Add art and reg_accept QMD

_quarto.yml

@@ -25,6 +25,8 @@ book:
  - trust.qmd
  - doc_trust.qmd
  - cost.qmd
+ - reg_accept.qmd
+ - art.qmd
  - references.qmd
 
 bibliography: references.bib

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

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