Control/Query Meeting Minutes (Heading 1)



Monday, 19 January, 2004

Q1 9-10:30: no scheduled meeting

Q2 11-12:30: no scheduled meeting

Q3 1:45-3:00: Introductions; Report from PhRMA Task Force on HL7; Ballot Response Reconciliation (Animal Toxicology Informative Ballot)

Q4 3:30-5:00: Ballot Response Reconciliation (Animal Toxicology Informative Ballot) (cont.); Ballot Response Reconciliation (Stability Report - PORT Ballot #2)

Tuesday, 20 January, 2004

Q1 9-10:30: Ballot Response Reconciliation (Structured Product Label (SPL) - CDA Derived Specification)

Q2 11-12:30: Ballot Response Reconciliation (Content Description Informative Document)

Q3 1:45-3:00: Protocol Representation Team Update and Ballot Plans

Q4 3:30-5:00: Ballot Response Reconciliation (Annotated ECG - PORT Ballot #1) (3:30-4:00pm); Report from Charlie Mead (Ambassador to CDISC) (4:00-5:00pm)

Wednesday, 21 January, 2004

Q1 9-10:30: Joint with Clinical Genomics (CG Hosting)

Q2 11-12:30: Joint with Clinical Genomics (CG Hosting)

Q3 1:45-3:00: Ballot Response Reconciliation cont.(discussion of any unresolved issues from earlier sessions); (Annotated ECG - PORT Ballot #1, Animal Toxicology Informative Ballot, Stability Report, Structured Product Label SPL, Content Description Informative Document)

Q4 3:30-5:00: Plan for Remaining Ballot Reconciliation; Set agenda for next Working Group Meeting

Thursday, 22 January, 2004

Q1 9-10:30: DMIM

Q2 11-12:30: Ballot Response Reconciliation (Public Health Reporting - PORR Ballot #3) Joint with Patient Safety SIG (RCRIM Hosting)

Q3 1:45-3:00: Ballot Response Reconciliation (Public Health Reporting - PORR Ballot #3) Joint with Patient Safety SIG (RCRIM Hosting)

Q4 3:30-5:00: Committee Session - Topic TBD

Friday, 23 January, 2004, No Meetings

RCRIM TC Meeting Minutes

Monday, 19 January, 2004

Attendees:

|NAME |AFFILIATION |EMAIL |Q3 |Q4 |

| | | | | |

|Bittner, Norbert |Up to Date |Norbert.bittner@ | |X |

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

|Canzanese, Lori |Merck |Lori_canzan@ | |X* |

|Cassells, Sally |Lincoln Tech |Sally.cassells@ |X |X |

|Dradransky, Paul |Merck |Paul_dradransky@ | |X* |

|Durben, Nick |Pfizer |Nick.durben@ |X |X |

|Friggle, Bill |Sawofi-Synthelabo |william.friggle@sawofi- |X |X |

|Getzin, Scott |Eli Lilly |sgetzin@ |X |X |

|Golchale, Hermant |Pharma Quest Corp. |hemant@ |X |X |

|Gregory, Norman |FDA/CVM |ngregory@cum. |X |X |

|Handu, Seema | |shandu@ |X |X |

|Hastak, Smita |NCICB |hastaks@mail. |X |X |

|Heimbuch, Ray |Novartis |raymond.heimbuch@pharma. |X |X |

|Hizer, Bob |Eli Lilly |hizer@ | |X |

|Hofer, Jeff |Eli Lilly | | |X* |

|Jaffe, Chuck |Astra Zeneca |charles.jaffe@ |X |X |

|Klein, Corbett |Merck |Corbett_Klein@ | |X* |

|Kubick, Wayne |Lincoln Tech |wayne.kubick@ |X |X |

|Levin, Randy |FDA |levinr@cder. |X |X |

|Matsuda, Miyuki |ASO Corporation |matsuda_m01@aso_group.co.jp |X | |

|Palmer, Michael |CDISC |mcpalmer@ |X |X |

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

|Rosen, Bill |Pfizer |William.rosen@ |X |X |

|Spahr, Kristoffer |Wyeth |spahrk@ |X |X |

|Stevens, Lise |FDA/CBER |stevensl@fda. | |X |

|Tardiff, Barbara |CDISC, Regeneron |barbara.tardiff@ |X |X |

|Tripp, Ed |Abbot Laboratories |Edwared.tripp@ |X |X |

|Walker, Mead |Mead Walker Consulting |dmead@ |X |X |

| | | | | |

|*via teleconference |

Q3 Monday 19 January 2004

I. Introductions

II. PhRMA Task Force

Kris Spahr (Wyeth Pharmaceuticals) and Scott Getzin (Lilly) presented and overview of the HL7 Phrma task force

[pic]

Goal of task force is to understand the status and activities around development of standards and involve more subject matter experts, focusing on Stability data and Structured Product Labeling. ECG waveform standard development process was brought forward as example of what they want to do:

What went right with development of ECG waveform standard:

• Industry awareness

• Clear objectives, sponsorship and involvement

• Industry input and involvement

• Developer had domain knowledge (of ECG waveform data)

• HL7 expert able to train in the new HL7 developer and navigate through process

• Flexibility in modeling the data

• Near-term compliance clearly understood

• Project management and communication

Recommendations for future projects:

• Follow defined development process

• Involve both business and IT folks in standard development

Objectives of the PhRMA HL7 Task Force:

• Get more involvement from industry

• Establish team for each project to include: project manager/coordinator, subject matter experts, FDA rep, HL7 developer with domain knowledge, vendor rep

Question: What about pharma / biotechs who are not PhRMA members?

Linda Quade agreed that there are a lot of other arrows that are not shown that feed into the red boxes. The intention is not to exclude anyone. The HL7 PhRMA Task Force should be seen as a communication vehicle to get the word out. The Task Force was formed within PhRMA regulatory submission group and may be uniquely positioned to help get the word out because of the numerous connections that folks managing regulatory submission tend to have.

Kris described two of the Taks Force’s efforts so far: 1) web-cast to inform about HL7 and stability standard-more than 65 lines and 23 companies connected; 2) use of point people in company to help spread word.

Scott emphasized that it is not enough to get the word out—there is an educational part that is required. The individual who is the point person that brings the standard forward may have good insight into to what extent the affected community is involved and to what degree they need to be educated

Action items:

• Need a presentation that acclimates people that are new to the process and HL7 standards as to what it is. This should be a general presentation so that it could be used over and over.

• For each new existing and new project establish a formal subteam with appropriate representation.

• Develop/describe the process for sending out a new ballot. The ballot may need to include additional information providing some specific educational background.

Mead has given an intro to V3 that used a totally different domain—getting a library card—and has found it to be pretty useful; he also asked us to think about what items of HL7 jargon are most impenetrable.

III. Ballot Response Reconciliation (Animal Toxicology Informative Ballot)

Seema Handu reviewed the results of the Animal Toxicology Informative Ballot.

Animal toxicology ballot: 42 people in pool; 41 votes; 6 abstain; 35 affirm

The SEND team is moving forward with a pilot project. Eight pharma and one biotech are participating; will be submitting data to FDA. FDA will review and analyze; both single and repeat dosing.

It is expected that feedback from pilot will result in revisions in the Animal Toxicology Informative Document. The SEND group is also working on vocabulary and some other things that were not completed in time for v 1.3. They plan to make those changes in the Informative document and then re ballot.

Ultimately the plan is to convert into HL7/RIM format.

Linda brought up that we need more people who can work as facilitators. Facilitator training is available as people are willing to get involved; Linda is willing to serve as a resource for new facilitators.

Wayne brought up that there are some inconsistencies based on evolution of clinical model that should be incorporated into the next version. DTC/DTM harmonization is probably something that should be done soon. Randy mentioned that these should be harmonized with other HL7 standards also.

SEND group will not be ready to ballot a RIM version by next ballot cycle; will plan to ballot an updated version of informative document

Randy suggested that we just have one document/one overriding model (for clinical and non-clinical submission); Wayne felt like it might be better to handle treat simultaneously.

Action items:

• Seema will coordinate the preparation of updated informative document for next ballot cycle.

• Wayne and Seema will work together to harmonize as much as possible across clinical and non-clinical submission standards for next ballot cycle.

Q4 Monday 19 January 2004

I. Ballot Response Reconciliation (Stability Report - PORT Ballot #2)

Mead Walker reviewed the results of the Committee Level ballot for the Stability Report.

Mead went through comments [discussion and resolutions documented on ballot reconciliation spreadsheet]

There was a great deal of discussion with regards to acceptance of this standard by the international community. The intent of the standard is to represent broad uses of these (stability) data. The HL7 process allows definition of different value sets for different regions/different national context and HL7 standards are intended to be flexible enough to accommodate regional variations. The proposed model has been developed to accommodate all known requirements within the current project scope. As additional requirements are brought forward and the scope extended, the model will be evaluated to ensure that it is able to accommodate these requirements and if necessary extended to meet these requirements.

Given the number of the comments and questions on this standard it was a agreed that a subteam would be formed to prereview and develop proposed resolutions to the comments prior to discussing them with the committee. The subteam will include: Mead Walker, Gunther Schadow, Norman Gregory, Scott Getzin, Linda Quade, and Barbara Tardiff. The subteam will meet Tuesday at lunch (1230-145pm). A continuation of the Stability Report ballot reconciliation and review and discussion of the resolutions as proposed by the subteam will occur on Wednesday Q3.

RCRIM TC Meeting Minutes

Tuesday, 20 January, 2004

Attendees:

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

| | | | | | | |

|Alschuler, Liora | |liora@the-word- | | |X |X |

|Bounds, Susan |FDA |seb@cdrh. |X | | | |

|Boyer, Sandy | |slboyer@ |X | |X | |

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

|Cassells, Sally |Lincoln Tech |Sally.cassells@ |X |X |X |X |

|Friggle, Bill |Sawofi-Synthelabo |william.friggle@sawofi- |X |X |X |X |

|Getzin, Scott |Eli Lilly |sgetzin@ |X |X |X |X |

|Gitterman, Steve |FDA |gitterman@cder. |X |X |X |X |

|Gregory, Norman |FDA/CVM |ngregory@cum. | |X |X | |

|Haber, Margaret |NCI |mhaber@mail. |X | |X |X |

|Hastak, Smita |NCICB |hastaks@mail. | | |X | |

|Heimbuch, Ray |Novartis |raymond.heimbuch@pharma. |X |X |X |X |

|Hernandez, Joyce |IBM/CDISC |jhernan@us. |X |X |X | |

|Hizer, Bob |Eli Lilly |hizer@ |X |X | | |

|Hollinger, Kathy |FDA |khollinger@oc. |X |X |X |X |

|Jaffe, Chuck |Astra Zeneca |charles.jaffe@ | | |X |X |

|Kubick, Wayne |Lincoln Tech |wayne.kubick@ |X |X |X |X |

|Kush, Rebecca |CDISC |rkush@ |X |X |X |X |

|Levin, Randy |FDA |levinr@cder. |X |X |X |X |

|Palmer, Michael |CDISC |mcpalmer@ |X |X |X | |

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

|Rosploch, June |Kaiser Permanente |June.rosploch@ |X | | | |

|Spahr, Kristoffer |Wyeth |spahrk@ |X |X |X |X |

|Stevens, Lise |FDA/CBER |stevensl@fda. |X | | | |

|Tardiff, Barbara |CDISC, Regeneron |barbara.tardiff@ |X |X |X |X |

|Tripp, Ed |Abbot Laboratories |Edwared.tripp@ |X |X |X |X |

|Wallace, Robert |Lilly |Wallace_r_h@ |X |X |X |X |

|Wold, Diane |GSK | | | |X* | |

|Ying, Hana |FDA | | | |X* | |

| | | | | | | |

|* via teleconference |

Q1 Tuesday 20 January 2004

I. Ballot Response Reconciliation (Structured Product Label (SPL) - CDA Derived Specification)

This standard has passed two Committee Level Ballots and was eligible for the Full Membership Level Ballot. It is felt that this is ready to be used; it is in an ‘almost cooked stage’. There has been a request to the HL7 Board to endorse as a DSTU. There is a need to determine the duration of the DSTU before going to full membership ballot. Interest by potential implementers has been expressed and PhRMA has become involved.

Sandy Boyer presented overview of ballot results and status of ballot.

[pic]

The ballot closed 9 January. The voting results were: affirmative, 18 negative, 1 abstain; 69.5% affirmative = Passed

The committee will need to reconcile negative comments and then request HL7 board to endorse as DSTU.

The 18 negative votes came from Kaiser, Lilly and HL7 UK

Kaiser - 2 negative comments

HL7 UK – several of these have come up before

Lilly – 3 negatives – nested lists, security, need for a style sheet

Other – relationship to final rule (e.g. PDF), need for implementation guide in formation, need for more examples, need for generic style sheet, options for tables, representation of special characters, how documents will be exchanged, clarification questions, how to relate observations to specific products when there are observations in multiple section; potential foe elimination of redundancy between narrative block codes, etc.

Note: Bob Dolin and Liora Alschuler made some of the ‘Other’ comments and were not present at this meeting to discuss, hence we may need to table some of these comments.

Key issues from negative comments:

• Use of product labeling v other international terms

• Relationship to Pharmacy DMIM

• Needed for generic style sheet

• Need for nested lists

• Clarification re access control for editing (security)

Key issues from affirmative comments:

• Relationship to final rule (from FDA)

• Options for tables

• Representation of special characters

• Questions as to how document will be exchanged

• General clarification questions

• How to relate observations to specific products

• Potential for elimination of redundancy

Negative comments, beginning with HL7 UK comments, were addressed individually [discussion and resolutions documented on ballot reconciliation spreadsheet]

For the most part, the comments from UK are being accommodated. In addition, we need to ensure that the modeling for the SPL is ‘cohesive’ with the Medications SIG work, e.g. disposition-related information.

Lilly comments were addressed next.

Specifically, with respect to formatting, graphic representation is not acceptable to FDA because they need the table/graphics to be a part of the SPL, not a separate pdf, or they will have to reconcile the two. This means that the generic style-sheet has paramount importance. If the style sheet doesn’t solve the issue, then this will need to be revisited. The Unicode question needs to go to a technical person to determine whether the model supports this already or if a change needs to be made.

The security issue relates to the exchange of information between vendors and sponsors, in addition to FDA. The CDISC ODM may be of use in terms of the W3C-based solution they have implemented. There is no protection today for what is in the public domain. One should always go back to the source to ensure that the label is accurate. Much of this becomes an issue in terms of application, which may need to be addressed post-HL7 balloting. However, if there is a way to nest security into the model/specification, this should be done. The issue is not whether or not security is important, rather where is should be addressed. Sandy will discuss with Wayne Kubick and Sally Cassells. Also, this may be a CDA issue at a higher level (i.e. for any XML document).

The following issues were still pending at the conclusion of the discussion:

• Discussion of a series of issues with Medication SIG

• Some additional research with regards to concerns noted above.

• Follow up with Liora Alschuler and Bob Dolin related to their comments (associated with affirmative ballots)

• Development of generic style sheet and implementation guide. Work has begun on the style sheet. Work will begin on the implementation guide. These need to be completed before the beginning of the DTSU comment period.

SPL was balloted as a DSTU. When published as a DTSU we will need to define the length of the comment period. There was a great deal of discussion regarding the length of the comment period for DSTU. We would not be able to move to balloting as a full standard until comment period had ended. The FDA reps (Randy Levin, Steve Gitterman) expressed strong interest in moving this forward for membership level ballot quickly and a concern that publication as a DTSU might not meet FDA needs (to have an official recognized standard to refer to in conjunction with publication of the final rule).

There was a motion to advance the SPL to full membership ballot the next ballot cycle: 11 aye, 3 nay, reminder of attendance list abstained

Action items:

• Sandy to coordinate resolution of negatives, integrating additional input from industry, and preparation of style sheet and implementation guide. Plan is resolve comments by mid February. Development of style sheet and implementation guide will take longer.

• Sandy will discuss series of issues related to representation of drug product with the Medications SIG and will take another issue (from Kaiser and relevant to the Pharmacy SIG) back to that Pharmacy group to have them help assess this comment.

• RCRIM leadership to work with Pharma task force and CDISC to ensure adequate education and review by industry prior to membership ballot.

Q2 Tuesday 20 January 2004

I. Ballot Response Reconciliation (Content Description Informative Document) (define.xml)

Sally Cassells presented overview of ballot results and status of ballot.

Ballot reconciliation

[pic]

There were 38 in pool, 15 affirm, 12 negative, 11 abstain. The 12 negative votes were from FDA.

Sally went through comments [discussion and resolutions documented on attached notes]

The key issues/requests were:

1. There is adequate description but insufficient conformance to SDS v3.1—new datasets/domains much be based on generic findings or events. Define.XML does not have a good means of describing this type of conformance constraint.

Not related: Agreed that is something that needs to be addressed. Proposed that the model be modified to address this in a future release. Randy said that this is acceptable.

2. Reference to external code lists should have sufficient information to permit an engine to use an external codelist as it would a contained code list.

Not persuasive. Could be addressed in the model by providing the name and the version of a dictionary.

3. Need a means of describing relationships among codelists.

Not related: Could be provided as an extension in a future version. Not technically difficult and useful, however, the standard is useful without it

4. Provide information on the natural ordering of items in a codelist e.g.

Not related. However it is good idea and plan is to incorporate into future version.

5. Directly support lists with multiple levels of granularity to their decoding e.g. MedDRA.

Not persuasive. Already supported by model. An example will be added to documentation.

6. Adequately handle characterizations of tests. Test names should be items in a controlled list. Test characteristics should include whether test value is count, continuous or coded.

Not persuasive. Already supported by model. An explanation and example will be added to documentation.

7. Document refers to New Drug Application—working should be changed or will only apply to CDER.

Persuasive. Will make change and change is not substantive.

Additional comments with affirmative vote (from ZBI)—ValueListItemDef element is not consistent with ODM metadata structures.

This was accepted as technical change.

Sally and Michael will enter comments into the spreadsheet with the negative input on the ballot and the determination on disposition for each comment. This spreadhsheet should be provided to Randy with the decisions and then FDA can determine whether or not to withdraw the negative votes. If FDA agrees to withdraw their negative votes, each individual voter should send a message to a co-chair and to HL7 HQ.

Action items:

• Barbara will send spreadsheet template to Sally and Michael.

• Sally and Michael will enter comments, dispositions, and disposition comments on to spreadsheet.

• Sally will send Barbara the spreadsheet and Barbara will send to Randy with a request to resolve negative votes.

• Randy will manage review and resolutions and withdrawals if applicable of FDA voters.

• Wayne raised question regarding need for backward compatibility for SDS v 3.1. Can variable that were deprecated in 3.0 be eliminated? Linda will investigate this and report back to committee.

• Wayne also asked about need for change log. This is not required for HL7 but may be include either within document or as a separate document. Barbara will send style guidelines to Wayne.

• Wayne, Barbara, Seema, and Kathy will work on naming scheme for documents that reflects relationships between different standards.

Additional Issues:

1) Question regarding the SDS V3.1 which is target for balloting next cycle: Can there be a statement that “variables formerly deprecated have been omitted from the this version” or is there another way these need to be addressed? These are not part of the old version. The rule is that new standards need to be backwardly compatible, i.e. if you implemented Version 1, this needs to under future versions. However, since these variables were marked at the last version as being deprecated, this may be sufficient. Linda will discuss this up with Gunther.

2) Question: How detailed should change log be? HL7 has a style guide for formatting documents, so it would be good to put the SDS V3.1 into this format before it is balloted the next round. Certain items in the style guide may not be applicable to all ballots.

3) Copyright issues related to publication by HL7 of CDISC copyrighted material need to be addressed.

4) Need to come up with a reasonable name for submission data standards that is meaningful to HL7 and CDISC. Barbara, Wayne and Seema should coordinate the naming activity. The naming conventions should reflect the relationships among SEND and SDS and between SDS and HL7 and also the Protocol work.

Q3 Tuesday 20 January 2004

I. Protocol Representation Team Update and Ballot Plans

Becky Kush, Kathy Hollinger, and Diane Wold presented an overview of the protocol representation subteam’s work.

[pic]

The objective of this project is publication of a standard, machine-readable model for protocol representation that will enable interchange of this data among systems and stakeholders.

The first step is development of a representation of a study protocol content. This is a complex document that requiring content development from E6.6, E3; harmonization with related projects (EMEA EUDRACT, clinical , Cochrane collaboration and CONSORT database), coordination with Regulatory Use Case, harmonization with other CDISC standards (SDS, ADAM, ODM).

The ultimate goal is development of machine processable approaches to protocol content; the informed consent document; and more detailed representation of specific protocol components.

Diane Wold present some of the work that is being done to present concepts.

Sandy presented a brief description of the CDA and the document analysis process. PR subteam as already done a lot of this in preparing the spreadsheet that details the requirements for protocol representation. Based on the analysis Sandy has built a CDA specification. The CDA specification is what will be balloted.

Sandy reviewed the work that she has done so far on this model. She indicated that there are things that are not in the first level priority that are already there in the basic CDA model. We need to determine whether on not they should be included in the model at this stage. We need to clarify exactly what is being balloted. It is a representation of the document with a data layer.

Action items:

• Sandy will provide a list of these elements to Kathy so that the subteam can review and determine whether or not they should be included in the model at this stage.

• Members of Protocol Representation Team will be meeting with EHR and Clinical Decision Support Q4 today to understand what those groups are working on and harmonize/coordinate activities.

Q4 Tuesday 20 January 2004

I. Ballot Response Reconciliation (Annotated ECG - PORT Ballot #1) (3:30-4:00pm)

Linda reviewed the results (34 affirm, 2 negative, 21 abstain) and comments for the ECG ballot specification [discussion and resolutions documented on ballot reconciliation spreadsheet]

One comment accepted; other judged not persuasive.

Action items:

• Linda will communicate the results of resolutions to the respondents and request that they withdraw their negative ballot..

• Linda will communicate results of reconciliation process to HL7 HQ with a request to have standard recognized by ANSI.

II. Report from Charlie Mead (Ambassador to CDISC) (4:00-5:00pm)

Charlie Mead presented a Report of his activities as RIM Ambassador to CDISC and summarized his recent presentation to CDISC Board of Directors. Charlie was designated RIM Ambassador to CDISC as part of a joint effort by CDISC and HL7 to explore ways the organizations can work together more effectively.

[pic]

As part of his information gathering efforts Charlie talked to 13 people associated with CDISC and HL7.

The presentation to CDISC Board was primarily directed to education with respect to concept of interoperability. The CDISC BOD was encouraged to consider whether interoperability was something that was important within the clinical trials/biopharm domain and, depending upon the perceived importance of interoperability as an objective, consider Charlie’s recommendations in the context of their strategic planning.

General recommendations were to: First) develop a single CDISC model that represented both structural and functional view and glossary that captures the relevant terminology; Second) harmonize/normalize the CDISC model with the RIM a ala the HDF; Third) develop relevant CDISC DMIMs etc, and Fourth) develop all CDISC-related interchange specification using RIM and V3 specifications.

The CDISC Board wholeheartedly embraced these recommendations and set short time line for implementing the recommendations.

Barbara raised question as to how aggressively we should move forward with specifications until some of the preliminary activities are completed. Charlie responded that his recommendation would be limit the development of new specifications until some of the preliminary activities have been completed.

It may be useful to consider each standard individually in terms of potential impact and risks as there are pressing business needs behind many of the development efforts

RCRIM TC Meeting Minutes

Wednesday, 21 January, 2004

Attendees:

|NAME |AFFILIATION |EMAIL |Q3 |Q4 |

| | | | | |

|Bain, Landen |CDISC |lbain@ | |X |

|Bittner, Norbert |Up to Date |Norbert.bittner@ | |X |

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

|Con, Lori |Merck | |X* | |

|Friggle, Bill |Sawofi-Synthelabo |william.friggle@sawofi- | |X |

|Getzin, Scott |Eli Lilly |sgetzin@ |X |X |

|Ginn, Jim |Lilly | |X* | |

|Gittmerman, Steve |FDA |gitterman@cder. |X |X |

|Gould, Rosemarie |Abbott | |X* | |

|Gregory, Norman |FDA/CVM |ngregory@cum. |X |X |

|Gross, Mark |Data Conversion Lab |markgross@ |X |X |

|Handu, Seema | |shandu@ |X* | |

|Hastak, Smita |NCICB |hastaks@mail. | |X |

|Heimbuch, Ray |Novartis |raymond.heimbuch@pharma. | |X |

|Hernandez, Joyce |IBM/HL7/CDISC |jhernan@us. |X |X |

|Hizer, Bob |Eli Lilly |hizer@ |X | |

|Isher, Mark |Astra Zeneca | |X* | |

|Jaffe, Chuck |Astra Zeneca |charles.jaffe@ |X |X |

|Klein, Corbett |Merck |Corbett_Klein@ |X* | |

|Kush, Rebecca |CDISC |rkush@ |X |X |

|Levin, Randy |FDA |levinr@cder. |X |X |

|Otodenie, Art |Pharmquest | |X* | |

|Palmer, Michael |CDISC |mcpalmer@ |X |X |

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

|Rosen, Bill |Pfizer |William.rosen@ |X |X |

|Spahr, Kristoffer |Wyeth |spahrk@ |X |X |

|Tardiff, Barbara |CDISC, Regeneron |barbara.tardiff@ |X |X |

|Tripp, Ed |Abbot Laboratories |Edwared.tripp@ |X |X |

| | | | | |

|Via teleconference |

Q1 Wednesday 21 January 2004

I. Joint with Clinical Genomics (CG Hosting)

(see Clinical genomics minutes)

Update on genomic content in Clinical Trial message

Barbara Tardiff introduced topic and presenter Phil Pochon, Covance (participating via phone)

Phil recognized the contribution of the following individuals:Tom Grundstrom, LabCorp, and Amnon Shabo, IBM Life Sciences.

See Phil’s CDISC PowerPoint –

[pic]

There was a suggestion to continue work on individual problems (use cases), but consider converging/generalizing at an early time point. We should also consider merging the Pharmacogenomics Clinical Genomics (Subteam 3) group and CDISC Clinical Genomics (LAB) groups. There is substantial overlapping participation.

Issues to consider:

1. How to capture when an entitiy is part of a study (group, researcher, steps…)

2. How to manage blinding - More than just anonomizing, must make it impossible, to trace results back to specific individual. In some cases may need to preserve links for a short period to link outcomes, then later throw away the key. Consents may be specific (e.g., include limits to what studies can be performed)—these data need to be passed on to other organizations,

3. Genomic data types

Action items:

• Phil to fit the BSML standard into the relevant human models

• Harmonize two human models Harmonize Phil and Clinical Genomic SIG models

• focus on variation first instead of commonalities

• get data and try to fit it in (e.g., XML elements and attributes)

• Amnon – Move from current DIM to RMIM – so that message model is very specific

• Later – look at viral models

• Evaluate potential sources of standards for certain data types

• Microarray – MAGE

• Sequence – BSML, GBSEQXML, CA-BIO (ncic, ncbi, nci)

• SNP/Haplotypes –

• Proteomics – UPO (in conjunction with Pedro)

• Set up onference call with ‘manufacturers’ and ‘vendors’ – Affymetrix, Genaissance. BeckmanDixon, Quest, Covance, LabCorp.

Q2 Wednesday 21 January 2004

I. Joint with Clinical Genomics (CG Hosting)

Jill Kaufman – Introduction

FDA issued draft guidance on voluntary Pharmacogenomics submission.

Jill Kaufman and Beck Kush – pull together 3 standards bodies, CDISC, HL7 and I3C to form 3 Subteams focused on defining standards needed for Pharmocogenomics submissions.

1. Preclinical Lab

2. Clinical Pharmacology

3. Clinical Genomics

Teams will review work and 90 day action plan (e.g., new use cases).

Clinical Genomics – ‘Sub team 3’

Barbara Tardiff – Lead

Other team participants - Chuanbo, Peter, Scott, Amnon, Usha, Sue Jane, Amy

[pic]

Barbara presented overview of subteam’s effort’s to date and plans.

Sue Jane – What is Barbara requesting of the FDA?

Barbara – Would like to increase group’s understanding of what the FDA would like to see. Barbara is looking to informal guidance to the team. Perhaps setting aside time on an upcoming conference call will be helpful.

FDA has had sample genomics submissions from Affymetrix and Amersham. FDA is looking at what submissions to understand what is similar and what is different. Looking at quality control, reusability. Collating concepts in the next few months. May result in another workshop or another guidance document.

Clinical Pharmacology – ‘Sub team 2’

Sue Jane Wang – Lead

Participants include: Amy, Amon, Chuanbo

Lot of overlap with Clinical Genomics team. Clinical Genomics Use Cases are very useful for Clinical Pharmacology.

Different from Pre-Clinical - Have SNP/Polymorphism data.

Amnon will take the lead to evolve the genotype/testing model.

QT Prolongation – Apply EKG waveform models. (see Barry Brown’s prior presentations.)

Chuanbo says the EKG model is very good for Clinical Genomics (similar to looking at peak of alleles).

Action – Amnon and Chuanbo to ‘harmonize’ Barry Brown’s model and Chuanbo’s Genaissance model.

Preclinical Lab – ‘Sub team 1’

Tom Papoian – Lead

Participants include: John Leighon, Scott Pine, Sabine Francke, Feleke Eshete, George Ikeda

Group considered various examples/use cases

2 categories

• Microarray data used early, in house during research to predict toxicity

• Similar to examples in Draft Guidance – Unexpected toxicity was found, so researcher may want to analyze microarray data to provide explanation and explore releance for humans.

90 day action plan

• Identify metadata for animal microarray data. Need a subgroup to look at animal toxicity studies. Many variables don’t need to be redefined. Question – What additional data is needed to interpret toxicity and microarray data?

• Define core variables – All observations are related to individual subjects. Attributes include: Subject ID, test result, time of sacrifice, name of gene, function of gene, definition of gene sequence/what probe used.

• Once model in hand, ask for pilot submissions that conform to the model.

Action items:

• Group 1 will follow-up with MIAMI tox.

• Jill will set up next joint call with all 3 teams.

• Each team needs to have calls/progress before the next joint call.

Q3 Wednesday 21 January 20

I. Ballot Response Reconciliation cont.(discussion of any unresolved issues from earlier sessions); Stability Report

The Stability report subteam reviewed comments and presented proposed resolutions [discussion and resolutions documented on ballot reconciliation spreadsheet].

The committee was unable to get to the last few comments. A follow-up call was scheduled for Thursday Q3 to address these remaining comments.

Q4 Wednesday 21 January 20

I. Presentation from Ken Rubin regarding Decision Making Processes

Presentation from Ken Rubin

[pic]

Ken presented an overview of the template document developed by the Process Improvement Committee. He pointed out some of the sections that certain technical committees have elected to modify. Each technical committee must adopt a variation of the template document by the end of the Spring Working Group meetings. If no action is taken the template process will become the committee’s decision making process by default.

RCRIM will review and adopt a decision making process at the next working group meeting.

II. Plan for Remaining Ballot Reconciliation; Set agenda for next Working Group Meeting

Review of status of current projects:

SEND (Q1 Monday): Need to harmonize with the latest version of the SDS informative document to combine to form one common document; try to make the next ballot cycle, but waiting to see whether this is feasible from a timing perspective; can be posted on the CDISC website now – for comment; FDA has it posted for a pilot now.

Motion to hold the declaration of the SEND informative document until it is combined with the coming SDS document. 17 – yes, 0 – opposed

Stability Report (Q2 Monday):

Certain of the changes will be substantive and, even if we get the negative votes retracted, we may want to go through another round of Committee ballot again. FDA is trying to start a pilot program (FR Notice is signed off) that would also flesh out all of the details. Need to get vendors enlisted, codes for the models, and pharmaceutical companies. We have a small group from PhRMA that has been involved, but we should communicate more broadly through CDISC, Vet Medicine and other channels. Continue to refine and remove negatives.

Motion to re-ballot through another Committee ballot. 18 – yes, 0 –opposed

Structured Product Label (Q1 Tuesday): Need implementation guide and style sheet. Although this passed as a standard for trial use, it was felt that there are business reasons to move this forward as a full membership standard on the next ballot, but this requires that we educate the stakeholder group and prepare the guides and style sheets. Individuals from the PhRMA task force and RCRIM wish to work on this.

This standard received DSTU status, but we voted not to move it forward at this time.

Content Description (Q2 Tuesday): Did not pass due to 12 negative votes from FDA, but the negative comments were discussed. The comments will be entered into the spreadsheet then forwarded to FDA to help remove the votes so that it can be moved to informative document status. It will pass if this occurs.

Protocol Representation (Q3 Tuesday): Presentation of progress and proposal to try to put a ballot together on high level. Joyce Hernandez went to the Decision Support TC during Q4 Tuesday. They are working on how to implement rules-based support, which is of interest with respect to the Janus model.

Concern was voiced that it was not clear was the purpose and use of the limited CDA (outline/table of contents of protocol sections) that was being targeted for balloting next cycle.

There is a desire to communicate what we are doing to the industry. The use case may be stronger on the Industry side; regulatory review may not be the highest priority. If education/communication is the short term objective then perhaps we should focus on strategies for gathering input and refining and expanding the model as opposed to pushing to ballot a limited model.

Motion to vote on three choices:

a) basic, structural CDA as a draft for comments; Yes - 2;

b) spreadsheet as an informative document for comment; Yes - 0;

c) ballot neither at the next cycle – Yes – 13

The intent of postponing a ballot is to allow for additional input and further definition of the requirements.

ECG Waveform Standard (Q4 Tuesday):

Passed membership ballots; 2 comments – ready to move forward to ANSI

Move to remove the Informative Document – Yes – 19; Opposed – 0

Charlie Mead RIM Ambassador presentation during Q4 Tuesday: Recommendations were made to the CDISC Board and communicated to RCRIM included creating an overall information model for this domain through a process of mapping out the business space and the data that is exchanged, prior to doing a D-MIM or information model.

This was prompted by explorations to determine how CDISC and HL7 should work together more effectively. The CDISC and RCRIM business space have substantial overlap and the result of this effort may be to redefine mission in terms of the scope for both CDISC and RCRIM. The representation of the mission and scope of the two organization may be a Venn diagram with a substantial area of common interest. This effort should be considered a CDISC-HL7 activity. It is in the RCRIM space and all RCRIM members should be involved in some way.

LAB standard moved to ANSI: Barbara and Linda will follow up.

Individual Patient Safety Report: To be discussed Thursday

Plans for Next Ballot Cycle and Next Meeting:

Structured Product Label:

Chris will be project lead for now; work with Becky to get word out through CDISC and also through other communication avenues; work on progressing implementation guide and style-sheet. Plan to reballot at membership level,

Stability:

Scott Getzin will be the project lead on ‘tapping the latent input’. Plan to reballot at committee level.

Protocol Representation:

Becky to continue to work with Kathy (project lead) on this activity.

Clinical Study Data:

Motion to ballot as an informative document CDISC SDS V 3.1 (second release of informative document (may or may not encompass SEND) – 16 – Yes; 0 – No – Wayne to be project lead on this; work with Seema on incorporating SEND

A proposal was made that the ballot focus on the core submission model with CDISC/SEND publishing implementation guides for the SEND and SDS metadata. (These latter documents do not get balloted but will be posted for comment through the CDISC process.) The advantages of this approach are: it might be straightforward to complete the core document and the two implementation guides for the next ballot than to fully merge the two documents; balloting the core submission model as a separate document means that it could be readily generally to other future domains without separate balloting and would minimize the repetitive harmonization as new domains are developed; and three implementation guides could be evolved and supplemented quickly as the team were able to complete additional domains.

Motion to ballot the submission data model as a core standard and to publish as implementation guides the domain specific material Yes – 11; No – 3

Opposing voters were concerned that implementation guides might not be managed through an adequately rigorous review and approval and change management process. It was pointed out that CDISC does have a formal documented process for review and approval for CDISC sanctioned material and if CDISC was responsible for the implementation guides this process would be followed. We need to understand HL7 policies with regards to implementation guides.

Additional action items:

Linda to research HL7 process for managing and controlling implementation guides.

RCRIM TC Meeting Minutes

Thursday, 22 January, 2004

Attendees:

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

| | | | | | | |

|Altamore, Rita |WA DOH |Rita.altamore@doh. | | |X | |

|Benson, Anita |DataScene |anita@ | |X |X | |

|Bittner, Norbert |Up To Data |Norbert.bittner@ | | |X | |

|Borotkanics, Rob |AHRQ |rborotka@ | |X |X | |

|Bounds, Susan |FDA |seb@cdrh. | |X |X | |

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

|Friggle, Bill |Sawofi-Synthelabo |william.friggle@sawofi- |X |X | | |

|Getzin, Scott |Eli Lilly |sgetzin@ | | |X | |

|Ginn, Jim |Lilly | | | |X* | |

|Gould, Rosemarie |Abbott | | | |X* | |

|Gregory, Norman |FDA/CVM |ngregory@cum. | |X |X | |

|Gross, Mark |DCL |markgross@ | | | | |

|Hastak, Smita |NCICB |hastaks@mail. |X |X |X | |

|Hizer, Bob |Eli Lilly |hizer@ |X |X | | |

|Isshin, Mark |Astra Zeneca | | | |X* | |

|Klein, Corbett |Merck | | | |X* | |

|Levin, Randy |FDA |levinr@cder. | |X | | |

|Pollock, Daniel |CDC Atlanta |dpollock@ | |X |X | |

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

|Rashidee, Ali |AHRQ |arashidee@ | |X |X | |

|Rosen, Bill |Pfizer |William.rosen@ |X |X | | |

|Stevens, Lise |FDA/CBER |stevensl@fda. | |X |X | |

|Tardiff, Barbara |CDISC, Regeneron |barbara.tardiff@ |X |X |X | |

|Tripp, Ed |Abbot Laboratories |Edwared.tripp@ |X |X | | |

|Walker, Mead |MWC |dmead@ |X |X |X | |

| | | | | | | |

|* via teleconference |

Q1 Thursday 23 January 20

I. DMIM

Linda presented an overview of the process for developing HL7 standards and work that she has does on a DMIM.

[pic] [pic]

She emphasized that the goal is interoperability. Interoperability consists of both syntactic (structure) and semantic (meaning) interoperability. Semantic interoperability is what makes information computable. Syntactic interoperability is what allows common processing.

There was a discussion regarding vocabularies and the fact multiple vocabularies are needed to express clinical concepts (e.g. SNOMED and MedDRA). Although the HL7 ideal is a single vocabulary (set of codes) the reality is that for the present we will likely need to use multiple vocabularies as they have different strengths.

Developing normative standards involving identifying a recommendation or need, doing a business analysis, and detailing the information requirements.

RIM is very abstract. DMIM allows us to be less abstract in our space.

Linda reviewed the DMIM that has been developed and used for the messages developed to date. The group discussed that this DMIM is likely to evolve as we work through an analysis of the clinical research/medical product development business space. We will be soliciting comments and feedback at various stages in this modeling process.

Q2 Thursday 23 January 20

I. Ballot Response Reconciliation (Public Health Reporting - PORR Ballot #3) Joint with Patient Safety SIG (RCRIM Hosting)

Joint with PSSIG—see PSSIG meeting minutes for details.

Ballot reconciliation for ICSR and Case Notification

Mead Walker led discussion. The PSSIG has previously worked through the ballot responses and grouped comments into relating specifically to ICSR, relating specifically to Case Notification, or applicable to both and has worked part way through these comments.

Mead went through outstanding comments [discussion and resolutions documented on ballot reconciliation spreadsheet]

Q3 Thursday 23 January 20

I. Ballot Response Reconciliation (Public Health Reporting - PORR Ballot #3) Joint with Patient Safety SIG (RCRIM Hosting)

Continued discussion of Stability responses

Continued discussion of ICSR/Case notification

Q4 Thursday 23 January 20

I. Committee Session – Harmonization of representation of drug products in RCRIM sponsored messages (Stability, ICSR, SPL) and messages related to prescribing, dispensing and administering medications.

Joint with Medication SIG and O & O—see Medication SIG meeting minutes for details.

Friday, 23 January, 2004, No Meetings

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