Minutes

04Sep2024

Agenda :

  1. Introduce ourselves and what we want to get out of this WG.
  2. Discuss and decide how we want to start this off and pick a template document we want to work with first (e.g. ADRG).
  3. How we want to track our work (e.g. github project board - create issues and self-assign to the work we feel comfortable doing)
  4. Frequency of our catch-ups to get status updates on work.
  5. Discuss FDA quarterly meeting presentation :

Hope this time works for you. If not, please let me know. First action is to create a set of slides to present at FDA quarterly meeting : 16 October at 14:00 BST. I was thinking we can create quarto md slides.

Actions/Issues & Timelines :

  1. KO meeting 04Sep2024.
  2. First draft of slides due 13Sep2024 (or sooner).
  • Intro : List out the current ADRG template we have now and how we want to update the template to include open-source metadata - Lovemore
  • Within the current ADRG from Pinnacle 21 vs an ADRG where Open-source submission was used, list out the differences and note these differecnes as the updates we want to make to the current ADRG template to be Open-Source friendly.
    • e.g., List out all of the tables in this ADRG, here, that we can automate and generate sourcing available metadata
      • 1.2 Study Data Standards and Dictionary Inventory (Can this come from the TS SDTM domain?)
      • 3.1 Core Variables (come from the define.xml specificaions)
      • 4.2 Data Dependencies (may need to some code scraping to read through each ADaM program and identify any other ADaMs being sourced in to create the ADaM)
      • 5.2 Analysis Datasets (read in all of the .xpts in the submission package to extract the metadata for each ADaM to fill in this table)
      • 6.2 Issues Summary (extract report from P21)
      • 7.2 ADaM Programs (read in all of the .xpts in the submission package to extract the list of ADaMs and it’s label for each ADaM to fill in this table)
      • 7.3 Analysis Output Programs (this one may be tricky as there are many study specific Selection Criteria to include)
      • 7.4 Proprietary R Packages (Joel has some code for this, in R, essentially using SessionInfo() and {renv})
      • eCTD structure.
  • With these listed updates we want to make, we can utilize metadata to help fill in this information in the ADRG (Let’s list write out specifications as to where )
  • Challenge the file format delivered to the FDA, not only .pdf, but can we additionally submit .qmd files (or other file formats) as well so that the ADRG can be reproduced on the Agency side to help better click on code from the ADRG to help execute. Note : eCTD specifications say we can submit .qmd for analysis, but can we also submit it as a form of ADRG documentation.
  • Do we want to bring up the possibility of creating an open-source package for this to help automate the use of metadata in the ADRG documentation.
  1. Review and Feedback due 20Sep2024.
  • Things to think about :
    • We want this template to be able to support multiple open-source languages. Currently, R is the go-to in Clinical Trial submission now in the industry for open-source. Do we want to create an ADRG based on R as first go or do we want to add the complexity of having to think about multiple open-source programming languages? It would be good to keep the template as simple and user-friendly as possible. Have a think offline.
  1. Update and finalize slides due 27Sep2024.
  2. Practice presentation due TBD (anytime between 4 & 6)
  3. Present 16Oct2024

Other actions :

  • Nicholas Masel to

    • find someone from CDISC as a POC for any questions we may have during this project.

    • add Steven H. from JnJ to this WG - Haesendonckx, Steven [JRDBE]

  • Hanming to

    • find out who from the FDA can get us invited to the next FDA quarterly meeting.

    • who will be the assigned FDA person(s) moving forward to collaborate with us on this project.

  • Joel to create base .qmd slides for FDA meeting.

  • All to contribute to the .qmd slides per the timelines above.

18Sep2024

Agenda :

  1. Get google accounts from the team members to collaborate on google slides for FDA quarterly meeting presentation : Enhancing Clinical Trials FDA Submission Documentation through the Power of Metadata - OSDocuMetaWG

  2. We should connect with the PHUSE WG who created the ADRG templates initially.

  3. We should connect with FDA, Paul and HyeSoo, YounKyeong to gain feedback on where they can see Open-Source documentation can go for FDA submissions.

Actions/Issues & Timelines :

  1. Ensure everyone has access to collaborate and edit the google slides by end of the week.

  2. We need to draft these slides by the end of next week then send to team to review.

  3. Finalize these slides by the end of the Month.

  4. The slides have assignments on them so we know who is working on which content, but feel free to collaboarate on each others content as needed.

  5. Joel to send email for bullet 3.

  6. Lovemore to send email for bullet 2.

16Oct2024


Attendees: Lovemore Gakava, Nicholas Masel, Steven Haesendonckx, Joel Laxamana
Facilitator: Joel Laxamana

Agenda:

  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.

  3. Coordination and Feedback from Key Stakeholders

  4. Future Meetings and Next Steps

Discussion Points:

  1. Feedback on ADRG Template Updates and Process:

    • Feedback from Team Members:

      • Presentation went well.

      • The team is awaiting feedback from a key colleague from Pfizer, Christine Rossin who has a stake in updating the ADRG.

      • The 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?

    • External Feedback:

      • Plan to check in with Mike Stackhouse to get his input after he reviews the meeting recording.

      • Need to get insights from an FDA contact (Nick’s mention) if they were on this morning’s PHUSE/FDA Quarterly call.

  2. Coordination and Feedback from Key Stakeholders:

    • David Epstein’s Role:

      • David Epstein, involved with ADRG template work in the past, might provide valuable input and help engage more contributors.

      • Communication with David planned post-meeting to gather and facilitate feedback, potentially via GitHub or alternative platforms for those without GitHub accounts.

    • Future Communications:

      • Follow-up emails post-meeting to ensure any unanswered questions are collected and addressed.

      • Nick will check for additional FDA members interested in the ADRG updates during the upcoming PHUSE meeting.

    • Enhancements and Tools:

      • Discussed creating a tool and an R package to bring in metadata effectively.

      • Importance of standardizing the ADRG template for future open-source submissions to drive consistency and efficiency in the industry.

  3. Future Meetings and Next Steps:

    • Internal Coordination:

      • Plan to migrate ADRG quarto markdown file to the PHUSE git area to continue work on this.

      • Testing the reproduction of the ADRG with metadata approaches. See List of other Metadata Opportunities slide in presentation.

    • Timeline and Deliverables:

      • Aim to schedule the next working group kickoff by mid-November.

      • Assignments on updating ADRG to be determined.

      • Emphasis on clear planning and setting deliverable dates.

    • Communication Plans:

      • Regular updates and feedback sessions to ensure all members are aligned.

      • Initiatives to include new members from upcoming meetings and engagements.

Action Items:

  1. Follow-Up with Key Contacts:

    • Nicholas 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.

    • Joel to contact David Epstein regarding additional member engagement and feedback collection methods from the audience in the FDA quarterly meeting this morning.

  2. Prepare for Next Meetings:

    • Joel to prepare the ADRG markdown file for migration and further testing.

    • Schedule next working group meeting in November 2025 and ensure clear objectives and tasks are assigned.

——– copy below and paste above, then update accordingly ———

Template for upcoming meetings :

ddmmmyyyy

Agenda :

  1. item 1
  2. item 2
  3. etc…

Actions/Issues & Timelines :

  1. action/issue 1 & planned due date
  2. action/issue 2 & planned due date
  3. etc…

Other Notes or Actions :

  • add any other business here

  • etc…