RCRIM minutes HL7 Working Group Meetings



RCRIM minutes HL7 Working Group Meetings

Monday, 24 January 2005

Attendees:

|NAME |AFFILIATION |EMAIL |Q3 |Q4 |

|Baranoski, Lori |BMS |Lori.baranoski@ |X |X |

|Barnes, Joan |U of MN |Jbarnes@ |X | |

|Buxton, Tim |EMEA |Tim.buxton@emea.eu.int |X |X |

|Eckert, Karen |W R Health |Keckert@ |X |X |

|Edwards, Claire |EMEA |Claire.edwards@emea.eu.int |X |X |

|Evans, Lee |Intrasphere |Lee.evans@ |X |X |

|Friggle, Bill |Sanofi-Synthelabo |William.friggle@sanofit. |X |X |

|Getzin, Scott |Lilly |Sgetzin@ |X | |

|Gibson, Laura |WK Health |Lgibson@ | | |

|Gitterman, Steve |FDA |Steven.gitterman@fob. |X |X |

|Gregory, Norman |FDA |Ngregory@com. |X |X |

|Hollinger, Kathy |FDA |Khollinger@oc. |X |x |

|Levin, Randy |FDA |Randy.levin@ |X |X |

|Martin, Ross |Pfizer, Inc. |ross.martin@ |X | |

|Mehta, Mukesh |Thomson |Mukesh.mehta@ |X |X |

|Palmer, Donald |Octagon Research |Dpalmer@ |X |X |

|Palmer, Michael |ZBI |Mcpalmer@ |X |X |

|Powell, Sarah |FCG |Spowell@ | |X |

|Quade, Linda |Lilly |LindaQ@ |X |X |

|Ruggieri, Alex |Amgen |Alex.ruggieri@ | | |

|Spaita, Kristofer |Wyeth |Spahrk@ |X |X |

|Tardiff, Barbara |Merck, CDISC |Barbara_Tardiff@ |X |X |

|Tripp, Ed |Abbott |Edward.tripp@ |X |X |

|Wallace, Robert |Lilly |Wallace.r.h.@ |X |X |

|Ward, Steve |Lilly |Stw@ |X |X |

| | | | | |

|On Phone: | | | | |

|Arnold, Liz |Merck | |X | |

|Jenkins, Joe |Arbortext | |X | |

|Stefano, Toni |FDA | |X |X |

|Thomas, Patrick |Octagon | |X |X |

|Wilusz, Mary Beth |Merck | |X | |

| | | | | |

|Thompson, Cheryl |UNMC |CBThompson@unmc.edu | |X |

|Hurley, Julie |Abbott Labs | |X |X |

|Rueda, J.A. |EMEA |Juan.rueda@emea.eu.int | | |

|Small, Lisa |Pfizer |Smalllw@pfizer,com | | |

| | | | | |

|Nijuota, Garrettq |Sanofi | | |X |

|Palsgrove, Drew |Wyeth | | |X |

|Ware, Rich |Astra Zeneca | | |X |

|Joshi, Samir |Wyeth | | |X |

Monday Q3

I. SPL Implementation Guide: SPL Release 2 (a)

Facilitators: Kris Spahr, Steve Gitterman

[pic]

[see ballot reconciliation]

1. Kris Spahr provided an overview of the SPL Project Team Organization and their efforts.

2. Strategy for ballot cycle - implementation guide, release 2a, and release 2b

3. Ballet responses for Implementation Guide and Release 2a to be covered this session. Release 2b to be covered next session.

4. Linda clarified that the committee needs to concur with responses to ballot comments and then we need to communicate resolution with each voter.

5. Steve Gitterman went through ballot comments on Implementation Guide. Majority were comments. Two negative ballots – one judged persuasive with modifications, the other persuasive. See ballot reconciliation for details.

6. Right now SPL points back to CDA. Changes to narrative block are being harmonized with CDA. Linda mentioned that there is an initiative underway to pull out common elements of structured document in one specification. Each implementation of structured documents would then be a constrained version of a structured document.

7. Implementation Guide is basically a guide for SPL 2(a). It is implementation including changes to release 2(a). Depending on vote on release 2 (b) the team will modify implementation guide. It would be helpful to have a committee ballot of the new implementation guide at the same time as the next ballot.

8. Motion to accept proposed resolution by Barbara Tardiff (BT), Linda Quade (LQ) seconded. 23 affirm, 0 negative, balance abstained.

9. Gunther reviewed the ballot comments for Release 2(a). Set ballot reconciliation for details. Robert Wallace clarified that not all content is structured.

Monday Q4

II. SPL Release 2(b)

Facilitators: Kris Spahr, Steve Gitterman

[see ballot reconciliation]

1. Continuation of review of responses and discussion from Q3. See ballot reconciliation.

2. Motion to accept proposed resolution by BT. LQ seconded. 22 affirm, 0 negative, balance abstained.

3. Motion to accept move SPL release 2 to membership ballot contingent on withdrawal of negative and agreement by TSC chair to allow despite modest substantive change by BT. NG seconded. 22 affirm, 0 negative, balance abstained.

Tuesday 25 January 2005

Attendees:

|NAME |AFFILIATION |EMAIL |Q1 |Q2 |Q3 |Q4 |

|Allard, Dave |IBM |Allard@us. |X | | | |

|Bakva, Vivinder |IBM |Bakra@us. |X | | | |

|Basson, Susan |CDISC |s.basson@ |X |X | | |

|Bennett, Craig |IBM |Cbennett@us. | | | | |

|Boes, Becky |U. Pitt |Boesr@upmc.edu |X |X | | |

|Brown, Barry |Mortara |Barry.brown@ |X | |X | |

|Buxton, Tim |EMEA |Tim.buxton@emea.eu | |X | | |

|Droust, Norwcu |Debost Assoc. | |X | | | |

|Evans, Julie |CDISC |Jevans@ |X | | | |

|Evans, Lee |Intrasphere |Lee.Evans@ |X |X |X | |

|Fendt, Kaye |UNC-Sch of Med |Kaye_fendt@unc.edu | | |X | |

|Franck, Richard |IBM |Richard.franch@us. | | | | |

|Fridsma, Doug |U of Pitt |Fridsma@cbmi.pitt.edu |X |X | | |

|Friggle, Bill |Sanofi-Synthelabo |William.friggle@sanofi- |X |X |X |X |

|Getzin, Scott |Lilly |Sgetzin@ |X |X |X | |

|Gitterman, Steven |FDA |Steven.gitterman@fob. |X |X | | |

|Hastak, Smita |Scenpro |Hastaks@mail. |X |X | | |

|Hernandez, Joyce |IBM |Jhernandez@us. |X |X | | |

|Hihai, Masaaki |Nihon Kohden |Masaaki_hihai@mgl.nkc.co.jp | | |X | |

|Hollinger, Kathy |FDA |Kholling@oc. | | | | |

|Hurley, Julie |Abbott, Labs |Julie.hurely@ |X |X |X |X |

|Kacher, Don |Oracle |Donald.kacher@ | |X |X | |

|Karen Pieper |DCRI |Karen.pieper@duke.edu | |X | | |

|Kaufman, Jill |IBM |Jill.kauf@ |X | | | |

|Kush, Rebecca |CDISZ |Rkush@ |X |X | | |

|Levin, Randy |FDA |Randy.levin@ |X |X |X | |

|Liu, Steven |NIH/NCICB |Liusi@mail. |X |X | | |

|McCourt, Brian |DCRI |Brianmccourt@duke.edu | |X | | |

|Murhpy, Shawn |Partners Healthcare |Murphy.shawn@mgh.harvard,edu | | | | |

|Nakaya, Jun |Kobe University |Junnaka@med.kobe.u.ac.jp |X |X | | |

|Nahm, Meredith |DCRI/CDISC |Meredith.nahme@duke.edu |X |X |X |X |

|O’Connor, Kristin |BIRI |Koconnor@rdg.boehringer- |X |X |X | |

|Obayashi, Masaharu |Kann Kogoku Ltd. |Obayashi@ktherapy.jp | | | | |

|Palmer, Donald |Octagon Research | |X | | |X |

|Palmer, Michael |ZBI |Mcpalmer@.int | |X | | |

|Quade, Linda |Lilly |Lindaq@ |X |X |X |X |

|Richesson, Rachel |USF/Rare Disease Network |Richesrl@moffitt.usf.edu |X |X |X | |

|Ruggieri, Alex |Amgen, Inc |Aruggier@ |X |X | | |

|Schmandt, Linda |U. Pitt |Lms@pitt.edu |X |X | | |

|Schulter, Paul |GE Healthcare |Paul.schulter@med. | | |X | |

|Shabo, Amnon |IBM |Shabo@ |X | | | |

|Spahr, Krisofer |Wyeth |Spahrk@ |X |X | | |

|Stevens, Lise |FDA |Stevensl@cbu. | | | | |

|Takasaka, Satami |Kanazawa Univ Hospital |Sanbista. | |X | | |

|Tardiff, Barbara |Merck |Barbara_tardiff@ |X |X |X |X |

|Thompson, Cheryl |UNMC-con |CBThompson@ |X |X | | |

|Tripp, Ed |Abbott |Edward.trip@ |X |X | | |

|Verhoef, Wendy |ScenPro/NCICB |Verhoefw@ |X |X | | |

|Walden, Anita |DCRI |Anita.walden@duke.edu | |X | | |

|Walden, Anita |DCRI |Anital.walden@duke,edu | | |X | |

|Walker,Mead |MWC |Dmed@ | | | |X |

|Willoughby, Cara |Lilly |Willoughby_cara@ |X |X | | |

Tuesday Q1

I. Business meeting: Approval of minutes, Updates from Teleconferences, Model management; co-chair election

Facilitators: Linda Quade

[pic]

1. Attendees introduced themselves. There were many new attendees.

2. Approval of minutes from September Working Group meeting. Linda made a motion to approve minutes as posted to web site. Motion was seconded and approved. 16 affirmative, 0 negative, 8 registered abstentions.

3. Actions from Teleconferences: Linda summarized actions from teleconferences (see word document) and reviewed teleconference schedule until next working group meeting.

4. Harmonization Update: Linda reviewed the purpose of the Harmonization Meeting and how it works. She summarized resolutions following recent requests from RCRIM. (see document)

5. There was a significant discussion around vocabulary. Patient Safety has initiated an effort related to vocabulary and offered to incorporate RCRIM into their efforts. Alex Ruggieri, Joyce Hernandez, Peter Elkin, Smita volunteered to work with Lise on this. Susan Bassion is leading a CDISC team and indicated an interest in getting a participant who understands HL7. There is an upcoming face-to-face meeting on February 11th.

6. Suggestions to set up a vocabulary group on RCRIM list serve. Individuals from CDISC and HL7 will collaborate in identifying a process for progressing vocabulary development and specifications. This group will present at the May meeting at joint RCRIM, Clinical Genomics SIG. Patient Safety SIG session.

7. Bill Friggle presented recently at PRIMAG – a group focused on electronic interchanges between trade associations and regulatory authorities in Europe. Clearly shared interests – their appeared to be a lot of interest and may generate some thoughts and participation.

8. Model management: Group has had a couple of teleconferences and has a series of recommendations.

9. Linda showed a high level flow of the models included in HDF process. Design Space Analysis Model (DSM) and ODM being mapped separate to RIM because of scope. Normally and in addition they constitute requirements for RCRIM Domain Analysis Model(s). Earliest standards (CT Lab, Case Notification) did not follow entire process. Second generation standards (ICSR, Annotated ECG) recognized commonly and led to development of Public Health Reporting and Clinical Trials DMIM. Now we are filling in the Domain Analysis Model. The Model Management committee has developed a series of recommendations. These will be presented and discussed next session.

Tuesday Q2

II. Domain space Analysis Model (aka Problem Space Model) Status and Next Steps: Presentation and discussion of NIH sponsored, DCRI led initiatives to develop Data Standards for selected domains (cardiovascular disease and TB)

Facilitators: Julie Evans, Tony Freibel, Charlie Mead; Meredith Nahm

[pic]

1. Julie reviewed the process and progress on developing the Domain Space Model. The initiative was initially called the Problem Space Model but since “problem” sounds negative to some ears the name was changed to domain space model. Timeline projects RIM harmonization Mar-May 2005 with V3 message development in June-Sept 2005 and balloting of these messages after October 2005.

2. Julie referred back to Linda’s diagram. One of the questions is whether there should be separate Domain Analysis Model for RCRIM (based on Domain Space Model) or if the Domain Space model is the Domain Analysis Model.

3. Recommendations:

1) Models should be made accessible via the RCRIM website

2) RCRIM should formally adopt the CDISC Design Space Analysis Model as working Domain Analysis Model for RCRIM. Expect that CDISC will continue to develop DSAM and RCRIM may expand model to accommodate requirements that are outside CDISC DSAM interest or scope.

3) RCRIM should establish a DAM development project which would be responsible for tracking changes to CDISC DSAM and keeping DAM up to date.

4) RCRIM should formally adopt the existing DMIMs on which current standards are based.

5) RCRIM should establish model reconciliation project to produce internal consistency among models.

6) RCRIM should continue to develop standards using existing V3 domains (Public Health Reporting and Regulated Studies). One TC can have more than one domain and domains can be populated by more than one TC

4. A number of individuals expressed a strong desire to see the DSAM be the RCRIM DAM and for CDISC and HL7 to develop a process to support versioning, change control, further development, etc.

5. Motion made to approve recommendations 1, 2 and 6 and ask the Model Management Project Team to develop other recommendations further and a process for maintaining the DSAM/DAM moving forward. Motion was seconded and approved: 30 affirmative, 0 negative, 0 registered abstentions.

[pic]

6. Meredith Nahm provided an overview of initiative to develop data standards for CV disease and TB. Group proposed including stakeholders across multiple areas to work with CDISC to develop standards and then ballot as standards through HL7. Need for use cases was discussed and opportunity to work with Vocabulary Team.

Tuesday Q3

III. aECG Implementation Guide

Facilitator: Barry Brown

[see ballot reconciliation]

1. Barry reviewed the negative votes and comments (see reconciliation spreadsheet). Most comments were minor. There were comments that generated discussion about whether and how to include reference ranges. Barry will follow up on this.

Tuesday Q4

IV. Stability Reporting

Facilitators: Mead Walker, Norman Gregory

1. There were no comments. Discussion focused on how we want to move forward. Meeting next week with FDA leadership to discuss CDER’s interest in receiving data as HL7 messages. Norman to discuss with Randy to try to get a statement of overall agency strategy. The consensus of the group in attendance was that we should advance to ballot. The final decision was deferred to Thursday discussion and input from rest of group and Randy.

Wednesday 26 January 2005

Attendees:

|NAME |AFFILIATION |EMAIL |Q1 |Q2 |Q3 |Q4 |

|Info Not Available | | | | | | |

Wednesday Q1

I. Project Updates: Clinical Trial Registry; CT Lab Implementation Guide; Additional Business

Facilitators: Scott Getzin, Linda Quade

[pic]

1. Scott reviewed background material on clinical trial registries. There is a weak business case for the limited implementation of registering clinical studies on but may be a stronger business case for a more futuristic use case around reporting protocol design and study results. The team will be exploring the larger business case over the next few months.

2. Linda provided an update on progress on the CT Lab reporting Implementation Guide. Covance and Oracle have been moving forward. The team anticipates having an implementation guide and possibly a new release reflecting enhancements coming out of implementation process to review prior to ballot.

3. Julie brought up for discussion the selection of modeling tool (Rational V. Enterprise Architect). There was general support for moving to Enterprise Architect because it is cheaper and a viewer is available. However we do need to coalesce the pieces and establish some infrastructure for providing comments, tool based source control, etc. before migrating and it was agreed that we should defer decision until after that.

Wednesday Q2

V. Hosting Clinical Decision Support; Protocol Representation Update

Facilitators: Becky Kush, Cara Willoughby

Individuals in attendance introduced themselves

[pic] [pic] [pic]

Bob Jenders and Robert Greenes provided an overview of the efforts of the Decision Support TC and Clinical Guidelines SIG

1. Cara Wiloughby provided an overview of the work that the Protocol Representation Team has done. Diane Wold provided an overview of the Trial Design Model.

2. Decision Support has explored both flow chart and state models (state determines management). Charlie Mead emphasized that in terms of modeling representation there are real but subtle differences between state and activity diagrams but concepts are usually best represented by one or another.

3. In a time frame before the end of the year RCRIM will need machinery that CDS has developed – particularly in selection criteria and protocol execution. By next meeting we should have enough representation that we should have some dialog. We plan to meet jointly again Wednesday Q2 in May. We will distribute a strawman and/or the design analysis model before this meeting.

4. Charlie offered to present an educational session on GELLO in advance of the joint meeting. We will try to schedule this for Monday.

Wednesday Q3

VI. Hosting PSSIG (ICSR ballot response review and reconciliation); OCSR

Facilitator: Lise Stevens

1. Lise went through the ballot responses and comments (see ballot reconciliation worksheet). Two sets of comments – Kaiser Permanente HVA and UK. Comments have been discussed with the voters and verbally agreed upon. Motion was made to accept the proposed resolutions. Seconded and carried with 28 affirmative, 0 negative, and 0 abstentions. If proposed resolutions are accepted and negatives are withdrawn and there is agreement that all changes are non-substantive then this message will pass membership ballot.

10. Motion to change definition of class code for investigative event to delete official. Seconded and approved. 33 affirmative, 0 negative, 0 registered abstentions.

Action Item: individual attending the Harmonization meeting will add this as a line item.

11. Clive Flashman presented proposed changes to Patient Safety SIG mission and vision (see word document). A few minor suggestions were made to ensure scope applied broadly to human and non-human patients and to clarify certain sections. A motion was made to submit the change in charter to the ARB and seconded and approved affirmative 35, negative 1. The negative vote related to residual concern over ambiguous language in second paragraph of mission related to decision support. The group agreed to clarify this language.

12. OCSR – a proposal was made to change the name to General Patient Safety Incident Report (GPSIR). Charlie proposed changing the word general to generic or generalized. Suggestion was also made to use name Generic Incident Notification (GIN).

Wednesday Q4

VII. Host Clinical Genomics

Facilitators: Phil Pochon & Jill Kaufman

[pic]

Amnon presented an overview of the CMET. He presented a summary of the comments received.

1. It was discussed that we have the possibility of enhancing the CT lab message to include genomics data. This would need to accommodate the additional requirements around confidentiality. Linda Quade as the lead for the CT Periodic Reporting of Lab Data team will liaise with Phil Pochon as lead of the Clinical Genomics.

Thursday 27 January 2005

Attendees:

|NAME |AFFILIATION |EMAIL |Q1 |Q2 |

|Baranoski, Lori |BMS |Lori.baranoski@ |X |X |

|Buxton, Tim |EMEA |Tim.buxton@emea.eu.int |X |X |

|Friggle, Bill |Sanofi-Synthelabo |William.friggle@sanofi- |X |X |

|Getzin, Scott |Lilly |Sgetzin@ |X |X |

|Gregory, Norman |FDA/CVM | |X |X |

|Hernandez, Joyce |IBM |Jhernan@us. |X |X |

|Hollinger, Kathy |FDA/ |Khollinger@oc. |X | |

|Hurley, Julie |Abbott |Julie.hurley@ |X | |

|Kush, Rebecca |CDISC |Rkush@ |X |X |

|Levin, Randy |FDA |Randy.levin@ |X |X |

|O’Connor, Kristin |BIPI | |X | |

|Quade, Linda |Lilly |Lindaq@ |X | |

|Smith, Elizabeth |FDA/CDER |SmithE@cder. |X | |

|Stevens, Lise |FDA |Stevensl@cber. |X |X |

|Tardiff, Barbara |Merck/CDISC |Barbara_tardiff@ |X |X |

|Trip, Edward |Abbott |Edward.tripp@ |X |X |

|Ward, Steve |Lilly |Stw@ |X | |

Thursday Q1

I. Review of outstanding ballot items including SPL ballot reconciliation; Planning for next meeting

1. Agenda Item:

Additional discussion regarding model management

Follow-up and decision re disposition of Stability message

Planning for next meeting.

13. Linda presented some additional ideas around model management coming out of discussions between Charlie, Linda, Joyce and Scott. There was general discussion but vote and decision to accept or reject was deferred until recommendations were considered by entire model management group. The recommendations will be discussed and voted on at a future teleconference. The group felt strongly that we should just use a single term, DAM is consistent with HDF documentation, to refer to the Domain Analysis. The committee encouraged the team to prioritize defining the process for model and change management including version control and management of any electronic representations.

14. The proposed resolutions to the stability message were accepted. There are advantages to moving forward to membership ballot to encourage pilot efforts and development of an implementation guide. Randy indicated that the FDA is moving forward with this, initially in a DVM. A motion was made to advance membership ballot and seconded. 14 affirmative, 0 negative, 2 abstentions. Both abstentions indicated their concerns re lack of support from CDER. The Stability team was strongly encouraged to begin development of an implementation guide and target presentation and review of draft at the May meeting.

15. Agenda topics for next meeting (suggestions)

Stability Data – include ICH, Abbott folks, regulators

16. SPL and PIM: review methodology for moving PIM to SPL for narrative text and structured data elements, potentially present draft implementation guide.

17. eCTD – M2 group working to update standard, changing from DTD to schema, still working from scratch xml, would be good to discuss potential of using HL7 for building xml; educational, lay out process and advantages; include concrete examples in how it works; use CDISC and DAM to show interoperability; NCI could share their message; related E2B, and ICSR, and SDTM – now not interoperable – what benefits would interoperability provide. Present benefits from multiple perspectives – regulatory agencies, pharma, European community, etc. May want to include protocol and registries.

18. Randy and I will coordinate pulling this together: Linda volunteered to help. Chuck Jaffe and Ed Helton would probably be willing to help. Ed Tripp will get someone from Pharma ERS. Tim Buxton will also try to get someone to participate. Could plan to present to HL7 Pharma Outreach and DIA.

Thursday Q2

Planning for next meeting continued.

Tentative schedule

|Session |Topic |Agenda |Special Invitees |

|FRIDAY |HL7 CDISC | | |

| |Outreach-Paris | | |

|MQ3 |GELLO |Educational | |

|MQ4 |Business Meeting |Model management update. Accepting | |

| | |minutes, teleconference decisions; | |

| | |updates on other projects (CT | |

| | |Registry) | |

|TQ1 |SPL |R2 ballot reconciliation R2 |? teleconf |

| | |implementation guide draft | |

| | |discussion Pre-discussion of PIM to| |

| | |SPL translation guide | |

|TQ2 |Stability reporting |Ballot reconciliation |? teleconf |

| |CT Lab |Implementation guide draft | |

| |Implementation |discussion | |

| |Guide (?) |Pilot update | |

|TQ3 |DAM |Update on development of DAM |? teleconf |

| | |ODM-RIM mapping | |

| | |DAM-RIM mapping project update | |

|TQ4 |Vocabulary |Update of progress of group; |Margaret Haber |

| | |working model, priorities, etc. |Susan Bassion |

| | | |Usha Reddy |

| | | |Lise Stevens |

| | | |? teleconf |

|WQ1 |Joint with Clinical Genomics |Report of Clinical Genomics RCRIM |Phil Pochon |

| | |project. Use cases, message status,|Amnon Shabl |

| | |ballot plans | |

|WQ2 |Joint with Clinical Decision |Report of Protocol Representation | |

| |Support |Team; application of GELLO, trial | |

| | |design, message status, ballot | |

| | |status | |

|WQ3 |Joint with Patient Safety |GIN (generic incident notification)| |

| | |ICSR Implementation Guide | |

|WQ4 |Unfinished business |Possible CT Lab Implementation | |

| |Planning for Sept WG |Guide | |

|TQ1 |HL7 Educational |Educational; business case for |EFPIA/PRIMAG (Ed Tripp, Bill |

| | |implementing esubs via HL7 xml |Friggle) Stan Van Belkum |

| | |messages |(Tim) |

| | | |EMEA committees |

| | | |(Tim Buxton) |

|TQ2 |HL7 Educational; Discussion |Educational; business case for |EFPIA/PRIMAG (Ed Tripp, Bill |

| | |implementing esubs via HL7 xml |Friggle) Stan Van Belkum |

| | |messages |(TIM) |

| | | |EMEA committees |

| | | |(Tim Buxton) |

| | | |ICH (through regulatory and Pharma |

| | | |reps to Steering committee) |

| | | |(Randy FDA rep, Barbara Pharma rep)|

|TQ3 |SPL |PIM to SPL translation (strawman, | |

| | |draft translation guide); narrative| |

| | |v. structured data elements | |

|TQ4 |Stability Reporting |Submission of stability data; |EFPIA/PRIMAG (Ed Tripp, Bill |

| | |Examples of how it works; Pilot |Friggle) |

| | |updates; Vendor (uptodata- Norbert |Abbott+vendor (Ed Tripp) |

| | |Bittner)plans |Stan Van Belkum |

| | | |(Tim) |

Also will want to encourage European-based pharma colleagues; CDISC

Consider Webcasts of some of the educational stuff during HL7 meeting and outside of meeting for extended outreach.

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