HL7 RCRIM Working Group Meeting Minutes



Monday Q2

Attendees

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

|Tim |Buxton |EMA |tim.buxton@ema.europa.eu |

|Todd |Cooper |Breakthrough Solutions |T.Cooper@ |

|Isabelle |Davias |Sanofi Aventis |isabelle.davias@sanofi- |

|Dave |Dean |IBM |davedean@us. |

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

|Julie |Evans |CDISC |jevans@ |

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

|Hugh |Glover |Bluewave |hugh@blue-wave.co.uk |

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

|Nicholas |Halsey |European Medicines Agency |Nick.Halsey@ema.europa.eu |

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

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

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

|Charlie |Mead |NCI |meadch@mail. |

|Abdul Malik |Shakir |Shakir Consulting |ashakir@ |

|Salimah |Shakir |Shakir Consulting |salimah@ |

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

|Sadamu |Takasaka |HL7 Japan |s-takasaka@m7.gyao.ne.jp |

|Ed |Tripp |Edward S. Tripp and Associates |edward.tripp@ |

|Wendy |Ver Hoef |Scenpro |wverhoef@ |

I. CRFQ-SFM DSTU Extension

The CRFQ-SFM DSTU is expiring and an extension of 24 months is needed to allow further testing. The primary reason is that the specification is getting some traction and the NCI is now formally launching a project around computable I/E criteria with a focus on cohort selection.  In addition, the European IMI project has identified 4 high-level business use cases on which they want to concentrate funding and two of the four are instances of CRFQ. 

Motion by John Speakman, and seconded by Abdul-Malik Shakir to approve a 24 month DSTU extension.

Affirmative: 14

Negative: 0

Abstain: 3

Motion Carries.

II. CTR&R DAM Ballot Reconciliation Abdul-Malik Shakir

AMS Presented the following slides:

[pic]

|. |Aff |Neg. |Abst. |NV |

|Consultant |1 |4 |3 |2 |

|General Int. |1 |5 |1 |4 |

|Payor |1 |0 |0 |0 |

|Pharmaceutical |45 |1 |0 |8 |

|Provider |10 |0 |15 |2 |

|Vendor |2 |0 |15 |4 |

|Totals |60 |10 |47 |26 |

|% of Votes |41.96% |6.99% |32.87% |18.18% |

|Quorum |81.82% |

|Approval |42 |

[pic]

III. CTR&R Message Ballot Reconciliation Abdul-Malik Shakir

|  |Aff. |Neg. |Abst. |NV |

|Affiliate |0 |0 |12 |6 |

|Consultant |1 |1 |7 |2 |

|General Int. |1 |5 |1 |3 |

|Payor |1 |0 |0 |0 |

|Pharmaceutical |44 |1 |0 |7 |

|Provider |10 |1 |15 |2 |

|Vendor |1 |1 |16 |4 |

|Totals |58 |9 |51 |24 |

|% of Votes |40.85% |6.34% |35.92% |16.90% |

|Quorum |83.10% |

|Approval |41 |

[pic]

The intent on reconciliation is to place the comments into categories and weed out duplicates. Then begin to identify what needs to be addressed and propose disposition. The proposed reconciliation will be reviewed at a future RCRIM teleconference.

The project intent is to reconcile, publish as a DSTU (a minimum of a year) and present some initial test results at the October WGM.

There is a proposal to move CTR&R to an international status. The following resolution was made at last week’s ISO meeting.

Resolution 18: Resolved that ISO/TC215 approves the WG 2 recommendation that the ISO/TC215 Secretariat circulates the NWIP ballot of “Clinical Trial Registration and Results” for approval as a new work item targeting [an International Standard] [a XX ] and that the Form 4 and a document arrives at the TC Secretariat no later than 2010-05-28 to be placed on the ISO/TC 215 balloting portal no later than 2010-06-14.

Monday Q3

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

|Larry |Callahan |FDA |Lawrence.Callahan@fda. |

|Isabelle |Davias |Sanofi Aventis |isabelle.davias@sanofi- |

|Dave |Dean |IBM |davedean@us. |

|Julie |Evans |CDISC |jevans@ |

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

|Hugh |Glover |Bluewave |hugh@blue-wave.co.uk |

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

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

|Rebecca |Kush |CDISC |rkush@ |

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

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

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

|Ken |Toyoda |HL7 Japan |kent105@ |

|Ed |Tripp |Edward S. Tripp and Associates |edward.tripp@ |

|Steve[1] |Ward |Lilly |stw@ |

I. BRIDG as a DAM Ballot Reconciliation Julie Evans

|  |Aff. |Neg. |Abst. |NV |

|Consultant |5 |4 |1 |2 |

|General Int. |1 |0 |5 |5 |

|Payor |1 |0 |0 |0 |

|Pharmaceutical |18 |18 |1 |8 |

|Provider |12 |1 |14 |4 |

|Vendor |1 |0 |16 |4 |

|Totals |46 |24 |41 |28 |

|% of Votes |33.09% |17.27% |29.50% |20.14% |

|Quorum |79.86% |

|Approval |42 |

[pic]

Julie presented the following slides

[pic]

The comments were reviewed and possible reconciliations were discussed. Target is to resolve all comments by end of July. The proposed reconciliation will be reviewed at a future RCRIM teleconference.

Monday Q4

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

|Larry |Callahan |FDA |Lawrence.Callahan@fda. |

|Isabelle |Davias |Sanofi Aventis |isabelle.davias@sanofi- |

|Dave |Dean |IBM |davedean@us. |

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

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

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

|Rebecca |Kush |CDISC |rkush@ |

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

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

|Gunther |Schadow |Regenstrief Institute, Inc. |gunther@aurora. |

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

|Ed |Tripp |Edward S. Tripp and Associates |edward.tripp@ |

|Steve[2] |Ward |Lilly |stw@ |

I. e-Stability Ballot Reconciliation Norman Gregory

|  |Aff. |Neg. |Abst. |NV |

|Affiliate |0 |1 |12 |4 |

|Consultant |2 |0 |3 |1 |

|General Int. |2 |0 |0 |0 |

|Payor |1 |0 |1 |0 |

|Pharmaceutical |24 |0 |3 |5 |

|Provider |21 |1 |2 |2 |

|Vendor |1 |0 |18 |4 |

|Totals |51 |2 |39 |16 |

|% of Votes |47.22% |1.85% |36.11% |14.81% |

|Quorum |85.19% |

|Approval |40 |

[pic]

All items were reviewed for disposition. It was agreed that use of Common Product Model would be in release 3 of the standard. The comment by Sylvia Thun requires follow-up with the commenter. If discussion can occur at the WGM, then we will revisit the reconciliation during meetings on Tuesday, otherwise, the proposed reconciliation will be reviewed at a future RCRIM teleconference.

II. SPL5r Ballot Reconciliation Gunther Schadow

|  |Aff. |Neg. |Abst. |NV |

|Affiliate |5 |0 |13 |6 |

|Consultant |3 |0 |3 |1 |

|General Int. |1 |1 |4 |6 |

|Payor |1 |0 |1 |0 |

|Pharmaceutical |48 |0 |4 |7 |

|Provider |1 |19 |3 |4 |

|Vendor |5 |0 |10 |4 |

|Totals |64 |20 |38 |28 |

|% of Votes |42.67% |13.33% |25.33% |18.67% |

|Quorum |81.33% |

|Approval |51 |

[pic]

Gunther presented proposals to address all comments. A motion was made by Norman Gregory and seconded by Andrew Marr to accept the reconciliation as presented by Gunther.

Affirmative: 12

Negative: 0

Abstain: 0

Motion Carries.

The reconciliation package will be posted and once a request to withdraw negatives has been made a DSTU publication request (12 months) will be reviewed at a future RCRIM teleconference.

End of Document[pic][pic][pic][pic][pic][pic][pic][pic]

-----------------------

[1] Attended via web meeting

[2] Attended via web meeting

................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download