2014-06-03 BRIDG WG 3 June 2014 Meeting Minutes

2014-06-03 BRIDG WG 3 June 2014 Meeting Minutes

2014-06-03 BRIDG WG 3 June 2014 Meeting Minutes

Agenda:

Review/Approve 20 June 2014 Meeting Minutes

ISO update from Becky Kush

PSS review with Jean Duteau / Smita Hastak

BRIDG Advisory Panel meeting this Friday

Other business

Attendees:

E Helton

Becky Kush

Jean Duteau

Julie James

Terry Hardin

Boris Brodsky

Bob Milius

Minutes approved -- motions by Terry H. and Jean D. No abstains/negatives vote -- approved

Becky Kush gave ISO Balloting of BRIDG update –

Preliminary Report Summary:

ISO TC 215 through WG 2 will go through process for directly going to DIS and one ballot for BRIDG 3.2– true international standard with no charge – allows update of BRIDG new version ( same as a DICOM model). This ballot does not preclude us from updating BRIDG as DICOM does. ISO facing document keeps BRIDG agnostic.

2014 Resolution 14 [WG2-R08] ISO/CD 14199 submitted for DIS ballot

For ISO/NP 14199 - Health informatics – Information Models: Biomedical Research Integrated Domain Group (BRIDG) Model

ISO/TC 215

 agrees with WG2 recommendation to submit ISO/NP 14199 for DIS ballot;

 instructs the PL to provide the disposition of NP comments, updated text to the WG2 secretary no later than 1 July 2014;

 instructs the WG2 secretary to provide these items to the TC215 secretary by 14 July 2014;

 instructs TC215 Secretary to submit to ISO/CS for DIS ballot by 28 July 2014.

Discussion:

JE: Would this structure allow us to easily update new versions?

BK: Yes. Using the model of DICOM, which preclude A SIMILAR updating OF BRIDG

SH: Does this mean the new versions would automatically become ISO?

BK: Cannot speak for ISO. In theory, not expected to go out of date quickly. Expected to go through the ballot in the near future. Next ISO meeting is in Berlin in October; expecting vote before that. Will update when get more information.

JE: Do we do the DIS first, then after FDIS BRIDG will become an ISO standard?

BK: Was only told DIS and then one ballot. Has emailed for clarifications several times, but hasn't received responses so far.

JJ: Wasn't even on the next ISO WG 2 agenda.

BK: Will provide the update as soon as she knows more.

PSS Review and Discussion

EH: Hugh Glover's comments…

HG: In HL7, there is modeling facilitator, but we may not need one. If all we are doing is taking the BRIDG documents that SCC generates, the WG may not be needed. Need to get out of RCRIM to be able to publish. If all we're doing is publishing documents, what is the authority of this WG? Who governs changes (HL7, this WG)?

EH: In preparation to ..., do we need to make further clarification – will be further resolved by BRIDG Advisory Panel 6 June 2014

JD: Steering division may ask the same questions we are asking; better have answers to those.

SH: Need to figure out what the WG will do. Traditional HL7 groups have particular sets of artifacts. How will they be related to current artifacts and portals BRIDG has been supporting for years (BRIDG website, Wiki, CDISC website, HL7 feedback mechanisms)? Need a consolidated picture how we move forward, to put in PSS. What does it mean when ISO approves and points to the BRIDG website? Which ones (BRIDG, HL7, ISO)?

JE: Would it be helpful to document all the options we discussed?

EH: Can we form a small committee that would put together a written plan with Smita's comments, share it by email, and be ready to finalize at the next meeting?

JD: May want to include in the PSS to show we've thought this through.

EH: Jean if you could have the comments organized as a supplement to PSS for the next meeting?

JD: Agreed.

EH: Will pass around through the listserv, everyone expected to help.

JD: May want to expand to show what the document means terms of the Advisory Panel, SCC, etc.

SH: 3rd comments (HL7 layer). Background in the past BRIDG models: In v3, went through a major change (mapping BRIDG to RIM); since v3.2 publication, no longer mapping BRIDG semantics to RIM. In context of HL7 WG, is the RIM representation of BRIDG a needed/useful artifact?

JE: Found it useful in our methodology. If not supported any longer, may be raising a concern.

EH: Never have received a firm decision whether HL7 would provide the support and knowledge to prepare RIM for an update into BRIDG 4.1 for example

BM: Did make it, because we counted on continued mapping.

EH: NCI no longer have funds to do it.

SH: Since 3.2, all the work that went into BRIDG no longer aligning/mapping to RIM. If want to include in 4.0, need to make it explicit, since much translational component.

JD: BRIDG WG may consider doing it in HL7. I.e. to perform mapping as a separate project outside SCC.

BK: (Will provide update on ISO to the listserv).

JJ: (1) Since there was much discussion on 4.0, what are the details on what's included? (2) How to add IDMP (much value to both FDA and EMA)?

SH: (1) 4.0 documentation not yet ready. If interested in seeing the components in 4.0, see working BRIDG model online (BRIDG website, download model tab). The Life Sciences DAM has been harmonized into BRIDG. (2) Bringing IDMP semantics into BRIDG: The process of bringing the new project is documented very thoroughly in a harmonization package (BRIDG website).

JJ: Is the process working?

SH: Making comments to existing models (moving from GForge tracker to JIRA) still challenging. Initiating new projects - submitted through a form that goes through SCC listserv – is working.

EH: BRIDG Advisory Panel (AP) will meet Friday. <listed members> Have a lot to talk about. Will review minutes from Phoenix and other meeting, to better define working relationships between BRIDG WG and SCC. If we have any documentation we discussed earlier (SH, JJ), could bring it in for another point of discussion. Haven't had AP meetings in the past few months (due to contractual constraints at NCI). Most attendees work in a volunteer rather than paid consultant status. Need to address a lot of matters very quickly.

BK: Thanked everyone for volunteering to proceed without the funds. Need to sort everything out to best support BRIDG. Always thought it would be good to have mapping to RIM (to maintain connection between clinical research and healthcare). Need to bring JE to help full-time. Thanked SH for helping CDISC prepare BRIDG online course.

EH: Diane Wold, an AP member, wrote a paper last Fall describing the use of BRIDG in GSK. We found it very encouraging. Suggests a great value in what we are doing.

BK: All Diane's money was contributed by GSK.

EH: At the next meeting, EH and BK will report on the AP meeting.

(Meeting adjourned)