From 5da8a7598d6cfdc4a517942b6d8354e007bf7ab8 Mon Sep 17 00:00:00 2001 From: Joel Laxamana Date: Wed, 27 Nov 2024 23:17:51 +0000 Subject: [PATCH] updated minutes for 27Nov2024 --- docs/minutes.html | 110 +++++++++++++++++- ... sections Screenshot 2024-11-27 145157.png | Bin 0 -> 119607 bytes docs/search.json | 13 ++- minutes.qmd | 102 ++++++++++++++++ ... sections Screenshot 2024-11-27 145157.png | Bin 0 -> 119607 bytes 5 files changed, 221 insertions(+), 4 deletions(-) create mode 100644 docs/references/ADRG required sections Screenshot 2024-11-27 145157.png create mode 100644 references/ADRG required sections Screenshot 2024-11-27 145157.png diff --git a/docs/minutes.html b/docs/minutes.html index 9ba1c4f..829e9ab 100644 --- a/docs/minutes.html +++ b/docs/minutes.html @@ -124,6 +124,7 @@

On this page

  • 18Sep2024
  • 16Oct2024
  • 13Nov2024
  • +
  • 27Nov2024
  • @@ -151,6 +152,8 @@

    Minutes

    04Sep2024

    +

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

    Agenda :

      @@ -224,6 +227,8 @@

      Actions:

    18Sep2024

    +

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

    Agenda :

      @@ -400,9 +405,112 @@
      Actions:
    1. Begin programming functions to create metadata information for the ADRG, with reference to Slide 7 of the provided presentation.

    2. Templatize open-source instructions for unpacking and re-executing analysis from the eSUB package in eCTD structure.

    3. +
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    27Nov2024

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    Agenda

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    • House Cleaning

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    • Updates from actions since last meeting

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    • New Topics

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    • Actions.

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    House Cleaning

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    • Minutes and actions from the last meeting added (follow-up).

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    • Q4 reports submitted by Lovemore (link).

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    • New members added to the working group’s G-drive.

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      • PHUSE WG does have a dedicated workspace to collaborate and save our Project WG files. Contact Alexandra Pearce (link).
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    Updates since last meeting

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    • FDA guidance on mandatory ADRG sections shared by Sam (details provided by Sam below).

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    • Create specifications for sourcing metadata from the eCTD structure to generate the ADRG.

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      • Joel drafted a template for specifications on sourcing metadata for the ADRG (link).
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    • Nick to contact Christine for the next meeting

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      • Christine was able to join today’s meeting.

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      • Continued conversations with her will be needed for input on the updated ADRG.

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    • Moving Pilot 3 adrg.qmd to the PHUSE working project repository

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      • Paused as further discussions with P21, CDISC Core and ADRG PHUSE WG still need to be had to align steps for us to contribute.
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    • Programming functions for ADRG metadata creation.

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      • Paused as further discussions with P21, CDISC Core and ADRG PHUSE WG still need to be had to align steps for us to contribute.
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    • Templatizing open-source instructions for unpacking and re-executing analysis

      +
        +
      • Paused as further discussions with P21, CDISC Core and ADRG PHUSE WG still need to be had to align steps for us to contribute.
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    New topics brought up with Christine R.

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    • Collaboration with Christine Rossin on reviewing the ADRG:

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      • 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).

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      • We then shared our Project WG ‘Mission Statement’ and the RCRSWG Pilot 3 ADRG with Christine to review, where some feedback from her included :

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        • Exclude eCTD directory structure.

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        • ADRG is an m5 directive, no need to mention m1 folder.

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        • P21 pre-populates some ADRG sections, but some require manual sponsor updates.

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        • Collaborating with P21 to improve metadata provision for the ADRG.

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    Actions

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    • Identify sections P21 populates and doesn’t populate in the ADRG.

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      • Joel to review and plan for automation contribution.
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    • Determine how to contribute to automation for new ADRG versions. Needs discussion for supporting hybrid approaches (various languages).

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      • Lovemore (and Sam P.) to get in contact with Christine R.

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        • 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.

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        • We need to know Christine’s preferred method for collaboration.

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        • We want to understand the submission process for approval of the updated template.

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        • We also want to know the distribution methods for the approved template for the public to use (e.g. Sponsor, Pinnacle 21, CDISC).

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    • Further potential support from other Novo colleagues

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      • Lovemore to provide colleague’s contact information for joining the WG.
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    • Contact Chris Price to find P21 and CDISC core contacts to see if we can get a meeting with them.

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      • Nick to get in touch with Chris P.
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    • Complete metadata programming specifications (date to be determined, but work on this can still begin to get our ideas out on ‘paper’).

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    Thoughts for next steps

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    • Decide on moving Pilot 3 adrg.qmd (further discussion needed).

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    • Templatize open-source unpacking/re-executing analysis instructions.

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    • Contact Alexandra Pearce regarding the PHUSE WG workspace (optional as current way of working may be fine, per Nick M).

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    -
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b/docs/search.json index 4b57b64..253f58f 100644 --- a/docs/search.json +++ b/docs/search.json @@ -74,21 +74,21 @@ "href": "minutes.html", "title": "Minutes", "section": "", - "text": "Introduce ourselves and what we want to get out of this WG.\nDiscuss and decide how we want to start this off and pick a template document we want to work with first (e.g. ADRG).\nHow we want to track our work (e.g. github project board - create issues and self-assign to the work we feel comfortable doing)\nFrequency of our catch-ups to get status updates on work.\nDiscuss FDA quarterly meeting presentation :\n\nHope 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.\n\n\n\n\nKO meeting 04Sep2024.\nFirst draft of slides due 13Sep2024 (or sooner).\n\n\nIntro : List out the current ADRG template we have now and how we want to update the template to include open-source metadata - Lovemore\nWithin 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.\n\ne.g., List out all of the tables in this ADRG, here, that we can automate and generate sourcing available metadata\n\n1.2 Study Data Standards and Dictionary Inventory (Can this come from the TS SDTM domain?)\n3.1 Core Variables (come from the define.xml specificaions)\n4.2 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)\n5.2 Analysis Datasets (read in all of the .xpts in the submission package to extract the metadata for each ADaM to fill in this table)\n6.2 Issues Summary (extract report from P21)\n7.2 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)\n7.3 Analysis Output Programs (this one may be tricky as there are many study specific Selection Criteria to include)\n7.4 Proprietary R Packages (Joel has some code for this, in R, essentially using SessionInfo() and {renv})\neCTD structure.\n\n\nWith 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 )\nChallenge 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.\nDo 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.\n\n\nReview and Feedback due 20Sep2024.\n\n\nThings to think about :\n\nWe 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.\n\n\n\n\n\n\nUpdate and finalize slides due 27Sep2024.\nPractice presentation due TBD (anytime between 4 & 6)\nPresent 16Oct2024\n\n\nNicholas Masel to\n\nfind someone from CDISC as a POC for any questions we may have during this project.\nadd Steven H. from JnJ to this WG - Haesendonckx, Steven [JRDBE] shaesen2@ITS.JNJ.com\n\nHanming to\n\nfind out who from the FDA can get us invited to the next FDA quarterly meeting.\nwho will be the assigned FDA person(s) moving forward to collaborate with us on this project.\n\nJoel to create base .qmd slides for FDA meeting.\nAll to contribute to the .qmd slides per the timelines above." + "text": "Attendees: Lovemore Gakava, Nicholas Masel, Steven Haesendonckx, Joel Laxamana, Hanming Tu\nFacilitator: Joel Laxamana\n\n\n\nIntroduce ourselves and what we want to get out of this WG.\nDiscuss and decide how we want to start this off and pick a template document we want to work with first (e.g. ADRG).\nHow we want to track our work (e.g. github project board - create issues and self-assign to the work we feel comfortable doing)\nFrequency of our catch-ups to get status updates on work.\nDiscuss FDA quarterly meeting presentation :\n\nHope 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.\n\n\n\n\nKO meeting 04Sep2024.\nFirst draft of slides due 13Sep2024 (or sooner).\n\n\nIntro : List out the current ADRG template we have now and how we want to update the template to include open-source metadata - Lovemore\nWithin 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.\n\ne.g., List out all of the tables in this ADRG, here, that we can automate and generate sourcing available metadata\n\n1.2 Study Data Standards and Dictionary Inventory (Can this come from the TS SDTM domain?)\n3.1 Core Variables (come from the define.xml specificaions)\n4.2 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)\n5.2 Analysis Datasets (read in all of the .xpts in the submission package to extract the metadata for each ADaM to fill in this table)\n6.2 Issues Summary (extract report from P21)\n7.2 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)\n7.3 Analysis Output Programs (this one may be tricky as there are many study specific Selection Criteria to include)\n7.4 Proprietary R Packages (Joel has some code for this, in R, essentially using SessionInfo() and {renv})\neCTD structure.\n\n\nWith 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 )\nChallenge 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.\nDo 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.\n\n\nReview and Feedback due 20Sep2024.\n\n\nThings to think about :\n\nWe 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.\n\n\n\n\n\n\nUpdate and finalize slides due 27Sep2024.\nPractice presentation due TBD (anytime between 4 & 6)\nPresent 16Oct2024\n\n\nNicholas Masel to\n\nfind someone from CDISC as a POC for any questions we may have during this project.\nadd Steven H. from JnJ to this WG - Haesendonckx, Steven [JRDBE] shaesen2@ITS.JNJ.com\n\nHanming to\n\nfind out who from the FDA can get us invited to the next FDA quarterly meeting.\nwho will be the assigned FDA person(s) moving forward to collaborate with us on this project.\n\nJoel to create base .qmd slides for FDA meeting.\nAll to contribute to the .qmd slides per the timelines above." }, { "objectID": "minutes.html#sep2024", "href": "minutes.html#sep2024", "title": "Minutes", "section": "", - "text": "Introduce ourselves and what we want to get out of this WG.\nDiscuss and decide how we want to start this off and pick a template document we want to work with first (e.g. ADRG).\nHow we want to track our work (e.g. github project board - create issues and self-assign to the work we feel comfortable doing)\nFrequency of our catch-ups to get status updates on work.\nDiscuss FDA quarterly meeting presentation :\n\nHope 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.\n\n\n\n\nKO meeting 04Sep2024.\nFirst draft of slides due 13Sep2024 (or sooner).\n\n\nIntro : List out the current ADRG template we have now and how we want to update the template to include open-source metadata - Lovemore\nWithin 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.\n\ne.g., List out all of the tables in this ADRG, here, that we can automate and generate sourcing available metadata\n\n1.2 Study Data Standards and Dictionary Inventory (Can this come from the TS SDTM domain?)\n3.1 Core Variables (come from the define.xml specificaions)\n4.2 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)\n5.2 Analysis Datasets (read in all of the .xpts in the submission package to extract the metadata for each ADaM to fill in this table)\n6.2 Issues Summary (extract report from P21)\n7.2 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)\n7.3 Analysis Output Programs (this one may be tricky as there are many study specific Selection Criteria to include)\n7.4 Proprietary R Packages (Joel has some code for this, in R, essentially using SessionInfo() and {renv})\neCTD structure.\n\n\nWith 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 )\nChallenge 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.\nDo 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.\n\n\nReview and Feedback due 20Sep2024.\n\n\nThings to think about :\n\nWe 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.\n\n\n\n\n\n\nUpdate and finalize slides due 27Sep2024.\nPractice presentation due TBD (anytime between 4 & 6)\nPresent 16Oct2024\n\n\nNicholas Masel to\n\nfind someone from CDISC as a POC for any questions we may have during this project.\nadd Steven H. from JnJ to this WG - Haesendonckx, Steven [JRDBE] shaesen2@ITS.JNJ.com\n\nHanming to\n\nfind out who from the FDA can get us invited to the next FDA quarterly meeting.\nwho will be the assigned FDA person(s) moving forward to collaborate with us on this project.\n\nJoel to create base .qmd slides for FDA meeting.\nAll to contribute to the .qmd slides per the timelines above." + "text": "Attendees: Lovemore Gakava, Nicholas Masel, Steven Haesendonckx, Joel Laxamana, Hanming Tu\nFacilitator: Joel Laxamana\n\n\n\nIntroduce ourselves and what we want to get out of this WG.\nDiscuss and decide how we want to start this off and pick a template document we want to work with first (e.g. ADRG).\nHow we want to track our work (e.g. github project board - create issues and self-assign to the work we feel comfortable doing)\nFrequency of our catch-ups to get status updates on work.\nDiscuss FDA quarterly meeting presentation :\n\nHope 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.\n\n\n\n\nKO meeting 04Sep2024.\nFirst draft of slides due 13Sep2024 (or sooner).\n\n\nIntro : List out the current ADRG template we have now and how we want to update the template to include open-source metadata - Lovemore\nWithin 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.\n\ne.g., List out all of the tables in this ADRG, here, that we can automate and generate sourcing available metadata\n\n1.2 Study Data Standards and Dictionary Inventory (Can this come from the TS SDTM domain?)\n3.1 Core Variables (come from the define.xml specificaions)\n4.2 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)\n5.2 Analysis Datasets (read in all of the .xpts in the submission package to extract the metadata for each ADaM to fill in this table)\n6.2 Issues Summary (extract report from P21)\n7.2 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)\n7.3 Analysis Output Programs (this one may be tricky as there are many study specific Selection Criteria to include)\n7.4 Proprietary R Packages (Joel has some code for this, in R, essentially using SessionInfo() and {renv})\neCTD structure.\n\n\nWith 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 )\nChallenge 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.\nDo 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.\n\n\nReview and Feedback due 20Sep2024.\n\n\nThings to think about :\n\nWe 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.\n\n\n\n\n\n\nUpdate and finalize slides due 27Sep2024.\nPractice presentation due TBD (anytime between 4 & 6)\nPresent 16Oct2024\n\n\nNicholas Masel to\n\nfind someone from CDISC as a POC for any questions we may have during this project.\nadd Steven H. from JnJ to this WG - Haesendonckx, Steven [JRDBE] shaesen2@ITS.JNJ.com\n\nHanming to\n\nfind out who from the FDA can get us invited to the next FDA quarterly meeting.\nwho will be the assigned FDA person(s) moving forward to collaborate with us on this project.\n\nJoel to create base .qmd slides for FDA meeting.\nAll to contribute to the .qmd slides per the timelines above." }, { "objectID": "minutes.html#sep2024-1", "href": "minutes.html#sep2024-1", "title": "Minutes", "section": "18Sep2024", - "text": "18Sep2024\n\nAgenda :\n\nGet 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\nWe should connect with the PHUSE WG who created the ADRG templates initially.\nWe should connect with FDA, Paul and HyeSoo, YounKyeong to gain feedback on where they can see Open-Source documentation can go for FDA submissions.\n\n\n\nDiscussion/Issues/Actions :\n\nEnsure everyone has access to collaborate and edit the google slides by end of the week.\nWe need to draft these slides by the end of next week then send to team to review.\nFinalize these slides by the end of the Month.\nThe 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.\nJoel to send email for bullet 3.\nLovemore to send email for bullet 2." + "text": "18Sep2024\nAttendees: Lovemore Gakava, Nicholas Masel, Steven Haesendonckx, Joel Laxamana, Hanming Tu\nFacilitator: Joel Laxamana\n\nAgenda :\n\nGet 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\nWe should connect with the PHUSE WG who created the ADRG templates initially.\nWe should connect with FDA, Paul and HyeSoo, YounKyeong to gain feedback on where they can see Open-Source documentation can go for FDA submissions.\n\n\n\nDiscussion/Issues/Actions :\n\nEnsure everyone has access to collaborate and edit the google slides by end of the week.\nWe need to draft these slides by the end of next week then send to team to review.\nFinalize these slides by the end of the Month.\nThe 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.\nJoel to send email for bullet 3.\nLovemore to send email for bullet 2." }, { "objectID": "minutes.html#oct2024", @@ -124,5 +124,12 @@ "title": "Minutes", "section": "13Nov2024", "text": "13Nov2024\n\nAttendees: Lovemore Gakava, Nicholas Masel, Joel Laxamana, Eric Nantz, Sam Parmar\nFacilitator: Joel Laxamana\n\nAgenda:\n\nHouse cleaning\nUpdates since FDA quartlery meeting presentation\nADRG discussion and steps to consider moving forward.\nActions\n\n\n\nDiscussion/Issues/Actions\n\nHouse Cleaning:\n\nWebsite updated with quarterly presentations to the FDA.\nAdded last month’s minutes and actions.\n\n\n\nUpdates since FDA quarterly meeting:\n\nNo further feedback from the FDA quarterly meeting yet; efforts to reach out to David will continue.\nChristine Rossin will be contacted by Nick for assistance with ADRG review, including Sam P. in the correspondence.\n\n\n\nADRG Discussion and review:\n\nDiscussion with Eric and Sam on using Quarto to generate ADRG and sending it as an HTML file in the eSUB package.\nNeed to support hybrid approaches for ADRG versioning (considering various languages, including SAS).\nInclude Christine Rossin in future meetings to discuss ADRG maintenance.\nContact vendors like P21 and CDISC core about the ADRG templates and discuss how the enhanced open-source ADRG will integrate. Christine might provide insights on how P21 sources templates from PHUSE WG.\nEric and Sam have joined the team.\n\n\n\nActions:\n\nAsk Sam to share FDA guidance on mandatory ADRG sections.\nCreate specifications for sourcing metadata from the eCTD structure to generate the ADRG.\nNick to contact Christine for the next meeting on 11 December 2024.\n\n\n\nConsider moving Pilot 3 adrg.qmd to the PHUSE working project repository.\nBegin programming functions to create metadata information for the ADRG, with reference to Slide 7 of the provided presentation.\nTemplatize open-source instructions for unpacking and re-executing analysis from the eSUB package in eCTD structure." + }, + { + "objectID": "minutes.html#nov2024-1", + "href": "minutes.html#nov2024-1", + "title": "Minutes", + "section": "27Nov2024", + "text": "27Nov2024\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.\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)." } ] \ No newline at end of file diff --git a/minutes.qmd b/minutes.qmd index 421e13a..0a16619 100644 --- a/minutes.qmd +++ b/minutes.qmd @@ -242,3 +242,105 @@ Hope this time works for you. If not, please let me know. First action is to cre - Begin programming functions to create metadata information for the ADRG, with reference to Slide 7 of the provided presentation. - Templatize open-source instructions for unpacking and re-executing analysis from the eSUB package in eCTD structure. + +## 27Nov2024 + +#### **Agenda** + +- House Cleaning + +- Updates from actions since last meeting + +- New Topics + +- Actions. + +#### **House Cleaning** + +- Minutes and actions from the last meeting added (follow-up). + +- Q4 reports submitted by Lovemore ([link](https://drive.google.com/file/d/1468KYPejuBPo8AVlxmA7-I60oQq6ahB6/view?usp=drive_link)). + +- New members added to the working group's [G-drive](https://drive.google.com/drive/folders/1MsSA2hHLdrqbjN-HvxWzLkhWoT9Rze9Y?usp=drive_link). + + - PHUSE WG does have a dedicated workspace to collaborate and save our Project WG files. Contact Alexandra Pearce ([link ](https://advance.hub.phuse.global/wiki/spaces/WEL/pages/26817363/Communication+of+Version+Metadata+for+Open-Source+Languages)). + +#### **Updates since last meeting** + +- FDA guidance on mandatory ADRG sections shared by Sam (details provided by Sam below). + + ![](references/ADRG required sections Screenshot 2024-11-27 145157.png) + +- Create specifications for sourcing metadata from the eCTD structure to generate the ADRG. + + - Joel drafted a template for specifications on sourcing metadata for the ADRG ([link](https://docs.google.com/document/d/1cxwenwSCa_Xh4dw-bqCcWVmYnjjGMgb3X3DGDCflktU/edit?usp=drive_link)). + +- Nick to contact Christine for the next meeting + + - Christine was able to join today's meeting. + + - Continued conversations with her will be needed for input on the updated ADRG. + +- Moving Pilot 3 adrg.qmd to the PHUSE working project repository + + - Paused as further discussions with P21, CDISC Core and ADRG PHUSE WG still need to be had to align steps for us to contribute. + +- Programming functions for ADRG metadata creation. + + - Paused as further discussions with P21, CDISC Core and ADRG PHUSE WG still need to be had to align steps for us to contribute. + +- Templatizing open-source instructions for unpacking and re-executing analysis + + - Paused as further discussions with P21, CDISC Core and ADRG PHUSE WG still need to be had to align steps for us to contribute. + +#### **New topics brought up with Christine R.** + +- Collaboration with Christine Rossin on reviewing the ADRG: + + - 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). + + - We then shared our Project WG 'Mission Statement' and the RCRSWG Pilot 3 ADRG with Christine to review, where some feedback from her included : + + - Exclude eCTD directory structure. + + - ADRG is an m5 directive, no need to mention m1 folder. + + - P21 pre-populates some ADRG sections, but some require manual sponsor updates. + + - Collaborating with P21 to improve metadata provision for the ADRG. + +#### **Actions** + +- Identify sections P21 populates and doesn't populate in the ADRG. + + - Joel to review and plan for automation contribution. + +- Determine how to contribute to automation for new ADRG versions. Needs discussion for supporting hybrid approaches (various languages). + + - Lovemore (and Sam P.) to get in contact with Christine R. We can still invite Christine to future meetings as needed. + + - 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. + + - We need to know Christine's preferred method for collaboration. + + - We want to understand the submission process for approval of the updated template. + + - We also want to know the distribution methods for the approved template for the public to use (e.g. Sponsor, Pinnacle 21, CDISC). + +- Further potential support from other Novo colleagues + + - Lovemore to provide colleague's contact information for joining the WG. + +- Contact Chris Price to find P21 and CDISC core contacts to see if we can get a meeting with them. + + - Nick to get in touch with Chris P. + +- Complete metadata [programming specifications](https://docs.google.com/document/d/1cxwenwSCa_Xh4dw-bqCcWVmYnjjGMgb3X3DGDCflktU/edit?usp=drive_link) (date to be determined, but work on this can still begin to get our ideas out on 'paper'). + +#### **Thoughts for next steps** + +- Decide on moving Pilot 3 adrg.qmd (further discussion needed). + +- Templatize open-source unpacking/re-executing analysis instructions. + +- Contact Alexandra Pearce regarding the PHUSE WG workspace (optional as current way of working may be fine, per Nick M). diff --git a/references/ADRG required sections Screenshot 2024-11-27 145157.png b/references/ADRG required sections Screenshot 2024-11-27 145157.png new file mode 100644 index 0000000000000000000000000000000000000000..73c0e9078c11f3196db0fc8bed2690a5ea9a5b17 GIT binary patch literal 119607 zcmdSBQ+T9J7dASvIk7RZ?POxxwr$%^Cbm7XJ+axbopfwt&-=aKw-5HgKHS&-5Blk= zy4Uk`UDdT#-S=8|RiuKPI07sV?6+^<5F{l;l)ilfoBZ|-lnom4?Hxh--`?=)Z~93G@K5On2!BFBN#kJmj4-{avGTZ&*;bhr$68U1$rcc zhr0?|ByUCcB?on(2R}+4E<^79LZmLVzX$Ub5Jah5MAhN<33g=H9e`dJ3U_f zkt%$V3j-ormGAhp`)qn4$t&43IXIs`l+)WI(hch8@H7^SlSeyr$T=bZ?-16z!+ngz z7@k!m5JEQfJedj%5cbC<&*7mD>=$* 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