Merge pull request #7 from phuse-org/20250108

2250108 Minutes

minutes.qmd

@@ -467,3 +467,147 @@ Hope this time works for you. If not, please let me know. First action is to cre
 **Future**:
 
 -   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.
+
+## 08Jan2025
+
+**Attendees:** Nicholas Masel, Sam Parmar, Cervan Girard, Eric Nantz\
+**Guest(s):** Christine Rossin (Guest from PHUSE ADRG WG)\
+**Facilitator:** Lovemore Gakava
+
+#### **Agenda**
+
+-   House Cleaning
+
+-   Updates from actions since last meeting
+
+-   Discussion Topics and actions
+
+-   Next Steps
+
+#### **House Cleaning**
+
+-   Minutes and actions from the last meeting added (follow-up).
+
+#### **Updates since last meeting**
+
+-   **CSS Breakout Session:**
+
+    -   [PHUSE/FDA CSS 2025](https://www.phuse-events.org/attend/frontend/reg/thome.csp?pageID=48211&eventID=75&traceRedir=2)
+
+        -   Decide whether a breakout session is needed.
+
+        -   If yes, decide whether it will be EU, US, or both.
+
+        -   **Deadline:** Before December 18th meeting.
+
+    -   **Communicate decision to:** Nick.
+
+        -   Nick, Joel, LG and Cervan to obtain approval from parent companies regarding attendance
+
+        -   Nick to determine if representation is needed from both:
+
+            -   USA
+
+            -   European
+
+            -   Verify European attendance cap/limitations
+
+                -   Note: Current attendance restrictions apply specifically to European participants.
+
+        -   when: ASAP
+
+<!-- -->
+
+-   **PHUSE WG, RCSubWG & FDA : ADRG \@ Wed Dec 18, 2024 7:15am - 8am (PST) ([hyesoo.cho\@fda.hhs.gov](mailto:hyesoo.cho@fda.hhs.gov)) discussion:**
+
+    -   Feedback/comments?
+        -   
+    -   **Action**:
+        -    pushing this topic to 22-Jan-2025 for team to discuss further.
+        -   Upload document to Google drive for team to review.
+            -   who: LG
+            -   when: 15-Jan-2025
+
+<!-- -->
+
+-   **PHUSE ADRG Collaboration:** Follow-up with Christine. (**When:** ASAP)
+
+    -   who: Sam
+
+    -   when: 15-Jan-2025
+
+    -   action: add her to the meeting invite
+
+-   **ADRG Development & Review:**
+
+    -   **Create a repository:** Use pilot3 or pilot4 ADRG as a starting template.
+
+        -   who: LG
+
+        -   when:15-Jan-2025
+
+        -   action: ensure that members have access to the [phuse-org](https://github.com/phuse-org) github organization
+
+        -   repo name : adrg-quarto
+
+    -   **Review metadata programming specifications:** Provide feedback on specifications.
+
+        -   check if everyone has access to Google drive?
+
+            -   **resolved**: everyone has access
+
+        -   when should everyone provide feedback?
+
+            -   when: TBD - pushed to future meeting to discuss the different sections in detail.
+
+    -   **Identify P21 population in ADRG:** Identify sections P21 populates and doesn't populate.
+
+        -   who: Cervan
+
+        -   how: use cdisc pilot study and run it through pinnacle 21 and provide report to team.
+
+        -   when: 22-Jan-2025
+
+        - Post meeting update: Joel has made a start - see document,  https://docs.google.com/document/d/16Pz4NkVP_yC-FsoykENZTaPcV5gDu3LN/edit?usp=sharing&ouid=103991081896680964420&rtpof=true&sd=true. Cervan to review.
+
+    -   **Start drafting** a template for open-source unpacking/re-executing analysis instructions.
+
+        -   who: Steven (we have volunteered you :-)) , LG & Cervan - provide NN example.
+
+        -   when: 22-Jan-2025
+
+        -   action: consider creating a package template to populate the adrg and this might be part of unpacking/re-executing analysis.
+
+-   **Automation Contribution Strategy:**
+
+    -   **Task:** Develop an initial draft of the automation contribution strategy.
+
+        -   drafts of template? to confirm with Joel
+
+    -   when: 15-Jan-2025
+
+-   **Invite Sam Hume** to explain the role of CDISC core.
+
+    -   who: Nick
+
+    -   when: Joel and LG to provide timelines to Nick by 15-Jan-2025
+
+#### **Discussion Topics:**
+
+#### Meeting Update - Discussion with Christine
+
+Christine joined the last 20 minutes of the meeting (thanks to Sam's invitation). During her time, we reviewed Hye Soo's comments and discussed the following key points:
+
+#### Key Discussion Points
+
+Regarding Section 7 (Appendix: Instructions to Execute Analysis Programs in R):
+
+-    Christine recommends moving this to a separate supporting document
+
+-   The ADRG template should remain software-neutral
+
+-    We should develop separate completion guidelines for different software (R, SAS, and potential future additions)
+
+#### Next Steps
+
+We need to include Christine in upcoming meetings to determine who will take ownership of writing the R completion guideline and discuss further the content of the template and the R completion guideline.