From 68fc1b2e0ce676d8ba358da6c07b5bcb5c790c01 Mon Sep 17 00:00:00 2001 From: Joel Laxamana Date: Sat, 2 Nov 2024 00:17:52 +0000 Subject: [PATCH] including presetnation to fda quarterly meeting on home page --- docs/index.html | 13 +++++++++++- docs/minutes.html | 4 ++++ ... Power of Metadata - OSDocuMetaWG.pptx.pdf | Bin 0 -> 1661520 bytes .../PHUSE_OSDocuMeta_WG_mission_statement.pdf | Bin 0 -> 80896 bytes docs/search.json | 20 +++++++++++++++--- index.qmd | 13 ++++++++++-- minutes.qmd | 10 ++++++--- ... Power of Metadata - OSDocuMetaWG.pptx.pdf | Bin 0 -> 1661520 bytes 8 files changed, 51 insertions(+), 9 deletions(-) create mode 100644 docs/references/Final - Enhancing Clinical Trials FDA Submission Documentation through the Power of Metadata - OSDocuMetaWG.pptx.pdf create mode 100644 docs/references/PHUSE_OSDocuMeta_WG_mission_statement.pdf create mode 100644 references/Final - Enhancing Clinical Trials FDA Submission Documentation through the Power of Metadata - OSDocuMetaWG.pptx.pdf diff --git a/docs/index.html b/docs/index.html index 07f9ba9..77cfe44 100644 --- a/docs/index.html +++ b/docs/index.html @@ -124,6 +124,8 @@

On this page

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On this page

Welcome to the PHUSE Open-Source Metadata Documentation Working Group Site

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Link to PHUSE Working Group Proposal, here.

Background

Historically, the use of proprietary statistical programming languages entailed the inclusion of general statements within the Statistical Analysis Plan (SAP) regarding the software and version employed for generating analyses. However, with the increasing adoption of open-source statistical programming languages, there is a necessity to provide detailed metadata for each package used, as a general statement is no longer adequate.

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Background

Mission

This project aims to develop a new template, or enhance an existing one such as the Study Data Standardization Plan (SDSP) or Analysis Data Reviewer’s Guide (ADRG), to ensure that metadata pertaining to the versions of statistical packages and procedures is consistently documented in alignment with health authority expectations. This standardized template will streamline the submission of clinical study metadata to health authorities as part of the regulatory review process.

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Proposal

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PHUSE Working Group Request

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Presentation

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PHUSE/FDA Quarterly meeting presentation. Presented on 16OCT2024.

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Github

diff --git a/docs/minutes.html b/docs/minutes.html index afbedcd..c39464b 100644 --- a/docs/minutes.html +++ b/docs/minutes.html @@ -255,6 +255,10 @@

16Oct2024

Agenda:

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  1. Announcement :

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    • Presented at PHUSE/FDA Quarterly meeting today. See ‘Home’ page for presentation slides.
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  2. Feedback from team on ADRG Template Updates and Process - PHUSE/FDA Quarterly meeting presentation.