OASIS Electronic Trial Master File Standard Technical Committee Meeting Agenda Comment Review Period December 1, :00 – 10:00 AM PDT

Agenda 2 TopicPresenter 9:00 - 9:05Call to Order, welcome new memberZack 9:05 - 9:08Roll Call (secretary: Aliaa)Aliaa 9:08 – 9:10Approval of 11/17 minutesAll 9:10 – 9:15Slate Process ReviewZack 9:15 – 9:35Slates: W39 – W43All 9:35 – 9:55Specification Revision ProcessZack 9:55 – 10:00New business & Next MeetingZack / 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 Fri. 11/24) –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 Appendix C Glossary - B2.1 Core Metadata Comments and Proposed Resolutions “Move to approve Comment Resolutions as written for Slate W39 which includes Comment Log reference numbers 61.CSD1, 57.CSD1, 58.CSD1, 60.CSD1, 59.CSD1, 116.CSD1, 115.CSD1, 101.CSD1, 104.CSD1, 102.CSD1, 99.CSD1, 100.CSD1, 95.CSD1, 96.CSD1, 97.CSD1, 64.CSD1, 49.CSD1, 138.CSD1, 141.CSD1.” Slate: W39

Metadata Vocab Spreadsheet Comments and Proposed Resolutions within range C – C “Move to approve Comment Resolutions as written for Slate W40 which includes Comment Log reference numbers 791.CSD1, 160.CSD1, 527.CSD1, 615.CSD1, 779.CSD1, 469.CSD1, 349.CSD1, 341.CSD1, 529.CSD1, 617.CSD1.” Slate: W40

Metadata Vocab Spreadsheet Comments and Proposed Resolutions within range C – C “Move to approve Comment Resolutions as written for Slate W41 which includes Comment Log reference numbers 175.CSD1, 528.CSD1, 616.CSD1, 393.CSD1, 407.CSD1, 473.CSD1, 153.CSD1, 154.CSD1, 237.CSD1, 377.CSD1, 532.CSD1, 620.CSD1.” Slate: W41

Metadata Vocab Spreadsheet Comments and Proposed Resolutions within range C C “Move to approve Comment Resolutions as written for Slate W42 which includes Comment Log reference numbers 394.CSD1, 523.CSD1, 821.CSD1, 412.CSD1, 392.CSD1, 526.CSD1, 614.CSD1, 530.CSD1, 618.CSD1, 531.CSD1, 619.CSD1, 794.CSD1, 533.CSD1.” Slate: W42

Metadata Vocab Spreadsheet Comments and Proposed Resolutions within range C – General Comments on IRB documents “Move to approve Comment Resolutions as written for Slate W43 which includes Comment Log reference numbers 395.CSD1, 624.CSD1, 792.CSD1, 524.CSD1, 525.CSD1, 317.CSD1, 540.CSD1.” Slate: W43

“I move to approve the comment resolutions for slates W39 – W43 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

91% DONE! 740 of 814 Comment Resolutions ready for vote OR already voted & approved! Spec WkGp: 169 of 243 (70%) complete Metadata WkGp: 571 of 571 (100%) complete Progress As Of Today

Aliaa integrating all comments/actions identified by Spec Work Group into specification Jennifer integrating all comments actions with metadata spreadsheet Future action items compiled into one list Spec ification Revision Process

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