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September 16, 2008 Tuesday Q1 – Stability and spl


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Regulated Clinical Research Information Management (RCRIM) Technical Committee Meeting Minutes

September 16, 2008

Tuesday Q1 – Stability and SPL


Attendees

First Name

Last Name

Affiliation

E-mail Address

Lori

Baranoski

BMS

lori.baranoski@bms.com

Terry

Brunone

GlaxoSmithKline

Theresa.M.Brunone@gsk.com

Norman

Gregory

FDA

norman.gregory@fda.hhs.gov

Raffael

Jovine

Int.Inst. For SAEE of Meds.

raffael.jovine@ii4sm.com

Peggy

Leizear

FDA

peggy.leizear@fda.hhs.gov

Tanya

Newton

SAFE-Biopharma Association

tanya.newton@safe-biopharma.org

Cecile

Pistre

Sanofi Aventis

cecile.pistre@sanofi-aventis.com

Kris

Spahr

Wyeth Pharmaceuticals

spahrk@wyeth.com

John

Speakman

NCI

john.speakman@nih.hhs.gov

Sylvia

Thun

DIMDI

sylvia.thun@dimdi.de

Ed

Tripp

Abbott Laboratories

edward.tripp@abbott.com

I.Stability IG Ballot Reconciliation – Norman Gregory


The ballot tally is listed in the table below

 

Aff.

Neg.

Abst.

NV

Affiliate

0

1

6

2

Consultant

7

0

0

1

General Int.

12

0

1

1

Payor

0

0

0

0

Pharmaceutical

15

1

1

1

Provider

11

0

4

2

Vendor

1

0

3

2

Totals

46

2

15

9

% of Votes

63.89%

2.78%

20.83%

12.50%




Quorum

87.50%

Approval

29

Norman Gregory walked through the ballot comments

There were no substantive changes.

Motion was made by Norman Gregory to accept the IG changes as proposed pending agreement of commenter, make changes to make the IG consistent with the changes being made to the specification with the intent to ballot again in January constraining the ballot to just the changes made.

Seconded by Kris Spahr

Affirmative 8

Negative 0

Abstain 2

Motion carries


II.Stability R2 Ballot Reconciliation – Norman Gregory


The ballot tally is listed in the table below

 

Aff.

Neg.

Abst.

NV

Affiliate

0

2

6

1

Consultant

5

0

1

1

General Int.

12

0

1

1

Payor

0

0

0

0

Pharmaceutical

17

1

1

0

Provider

11

2

3

1

Vendor

6

0

4

2

Totals

51

5

16

6

% of Votes

65.38%

6.41%

20.51%

7.69%




Quorum

92.31%

Approval

34

Norman Gregory walked through the ballot comments

There were several substantive changes

A motion was made to modify the model to address the changes and bring to ballot in January, however the ballot will be constrained to the changes made. Moved by Gunther and seconded by Terry Burrone.

Vote:


10 Affirmative

0 Negative

1 Abstain

Motion carries


III.SPL - Lori Baranoski, Gunther Schadow


Terry Brunone presented the following slides


Tuesday Q2 – Product Model for SPL, ICSR and Pharmacy's medication DMIM: Pharmacy Work Group to Host


See Pharmacy minutes

Tuesday Q3 – SPL – Joint Meeting with Health Care Devices


See Health Care Devices minutes for attendance

I.SPL – Randy Levin


Randy Levin explained the use of SPLr4 to provide listing information for drug products. The following was presented as an illustration of how SPLr4 is constructed



There was a question if the FDA was working with the Global Harmonization Task Force. Randy responded that the appropriate representatives from FDA was discussing unique device identifiers and listing with the GHTF.

Randy shared examples of device data elements FDA is considering for Devices. There is the concept of a unique device identifier that was discussed. There is a need for domain expertise to deal with the concept of devices being a component of another device.

How is this standard effort tied into the CDRH UDI efforts. Randy stated that the people in FDA working on UDI have provided input into the current device elements that were shared.

Electronic devices use a unique address that could be used. Gunther responded that it is usable for an instance identifier but not a type identifier.

The model for device communication provided a place for the GMDN. For the purpose of device communication the GMDN is not useful but is provided for information purposes.

There was an invitation to participate in Q2 Tuesday joint session on the Product Model.

The request was made for RCRIM to provide use cases to Health Care Devices. Additionally there will be a future joint meeting to discuss SPL and UDI. We will schedule a joint meeting Tuesday Q3 at the next WGM.


Tuesday Q4 – SPL


First Name

Last Name

Affiliation

E-mail Address

Lori

Baranoski

BMS

lori.baranoski@bms.com

Terry

Brunone

GlaxoSmithKline

Theresa.M.Brunone@gsk.com

Gary

Ginsinger

FDA

gary.gensinger@fda.hhs.gov

Norman

Gregory

FDA

norman.gregory@fda.hhs.gov

Peggy

Leizear

FDA

peggy.leizear@fda.hhs.gov

Andrew

Marr

GSK

Andrew.p.marr@gsk.com

Charles

Mathis

Lorenz Life Sciences

cmathis@lorenz.cc

Gunther

Schadow

Regenstrief Institute, Inc.

gunther@aurora.regenstrief.org

Kris

Spahr

Wyeth Pharmaceuticals

spahrk@wyeth.com

Ed

Tripp

Abbott Laboratories

edward.tripp@abbott.com

Steve

Ward

Lilly

stw@lilly.com

I.SPL Ballot Reconciliation - Lori Baranoski, Gunther Schadow


The ballot tally is listed in the table below


 

Aff.

Neg.

Abst.

NV

Affiliate

0

0

8

1

Consultant

2

0

3

0

General Int.

11

0

2

4

Payor

0

0

0

0

Pharmaceutical

32

0

1

7

Provider

18

0

4

6

Vendor

3

0

12

15

Totals

66

0

30

33

% of Votes

51.16%

0.00%

23.26%

25.58%



Quorum

74.42%

Approval

50

Motion was made by Kris Spahr to accept the results as a normative ballot. Seconded by Norman Gregory

Affirmative 11

Negative 0

Abstain 0

Motion passes.

Randy will inform HL7 to include it in the normative edition


II.SPL Other business - Lori Baranoski, Gunther Schadow


The common product model will be included in a future update of SPL. is currently Orders and Observations proposed the common product model and intends to ballot as a common data structure.

How to move the common product model forward to ballot will be discussed further on Q2 Thursday.

The intent is to ballot the SPL implementation guide. This will be voted on by RCRIM in Q3 Wednesday.

SPL will need a joint meeting with Pharmacy and patient safety, one joint meeting with Health Care Devices. Reconciliation of SPL IG ballot needs a quarter.



End of Document


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