.org/tlf-efficacy-ancova.html - 2023-07-09T06:49:03.214Z + 2023-07-29T15:04:50.369Z https://r4csr.org/tlf-efficacy-km.html - 2023-07-09T06:49:03.226Z + 2023-07-29T15:04:50.381Z https://r4csr.org/tlf-ae-summary.html - 2023-07-09T06:49:03.258Z + 2023-07-29T15:04:50.405Z https://r4csr.org/tlf-ae-specific.html - 2023-07-09T06:49:03.286Z + 2023-07-29T15:04:50.429Z https://r4csr.org/tlf-assemble.html - 2023-07-09T06:49:03.298Z + 2023-07-29T15:04:50.437Z https://r4csr.org/project-overview.html - 2023-07-09T06:49:03.314Z + 2023-07-29T15:04:50.449Z https://r4csr.org/project-folder.html - 2023-07-09T06:49:03.330Z + 2023-07-29T15:04:50.461Z https://r4csr.org/project-management.html - 2023-07-09T06:49:03.346Z + 2023-07-29T15:04:50.473Z https://r4csr.org/submission-overview.html - 2023-07-09T06:49:03.350Z + 2023-07-29T15:04:50.481Z https://r4csr.org/submission-package.html - 2023-07-09T06:49:03.398Z + 2023-07-29T15:04:50.513Z https://r4csr.org/submission-environment.html - 2023-07-09T06:49:03.414Z + 2023-07-29T15:04:50.525Z https://r4csr.org/references.html - 2023-07-09T06:49:03.422Z + 2023-07-29T15:04:50.533Z https://r4csr.org/R-for-Clinical-Study-Reports-and-Submission.pdf - 2023-07-09T06:49:02.330Z + 2023-07-29T15:04:49.709Z diff --git a/slides/fda-workshop-slides.Rmd b/slides/fda-workshop-slides.Rmd index 0d1aabf..b2d7b1b 100644 --- a/slides/fda-workshop-slides.Rmd +++ b/slides/fda-workshop-slides.Rmd @@ -194,7 +194,7 @@ As an organization, we need to ensure compliance and reduce the risk of using R - R is widely used in visualization - [metalite.table1](https://elong0527.github.io/metalite.table1/articles/metalite-table1.html): Interactive demographic table. - - [forestly](https://elong0527.github.io/forestly/articles/forestly.html): Interactive forest plot for DMC safety monitoring in clinical trials + - [forestly](https://merck.github.io/forestly/articles/forestly.html): Interactive forest plot for DMC safety monitoring in clinical trials ## Philosophy diff --git a/slides/fda-workshop-slides.html b/slides/fda-workshop-slides.html index 59cb019..abda1c2 100644 --- a/slides/fda-workshop-slides.html +++ b/slides/fda-workshop-slides.html @@ -3424,7 +3424,7 @@

diff --git a/slides/r4csr-gwu.Rmd b/slides/r4csr-gwu.Rmd index cb51bec..23cc6fb 100644 --- a/slides/r4csr-gwu.Rmd +++ b/slides/r4csr-gwu.Rmd @@ -59,7 +59,7 @@ As an organization, we need to ensure compliance and reduce the risk of using R - R is widely used in visualization - [SafetyGraphics](https://github.com/SafetyGraphics/safetyGraphics) - - [forestly](https://elong0527.github.io/forestly/articles/forestly.html): [Interactive forest plot for DMC safety monitoring in clinical trials](https://rinpharma.com/publication/rinpharma_206/) + - [forestly](https://merck.github.io/forestly/articles/forestly.html): [Interactive forest plot for DMC safety monitoring in clinical trials](https://rinpharma.com/publication/rinpharma_206/) ## Background @@ -144,7 +144,7 @@ sponsor shall enhance reproducibility. - Fixed R version: e.g., R 4.1.0 - Fixed R package snapshot date: e.g., 2021-08-31 - [Posit Package Manager](https://packagemanager.posit.co/) - - [CRAN Time Machine by MRAN](https://mran.microsoft.com/timemachine) + - CRAN Time Machine by MRAN - Flexibility of input and output path: - Define path as parameter. - eCTD deliverables dry-run in Windows environment diff --git a/slides/r4csr-gwu.html b/slides/r4csr-gwu.html index 0bcf38e..d5de2f3 100644 --- a/slides/r4csr-gwu.html +++ b/slides/r4csr-gwu.html @@ -3802,7 +3802,7 @@

@@ -3904,7 +3904,7 @@

Assumptions

  • Flexibility of input and output path: diff --git a/slides/r4csr-psi.Rmd b/slides/r4csr-psi.Rmd index d1bb0da..33367a7 100644 --- a/slides/r4csr-psi.Rmd +++ b/slides/r4csr-psi.Rmd @@ -133,7 +133,7 @@ As an organization, we need to ensure compliance and reduce the risk of using R - R is widely used in visualization - [metalite.table1](https://elong0527.github.io/metalite.table1/articles/metalite-table1.html): Interactive demographic table. - - [forestly](https://elong0527.github.io/forestly/articles/example.html#construct-interactive-forest-plot-1): [Interactive forest plot for DMC safety monitoring in clinical trials](https://rinpharma.com/publication/rinpharma_206/) + - [forestly](https://merck.github.io/forestly/articles/forestly.html): [Interactive forest plot for DMC safety monitoring in clinical trials](https://rinpharma.com/publication/rinpharma_206/) ## Background @@ -248,7 +248,7 @@ sponsor shall enhance reproducibility. - Fixed R version: e.g., R 4.1.0 - Fixed R package snapshot date: e.g., 2021-08-31 - [Posit Package Manager](https://packagemanager.posit.co/) - - [CRAN Time Machine by MRAN](https://mran.microsoft.com/timemachine) + - CRAN Time Machine by MRAN - Flexibility of input and output path: - Define path as parameter. - eCTD deliverables dry-run in Windows environment diff --git a/slides/r4csr-psi.html b/slides/r4csr-psi.html index d13c513..0af712a 100644 --- a/slides/r4csr-psi.html +++ b/slides/r4csr-psi.html @@ -3337,7 +3337,7 @@

    • @@ -3483,7 +3483,7 @@

    Revised Submission

  • Flexibility of input and output path: diff --git a/slides/r4csr-rstudio.Rmd b/slides/r4csr-rstudio.Rmd index 93da07c..be2fe44 100644 --- a/slides/r4csr-rstudio.Rmd +++ b/slides/r4csr-rstudio.Rmd @@ -135,7 +135,7 @@ As an organization, we need to ensure compliance and reduce the risk of using R - R is widely used in visualization - [SafetyGraphics](https://github.com/SafetyGraphics/safetyGraphics) - - [forestly](https://elong0527.github.io/forestly/articles/example.html#construct-interactive-forest-plot-1): [Interactive forest plot for DMC safety monitoring in clinical trials](https://rinpharma.com/publication/rinpharma_206/) + - [forestly](https://merck.github.io/forestly/articles/forestly.html): [Interactive forest plot for DMC safety monitoring in clinical trials](https://rinpharma.com/publication/rinpharma_206/) ## Background @@ -238,7 +238,7 @@ sponsor shall enhance reproducibility. - Fixed R version: e.g., R 4.1.0 - Fixed R package snapshot date: e.g., 2021-08-31 - [Posit Package Manager](https://packagemanager.posit.co/) - - [CRAN Time Machine by MRAN](https://mran.microsoft.com/timemachine) + - CRAN Time Machine by MRAN - Flexibility of input and output path: - Define path as parameter. - eCTD deliverables dry-run in Windows environment diff --git a/slides/r4csr-rstudio.html b/slides/r4csr-rstudio.html index 36f8855..11a0504 100644 --- a/slides/r4csr-rstudio.html +++ b/slides/r4csr-rstudio.html @@ -3337,7 +3337,7 @@

    • @@ -3467,7 +3467,7 @@

    Revised Submission

  • Flexibility of input and output path: diff --git a/tlf-overview.html b/tlf-overview.html index 851f42a..2312840 100644 --- a/tlf-overview.html +++ b/tlf-overview.html @@ -361,7 +361,7 @@

    1.1 Background

    -

    Submitting clinical trial results to regulatory agencies is a crucial aspect of clinical development. The Electronic Common Technical Document (eCTD) has emerged as the global standard format for regulatory submissions. For instance, the United States Food and Drug Administration (US FDA) mandates the use of eCTD for new drug applications and biologics license applications.

    +

    Submitting clinical trial results to regulatory agencies is a crucial aspect of clinical development. The Electronic Common Technical Document (eCTD) has emerged as the global standard format for regulatory submissions. For instance, the United States Food and Drug Administration (US FDA) mandates the use of eCTD for new drug applications and biologics license applications.

    A CSR provides comprehensive information about the methods and results of an individual clinical study. To support the statistical analysis, numerous tables, listings, and figures are included within the main text and appendices. As part of the CDISC pilot project, an example CSR is also available for reference. If you seek additional examples of CSR, you can visit the clinical data website of the European Medicines Agency (EMA) clinical data website.

    The creation of CSR is a collaborative effort that involves various professionals such as clinicians, medical writers, statisticians, statistical programmers. In this context, we will focus on the specific deliverables provided by statisticians and statistical programmers.

    Within an organization, these professionals typically collaborate to define, develop, validate, and deliver the necessary tables, listings, and figures (TLFs) for a CSR. These TLFs serve to summarize the efficacy and/or safety of the pharmaceutical product under study. In the pharmaceutical industry, Microsoft Word is widely utilized for CSR preparation. As a result, the deliverables from statisticians and statistical programmers are commonly provided in formats such as .rtf, .doc, .docx to align with industry standards and requirements.

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    • metalite.table1: Interactive demographic table.
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