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Quarto GHA Workflow Runner committed Jul 29, 2023
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2 changes: 1 addition & 1 deletion .nojekyll
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2 changes: 1 addition & 1 deletion slides/fda-workshop-slides.Rmd
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Expand Up @@ -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

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<ul>
<li><a href='https://elong0527.github.io/metalite.table1/articles/metalite-table1.html' title=''>metalite.table1</a>: Interactive demographic table.</li>
<li><a href='https://elong0527.github.io/forestly/articles/forestly.html' title=''>forestly</a>: Interactive forest plot for DMC safety monitoring in clinical trials</li>
<li><a href='https://merck.github.io/forestly/articles/forestly.html' title=''>forestly</a>: Interactive forest plot for DMC safety monitoring in clinical trials</li>
</ul></li>
</ul>

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4 changes: 2 additions & 2 deletions slides/r4csr-gwu.Rmd
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Expand Up @@ -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

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- 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
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Expand Up @@ -3802,7 +3802,7 @@ <h2 data-config-subtitle><!-- populated from slide_config.json --></h2>

<ul>
<li><a href='https://github.com/SafetyGraphics/safetyGraphics' title=''>SafetyGraphics</a></li>
<li><a href='https://elong0527.github.io/forestly/articles/forestly.html' title=''>forestly</a>: <a href='https://rinpharma.com/publication/rinpharma_206/' title=''>Interactive forest plot for DMC safety monitoring in clinical trials</a></li>
<li><a href='https://merck.github.io/forestly/articles/forestly.html' title=''>forestly</a>: <a href='https://rinpharma.com/publication/rinpharma_206/' title=''>Interactive forest plot for DMC safety monitoring in clinical trials</a></li>
</ul></li>
</ul>

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<ul>
<li><a href='https://packagemanager.posit.co/' title=''>Posit Package Manager</a></li>
<li><a href='https://mran.microsoft.com/timemachine' title=''>CRAN Time Machine by MRAN</a></li>
<li>CRAN Time Machine by MRAN</li>
</ul></li>
<li>Flexibility of input and output path:

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4 changes: 2 additions & 2 deletions slides/r4csr-psi.Rmd
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Expand Up @@ -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

Expand Down Expand Up @@ -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
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<ul>
<li><a href='https://elong0527.github.io/metalite.table1/articles/metalite-table1.html' title=''>metalite.table1</a>: Interactive demographic table.</li>
<li><a href='https://elong0527.github.io/forestly/articles/example.html#construct-interactive-forest-plot-1' title=''>forestly</a>: <a href='https://rinpharma.com/publication/rinpharma_206/' title=''>Interactive forest plot for DMC safety monitoring in clinical trials</a></li>
<li><a href='https://merck.github.io/forestly/articles/forestly.html' title=''>forestly</a>: <a href='https://rinpharma.com/publication/rinpharma_206/' title=''>Interactive forest plot for DMC safety monitoring in clinical trials</a></li>
</ul></li>
</ul>

Expand Down Expand Up @@ -3483,7 +3483,7 @@ <h3>Revised Submission</h3>

<ul>
<li><a href='https://packagemanager.posit.co/' title=''>Posit Package Manager</a></li>
<li><a href='https://mran.microsoft.com/timemachine' title=''>CRAN Time Machine by MRAN</a></li>
<li>CRAN Time Machine by MRAN</li>
</ul></li>
<li>Flexibility of input and output path:

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4 changes: 2 additions & 2 deletions slides/r4csr-rstudio.Rmd
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Expand Up @@ -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

Expand Down Expand Up @@ -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
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Expand Up @@ -3337,7 +3337,7 @@ <h2 data-config-subtitle><!-- populated from slide_config.json --></h2>

<ul>
<li><a href='https://github.com/SafetyGraphics/safetyGraphics' title=''>SafetyGraphics</a></li>
<li><a href='https://elong0527.github.io/forestly/articles/example.html#construct-interactive-forest-plot-1' title=''>forestly</a>: <a href='https://rinpharma.com/publication/rinpharma_206/' title=''>Interactive forest plot for DMC safety monitoring in clinical trials</a></li>
<li><a href='https://merck.github.io/forestly/articles/forestly.html' title=''>forestly</a>: <a href='https://rinpharma.com/publication/rinpharma_206/' title=''>Interactive forest plot for DMC safety monitoring in clinical trials</a></li>
</ul></li>
</ul>

Expand Down Expand Up @@ -3467,7 +3467,7 @@ <h3>Revised Submission</h3>

<ul>
<li><a href='https://packagemanager.posit.co/' title=''>Posit Package Manager</a></li>
<li><a href='https://mran.microsoft.com/timemachine' title=''>CRAN Time Machine by MRAN</a></li>
<li>CRAN Time Machine by MRAN</li>
</ul></li>
<li>Flexibility of input and output path:

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Expand Up @@ -361,7 +361,7 @@ <h1 class="title"><span id="tlf-overview" class="quarto-section-identifier"><spa

<section id="background" class="level2" data-number="1.1">
<h2 data-number="1.1" class="anchored" data-anchor-id="background"><span class="header-section-number">1.1</span> Background</h2>
<p>Submitting clinical trial results to regulatory agencies is a crucial aspect of clinical development. The <a href="https://en.wikipedia.org/wiki/Electronic_common_technical_document">Electronic Common Technical Document (eCTD)</a> has emerged as the global standard format for regulatory submissions. For instance, the United States Food and Drug Administration (US FDA) <a href="(https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd)">mandates the use of eCTD</a> for new drug applications and biologics license applications.</p>
<p>Submitting clinical trial results to regulatory agencies is a crucial aspect of clinical development. The <a href="https://en.wikipedia.org/wiki/Electronic_common_technical_document">Electronic Common Technical Document (eCTD)</a> has emerged as the global standard format for regulatory submissions. For instance, the United States Food and Drug Administration (US FDA) <a href="https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd">mandates the use of eCTD</a> for new drug applications and biologics license applications.</p>
<p>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 <a href="https://github.com/cdisc-org/sdtm-adam-pilot-project/blob/master/updated-pilot-submission-package/900172/m5/53-clin-stud-rep/535-rep-effic-safety-stud/5351-stud-rep-contr/cdiscpilot01/cdiscpilot01.pdf">example CSR</a> is also available for reference. If you seek additional examples of CSR, you can visit the clinical data website of the <a href="https://clinicaldata.ema.europa.eu/web/cdp/home">European Medicines Agency (EMA) clinical data website</a>.</p>
<p>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.</p>
<p>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 <code>.rtf</code>, <code>.doc</code>, <code>.docx</code> to align with industry standards and requirements.</p>
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