updated minutes for 27Nov2024

docs/minutes.html

@@ -124,6 +124,7 @@ <h2 id="toc-title">On this page</h2>
   <li><a href="#sep2024-1" id="toc-sep2024-1" class="nav-link" data-scroll-target="#sep2024-1">18Sep2024</a></li>
   <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>
   </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>
@@ -151,6 +152,8 @@ <h1 class="title">Minutes</h1>
 
 <section id="sep2024" class="level2">
 <h2 class="anchored" data-anchor-id="sep2024">04Sep2024</h2>
+<p><strong>Attendees:</strong> Lovemore Gakava, Nicholas Masel, Steven Haesendonckx, Joel Laxamana, Hanming Tu<br>
+<strong>Facilitator:</strong> Joel Laxamana</p>
 <section id="agenda" class="level4">
 <h4 class="anchored" data-anchor-id="agenda">Agenda :</h4>
 <ol type="1">
@@ -224,6 +227,8 @@ <h4 class="anchored" data-anchor-id="actions">Actions:</h4>
 </section>
 <section id="sep2024-1" class="level2">
 <h2 class="anchored" data-anchor-id="sep2024-1">18Sep2024</h2>
+<p><strong>Attendees:</strong> Lovemore Gakava, Nicholas Masel, Steven Haesendonckx, Joel Laxamana, Hanming Tu<br>
+<strong>Facilitator:</strong> Joel Laxamana</p>
 <section id="agenda-1" class="level4">
 <h4 class="anchored" data-anchor-id="agenda-1">Agenda :</h4>
 <ol type="1">
@@ -400,9 +405,112 @@ <h5 class="anchored" data-anchor-id="actions-1"><strong>Actions:</strong></h5>
 <li><p>Begin programming functions to create metadata information for the ADRG, with reference to Slide 7 of the provided presentation.</p></li>
 <li><p>Templatize open-source instructions for unpacking and re-executing analysis from the eSUB package in eCTD structure.</p></li>
 </ul>
+</section>
+</section>
+</section>
+<section id="nov2024-1" class="level2">
+<h2 class="anchored" data-anchor-id="nov2024-1">27Nov2024</h2>
+<section id="agenda-4" class="level4">
+<h4 class="anchored" data-anchor-id="agenda-4"><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-1" class="level4">
+<h4 class="anchored" data-anchor-id="house-cleaning-1"><strong>House Cleaning</strong></h4>
+<ul>
+<li><p>Minutes and actions from the last meeting added (follow-up).</p></li>
+<li><p>Q4 reports submitted by Lovemore (<a href="https://drive.google.com/file/d/1468KYPejuBPo8AVlxmA7-I60oQq6ahB6/view?usp=drive_link">link</a>).</p></li>
+<li><p>New members added to the working group’s <a href="https://drive.google.com/drive/folders/1MsSA2hHLdrqbjN-HvxWzLkhWoT9Rze9Y?usp=drive_link">G-drive</a>.</p>
+<ul>
+<li>PHUSE WG does have a dedicated workspace to collaborate and save our Project WG files. Contact Alexandra Pearce (<a href="https://advance.hub.phuse.global/wiki/spaces/WEL/pages/26817363/Communication+of+Version+Metadata+for+Open-Source+Languages">link</a>).</li>
+</ul></li>
+</ul>
+</section>
+<section id="updates-since-last-meeting" class="level4">
+<h4 class="anchored" data-anchor-id="updates-since-last-meeting"><strong>Updates since last meeting</strong></h4>
+<ul>
+<li><p>FDA guidance on mandatory ADRG sections shared by Sam (details provided by Sam below).</p>
+<p><img src="references/ADRG required sections Screenshot 2024-11-27 145157.png" class="img-fluid"></p></li>
+<li><p>Create specifications for sourcing metadata from the eCTD structure to generate the ADRG.</p>
+<ul>
+<li>Joel drafted a template for specifications on sourcing metadata for the ADRG (<a href="https://docs.google.com/document/d/1cxwenwSCa_Xh4dw-bqCcWVmYnjjGMgb3X3DGDCflktU/edit?usp=drive_link">link</a>).</li>
+</ul></li>
+<li><p>Nick to contact Christine for the next meeting</p>
+<ul>
+<li><p>Christine was able to join today’s meeting.</p></li>
+<li><p>Continued conversations with her will be needed for input on the updated ADRG.</p></li>
+</ul></li>
+<li><p>Moving Pilot 3 adrg.qmd to the PHUSE working project repository</p>
+<ul>
+<li>Paused as further discussions with P21, CDISC Core and ADRG PHUSE WG still need to be had to align steps for us to contribute.</li>
+</ul></li>
+<li><p>Programming functions for ADRG metadata creation.</p>
+<ul>
+<li>Paused as further discussions with P21, CDISC Core and ADRG PHUSE WG still need to be had to align steps for us to contribute.</li>
+</ul></li>
+<li><p>Templatizing open-source instructions for unpacking and re-executing analysis</p>
+<ul>
+<li>Paused as further discussions with P21, CDISC Core and ADRG PHUSE WG still need to be had to align steps for us to contribute.</li>
+</ul></li>
+</ul>
+</section>
+<section id="new-topics-brought-up-with-christine-r." class="level4">
+<h4 class="anchored" data-anchor-id="new-topics-brought-up-with-christine-r."><strong>New topics brought up with Christine R.</strong></h4>
+<ul>
+<li><p>Collaboration with Christine Rossin on reviewing the ADRG:</p>
+<ul>
+<li><p>Christine shared the current ADRG that is in review (unfortunatley public review has been closed, but we are asking for inclusion in the ADRG review).</p></li>
+<li><p>We then shared our Project WG ‘Mission Statement’ and the RCRSWG Pilot 3 ADRG with Christine to review, where some feedback from her included :</p>
+<ul>
+<li><p>Exclude eCTD directory structure.</p></li>
+<li><p>ADRG is an m5 directive, no need to mention m1 folder.</p></li>
+<li><p>P21 pre-populates some ADRG sections, but some require manual sponsor updates.</p></li>
+<li><p>Collaborating with P21 to improve metadata provision for the ADRG.</p></li>
+</ul></li>
+</ul></li>
+</ul>
+</section>
+<section id="actions-2" class="level4">
+<h4 class="anchored" data-anchor-id="actions-2"><strong>Actions</strong></h4>
+<ul>
+<li><p>Identify sections P21 populates and doesn’t populate in the ADRG.</p>
+<ul>
+<li>Joel to review and plan for automation contribution.</li>
+</ul></li>
+<li><p>Determine how to contribute to automation for new ADRG versions. Needs discussion for supporting hybrid approaches (various languages).</p>
+<ul>
+<li><p>Lovemore (and Sam P.) to get in contact with Christine R.</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>
+</ul></li>
+<li><p>Further potential support from other Novo colleagues</p>
+<ul>
+<li>Lovemore to provide colleague’s contact information for joining the WG.</li>
+</ul></li>
+<li><p>Contact Chris Price to find P21 and CDISC core contacts to see if we can get a meeting with them.</p>
+<ul>
+<li>Nick to get in touch with Chris P.</li>
+</ul></li>
+<li><p>Complete metadata <a href="https://docs.google.com/document/d/1cxwenwSCa_Xh4dw-bqCcWVmYnjjGMgb3X3DGDCflktU/edit?usp=drive_link">programming specifications</a> (date to be determined, but work on this can still begin to get our ideas out on ‘paper’).</p></li>
+</ul>
+</section>
+<section id="thoughts-for-next-steps" class="level4">
+<h4 class="anchored" data-anchor-id="thoughts-for-next-steps"><strong>Thoughts for next steps</strong></h4>
+<ul>
+<li><p>Decide on moving Pilot 3 adrg.qmd (further discussion needed).</p></li>
+<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>