From ae1b87fe14e81db17e175e429767fd7bcad85171 Mon Sep 17 00:00:00 2001
From: MichaelRimler <michael.rimler@gmail.com>
Date: Thu, 30 Nov 2023 13:14:53 +0000
Subject: [PATCH] Add art and reg_accept QMD

---
 _quarto.yml    |  2 ++
 art.qmd        | 24 ++++++++++++++++++++++++
 reg_accept.qmd | 27 +++++++++++++++++++++++++++
 3 files changed, 53 insertions(+)
 create mode 100644 art.qmd
 create mode 100644 reg_accept.qmd

diff --git a/_quarto.yml b/_quarto.yml
index 22b97b5..20188a4 100644
--- a/_quarto.yml
+++ b/_quarto.yml
@@ -25,6 +25,8 @@ book:
     - trust.qmd
     - doc_trust.qmd
     - cost.qmd
+    - reg_accept.qmd
+    - art.qmd
     - references.qmd
 
 bibliography: references.bib
diff --git a/art.qmd b/art.qmd
new file mode 100644
index 0000000..78b86f9
--- /dev/null
+++ b/art.qmd
@@ -0,0 +1,24 @@
+---
+title: "GxP Compliance"
+---
+
+## How do you establish reproducibility and traceability?
+
+GxP compliance means establishing accuracy, reproducibility, and traceability. When working with open source solutions to process and analyze clinical trial data:
+
+-   How do we establish reproducibility of the outputs?
+
+-   How do we establish traceability of the input through to the output?
+
+## How to Contribute
+
+Contribute to the discussion here in GitHub Discussions:\
+[How do you establish reproducibility and traceability with open source solutions?](https://github.com/phuse-org/OSTCDA/discussions/8)
+
+## Guidance
+
+-   Provide your thoughts and perspectives
+
+-   Provide references to articles, webinars, presentations (citations, links)
+
+-   Be respectful in this community
diff --git a/reg_accept.qmd b/reg_accept.qmd
new file mode 100644
index 0000000..8fa6d55
--- /dev/null
+++ b/reg_accept.qmd
@@ -0,0 +1,27 @@
+---
+title: "Regulatory Acceptance"
+---
+
+## Will the regulatory agencies accept data and analyses generated with solutions developed and available as open source?
+
+-   What do we know regarding data submissions to FDA?
+
+-   What do we know regarding data submissions to other regulatory agencies?
+
+-   Are there technical considerations for the creation of submission data packages?
+
+## How to Contribute
+
+Contribute to the discussion here in GitHub Discussions:
+
+1.  [Will the **FDA** accept data and analyses generated with solutions developed and available as open source?](https://github.com/phuse-org/OSTCDA/discussions/6)
+
+2.  [Will **other regulatory agencies** accept data and analyses generated with solutions developed and available as open source?](https://github.com/phuse-org/OSTCDA/discussions/7)
+
+## Guidance
+
+-   Provide your thoughts and perspectives
+
+-   Provide references to articles, webinars, presentations (citations, links)
+
+-   Be respectful in this community