Electronic Trial Master File Standard Technical Committee Meeting - - PowerPoint PPT Presentation

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Electronic Trial Master File Standard Technical Committee Meeting - - PowerPoint PPT Presentation

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OASIS Electronic Trial Master File Standard Technical Committee Meeting Agenda Comment Review Period October 6, 2014 9:00 10:00 AM PDT Dial 860-970-0010 ID: 567-753-030# Agenda Topic Presenter 9:00 - 9:05 Call to Order (secretary:

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SLIDE 1

OASIS Electronic Trial Master File Standard Technical Committee

Meeting Agenda Comment Review Period

October 6, 2014 9:00 – 10:00 AM PDT Dial 860-970-0010 ID: 567-753-030#

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SLIDE 2

Agenda

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Topic Presenter

9:00 - 9:05 Call to Order (secretary: Mead) Zack 9:05 - 9:08 Roll Call Jennifer 9:08 – 9:10 Approval of 9/8 and 9/15 minutes Mead 9:10 – 9:15 Slate Process Review Zack 9:15 – 9:50 Slates: W8, W9, W10, W12, W13, W14 All 9:50 – 9:55 Provider Solutions Webinar Zack 9:55 – 10:00 New business & Next Meeting Zack / All

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SLIDE 3

Roll Call

Name Company Voting Status Present?

Jennifer Alpert Palchak CareLex Member/Voter Aliaa Badr CareLex Member/Voter Oleksiy (Alex) Palinkash CareLex Member/Voter Beau Grignon Forte Research Systems Member Troy Jacobson Forte Research Systems Member/Voter Junichi Ishida Fujitsu Limited Member/1st Meeting Mead Walker Health Level 7 (HL7) Member Lou Chappuie Individual Member/Voter Lisa Mulcahey Individual Member Sharon Elcombe Mayo Clinic Member/Voter Robert Gehrke Mayo Clinic Member Sharon Ames NextDocs Member/Voter Prabhat Vatsal NextDocs Member Rich Lustig Oracle Member/Voter Michael Agard Paragon Solutions Member/Voter Chris McSpiritt Paragon Solutions Member Jamie O'Keefe Paragon Solutions Member Fran Ross Paragon Solutions Member/Voter Peter McNaney Phlexglobal Ltd. Member Peter Alterman SAFE-BioPharma Association Member/Voter Catherine Schmidt SterlingBio Member/Voter Ayrat Sadreev SureClinical Member/2nd Meeting Zack Schmidt, Co-Chair SureClinical Member/Voter Trish Whetzel SureClinical Member/Voter Robin Cover OASIS OASIS Staff Contact Chet Ensign OASIS OASIS Staff Contact

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SLIDE 4
  • TC’s often use Slates (vote on group of resolutions)

– Slates posted and reviewed by TC prior to meeting (posted Wed 10/1) – Slate announced, TC members ‘pull’ items to discuss – TC votes on items that remain on slate up for vote – TC then discusses items pulled from slate followed by vote

  • Voting on comment response only, does not limit

alterations to actual Spec, MV, Code

  • Changes to be integrated in Spec, RDF/XML code, and MV

spreadsheet and will be reviewed again by TC

Use of Slates for Voting

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SLIDE 5
  • Specification Section 1 & 2 Comments and Proposed

Resolutions “Move to approve Comment Resolutions as written for Slate W8 which includes Comment Log reference numbers 765.CSD1, 763.CSD1, 761.CSD1, 762.CSD1, 764.CSD1, 514.CSD1, 121.CSD1, 214.CSD1, 74.CSD1, 769.CSD1 , 163.CSD1 , 243.CSD1 , 759.CSD1.”

Slate: W8

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SLIDE 6
  • Specification Section 3 & 4 Comments and Proposed

Resolutions “Move to approve Comment Resolutions as written for Slate W9, which includes Comment Log reference numbers 758.CSD1, 244.CSD1, 82.CSD1, 45.CSD1, 46.CSD1, 83.CSD1, 746.CSD1, 309.CSD1, 756.CSD1, 245.CSD1, 123.CSD1, 127.CSD1.”

Slate: W9

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SLIDE 7
  • Specification Section 5 Comments and Proposed

Resolutions “Move to approve Comment Resolutions as written for Slate W10 which includes Comment Log reference numbers 745.CSD1, 310.CSD1, 126.CSD1, 824.CSD1, 809.CSD1, 515.CSD1, 755.CSD1, 84.CSD1, 240.CSD1, 247.CSD1, 241.CSD1, 85.CSD1.”

Slate: W10

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SLIDE 8
  • Specification Section 6 and Appendix B Comments and

Proposed Resolutions

  • “Move to approve Comment Resolutions as written for

Slate W11, which includes Comment Log reference numbers 89.CSD1, 90.CSD1, 91.CSD1, 92.CSD1, 48.CSD1, 53.CSD1, 50.CSD1, 51.CSD1, 56.CSD1, 75.CSD1.”

Slate: W11

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SLIDE 9
  • Metadata Vocab Spreadsheet Comments and

Proposed Resolutions within range C101129 - C115470 “Move to approve Comment Resolutions as written for Slate W12 which includes Comment Log reference numbers 726.CSD1, 416.CSD1, 415.CSD1, 493.CSD1, 414.CSD1, 492.CSD1, 712.CSD1, 721.CSD1, 671.CSD1, 494.CSD1, 427.CSD1, 648.CSD1.”

Slate: W12

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SLIDE 10
  • Metadata Vocab Spreadsheet Comments and Proposed

Resolutions within range C115476 – C115505 “Move to approve Comment Resolutions as written for Slate W13, which includes Comment Log reference numbers 381.CSD1, 600.CSD1, 378.CSD1, 685.CSD1, 480.CSD1, 703.CSD1, 564.CSD1, 455.CSD1, 662.CSD1, 460.CSD1, 669.CSD1, 477.CSD1, 699.CSD1.”

Slate: W13

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SLIDE 11
  • Metadata Vocab Spreadsheet Comments and Proposed

Resolutions within range C115506 - C115524 “Move to approve Comment Resolutions written for Slate W14, which includes Comment Log reference numbers 445.CSD1, 652.CSD1, 448.CSD1, 656.CSD1, 488.CSD1, 711.CSD1, 467.CSD1, 676.CSD1, 356.CSD1, 576.CSD1, 680.CSD1, 470.CSD1, 681.CSD1, 386.CSD1, 604.CSD1.”

Slate: W14

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SLIDE 12
  • “I move to approve the comment resolutions for slates

W8 – W14 as described in the Comment Log and listed in the meeting slides, with the exception that any references to individual names in the comments shall be removed prior to publication.”

Voting On Slates

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SLIDE 13
  • New Business

– Zack: Upcoming DIA Solution Provider webinar – Spec workgroup: Wednesdays, 8:00-9:30 PST – MV workgroup: Wednesdays, 1pm- 2:30 pm PST

  • Next TC Meetings (all 9am-10:30 PDT unless otherwise agreed)

– October 20 secretary = Michael Agard – November 3 secretary = Rich Lustig – November 17 secretary = needed

New Business & Next Meeting