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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.
      • +

  2. Feedback from team on ADRG Template Updates and Process - PHUSE/FDA Quarterly meeting presentation.

    • Pre-recording

      • diff --git a/docs/references/Final - Enhancing Clinical Trials FDA Submission Documentation through the Power of Metadata - OSDocuMetaWG.pptx.pdf b/docs/references/Final - Enhancing Clinical Trials FDA Submission Documentation through the Power of Metadata - OSDocuMetaWG.pptx.pdf new file mode 100644 index 0000000..562a1c8 Binary files /dev/null and b/docs/references/Final - Enhancing Clinical Trials FDA Submission Documentation through the Power of Metadata - OSDocuMetaWG.pptx.pdf differ diff --git a/docs/references/PHUSE_OSDocuMeta_WG_mission_statement.pdf b/docs/references/PHUSE_OSDocuMeta_WG_mission_statement.pdf new file mode 100644 index 0000000..515f0ac Binary files /dev/null and b/docs/references/PHUSE_OSDocuMeta_WG_mission_statement.pdf differ diff --git a/docs/search.json b/docs/search.json index c55a501..31e6426 100644 --- a/docs/search.json +++ b/docs/search.json @@ -25,7 +25,7 @@ "href": "index.html", "title": "Welcome to the PHUSE Open-Source Metadata Documentation Working Group Site", "section": "", - "text": "Link to PHUSE Working Group Proposal, here.\n\n\nHistorically, 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.\n\n\n\nThis 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.\nGithub" + "text": "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.\n\n\n\nThis 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.\n\n\n\nPHUSE Working Group Request\n\n\n\n\nPHUSE/FDA Quarterly meeting presentation. Presented on 16OCT2024.\n\nGithub" }, { "objectID": "index.html#background", @@ -39,7 +39,7 @@ "href": "index.html#mission", "title": "Welcome to the PHUSE Open-Source Metadata Documentation Working Group Site", "section": "", - "text": "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.\nGithub" + "text": "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." }, { "objectID": "aboutus.html", @@ -95,7 +95,7 @@ "href": "minutes.html#oct2024", "title": "Minutes", "section": "16Oct2024", - "text": "16Oct2024\n\nAttendees: Lovemore Gakava, Nicholas Masel, Steven Haesendonckx, Joel Laxamana\nFacilitator: Joel Laxamana\n\nAgenda:\n\nFeedback from team on ADRG Template Updates and Process - PHUSE/FDA Quarterly meeting presentation.\n\nPre-recording\nSlides\n\nCoordination and Feedback from Key Stakeholders\nFuture Meetings and Next Steps\n\n\n\nDiscussion Points:\n\nFeedback on ADRG Template Updates and Process:\n\nFeedback from Team Members:\n\nPresentation went well.\nThe team is awaiting feedback from a key colleague from Pfizer, Christine Rossin who has a stake in updating the ADRG.\nThe necessity of ensuring the ADRG updates align with the expectations of stakeholders. For our first delivery do we want to include everything we mentioned in our slides or piece-meal our work and deliver in iterative approaches with timelines for each milestone?\n\nExternal Feedback:\n\nPlan to check in with Mike Stackhouse to get his input after he reviews the meeting recording.\nNeed to get insights from an FDA contact (Nick’s mention) if they were on this morning’s PHUSE/FDA Quarterly call.\n\n\nCoordination and Feedback from Key Stakeholders:\n\nDavid Epstein’s Role:\n\nDavid Epstein, involved with ADRG template work in the past, might provide valuable input and help engage more contributors.\nCommunication with David planned post-meeting to gather and facilitate feedback, potentially via GitHub or alternative platforms for those without GitHub accounts.\n\nFuture Communications:\n\nFollow-up emails post-meeting to ensure any unanswered questions are collected and addressed.\nNick will check for additional FDA members interested in the ADRG updates during the upcoming PHUSE meeting.\n\nEnhancements and Tools:\n\nDiscussed creating a tool and an R package to bring in metadata effectively.\nImportance of standardizing the ADRG template for future open-source submissions to drive consistency and efficiency in the industry.\n\n\nFuture Meetings and Next Steps:\n\nInternal Coordination:\n\nPlan to migrate ADRG quarto markdown file to the PHUSE git area to continue work on this.\nTesting the reproduction of the ADRG with metadata approaches. See List of other Metadata Opportunities slide in presentation.\n\nTimeline and Deliverables:\n\nAim to schedule the next working group kickoff by mid-November.\nAssignments on updating ADRG to be determined.\nEmphasis on clear planning and setting deliverable dates.\n\nCommunication Plans:\n\nRegular updates and feedback sessions to ensure all members are aligned.\nInitiatives to include new members from upcoming meetings and engagements.\n\n\n\nAction Items:\n\nFollow-Up with Key Contacts:\n\nNicholas to follow up with Mike Stackhouse as well as others in the PHUSE meeting this coming Friday, 18Oct2024, regarding any further feedback or points to consider before we begin work.\nJoel to contact David Epstein regarding additional member engagement and feedback collection methods from the audience in the FDA quarterly meeting this morning.\n\nPrepare for Next Meetings:\n\nJoel to prepare the ADRG markdown file for migration and further testing.\nSchedule next working group meeting in November 2025 and ensure clear objectives and tasks are assigned.\n\n\n——– copy below and paste above, then update accordingly ———" + "text": "16Oct2024\n\nAttendees: Lovemore Gakava, Nicholas Masel, Steven Haesendonckx, Joel Laxamana\nFacilitator: Joel Laxamana\n\nAgenda:\n\nAnnouncement :\n\nPresented at PHUSE/FDA Quarterly meeting today. See ‘Home’ page for presentation slides.\n\nFeedback from team on ADRG Template Updates and Process - PHUSE/FDA Quarterly meeting presentation.\n\nPre-recording\nSlides\n\nCoordination and Feedback from Key Stakeholders\nFuture Meetings and Next Steps\n\n\n\nDiscussion Points:\n\nFeedback on ADRG Template Updates and Process:\n\nFeedback from Team Members:\n\nPresentation went well.\nThe team is awaiting feedback from a key colleague from Pfizer, Christine Rossin who has a stake in updating the ADRG.\nThe necessity of ensuring the ADRG updates align with the expectations of stakeholders. For our first delivery do we want to include everything we mentioned in our slides or piece-meal our work and deliver in iterative approaches with timelines for each milestone?\n\nExternal Feedback:\n\nPlan to check in with Mike Stackhouse to get his input after he reviews the meeting recording.\nNeed to get insights from an FDA contact (Nick’s mention) if they were on this morning’s PHUSE/FDA Quarterly call.\n\n\nCoordination and Feedback from Key Stakeholders:\n\nDavid Epstein’s Role:\n\nDavid Epstein, involved with ADRG template work in the past, might provide valuable input and help engage more contributors.\nCommunication with David planned post-meeting to gather and facilitate feedback, potentially via GitHub or alternative platforms for those without GitHub accounts.\n\nFuture Communications:\n\nFollow-up emails post-meeting to ensure any unanswered questions are collected and addressed.\nNick will check for additional FDA members interested in the ADRG updates during the upcoming PHUSE meeting.\n\nEnhancements and Tools:\n\nDiscussed creating a tool and an R package to bring in metadata effectively.\nImportance of standardizing the ADRG template for future open-source submissions to drive consistency and efficiency in the industry.\n\n\nFuture Meetings and Next Steps:\n\nInternal Coordination:\n\nPlan to migrate ADRG quarto markdown file to the PHUSE git area to continue work on this.\nTesting the reproduction of the ADRG with metadata approaches. See List of other Metadata Opportunities slide in presentation.\n\nTimeline and Deliverables:\n\nAim to schedule the next working group kickoff by mid-November.\nAssignments on updating ADRG to be determined.\nEmphasis on clear planning and setting deliverable dates.\n\nCommunication Plans:\n\nRegular updates and feedback sessions to ensure all members are aligned.\nInitiatives to include new members from upcoming meetings and engagements.\n\n\n\nAction Items:\n\nFollow-Up with Key Contacts:\n\nNicholas to follow up with Mike Stackhouse as well as others in the PHUSE meeting this coming Friday, 18Oct2024, regarding any further feedback or points to consider before we begin work.\nJoel to contact David Epstein regarding additional member engagement and feedback collection methods from the audience in the FDA quarterly meeting this morning.\n\nPrepare for Next Meetings:\n\nJoel to prepare the ADRG markdown file for migration and further testing.\nSchedule next working group meeting in November 2025 and ensure clear objectives and tasks are assigned.\n\n\n——– copy below and paste above, then update accordingly ———" }, { "objectID": "minutes.html#ddmmmyyyy", @@ -103,5 +103,19 @@ "title": "Minutes", "section": "ddmmmyyyy", "text": "ddmmmyyyy\n\nAgenda :\n\nitem 1\nitem 2\netc…\n\n\n\nActions/Issues & Timelines :\n\naction/issue 1 & planned due date\naction/issue 2 & planned due date\netc…\n\n\n\nOther Notes or Actions :\n\nadd any other business here\netc…" + }, + { + "objectID": "index.html#proposal", + "href": "index.html#proposal", + "title": "Welcome to the PHUSE Open-Source Metadata Documentation Working Group Site", + "section": "", + "text": "PHUSE Working Group Request" + }, + { + "objectID": "index.html#presentation", + "href": "index.html#presentation", + "title": "Welcome to the PHUSE Open-Source Metadata Documentation Working Group Site", + "section": "", + "text": "PHUSE/FDA Quarterly meeting presentation. Presented on 16OCT2024.\n\nGithub" } ] \ No newline at end of file diff --git a/index.qmd b/index.qmd index 099451c..c168d49 100644 --- a/index.qmd +++ b/index.qmd @@ -4,8 +4,6 @@ title: "" # **Welcome to the PHUSE Open-Source Metadata Documentation Working Group Site** -Link to PHUSE Working Group Proposal, [here](https://github.com/phuse-org/OSDocuMeta/blob/main/references/PHUSE_OSDocuMeta_WG_mission_statement.pdf). - ## 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. @@ -14,6 +12,17 @@ Historically, the use of proprietary statistical programming languages entailed 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. +## Proposal + +PHUSE Working Group Request + +![](/references/PHUSE_OSDocuMeta_WG_mission_statement.pdf){width=100% height=1000px} + +## Presentation +PHUSE/FDA Quarterly meeting presentation. Presented on 16OCT2024. + +![](/references/Final - Enhancing Clinical Trials FDA Submission Documentation through the Power of Metadata - OSDocuMetaWG.pptx.pdf){width=100% height=1000px} + [Github](https://phuse-org.github.io/OSDocuMeta/) ## diff --git a/minutes.qmd b/minutes.qmd index 19d4a56..219d176 100644 --- a/minutes.qmd +++ b/minutes.qmd @@ -94,15 +94,19 @@ Hope this time works for you. If not, please let me know. First action is to cre #### **Agenda:** -1. Feedback from team on ADRG Template Updates and Process - PHUSE/FDA Quarterly meeting presentation. +1. Announcement : + + - Presented at PHUSE/FDA Quarterly meeting today. See 'Home' page for presentation slides. + +2. Feedback from team on ADRG Template Updates and Process - PHUSE/FDA Quarterly meeting presentation. - [Pre-recording](https://drive.google.com/file/d/1C3DNZaGuEiQYqKlocLPuNDgUoOVAGbpI/view?usp=drive_link) - [Slides](https://docs.google.com/presentation/d/102NiwqffXKVK5v83kc--MMdEnYsDIZJ4/edit?usp=drive_link&ouid=103991081896680964420&rtpof=true&sd=true) -2. Coordination and Feedback from Key Stakeholders +3. Coordination and Feedback from Key Stakeholders -3. Future Meetings and Next Steps +4. Future Meetings and Next Steps #### **Discussion Points:** diff --git a/references/Final - Enhancing Clinical Trials FDA Submission Documentation through the Power of Metadata - OSDocuMetaWG.pptx.pdf b/references/Final - Enhancing Clinical Trials FDA Submission Documentation through the Power of Metadata - OSDocuMetaWG.pptx.pdf new file mode 100644 index 0000000..562a1c8 Binary files /dev/null and b/references/Final - Enhancing Clinical Trials FDA Submission Documentation through the Power of Metadata - OSDocuMetaWG.pptx.pdf differ