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Meeting minutes for 20241212.
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Expand Down Expand Up @@ -150,12 +150,12 @@ <h2 class="anchored" data-anchor-id="mission">Mission</h2>
<section id="proposal" class="level2">
<h2 class="anchored" data-anchor-id="proposal">Proposal</h2>
<p>PHUSE Working Group Request</p>
<p><embed src="./references/PHUSE_OSDocuMeta_WG_mission_statement.pdf" style="width:100.0%" height="1000"></p>
<p><embed src=".\references/PHUSE_OSDocuMeta_WG_mission_statement.pdf" style="width:100.0%" height="1000"></p>
</section>
<section id="presentation" class="level2">
<h2 class="anchored" data-anchor-id="presentation">Presentation</h2>
<p>PHUSE/FDA Quarterly meeting presentation. Presented on 16OCT2024.</p>
<p><embed src="./references/Final - Enhancing Clinical Trials FDA Submission Documentation through the Power of Metadata - OSDocuMetaWG.pptx.pdf" style="width:100.0%" height="1000"></p>
<p><embed src=".\references/Final - Enhancing Clinical Trials FDA Submission Documentation through the Power of Metadata - OSDocuMetaWG.pptx.pdf" style="width:100.0%" height="1000"></p>
<p><a href="https://phuse-org.github.io/OSDocuMeta/">Github</a></p>
</section>
<section id="section" class="level2">
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Expand Down Expand Up @@ -125,6 +125,7 @@ <h2 id="toc-title">On this page</h2>
<li><a href="#oct2024" id="toc-oct2024" class="nav-link" data-scroll-target="#oct2024">16Oct2024</a></li>
<li><a href="#nov2024" id="toc-nov2024" class="nav-link" data-scroll-target="#nov2024">13Nov2024</a></li>
<li><a href="#nov2024-1" id="toc-nov2024-1" class="nav-link" data-scroll-target="#nov2024-1">27Nov2024</a></li>
<li><a href="#dec2024" id="toc-dec2024" class="nav-link" data-scroll-target="#dec2024">11Dec2024</a></li>
</ul>
<div class="quarto-other-links"><h2>Other Links</h2><ul><li><a href="https://github.com/phuse-org/OSDocuMeta"><i class="bi bi-link-45deg"></i>Github</a></li></ul></div></nav>
</div>
Expand Down Expand Up @@ -512,6 +513,124 @@ <h4 class="anchored" data-anchor-id="thoughts-for-next-steps"><strong>Thoughts f
<li><p>Templatize open-source unpacking/re-executing analysis instructions.</p></li>
<li><p>Contact Alexandra Pearce regarding the PHUSE WG workspace (optional as current way of working may be fine, per Nick M).</p></li>
</ul>
</section>
</section>
<section id="dec2024" class="level2">
<h2 class="anchored" data-anchor-id="dec2024">11Dec2024</h2>
<p><strong>Attendees:</strong> Nicholas Masel, Sam Parmar, Steven Haesendonckx, Cervan Girard, Eric Nantz<br>
<strong>Guest(s):</strong><br>
<strong>Facilitator:</strong> Lovemore Gakava</p>
<section id="agenda-5" class="level4">
<h4 class="anchored" data-anchor-id="agenda-5"><strong>Agenda</strong></h4>
<ul>
<li><p>House Cleaning</p></li>
<li><p>Updates from actions since last meeting</p></li>
<li><p>New Topics</p></li>
<li><p>Actions.</p></li>
</ul>
</section>
<section id="house-cleaning-2" class="level4">
<h4 class="anchored" data-anchor-id="house-cleaning-2"><strong>House Cleaning</strong></h4>
<ul>
<li><p>Welcome Cervan Girard</p></li>
<li><p>Minutes and actions from the last meeting added (follow-up).</p></li>
</ul>
</section>
<section id="updates-since-last-meeting-1" class="level4">
<h4 class="anchored" data-anchor-id="updates-since-last-meeting-1"><strong>Updates since last meeting</strong></h4>
<ul class="task-list">
<li><p><label><input type="checkbox" checked="">Further potential support from other Novo colleagues</label></p>
<ul>
<li>Lovemore to provide colleague’s contact information for joining the WG.</li>
</ul></li>
<li><p><label><input type="checkbox" checked="">Determine how to contribute to automation for new ADRG versions. Needs discussion for supporting hybrid approaches (various languages).</label></p>
<ul>
<li><p>Lovemore (and Sam P.) to get in contact with Christine R. We can still invite Christine to future meetings as needed.</p>
<ul>
<li><p>We need to know what the specific changes we want to see updated in the ADRG for open-source submissions as well as the process for submitting updates.</p></li>
<li><p>We need to know Christine’s preferred method for collaboration.</p></li>
<li><p>We want to understand the submission process for approval of the updated template.</p></li>
<li><p>We also want to know the distribution methods for the approved template for the public to use (e.g.&nbsp;Sponsor, Pinnacle 21, CDISC).</p></li>
</ul></li>
<li><p><em>Status: Lovemore has already emailed Christine, and we’re awaiting her response on how to proceed with the ADRG template review and future collaboration.</em></p></li>
</ul></li>
<li><p><label><input type="checkbox">Identify sections P21 populates and doesn’t populate in the ADRG.</label></p>
<ul>
<li>Joel to review and plan for automation contribution.
<ul>
<li><em>Status - Ongoing. Team is encouraged to review the draft specification by Joel and we can discuss in our next scheduled meeting.</em></li>
</ul></li>
</ul></li>
<li><p><label><input type="checkbox" checked="">Contact Chris Price to find P21 and CDISC core contacts to see if we can get a meeting with them.</label></p>
<ul>
<li><p><em>Nick’s feedback from communications with Chris Price:</em></p>
<p><em>To avoid endorsing proprietary software, Chris recommends not collaborating with Pinnacle 21. Instead, we should develop an open and flexible solution that doesn’t lock sponsors into a specific vendor. Ultimately, we aim to provide a solution that adheres to CDISC core principles while allowing sponsors the freedom to integrate it seamlessly into their existing workflows.</em></p></li>
<li><p><em>Action: To ensure our approach aligns with industry standards, we’ll invite Sam Hume to explain the role of CDISC core. This will help us integrate CDISC standards into our solution effectively.</em></p></li>
</ul></li>
</ul>
</section>
<section id="discussion-topics" class="level4">
<h4 class="anchored" data-anchor-id="discussion-topics"><strong>Discussion Topics</strong></h4>
<ul>
<li><p>Confirm collaboration method with Christine R.</p>
<ul>
<li><em>Status: ongoing</em></li>
</ul></li>
<li><p>Nick to give update on PHUSE/FDA Computational Science Symposium (CSS) potential slot to have a breakout session:</p>
<ul>
<li><p><em>Nick reached out to the organizers and it was agreed that at the moment the breakout session will focus on the use of TEAL: industry adoption and the collaborative unified ecosystem.</em></p></li>
<li><p><em>Action: Discuss with team to decide whether we need a breakout session and if it’s going to be in the EU or US or both session?</em></p></li>
</ul></li>
<li><p>Decide on moving Pilot 3 adrg.qmd (further discussion needed).</p>
<ul>
<li><p><em>Action: create a repository and use pilot3 or pilot 4 ADRG as starting template.</em></p>
<ul>
<li><a href="https://github.com/RConsortium/submissions-pilot4-webR/"><em>https://github.com/RConsortium/submissions-pilot4-webR/</em></a></li>
</ul></li>
</ul></li>
<li><p>Templatize open-source unpacking/re-executing analysis instructions.</p>
<ul>
<li><p><em>Discussions:</em></p>
<ul>
<li><em><strong>OS computing environment:</strong> The idea of having an OS computing environment was discussed but dismissed as not currently viable due to legal and independence concerns for regulatory authorities.</em>
<ul>
<li><em><strong>Accumulus Synergy:</strong> A similar initiative, Accumulus Synergy, was mentioned (Home - Accumulus Synergy). This platform provides a secure way for life sciences organizations and regulatory authorities to exchange information and collaborate.</em></li>
<li><em><strong>Scope:</strong> It was decided that further exploration of these ideas is outside the current scope and can be revisited after the first deliverable.</em></li>
</ul></li>
</ul></li>
<li><p><em>Action: Start on draft of an open-source unpacking/re-executing analysis instructions template. (when?)</em></p></li>
</ul></li>
</ul>
</section>
<section id="action-items-1" class="level4">
<h4 class="anchored" data-anchor-id="action-items-1"><strong>Action Items:</strong></h4>
<ul>
<li><p><strong>PHUSE ADRG Collaboration:</strong> Follow-up with Christine. (<strong>When:</strong> ASAP)</p></li>
<li><p><strong>CSS Breakout Session:</strong></p>
<ul>
<li><p>Decide whether a breakout session is needed.</p></li>
<li><p>If yes, decide whether it will be EU, US, or both.</p></li>
<li><p><strong>Deadline:</strong> Before December 18th meeting.</p></li>
<li><p><strong>Communicate decision to:</strong> Nick.</p></li>
</ul></li>
<li><p><strong>ADRG Development &amp; Review:</strong></p>
<ul>
<li><p><strong>Create a repository:</strong> Use pilot3 or pilot4 ADRG as a starting template.</p></li>
<li><p><strong>Review metadata programming specifications:</strong> Provide feedback on specifications.</p></li>
<li><p><strong>Identify P21 population in ADRG:</strong> Identify sections P21 populates and doesn’t populate.</p></li>
<li><p><strong>Start drafting</strong> a template for open-source unpacking/re-executing analysis instructions.</p></li>
<li><p><strong>Deadline for all the above:</strong> Before December 18th meeting (work can begin immediately).</p></li>
</ul></li>
<li><p><strong>Automation Contribution Strategy:</strong></p>
<ul>
<li><p><strong>Task:</strong> Develop an initial draft of the automation contribution strategy.</p></li>
<li><p><strong>Deadline:</strong> Before December 18th meeting.</p></li>
</ul></li>
</ul>
<p><strong>Future</strong>:</p>
<ul>
<li>To ensure our approach aligns with industry standards, we’ll <strong>invite Sam Hume</strong> to explain the role of CDISC core. This will help us integrate CDISC standards into our solution effectively.</li>
</ul>


</section>
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"title": "Minutes",
"section": "27Nov2024",
"text": "27Nov2024\nAttendees: Lovemore Gakava, Nicholas Masel, Joel Laxamana, Sam Parmar\nGuest(s):Christine Rossin (Guest from PHUSE ADRG WG)\nFacilitator: Joel Laxamana\n\nAgenda\n\nHouse Cleaning\nUpdates from actions since last meeting\nNew Topics\nActions.\n\n\n\nHouse Cleaning\n\nMinutes and actions from the last meeting added (follow-up).\nQ4 reports submitted by Lovemore (link).\nNew members added to the working group’s G-drive.\n\nPHUSE WG does have a dedicated workspace to collaborate and save our Project WG files. Contact Alexandra Pearce (link).\n\n\n\n\nUpdates since last meeting\n\nFDA guidance on mandatory ADRG sections shared by Sam (details provided by Sam below).\n\nCreate specifications for sourcing metadata from the eCTD structure to generate the ADRG.\n\nJoel drafted a template for specifications on sourcing metadata for the ADRG (link).\n\nNick to contact Christine for the next meeting\n\nChristine was able to join today’s meeting.\nContinued conversations with her will be needed for input on the updated ADRG.\n\nMoving Pilot 3 adrg.qmd to the PHUSE working project repository\n\nPaused as further discussions with P21, CDISC Core and ADRG PHUSE WG still need to be had to align steps for us to contribute.\n\nProgramming functions for ADRG metadata creation.\n\nPaused as further discussions with P21, CDISC Core and ADRG PHUSE WG still need to be had to align steps for us to contribute.\n\nTemplatizing open-source instructions for unpacking and re-executing analysis\n\nPaused as further discussions with P21, CDISC Core and ADRG PHUSE WG still need to be had to align steps for us to contribute.\n\n\n\n\nNew topics brought up with Christine R.\n\nCollaboration with Christine Rossin on reviewing the ADRG:\n\nChristine shared the current ADRG that is in review (unfortunatley public review has been closed, but we are asking for inclusion in the ADRG review).\nWe then shared our Project WG ‘Mission Statement’ and the RCRSWG Pilot 3 ADRG with Christine to review, where some feedback from her included :\n\nExclude eCTD directory structure.\nADRG is an m5 directive, no need to mention m1 folder.\nP21 pre-populates some ADRG sections, but some require manual sponsor updates.\nCollaborating with P21 to improve metadata provision for the ADRG.\n\n\n\n\n\nActions\n\nIdentify sections P21 populates and doesn’t populate in the ADRG.\n\nJoel to review and plan for automation contribution.\n\nDetermine how to contribute to automation for new ADRG versions. Needs discussion for supporting hybrid approaches (various languages).\n\nLovemore (and Sam P.) to get in contact with Christine R. We can still invite Christine to future meetings as needed.\n\nWe need to know what the specific changes we want to see updated in the ADRG for open-source submissions as well as the process for submitting updates.\nWe need to know Christine’s preferred method for collaboration.\nWe want to understand the submission process for approval of the updated template.\nWe also want to know the distribution methods for the approved template for the public to use (e.g. Sponsor, Pinnacle 21, CDISC).\n\n\nFurther potential support from other Novo colleagues\n\nLovemore to provide colleague’s contact information for joining the WG.\n\nContact Chris Price to find P21 and CDISC core contacts to see if we can get a meeting with them.\n\nNick to get in touch with Chris P.\n\nComplete metadata programming specifications (date to be determined, but work on this can still begin to get our ideas out on ‘paper’).\n\n\n\nThoughts for next steps\n\nDecide on moving Pilot 3 adrg.qmd (further discussion needed).\nTemplatize open-source unpacking/re-executing analysis instructions.\nContact Alexandra Pearce regarding the PHUSE WG workspace (optional as current way of working may be fine, per Nick M)."
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"section": "11Dec2024",
"text": "11Dec2024\nAttendees: Nicholas Masel, Sam Parmar, Steven Haesendonckx, Cervan Girard, Eric Nantz\nGuest(s):\nFacilitator: Lovemore Gakava\n\nAgenda\n\nHouse Cleaning\nUpdates from actions since last meeting\nNew Topics\nActions.\n\n\n\nHouse Cleaning\n\nWelcome Cervan Girard\nMinutes and actions from the last meeting added (follow-up).\n\n\n\nUpdates since last meeting\n\nFurther potential support from other Novo colleagues\n\nLovemore to provide colleague’s contact information for joining the WG.\n\nDetermine how to contribute to automation for new ADRG versions. Needs discussion for supporting hybrid approaches (various languages).\n\nLovemore (and Sam P.) to get in contact with Christine R. We can still invite Christine to future meetings as needed.\n\nWe need to know what the specific changes we want to see updated in the ADRG for open-source submissions as well as the process for submitting updates.\nWe need to know Christine’s preferred method for collaboration.\nWe want to understand the submission process for approval of the updated template.\nWe also want to know the distribution methods for the approved template for the public to use (e.g. Sponsor, Pinnacle 21, CDISC).\n\nStatus: Lovemore has already emailed Christine, and we’re awaiting her response on how to proceed with the ADRG template review and future collaboration.\n\nIdentify sections P21 populates and doesn’t populate in the ADRG.\n\nJoel to review and plan for automation contribution.\n\nStatus - Ongoing. Team is encouraged to review the draft specification by Joel and we can discuss in our next scheduled meeting.\n\n\nContact Chris Price to find P21 and CDISC core contacts to see if we can get a meeting with them.\n\nNick’s feedback from communications with Chris Price:\nTo avoid endorsing proprietary software, Chris recommends not collaborating with Pinnacle 21. Instead, we should develop an open and flexible solution that doesn’t lock sponsors into a specific vendor. Ultimately, we aim to provide a solution that adheres to CDISC core principles while allowing sponsors the freedom to integrate it seamlessly into their existing workflows.\nAction: To ensure our approach aligns with industry standards, we’ll invite Sam Hume to explain the role of CDISC core. This will help us integrate CDISC standards into our solution effectively.\n\n\n\n\nDiscussion Topics\n\nConfirm collaboration method with Christine R.\n\nStatus: ongoing\n\nNick to give update on PHUSE/FDA Computational Science Symposium (CSS) potential slot to have a breakout session:\n\nNick reached out to the organizers and it was agreed that at the moment the breakout session will focus on the use of TEAL: industry adoption and the collaborative unified ecosystem.\nAction: Discuss with team to decide whether we need a breakout session and if it’s going to be in the EU or US or both session?\n\nDecide on moving Pilot 3 adrg.qmd (further discussion needed).\n\nAction: create a repository and use pilot3 or pilot 4 ADRG as starting template.\n\nhttps://github.com/RConsortium/submissions-pilot4-webR/\n\n\nTemplatize open-source unpacking/re-executing analysis instructions.\n\nDiscussions:\n\nOS computing environment: The idea of having an OS computing environment was discussed but dismissed as not currently viable due to legal and independence concerns for regulatory authorities.\n\nAccumulus Synergy: A similar initiative, Accumulus Synergy, was mentioned (Home - Accumulus Synergy). This platform provides a secure way for life sciences organizations and regulatory authorities to exchange information and collaborate.\nScope: It was decided that further exploration of these ideas is outside the current scope and can be revisited after the first deliverable.\n\n\nAction: Start on draft of an open-source unpacking/re-executing analysis instructions template. (when?)\n\n\n\n\nAction Items:\n\nPHUSE ADRG Collaboration: Follow-up with Christine. (When: ASAP)\nCSS Breakout Session:\n\nDecide whether a breakout session is needed.\nIf yes, decide whether it will be EU, US, or both.\nDeadline: Before December 18th meeting.\nCommunicate decision to: Nick.\n\nADRG Development & Review:\n\nCreate a repository: Use pilot3 or pilot4 ADRG as a starting template.\nReview metadata programming specifications: Provide feedback on specifications.\nIdentify P21 population in ADRG: Identify sections P21 populates and doesn’t populate.\nStart drafting a template for open-source unpacking/re-executing analysis instructions.\nDeadline for all the above: Before December 18th meeting (work can begin immediately).\n\nAutomation Contribution Strategy:\n\nTask: Develop an initial draft of the automation contribution strategy.\nDeadline: Before December 18th meeting.\n\n\nFuture:\n\nTo ensure our approach aligns with industry standards, we’ll invite Sam Hume to explain the role of CDISC core. This will help us integrate CDISC standards into our solution effectively."
}
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