Control/Query Meeting Minutes (Heading 1)



Regulated Clinical Research Information Management (RCRIM) Work Group Meeting Minutes

January 12, 2009

Monday Q3 – Announcement of Co-chair Elections and RPSr2

Attendees

|First Name |Last Name |Affiliation |E-mail Address |

|Yasuhiro |Araki |Pharmaceuticals & Medical Devices|araki-yasuhiro@pmda.go.jp |

|Terri |Booth-Genthe |Wyeth Pharmaceuticals |bootht@ |

|Louis |Boulay |Health Canada |Louis.boulay@nc-sc.gc.ca |

|Alison |Buno |Pfizer |alison.buno@ |

|Doug |Del Prete |IBM |dougdp@us. |

|Robert |DiLaura |Cleveland Clinic |dilaura@ |

|David |Donohue |GlaxoSmithKline |david.a.donohue@ |

|Daigoro |Ebina |Pharmaceuticals & Medical Devices|ebina.daigoro@pmda.go.jp |

|Kristi |Eckerson |Emory University |keckers@emory.edu |

|Joel |Finkle |Image Solutions, Inc. |joel.finkle@ |

|Myron |Finseth |Medtronic |myron.finseth@ |

|William |Friggle |Sanofi Aventis |William.Friggle@sanofi- |

|Richard |Furr |SAFE-Biopharma Association |rfurr@ |

|Davera |Gabriel |University of California, Davis |davera@ucdavis.edu |

|Patricia |Garvey |FDA |patricia.garvey@fda. |

|Scott |Getzin |Eli Lilly and Company |sgetzin@ |

|Gary |Ginsinger |FDA |gary.gensinger@fda. |

|Mark |Gray |FDA |mark.gray@fda. |

|Norman |Gregory |FDA |norman.gregory@fda. |

|Ed |Helton |NCI |heltone2@mail. |

|Joyce |Hernandez |Merck |joyce.hernandez@ |

|David |Iberson-Hurst |CDISC |dibersonhurst@ |

|Wendy |Joarnt |Boston Scientific |wendy.joarnt@ |

|Linda |King |Eli Lilly & Company |king_linda_s@ |

|John |Kiser |Abbott Laboratories |john.kiser@ |

|Rebecca |Kush |CDISC |rkush@ |

|Pierr-Yves |Lastic |Sanofi Aventis |pierre-yves.lastic@sanofi- |

|Peggy |Leizear |FDA |peggy.leizear@fda. |

|Randy |Levin |FDA |Randy.levin@fda. |

|Andrew |Marr |GSK |Andrew.p.marr@ |

|Monica |Mehta |Genzyme |monica.mehta@ |

|Bimal |Nair |HL7 India |bimaln@ |

|Cynthia |Piccirillo |Bristol-Myers Squibb |cynthia.piccirillo@ |

|Cecile |Pistre |Sanofi Aventis |cecile.pistre@sanofi- |

|Mitra |Rocca |Novartis |mitra.rocca@ |

|Jason |Rock |Global Submit |jason.rock@ |

|Karin |Sailor |Medtronic |karin.sailor@ |

|Steve |Sandburg |Mayo Clinic/Foundation |ssandberg@mayo.edu |

|Joerg |Schnitzler |Wyeth Pharmaceuticals |schnitj@ |

|Benjamin |Schoenbrun |Booz Allen Hamilton |schoenbrun.benjamin@ |

|Mary Ann |Slack |FDA |maryann.slack@fda. |

|Kris |Spahr |Wyeth Pharmaceuticals |spahrk@ |

|John |Speakman |NCI |john.speakman@ |

|Ed |Tripp |Abbott Laboratories |edward.tripp@ |

|Marti |Velezis |Sonrisa Consulting |marti.velezis@ |

|Steve |Ward |Lilly |stw@ |

|Taku |Watanbe |PMDA |watanabe-taku@pmda.go.jp |

Attendees by phone and Web Conferencing

|First Name |Last Name |Affiliation |E-mail Address |

|Scott |Becker |Merck |scott_becker@ |

|Dirk |Beth |Mission 3 |dirk@ |

|Bob |Birmingham |J&J |rbirming@prdus. |

|Brent |Jones |Sanofi Aventis |jjoness@ |

|Leah |Kleylein |Octagon |lkleylein@ |

|Shy |Kumar |Datafarm |shy@ |

|Matthew |Lukela |Otsuka Pharmaceutical |matthew.lukela@otsuka- |

|Klaus |Menges |Bfarm |k.menges@bfarm.de |

|Mary |Padgett |FDA |mary.padgett@fda. |

|Donald |Palmer |MedImmune |palmerd@ |

|Mindy |Sperling |Sanofi Aventis |mindy.sperling@sanofi- |

|Sriram |Thiruvengadam |Datafarm |sriram@ |

|Geoff |Williams |Roche |geoff.williams@ |

I. Announcement of co-chair elections – Ed Tripp

There are two openings for co-chair. The seats held by Randy Levin and Ed Helton seats are up for election. Ed Helton is the only candidate for co-chair. There is a new election process this Working Group Meeting. Polls are now open. Those wishing to vote for the co-chair position may pick up a ballot at the registration desk and return it by 5:30 today. The ballot will contain a space for a write in if you desire. To vote you must be an HL7 member and a subscriber to the RCRIM primary listserver as of January 7, 2009. Results will be available tomorrow.

II. RPSr2 - Mary Ann Slack, Jason Rock

The attached slides were presented by Mary Ann to introduce the product.

[pic]

Jason Rock presented the following information about RPS release 1

[pic]

There was a question about the XML Schema for Iteration 1 development.  Mary Ann Slack indicated that Jason had a problem generating the schema based on a technology problem, but that Jason had contacted HL7 and the schema would be generated for him.  Peggy Leizear will follow up with Jason Rock to determine if the schema had been developed yet.

Monday Q4 – RPS

|First Name |Last Name |Affiliation |E-mail Address |

|Paolo |Alcini |EMEA |paolo.alcini@emea.europa.eu |

|Yasuhiro |Araki |Pharmaceuticals & Medical Devices |araki-yasuhiro@pmda.go.jp |

|Bob |Birmingham |J&J |rbirming@prdus. |

|Terri |Booth-Genthe |Wyeth Pharmaceuticals |bootht@ |

|Louis |Boulay |Health Canada |Louis.boulay@nc-sc.gc.ca |

|Alison |Buno |Pfizer |alison.buno@ |

|Tim |Buxton |EMEA |tim.buxton@emea.europa.eu |

|Robert |DiLaura |Cleveland Clinic |dilaura@ |

|David |Donohue |GlaxoSmithKline |david.a.donohue@ |

|Daigoro |Ebina |Pharmaceuticals & Medical Devices |ebina.daigoro@pmda.go.jp |

|Joel |Finkle |Image Solutions, Inc. |joel.finkle@ |

|Myron |Finseth |Medtronic |myron.finseth@ |

|William |Friggle |Sanofi Aventis |William.Friggle@sanofi- |

|Richard |Furr |SAFE-Biopharma Association |rfurr@ |

|Patricia |Garvey |FDA |patricia.garvey@fda. |

|Gary |Ginsinger |FDA |gary.gensinger@fda. |

|Mark |Gray |FDA |mark.gray@fda. |

|Norman |Gregory |FDA |norman.gregory@fda. |

|Ed |Helton |NCI |heltone2@mail. |

|Joyce |Hernandez |Merck |joyce.hernandez@ |

|David |Iberson-Hurst |CDISC |dibersonhurst@ |

|Wendy |Joarnt |Boston Scientific |wendy.joarnt@ |

|John |Kiser |Abbott Laboratories |john.kiser@ |

|Rebecca |Kush |CDISC |rkush@ |

|Peggy |Leizear |FDA |peggy.leizear@fda. |

|Andrew |Marr |GSK |Andrew.p.marr@ |

|Monica |Mehta |Genzyme |monica.mehta@ |

|Cynthia |Piccirillo |Bristol-Myers Squibb |cynthia.piccirillo@ |

|Cecile |Pistre |Sanofi Aventis |cecile.pistre@sanofi- |

|Jason |Rock |Global Submit |jason.rock@ |

|Karin |Sailor |Medtronic |karin.sailor@ |

|Steve |Sandburg |Mayo Clinic/Foundation |ssandberg@mayo.edu |

|Joerg |Schnitzler |Wyeth Pharmaceuticals |schnitj@ |

|Benjamin |Schoenbrun |Booz Allen Hamilton |schoenbrun.benjamin@ |

|Mary Ann |Slack |FDA |maryann.slack@fda. |

|Kris |Spahr |Wyeth Pharmaceuticals |spahrk@ |

|John |Speakman |NCI |john.speakman@ |

|Ed |Tripp |Abbott Laboratories |edward.tripp@ |

|Marti |Velezis |Sonrisa Consulting |marti.velezis@ |

|Steve |Ward |Lilly |stw@ |

|Taku |Watanbe |PMDA |watanabe-taku@pmda.go.jp |

Attendees by phone and Web Conferencing

|First Name |Last Name |Affiliation |E-mail Address |

|Brent |Jones |Sanofi Aventis |jjoness@ |

|Leah |Kleylein |Octagon |lkleylein@ |

|Matthew |Lukela |Otsuka Pharmaceutical |matthew.lukela@otsuka- |

|Klaus |Menges |Bfarm |k.menges@bfarm.de |

|Mary |Padgett |FDA |mary.padgett@fda. |

|Donald |Palmer |MedImmune |palmerd@ |

|Mindy |Sperling |Sanofi Aventis |mindy.sperling@sanofi- |

|Sriram |Thiruvengadam |Datafarm |sriram@ |

|Geoff |Williams |Roche |geoff.williams@ |

III. RPSr2 Development Status - Jason Rock

Jason presented the attached material

[pic]

There was a concern that there is not a defined vocabulary that can be used in testing. This will be addressed in next Tuesday’s conference call. There will also be a discussion with RCRIM Vocabulary on Q4 Wednesday.

Jason provided clarification to the some questions about the proposed specification.  The RMIM has been out for comment for the past 4-6 weeks.  If stakeholders have comments, they should send that information to Jason as soon as possible.  Once the schema is developed, it will be provided to the testing team and vendors.

Marti Velezis reviewed the agenda for the work sessions for Tuesday.

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