OASIS Electronic Trial Master File Standard Technical Committee Meeting Agenda Comment Review Period November 17, :00 – 10:00 AM PDT

Agenda 2 TopicPresenter 9:00 - 9:05Call to Order, welcome new membersJennifer 9:05 - 9:08Roll Call (secretary: Mead)Mead 9:08 – 9:10Approval of 10/6 & 11/3 minutesAll 9:10 – 9:15Slate Process ReviewJennifer 9:15 – 9:50Slates: W31 – W38All 9:50 – 9:55Progress ReportJennifer 9:55 – 10:00New business & Next MeetingJennifer / All

Roll Call NameCompanyVoting StatusPresent? Jennifer Alpert PalchakCareLexMember/Voter Aliaa BadrCareLexMember/Voter Oleksiy (Alex) PalinkashCareLexMember Beau GrignonForte Research SystemsMember Troy JacobsonForte Research SystemsMember/Voter Junichi IshidaFujitsu LimitedMember Mead WalkerHealth Level 7 (HL7)Member Lou ChappuieIndividualMember/Voter Lisa MulcaheyIndividualMember Sharon ElcombeMayo ClinicMember Robert GehrkeMayo ClinicMember Sharon AmesNextDocsMember Prabhat VatsalNextDocsMember Rich LustigOracleMember/Voter Lorie McClainOracleMember Michael AgardParagon SolutionsMember/Voter Karen McCarthy SchauParagon SolutionsMember/Voter Chris McSpirittParagon SolutionsMember Jamie O'KeefeParagon SolutionsMember Fran RossParagon SolutionsMember Peter McNaneyPhlexglobal Ltd.Member Peter AltermanSAFE-BioPharma AssociationMember/Voter Catherine SchmidtSterlingBioMember/Voter Chris IbellSureClinicalMember/Voter Ayrat SadreevSureClinicalMember/Voter Zack Schmidt, Co-ChairSureClinicalMember/Voter Trish WhetzelSureClinicalMember

TC’s often use Slates (vote on group of resolutions) –Slates posted and reviewed by TC prior to meeting ( posted Thur. 11/11) –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

Specification Section 6.2 – B2.1 Comments and Proposed Resolutions “Move to approve Comment Resolutions as written for Slate W31 which includes Comment Log reference numbers 26.CSD1, 135.CSD1, 27.CSD1, 143.CSD1, 215.CSD1, 813.CSD1, 238.CSD1, 258.CSD1, 259.CSD1, 103.CSD1, 105.CSD1, 98.CSD1, 94.CSD1,137.CSD1.” Slate: W31

Metadata Vocab Spreadsheet Comments and Proposed Resolutions within range C C “Move to approve Comment Resolutions as written for Slate W32 which includes Comment Log reference numbers 468.CSD1, 426.CSD1, 172.CSD1, 340.CSD1, 472.CSD1, 436.CSD1, 636.CSD1, 435.CSD1, 635.CSD1, 171.CSD1, 773.CSD1, 561.CSD1, 164.CSD1, 264.CSD1, 559.CSD1, 167.CSD1, 771.CSD1, 337.CSD1.” Slate: W32

Metadata Vocab Spreadsheet Comments and Proposed Resolutions within range C C16735 “Move to approve Comment Resolutions as written for Slate W33 which includes Comment Log reference numbers 169.CSD1, 170.CSD1, 772.CSD1, 168.CSD1, 338.CSD1, 562.CSD1, 770.CSD1, 336.CSD1, 231.CSD1, 166.CSD1, 397.CSD1, 339.CSD1, 491.CSD1, 413.CSD1, 490.CSD1, 354.CSD1, 200.CSD1.” Slate: W33

Metadata Vocab Spreadsheet Comments and Proposed Resolutions within range C C42774 “Move to approve Comment Resolutions as written for Slate W34 which includes Comment Log reference numbers 495.CSD1, 713.CSD1, 417.CSD1, 715.CSD1, 722.CSD1, 728.CSD1,191CSD1, 192.CSD1, 190.CSD1, 419.CSD1, 719.CSD1, 716.CSD1, 724.CSD1, 420.CSD1, 723.CSD1, 572.CSD1, 197.CSD1, 196.CSD1, 729.CSD1, 718.CSD1, 727.CSD1.” Slate: W34

Metadata Vocab Spreadsheet Comments and Proposed Resolutions within range C54623 – C97107 “Move to approve Comment Resolutions as written for Slate W35 which includes Comment Log reference numbers 605.CSD1, 369.CSD1, 584.CSD1, 714.CSD1, 360.CSD1, 219.CSD1, 370.CSD1, 781.CSD1, 221.CSD1, 220.CSD1, 281.CSD1, 361.CSD1, 273.CSD1, 418.CSD1, 717.CSD1, 807.CSD1, 438.CSD1, 644.CSD1, 496.CSD1, 725.CSD1, 720.CSD1, 589.CSD1, 374.CSD1, 782.CSD1.” Slate: W35

General Commentary and Questions on the Specification and Metadata Vocabulary “Move to approve Comment Resolutions as written for Slate W36 which includes Comment Log reference numbers 823.CSD1, 150.CSD1, 151.CSD1, 149.CSD1, 161.CSD1, 308.CSD1, 232.CSD1, 411.CSD1, 549.CSD1, 230.CSD1, 409.CSD1, 774.CSD1, 66.CSD1, 69.CSD1, 76.CSD1, 80.CSD1, 73.CSD1, 72.CSD1, 62.CSD1, 77.CSD1, 78.CSD1, 79.CSD1.” Slate: W36

Commentary on Requested Metadata Vocabulary “Move to approve Comment Resolutions as written for Slate W37 which includes Comment Log reference numbers 501.CSD1, 734.CSD1, 522.CSD1, 507.CSD1, 736.CSD1, 242.CSD1, 504.CSD1, 304.CSD1, 737.CSD1, 502.CSD1, 735.CSD1, 499.CSD1, 302.CSD1, 732.CSD1, 498.CSD1, 731.CSD1, 301.CSD1, 286.CSD1, 608.CSD1, 789.CSD1, 497.CSD1, 300.CSD1.” Slate: W37

Commentary on Requested Metadata Vocabulary “Move to approve Comment Resolutions as written for Slate W38 which includes Comment Log reference numbers 730.CSD1, 505.CSD1, 305.CSD1, 738.CSD1, 535.CSD1, 500.CSD1, 303.CSD1, 733.CSD1, 503.CSD1, 739.CSD1, 639.CSD1, 288.CSD1, 287.CSD1, 638.CSD1, 283.CSD1, 391.CSD1, 521.CSD1, 610.CSD1, 790.CSD1, 546.CSD1.” Slate: W38

“I move to approve the comment resolutions for slates W31 – W38 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

Progress As of Today

New Business –All –Spec workgroup: Wednesdays, 8:00-9:30 PST –MV workgroup: Wednesdays,1:00-2:30 PST Upcoming TC Meetings (all 9am-10:30 PST unless otherwise agreed) –November 17 secretary = Mead Walker –December 1 secretary = Aliaa Badr –December 15 secretary = Karen McCarthy Schau –January 5 secretary = Needed –January 19 secretary = Needed New Business & Next Meeting