Difference between revisions of "Data Standards Monthly Project Lead 28 January 2019 Meeting Minutes"

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(Created page with "=2019-01-28= ==Agenda== <br /> * Project team updates <br /> ==Attendees== * Bess LeRoy * Dmitry Kolosov * Jane Lozano * Lex Jansen * Lisa Brooks * Marcelina Hungria * Mike...")
 
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==Attendees==
 
==Attendees==
* Bess LeRoy
+
* Amy Palmer
* Dmitry Kolosov
 
 
* Jane Lozano
 
* Jane Lozano
* Lex Jansen
 
 
* Lisa Brooks
 
* Lisa Brooks
* Marcelina Hungria
 
 
* Mike Hamidi
 
* Mike Hamidi
 +
* Scott Bahlavooni
 
* Wendy Dobson
 
* Wendy Dobson
  
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| '''Working Group'''||'''Lead'''||'''Minutes'''
 
| '''Working Group'''||'''Lead'''||'''Minutes'''
 
|-
 
|-
|Best Practices for Data Collection Instructions||Todd Bazin||Team collaborating on adverse events treatment emergence with the Standard Analysis and Code Sharing working group.  No new updatesJane to contact Todd.
+
|Best Practices for Data Collection Instructions||Todd Bazin||No new updates.  Team collaborating on adverse events treatment emergence with the Standard Analysis and Code Sharing working group.  If there is no movement on this project, it may have to be parked temporarilyMike Hamidi mentioned that the TransCelerate organization may be doing something similar.
 
|-
 
|-
|Best Practices for Metadata Documentation (Define-XML document versus reviewer's guide)||Sandy VanPelt Nguyen||The document is ready for public review. Wendy to put on PhUSE site.
+
|Best Practices for Metadata Documentation (Define-XML document versus reviewer's guide)||Sandy VanPelt Nguyen||The document should be ready for publishing in February. Review period has ended and Sandy is working with the project team to make any suggested updates.
 
|-
 
|-
|CDISC Primer||Beate Hientzsch, Yvonne Moore and Bess LeRoy||Next meeting is 6 December. The team is ensuring the current scope is in alignment with what Peter had planned when this project began.
+
|CDISC Primer||Beate Hientzsch, Yvonne Moore, Bess LeRoy,||Project is regrouping with the plan to have a deliverable published in Q4 2019. They will look to share their draft at the CSS event in June. There are four sub-teams and two of them have leads.  CDISC members can assist with the other 2 projects to help move this forward.
 
|-
 
|-
|Clinical Legacy Data Conversion Plan & Report||Lisa Brooks and Jane Lozano||cSDRG deliverables have been sent to Wendy and will be published this week.  Jane will present at the Webinar on Wednesday a summary of the changes.  ADRG is in progress with all documents drafted and will go to steering committee soon (final drafts completed for template, example, and completion guidelines).
+
|Clinical Legacy Data Conversion Plan & Report||Lisa Brooks and Jane Lozano||cSDRG deliverables have been published on the PhUSE site.  ADRG is in the public review period.
 
|-
 
|-
|Data Reviewer's Guide in XML||Mike Hamidi||Changes have been implemented from the public review.  The deliverables will be published after the meeting with FDA to discuss a pilot.  Mike is aware of changes to the cSDRG and will need to apply updates to his deliverables.
+
|Data Reviewer's Guide in XML||Mike Hamidi||Changes have been implemented from the public review.  FDA is going to do a pilot and the deliverables will be published after pilot.  Will look to do an FR notice with a view to have the paper published in Q419
 
|-
 
|-
|Data Standards for Non-Interventional Studies||Yuliia Bahatska and Vladlen Ivanushkin||Team is working on data examples.  Ron Stewart (Amgen) is scheduled to give a presentation about OMOP and cases that don't fit into ADaM.
+
|Data Standards for Non-Interventional Studies||Yuliia Bahatska and Vladlen Ivanushkin||No new updates.  Team is working on data examples.  Ron Stewart (Amgen) is scheduled to give a presentation about OMOP and cases that don't fit into ADaM. Yuliia is transitioning to a new Company and will look to kick start meetings in February
 
|-
 
|-
|Define-XML v2.0 Completion Guidelines||Marcelina Hungria and Prafulla Girase|| The team has applied updates based on feedback from the steering committee. It will be sent back this week. Public review will be the month of December and part of January.
+
|Define-XML v2.0 Completion Guidelines||Marcelina Hungria and Prafulla Girase|| The team requested additional public review to be extended until January 15th. Public review period is now closed and the project is looking to finalise their White Paper
 +
|-
 +
|Define-XML v2.0 Stylesheet Recomendation)||Dmitry Kolosov and Lex Jansen|| The deliverables have been published on the PhUSE site. This project will not continue as originally discussed. Teamwork will remain open to allow for any communications and the team will manage any questions as and when they come in.
 
|-
 
|-
|Define-XML v2.0 Stylesheet Recomendation)||Dmitry Kolosov and Lex Jansen|| The deliverables have been updated based on public reviewThey are ready to be published. Dmitry and Lex will create a document to summarize the changes based on public review.  Wendy will ask Scott if there is a template that can be used. 
+
|Industry Experiences Submitting Standardised Study Data to Regulatory Authorities||Todd Case and Vincent Guo||No new updates.  The three sub-teams are Communication with Health Authorities (including recommendations), Submission Strategies, and Differences Between FDA and PMDAThe project is meeting weekly to collate all content into one White Paper. Will look to share draft by end of February with Working Group Leads. Aim to go through the review process and present at the CSS in June
 
|-
 
|-
|Industry Experiences Submitting Standardised Study Data to Regulatory Authorities||Todd Case and Vincent Guo||The three sub-teams are Communication with Health Authorities (including recommendations), Submission Strategies, and Differences Between FDA and PMDA.  Team plans to have a draft white paper by year end with conclusion by CSS.
+
|SDTM ADaM Implementation FAQ||Bhavin Bhusa, Amy Palmer, and Kiran Kundarapu||Ongoing project.  Team working on adjudication and ISS/ISE white papers.  White Papers due to be finalised by end of Q1 with a view to having a breakout session at CSS in June. Team continue to receive and respond to questions posted.
|-
 
|SDTM ADaM Implementation FAQ||Bhavin Bhusa, Amy Palmer, and Kiran Kundarapu||Ongoing project.  Team working on adjudication and ISS/ISE white papers.  The was a new question on data submissions that has been answered.
 
 
|-
 
|-
 
|}
 
|}
 
<br />
 
<br />
 +
* Scott presented to those on the call PhUSE Working Group Leads and Project Leads Roles and Responsibilities, including Steering Committee responsibilities. 
 
* Starting to plan for US CSS in June.
 
* Starting to plan for US CSS in June.
 
<br />
 
<br />
  
 
==Action Items==
 
==Action Items==
* [Wendy] Follow-up with Chris regarding where deliverables should reside until they are ready for public review.  Most teams use TeamWorks.
+
* [Jane] Follow-up with Todd Bazin and request an update in timeline for first white paper deliverable.  Include Lisa and Wendy in the email.
* [Wendy] Ask Scott for an example of a document that summarizes changes to deliverables based on public review.
 
* [Todd] Jane to follow up with Todd Bazin and request an update in timeline for first white paper deliverable.  Include Wendy in the email
 
* [Jane] Send updated project tracking spreadsheet to Scott, Wendy, and Bess.  Also put it on the ODS Wiki page.
 
 
----
 
----
  
 
[[Category:Minutes]]
 
[[Category:Minutes]]

Latest revision as of 09:40, 30 January 2019

2019-01-28

Agenda


  • Project team updates


Attendees

  • Amy Palmer
  • Jane Lozano
  • Lisa Brooks
  • Mike Hamidi
  • Scott Bahlavooni
  • Wendy Dobson

Meeting Discussion


Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd Bazin No new updates. Team collaborating on adverse events treatment emergence with the Standard Analysis and Code Sharing working group. If there is no movement on this project, it may have to be parked temporarily. Mike Hamidi mentioned that the TransCelerate organization may be doing something similar.
Best Practices for Metadata Documentation (Define-XML document versus reviewer's guide) Sandy VanPelt Nguyen The document should be ready for publishing in February. Review period has ended and Sandy is working with the project team to make any suggested updates.
CDISC Primer Beate Hientzsch, Yvonne Moore, Bess LeRoy, Project is regrouping with the plan to have a deliverable published in Q4 2019. They will look to share their draft at the CSS event in June. There are four sub-teams and two of them have leads. CDISC members can assist with the other 2 projects to help move this forward.
Clinical Legacy Data Conversion Plan & Report Lisa Brooks and Jane Lozano cSDRG deliverables have been published on the PhUSE site. ADRG is in the public review period.
Data Reviewer's Guide in XML Mike Hamidi Changes have been implemented from the public review. FDA is going to do a pilot and the deliverables will be published after pilot. Will look to do an FR notice with a view to have the paper published in Q419
Data Standards for Non-Interventional Studies Yuliia Bahatska and Vladlen Ivanushkin No new updates. Team is working on data examples. Ron Stewart (Amgen) is scheduled to give a presentation about OMOP and cases that don't fit into ADaM. Yuliia is transitioning to a new Company and will look to kick start meetings in February
Define-XML v2.0 Completion Guidelines Marcelina Hungria and Prafulla Girase The team requested additional public review to be extended until January 15th. Public review period is now closed and the project is looking to finalise their White Paper
Define-XML v2.0 Stylesheet Recomendation) Dmitry Kolosov and Lex Jansen The deliverables have been published on the PhUSE site. This project will not continue as originally discussed. Teamwork will remain open to allow for any communications and the team will manage any questions as and when they come in.
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo No new updates. The three sub-teams are Communication with Health Authorities (including recommendations), Submission Strategies, and Differences Between FDA and PMDA. The project is meeting weekly to collate all content into one White Paper. Will look to share draft by end of February with Working Group Leads. Aim to go through the review process and present at the CSS in June
SDTM ADaM Implementation FAQ Bhavin Bhusa, Amy Palmer, and Kiran Kundarapu Ongoing project. Team working on adjudication and ISS/ISE white papers. White Papers due to be finalised by end of Q1 with a view to having a breakout session at CSS in June. Team continue to receive and respond to questions posted.


  • Scott presented to those on the call PhUSE Working Group Leads and Project Leads Roles and Responsibilities, including Steering Committee responsibilities.
  • Starting to plan for US CSS in June.


Action Items

  • [Jane] Follow-up with Todd Bazin and request an update in timeline for first white paper deliverable. Include Lisa and Wendy in the email.