Difference between revisions of "Data Standards Monthly Project Lead 30 July 2018 Meeting Minutes"

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(Created page with "=2018-07-30= ==Agenda== <br /> * Project team updates <br /> ==Attendees== * Jane Lozano * Lisa Brooks * Nate Friemark * Sandy VanPelt * Wendy Dobson * Yuliia Bahatska * Lex...")
 
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==Attendees==
 
==Attendees==
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* Dmitry Kolosov
 
* Jane Lozano
 
* Jane Lozano
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* Lex Jansen
 
* Lisa Brooks
 
* Lisa Brooks
 +
* Mike Hamidi
 
* Nate Friemark
 
* Nate Friemark
* Sandy VanPelt
 
 
* Wendy Dobson
 
* Wendy Dobson
* Yuliia Bahatska
 
* Lex Jansen
 
* Mike Hamidi
 
  
 
==Meeting Discussion==   
 
==Meeting Discussion==   
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| '''Working Group'''||'''Lead'''||'''Minutes'''
 
| '''Working Group'''||'''Lead'''||'''Minutes'''
 
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|Best Practices for Data Collection Instructions||Todd Bazin||Team has finished disposition and is now working on adverse events.  Todd is looking through a LONG list of AE related questions and looking to define clear data entry recommendations.  Todd still looking for a co-lead. (No new update from last month)  At Raleigh there is a possible co-lead for Todd.  Wendy to confirm.
+
|Best Practices for Data Collection Instructions||Todd Bazin||Team has finished disposition and is now working on adverse events.  Todd is going to collaborate with the Standard Analysis and Code Sharing working group on adverse eventsMeetings are scheduled in September and October.
|-
 
|Best Practices for Metadata Documentation (Define-XML document versus reviewer's guide)||Sandy VanPelt Nguyen||Team continuing on white paper.  Finishing up on examples and combining content into one paper.  Included is what type of metadata and where it should be documented (Define-XML or reviewer's guide) with the objective to eliminate redundancy.  There is a section on how to handle outliers along with differences between review agenciesWhite paper will be available for Steering Committee review in the last half of June./Running behind between summer vacations and attending Connect.  Looking at middle of July.  Scope will be reduced in order to meet timeline (beyond original scope).  Could submit new project request for additional scope.
 
 
|-
 
|-
|CDISC Primer||Scott Bahlavooni and Peter Van Reusel||Team starting with visualizations.  Final deliverable not yet definedTeam still recruiting members.  (No new update from last month)/Defining scope and boundaries for four topics and have identified a lead for each of themScott has had to step back due to work related duties and Peter has been working on CDISC trainingLooking into interactive tools for this project.  Jasmine Kestermont (Peter's wife) has been involved with the project.  Final deliverable would be interactive visual tools.  Will present at July webinar and to recruit people to start building the tools.   
+
|Best Practices for Metadata Documentation (Define-XML document versus reviewer's guide)||Sandy VanPelt Nguyen||Team continuing on white paperSuggestions for updating the cSDRG template were provided to Jane and were discussed in a LDCP&R meetingFeedback was provided to SandyJane to follow up with her.   
 
|-
 
|-
|Clinical Legacy Data Conversion Plan & Report||Jane Lozano||cSDRG template and completion guidelines updated for the LDCP and to be in alignment with the TCG.  These are to be finalized at the next meeting.  All example documents will be updated after the template is finalized.  The deliverables may be sent to the steering committee separately as the cSDRG is farther along than the ADRG.  The ADRG template has been updated to include the LDCP and to be in alignment with the TCG.  Jane contacted the original authors of the ADRG to ask if they would like to be included in this update.  Jane also let Crystal (FDA) know why a FDA representative would be needed for input similar to what was done with the cSDRG./cSDRG template for LCDP and alignment with TCG along with completion guidelinesNext step is to update the example documents with the LDCP and the current example documents.  The ADRG example document needs an ADRG expert to apply ADaM rules and align the LDCP section with the main section.  A lot of comments, but no one to update it based on the comments.  John Brega gave Jane a name that may be helpful with this taskJane to send email and if not successful Wendy can assist with communications to recruit a volunteerSandy's white paper will have suggestions for the cSDRG.   
+
|CDISC Primer||Scott Bahlavooni and Jasmine Kestermont||The CDISC standards page has been restructured to be more interactive and include visualizationsCDISC and PhUSE to determine how to best collaborate on this projectPresented at the July webinarOut of scope are any FAQs as they are addressed by the SDTM ADaM Implementation FAQ project team.   
 
|-
 
|-
|Data Standards for Observational Studies||Yuliia Bahatska and Vladlen Ivanushkin||New projectWendy indicated that there is a new project memberJane sent project start-up slides to Yuliia and Vladlen to assist with updating the Wiki page for this project./Going to present at July webinar.
+
|Clinical Legacy Data Conversion Plan & Report||Lisa Brooks and Jane Lozano||cSDRG deliverables have been sent to Wendy for discussion at the 10 August CSS Steering Committee meetingDeliverables include the cSDRG template, completion guidelines, two new example documents, updated existing example documents, and a summary of the changes made to the templateThe ADRG template has been updated and the team is working on updating one of the example documents.    
 
|-
 
|-
|Data Reviewer's Guide in XML||Mike Hamidi||Project team is focusing on finalizing the remainder of the XML/Schema content for the DRG in XMLTechnical findings with Schema and StylesheetTeam should have deliverables in June for steering committee review.   (No new update from last month)/Finished a majority of the technical aspects of the projectCurrently fine-tuning the remaining schema tasksAlso working on draft reference document.  Team should have deliverables in July for Lisa and Jane to review.   
+
|Data Reviewer's Guide in XML||Mike Hamidi||The project deliverables are ready for the CSS Steering Committee and will be included in the agenda for the 10 August meetingThere are many deliverablesThe main ones are 1) csdrg.xml 2) sdrg1-0-0.xsl 3) schema folder 4) sdrg-ns.htmlThis is a prototype only and not the final productMike is available on 10 August and will check with a couple other people within his team as he would like them present to answer any questions.   
 
|-
 
|-
|Define-XML v2.0 Completion Guidelines & Stylesheet Recommendations - Define-XML v2.0 Completion Guidelines||Marcellina Hungary and Prafulla Girase||Timeline updated to provide deliverable to Jane and Lisa in AugustTeam members include representatives from CDISC Development TeamHowever, a broader CDISC review will occur after the Steering Committee has reviewed the document.  (No new update from last month)/Last week of July for deliverables.  
+
|Data Standards for Observational Studies||Yuliia Bahatska and Vladlen Ivanushkin||Kick-off meeting plannedDid not have time to present at the July webinarThere are enough people to get started.
 
|-
 
|-
|Define-XML v2.0 Completion Guidelines & Stylesheet Recommendations - Define-XML v2.0 Stylesheet Recomendation)||Dmitry Kolosov and Lex Jansen||Lisa provided comments to Dmitry and LexShe also asked a few people to look at the stylesheetAfter the updates are made, the deliverables will be shared with the steering committee./Lisa's comments (and those from the person that she asked) reviewed by the team.  Next team meeting is 3 July.  Team needs to tighten loose ends before sending to steering committee.  Deliverables will be available for review in July and steering committee agenda on 10 August.  The PhUSE process will ensure that all groups can review.  The project team can send to other groups with the link to the deliverables on the PhUSE site.
+
|Define-XML v2.0 Completion Guidelines||Marcellina Hungary and Prafulla Girase||Timeline updated to provide deliverable to Jane and Lisa in AugustTeam members include representatives from CDISC Development TeamHowever, a broader CDISC review will occur after the Steering Committee has reviewed the document.   (No new update from last month)/Last week of July for deliverables.  
 
|-
 
|-
|Industry Experiences Submitting Standardised Study Data to Regulatory Authorities||Todd Case and Vincent Guo||Jane followed up with Todd and Vincent regarding meeting minutes.  They are also in TeamworksHowever, not everyone has access to Teamworks./Todd, Wendy, and Vincent met last weekMeeting again on 26 June and then will assign people to work on the white paper.  May change name of project - discussion forum live on the Wiki pageKiran and Bhavin attend these meetings to ensure there is no overlap.   
+
|Define-XML v2.0 Stylesheet Recomendation)||Dmitry Kolosov and Lex Jansen||The deliverables are ready for review by the CSS Steering CommitteeThe zip file that Dmitry sent to Wendy, Lisa, and Jane can be provided to the steering committeeAlso, Dmitry and Wendy have had discussions about the survey which will be included in the deliverables sent to the steering committee.   
 
|-
 
|-
|Pooling WHO Drug B3 Format (Best Practices for Integrated Databases)||Joyce Leflar and Marlo Searcy||White paper review period has endedWendy will follow up with Marlo and Joyce to see if they received any comments./Marlo updated the white paper and it has been published on the PhUSE site.  Marlo will present at next quarterly FDA meeting in September.  Project is now concluded and Wendy will archive the project on the Wiki.
+
|Industry Experiences Submitting Standardised Study Data to Regulatory Authorities||Todd Case and Vincent Guo||The project team has divided into three sub-teamsNot sure if one white paper or one from each sub-team.  
 
|-
 
|-
|SDTM ADaM Implementation FAQ||Bhavin Bhusa, Peter Van Reusel, and Kiran Kundarapu||Ongoing project.  Team attended internal quarterly FDA meeting.  Team working on ISS/ISE white paper projectCreated adjudication teamNeed FDA support and team putting together more documentation to request their support.   
+
|SDTM ADaM Implementation FAQ||Bhavin Bhusa, Peter Van Reusel, and Kiran Kundarapu||Ongoing project.  Amy from CDISC is replacing Peter due to his new position at CDISC.  Team is going to write two white papers which will be shared with the CSS Steering Committee at the meeting on 10 AugustDocuments created to request FDA supportTwo new questions and answers have been published.   
 
|-
 
|-
 
|}
 
|}
 
<br />
 
<br />
  
US CSS for 2019 will be in June in Silver SpringUS Connect will be in February 2019 in Baltimore. Registration opens 2 July.   
+
Wendy will have a discussion with Chris regarding the storage location for deliverables that are not published yet but teams are working on them.  Should the Wiki be the place for these documents?
 +
 
 +
<br />
 +
 
 +
The next meeting is 27 August which is a bank holiday in the UKJane will send Wendy her joinme information so that the teams can still meet
  
 
<br />
 
<br />
  
 
==Action Items==
 
==Action Items==
* [Lisa] Follow-up with the people that she asked to look at the Define-XML 2.0 Stylesheet.
+
* [Jane] Follow-up with Sandy regarding the white paper.
* [Wendy] Follow-up with Marlo and Joyce regarding the review of their white paper prior to publishing as a final deliverable.
+
* [Wendy] Follow-up with Chris regarding where deliverables should reside until they are ready for public review.
 
----
 
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[[Category:Minutes]]
 
[[Category:Minutes]]

Latest revision as of 18:04, 30 July 2018

2018-07-30

Agenda


  • Project team updates


Attendees

  • Dmitry Kolosov
  • Jane Lozano
  • Lex Jansen
  • Lisa Brooks
  • Mike Hamidi
  • Nate Friemark
  • Wendy Dobson

Meeting Discussion


Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd Bazin Team has finished disposition and is now working on adverse events. Todd is going to collaborate with the Standard Analysis and Code Sharing working group on adverse events. Meetings are scheduled in September and October.
Best Practices for Metadata Documentation (Define-XML document versus reviewer's guide) Sandy VanPelt Nguyen Team continuing on white paper. Suggestions for updating the cSDRG template were provided to Jane and were discussed in a LDCP&R meeting. Feedback was provided to Sandy. Jane to follow up with her.
CDISC Primer Scott Bahlavooni and Jasmine Kestermont The CDISC standards page has been restructured to be more interactive and include visualizations. CDISC and PhUSE to determine how to best collaborate on this project. Presented at the July webinar. Out of scope are any FAQs as they are addressed by the SDTM ADaM Implementation FAQ project team.
Clinical Legacy Data Conversion Plan & Report Lisa Brooks and Jane Lozano cSDRG deliverables have been sent to Wendy for discussion at the 10 August CSS Steering Committee meeting. Deliverables include the cSDRG template, completion guidelines, two new example documents, updated existing example documents, and a summary of the changes made to the template. The ADRG template has been updated and the team is working on updating one of the example documents.
Data Reviewer's Guide in XML Mike Hamidi The project deliverables are ready for the CSS Steering Committee and will be included in the agenda for the 10 August meeting. There are many deliverables. The main ones are 1) csdrg.xml 2) sdrg1-0-0.xsl 3) schema folder 4) sdrg-ns.html. This is a prototype only and not the final product. Mike is available on 10 August and will check with a couple other people within his team as he would like them present to answer any questions.
Data Standards for Observational Studies Yuliia Bahatska and Vladlen Ivanushkin Kick-off meeting planned. Did not have time to present at the July webinar. There are enough people to get started.
Define-XML v2.0 Completion Guidelines Marcellina Hungary and Prafulla Girase Timeline updated to provide deliverable to Jane and Lisa in August. Team members include representatives from CDISC Development Team. However, a broader CDISC review will occur after the Steering Committee has reviewed the document. (No new update from last month)/Last week of July for deliverables.
Define-XML v2.0 Stylesheet Recomendation) Dmitry Kolosov and Lex Jansen The deliverables are ready for review by the CSS Steering Committee. The zip file that Dmitry sent to Wendy, Lisa, and Jane can be provided to the steering committee. Also, Dmitry and Wendy have had discussions about the survey which will be included in the deliverables sent to the steering committee.
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo The project team has divided into three sub-teams. Not sure if one white paper or one from each sub-team.
SDTM ADaM Implementation FAQ Bhavin Bhusa, Peter Van Reusel, and Kiran Kundarapu Ongoing project. Amy from CDISC is replacing Peter due to his new position at CDISC. Team is going to write two white papers which will be shared with the CSS Steering Committee at the meeting on 10 August. Documents created to request FDA support. Two new questions and answers have been published.


Wendy will have a discussion with Chris regarding the storage location for deliverables that are not published yet but teams are working on them. Should the Wiki be the place for these documents?


The next meeting is 27 August which is a bank holiday in the UK. Jane will send Wendy her joinme information so that the teams can still meet


Action Items

  • [Jane] Follow-up with Sandy regarding the white paper.
  • [Wendy] Follow-up with Chris regarding where deliverables should reside until they are ready for public review.