From eaba0e989e3f782cbcdc429bce3bd2c9c7bd2058 Mon Sep 17 00:00:00 2001 From: Lovemore Gakava Date: Wed, 8 Jan 2025 20:28:19 +0000 Subject: [PATCH 1/2] draft minutes added for 20250108 --- minutes.qmd | 142 ++++++++++++++++++++++++++++++++++++++++++++++++++++ 1 file changed, 142 insertions(+) diff --git a/minutes.qmd b/minutes.qmd index 0bde09e..7c68927 100644 --- a/minutes.qmd +++ b/minutes.qmd @@ -467,3 +467,145 @@ 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 + + - **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. From 5a11693ae33ff109409b10cd5fa679f0e32173be Mon Sep 17 00:00:00 2001 From: Lovemore Gakava <38993208+Lovemore-Gakava@users.noreply.github.com> Date: Fri, 10 Jan 2025 18:17:04 +0000 Subject: [PATCH 2/2] Update minutes.qmd --- minutes.qmd | 2 ++ 1 file changed, 2 insertions(+) diff --git a/minutes.qmd b/minutes.qmd index 7c68927..d69b3e3 100644 --- a/minutes.qmd +++ b/minutes.qmd @@ -568,6 +568,8 @@ Hope this time works for you. If not, please let me know. First action is to cre - 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.