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Difference between revisions of "Common Product Model"

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* Pharmacy (for Medication and possibly for devices)
 
* Pharmacy (for Medication and possibly for devices)
 
* Patient Safety (for Individual Case Safety Reports)
 
* Patient Safety (for Individual Case Safety Reports)
−
* RCRIM (for Structured Product Labeling and Regulated Product Submissions)
+
* RCRIM (for Structured Product Labeling, Regulated Product Submissions, and Drug Product Stability)
 
* PHER (for vaccines used in Immunization)
 
* PHER (for vaccines used in Immunization)
  
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* [[CPM Storyboards Immunization|Immunization related storyboards]]
 
* [[CPM Storyboards Immunization|Immunization related storyboards]]
  
−
== Current CPM Technical Corrections ==
+
== Governance ==
−
Here is a list of issues that require technical corrections to the CPM.  Each point is followed by the proposed correction.
 
  
−
=== R_ProductListed (POCP_RM010100UV) ===
+
[[CPM Governance]] as adopted during the San Diego WGM Sept 2011
−
* There are a number of Marketing Authorization Dates: First Authorization Date, Renewal Date, Variation Date, Withdrawal Date, Expiry Date
 
−
** Provide a recursive COMP relationship from an authorization to itself.
 
−
::DONE [[User:Gschadow|Gunther]] 16:33, 17 November 2010 (UTC)
 
−
* Each Marketing Authorization produces a GTIN
 
−
** Provide a SubjectOf shadow from IdentifiedEntity.
 
−
::DONE [[User:Gschadow|Gunther]] 16:33, 17 November 2010 (UTC)
 
−
*IdentifiedEntity needs an effectiveTime
 
−
::DONE [[User:Gschadow|Gunther]] 16:33, 17 November 2010 (UTC)
 
−
*SubjectOf needs a time to indicate when the relevant product information took effect
 
−
::QUESTION: such time range would be provided by the connected Act, wouldn't it?
 
−
::::REMOVED: My thought was that the effectiveTime of the document could be different from the time when it was attached to the product.  But now that I look at it, I don't think that distinction makes sense.
 
−
*We need to indicate the dose form and the product classification that the marketing authorization pertains to.
 
−
::QUESTION: that is already supported because the Approval is connected to a Role whose player Entity has a dose form and can have classifications. [[User:Gschadow|Gunther]] 00:51, 18 November 2010 (UTC)
 
−
::ANSWER: the authorization pertains to a specific form and classification.  I'm unsure which Role you are referring to as the one with ProductEstablishment doesn't let me detail this.
 
−
*We need to have the address of the governing agency address.
 
−
::ADDED [[User:Gschadow|Gunther]] 00:51, 18 November 2010 (UTC)
 
−
*How to tie the Marketing Authorization Procedure to the marketing authorization.
 
−
::ANSWER: the procedure may be reflected in the Approval.code, as it is in the U.S. or you might use the new Approval components to represent these procedures and other smaller actions.
 
−
*How do we indicate the point where a measurement was made.
 
−
::QUESTION: What point? Example please?
 
−
::ANSWER: I am getting clarification from EMA on this.
 
−
*How do we indicate a country or countries where an Ingredient Strength quantity is valid.
 
−
::ANSWER: ingredient strength is connected to a product and if the strength is different, then it is a different product. The country-specificity can be done with the Approval act.
 
  
−
=== R_Substance (POCP_RM080300UV) ===
+
The SVN repository is at http://gforge.hl7.org/svn/hl7v3/trunk/cpm
−
*There needs to be a way to link characteristics to each other - either as a grouping of related characteristics or as a parent/child relationship.
+
 
−
::QUESTION: It's easy to add this, but there should be at least one use case. What is it?
+
== CPM Technical Corrections ==
−
::ANSWER: I have a Protein Substance that has information about the sequence.  There are characteristics that are all about the sequence. As well, each sequence has a number of sub-units and each sub-unit has a number of characteristics.  So it would be nice to tie all of the sub-unit characteristics together and I believe that it is necessary to indicate that each subunit set pertains to the sequence.
+
 
−
*How to indicate the Gene and the specific Gene element that a Substance is derived from?
+
Details of Current Technical Corrections and Archived Technical Corrections can be found on separate pages by clicking on the links below.
−
::ANSWER: IdentifiedSubstance - productOf - DerivationProcess - interactor - IdentifiedSubstance [[User:Gschadow|Gunther]] 00:51, 18 November 2010 (UTC)
+
 
−
*We have a status and domain of names.
+
[[Current Technical Corrections]]
−
::ANSWER: for domain: NamedEntity - subjectOf - Policy [[User:Gschadow|Gunther]] 00:51, 18 November 2010 (UTC)
+
 
−
::QUESTION: for "status", what are those statuses?
+
[[Archived CPM Technical Corrections]]
−
*Many codes have a status and change date of the code.
+
 
−
::QUESTION: which codes? the "last change date" is a database-ism that does not really do much, in most cases you can refer to the Document that contains the change if you wanted to.
+
[[Deprecating Lot Number Text]]
−
*Need to indicate a substance that is related to a characteristic (antigen ID for cells)
+
 
−
::ANSWER: this is what Interaction is for: antibody - interactsIn - Interaction[Ab-Ag-binding] - interactor - antigen
+
[[Storage Conditions and Shelf Life]]
−
*How to indicate what the amount of a moiety is (mole ratio, weight percent) - this may be similar to the "Amount Type" that is present on all amounts.
+
 
−
::ANSWER: the Role.quantity gives you a ratio, if you put there 1 mol : 1 mol it's a mole-ratio, if you put 1 g : 1 g it's a mass ratio.
+
== Meeting Minutes ==
−
*We need a "SubjectOf" relationship on the NamedEntity to indicate reference information for the names.
+
===June 7, 2012===
−
::DONE [[User:Gschadow|Gunther]] 00:51, 18 November 2010 (UTC)
+
Attendees: Hugh Glover, Julie James, Keith Thomas, Erin Fitzsimmons, Hans Buitendijk, Gunther Schadow
−
*How to indicate how much of a substance is related to a substance specification's observation?
+
*
−
::QUESTION: not clear what is being asked for, use case please? The observation on Substance specification is for analytical data. That would typically be presented as some concentration (umol/L, ug/L, ppm, etc.)
+
===March 22, 2012===
−
*Need to provide documentation of a characteristic.
+
Attendees: Julie James, Keith Thomas, Hans Buitendijk, Gunther Schadow
−
::QUESTION: use case please? Do you mean the subjectOf relationship to Document should be added?
+
* Gunther distributed Substance Mapping spreadsheet on 2.3.A, but unclear current state.  Julie/Hugh submitted 6.1.5 mapping but had not heard until earlier this week.
−
*We have processSteps that have sub-processSteps.  SubstanceSpecification does not allow this.
+
** At this time, everybody hoping the way it works.
−
::DONE [[User:Gschadow|Gunther]] 00:51, 18 November 2010 (UTC)
+
** Anticipate ICH may start a set of testing.  Based on that will get better feedback.
 +
* Lot Number Text
 +
** Enough support to remove from model, and then deprecate from RIM in next harmonization.
 +
 
 +
===March 8, 2012===
 +
Attendees: Julie James, Keith Thomas, Norman Gregory, Gunther Schadow, Rob Savage, Hans Buitendijk
 +
*[[Storage Conditions and Shelf Life]]
 +
**eStability focuses on new products and their storage conditions
 +
**eStability does not have shelf life, only expirationTime.  Would not use shelf live.   
 +
**The Storage act contains the storage conditions as observations.
 +
**Motion to include eStability Storage and StorageCondition into CPM model.  Change class code to Storage instead of Act on Storage and change mood code to Definition on Storage.  Would need to create a future harmonization proposal for a domains space on code in StorageCondition.  It will be put in the Product Information choice box. Gunther Schadow, Norman Gregory.
 +
***Against: 0; Abstain: 0; In favor: 3
 +
**With addition of this to CPM there is a potential to deprecate existence time, but no rush.  So for now will leave it as is.
 +
*[[Deprecating Lot Number Text]]
 +
**Julie's Questions related to Tom's comment: "sending a batch or lot ID would work by adding a 'part of' participation to a parent 'manufactured material' class, since the ID is *not* an instance identifier of the medicine (or other product) instance, but of the batch or lot that it was a part of".
 +
***No one has picked up on this?
 +
***Is it right that there are two alternative approaches?
 +
**Lots are a product instance.
 +
**Ingredients used for mixed lots, while part is used for combinations such as kits.
 +
**Looks like we have what we need and moving towards concensus.
 +
 
 +
===February 23, 2012===
 +
Attendees: Gunther Schadow, Keith Thomas, Hans Buitendijk, Julie James, Myron Finseth, Hugh Glover
 +
*Harmonization Proposals
 +
**Reconstitution Procedure - CPM24
 +
***[[File:HL7 Harmonization Proposal Reconstitution Procedure CPM24.doc]]
 +
***There is a variance between Gunther's original vs. the snippet in the proposal.
 +
***Concerned that there will be a possible ripple effect to other areas where Act is used in general, but not a concern here.
 +
***Motion to accept as proposed. Keith Thomas, Myron Finseth
 +
****Against: 0; Abstain: 0; In Favor: 5
 +
**Disease Qualifier - CPM25
 +
***[[File:HL7 Harmonization Proposal Disease Qualifier CPM25.doc]]
 +
***Where does it live in the model? In the clinical area with contraindications, indications, severity, frequency, etc.
 +
***There is another approach possibly using Coded Data type (CD) with qualifiers.
 +
***Problem is that pre-coordination is not available in MedDRA.
 +
***Although there is concern that this proposal will not solve the real problem.  It may have to be resolved back in the FDIS.
 +
***Concept domain does not impact the model.
 +
***FDIS is in ballot, so cannot change this type of issue anymore given ISO ballot process only allows minor changes at this stage.
 +
***What happened to the CD Qualifier?  Would have to be coordinated with the terminology.  Suggestion was that post-coordination was to be done through implementation guidance.
 +
***No need to change the model to accommodate CD Data Type qualifier.
 +
***Motion to accept the proposal as is. Julie James, Gunther Schadow.
 +
****Should not result in and create a separate class in the CPM model to accommodate. 
 +
****Suggestion to include: Terms would only be used with in post coordination within an existing CD.  Concern that is too complex.
 +
****Gunther wants the proposal as-is.
 +
****Against: 0; Abstain: 0; In favor: 5
 +
**Storage & Shelf Live - CPM26
 +
***[[File:HL7 Harmonisation Proposal Storage and Shelf Life CPM26.doc]]
 +
***e-Stability addressed this area, but did not get included in CPM.
 +
***Julie will reach out to Norman Gregory and RCRIM to get input into this proposal with goal to conclude during next week's call.
 +
 
 +
===February 16, 2012===
 +
Attendees: Hugh Glover, Gunther Schadow, Myron Finseth, Keith Thomas, Hans Buitendijk, Rob Savage
 +
*Agenda:
 +
** How to tie IDMP back to CPM
 +
** Harmonization Proposals (9 total - 3 a week)
 +
** Technical Corrections
 +
*IDMP to CPM
 +
** So far we grew CPM to cover IDMP, but is becoming unwieldy.
 +
** Primary objection/concerns that if you unroll CPM people get schemas that are new to them.
 +
** Present CPM with CMETs, but include guidance on where things for IDMP, how to thread it together, serialization.
 +
** Should that information in CPM or IDMP implementation documentation?  Should be in IDMP documentation.
 +
** We're reviewing it here as there will be adjustments likely.
 +
** IDMP is on same May Ballot Cycle.
 +
* Harmonization Proposals
 +
** Combined Dose Form Concept Domain - CPM-21
 +
*** [[File:Combined Dose Form.doc]]
 +
*** Motion to accept as proposed. Hugh Glover, Rob Savage  Against: 0; Abstain: 0; In Favor: 4
 +
** Material Form - CPM-22
 +
*** [[File:Material Form.doc]]
 +
*** Concern that this cannot be put above Material.  A Combined Dose Form could consist of multiple materials of different forms.
 +
*** Suggest to carry into OO discussion in next 2 weeks.
 +
** Container Form Concept Definition - CPM-23
 +
*** [[File:Container Form.doc]]
 +
*** Motion to accept as is.  Gunther Schadow, Hugh Glover. Against: 0; Abstain: 0; In Favor: 4
 +
*RIM Proposals
 +
**Contaminant is an Ingredient
 +
***[[File:RoleClass Contaminant is an Ingredient.doc]]
 +
***Motion to accept as is.  Gunther Schadow, ??. • Against: 0; Abstain:0; In Favor: 4
 +
** Living Subject
 +
*** [[File:Living Subject.doc]]
 +
*** Not yet discussed.  Next week

Latest revision as of 13:07, 7 June 2012

This page will be used to discuss the content and publication of the Common Product Model.

Ambitions & Scope

The Common Product Model (CPM) will be an overarching domain information model relating to the HL7 v3 modeling of any kind (or instance) of a 'product'. The definition of the term product is intentionally kept loose at this point, but will definitely include:

  • Medication, incl. vaccines
  • Devices used in medical services
  • Anything else a person can be exposed to

The CPM is set up as a joint initiative within HL7 project, 'sponsored' by the O&O work group.

The following stakeholders have been identified:

  • Pharmacy (for Medication and possibly for devices)
  • Patient Safety (for Individual Case Safety Reports)
  • RCRIM (for Structured Product Labeling, Regulated Product Submissions, and Drug Product Stability)
  • PHER (for vaccines used in Immunization)

Storyboards

This space will list a number of storyboards that relate to the different perspectives on what a product is and how it is used.

These storyboards are divided into groups:

Governance

CPM Governance as adopted during the San Diego WGM Sept 2011

The SVN repository is at http://gforge.hl7.org/svn/hl7v3/trunk/cpm

CPM Technical Corrections

Details of Current Technical Corrections and Archived Technical Corrections can be found on separate pages by clicking on the links below.

Current Technical Corrections

Archived CPM Technical Corrections

Deprecating Lot Number Text

Storage Conditions and Shelf Life

Meeting Minutes

June 7, 2012

Attendees: Hugh Glover, Julie James, Keith Thomas, Erin Fitzsimmons, Hans Buitendijk, Gunther Schadow

March 22, 2012

Attendees: Julie James, Keith Thomas, Hans Buitendijk, Gunther Schadow

  • Gunther distributed Substance Mapping spreadsheet on 2.3.A, but unclear current state. Julie/Hugh submitted 6.1.5 mapping but had not heard until earlier this week.
    • At this time, everybody hoping the way it works.
    • Anticipate ICH may start a set of testing. Based on that will get better feedback.
  • Lot Number Text
    • Enough support to remove from model, and then deprecate from RIM in next harmonization.

March 8, 2012

Attendees: Julie James, Keith Thomas, Norman Gregory, Gunther Schadow, Rob Savage, Hans Buitendijk

  • Storage Conditions and Shelf Life
    • eStability focuses on new products and their storage conditions
    • eStability does not have shelf life, only expirationTime. Would not use shelf live.
    • The Storage act contains the storage conditions as observations.
    • Motion to include eStability Storage and StorageCondition into CPM model. Change class code to Storage instead of Act on Storage and change mood code to Definition on Storage. Would need to create a future harmonization proposal for a domains space on code in StorageCondition. It will be put in the Product Information choice box. Gunther Schadow, Norman Gregory.
      • Against: 0; Abstain: 0; In favor: 3
    • With addition of this to CPM there is a potential to deprecate existence time, but no rush. So for now will leave it as is.
  • Deprecating Lot Number Text
    • Julie's Questions related to Tom's comment: "sending a batch or lot ID would work by adding a 'part of' participation to a parent 'manufactured material' class, since the ID is *not* an instance identifier of the medicine (or other product) instance, but of the batch or lot that it was a part of".
      • No one has picked up on this?
      • Is it right that there are two alternative approaches?
    • Lots are a product instance.
    • Ingredients used for mixed lots, while part is used for combinations such as kits.
    • Looks like we have what we need and moving towards concensus.

February 23, 2012

Attendees: Gunther Schadow, Keith Thomas, Hans Buitendijk, Julie James, Myron Finseth, Hugh Glover

  • Harmonization Proposals
    • Reconstitution Procedure - CPM24
      • File:HL7 Harmonization Proposal Reconstitution Procedure CPM24.doc
      • There is a variance between Gunther's original vs. the snippet in the proposal.
      • Concerned that there will be a possible ripple effect to other areas where Act is used in general, but not a concern here.
      • Motion to accept as proposed. Keith Thomas, Myron Finseth
        • Against: 0; Abstain: 0; In Favor: 5
    • Disease Qualifier - CPM25
      • File:HL7 Harmonization Proposal Disease Qualifier CPM25.doc
      • Where does it live in the model? In the clinical area with contraindications, indications, severity, frequency, etc.
      • There is another approach possibly using Coded Data type (CD) with qualifiers.
      • Problem is that pre-coordination is not available in MedDRA.
      • Although there is concern that this proposal will not solve the real problem. It may have to be resolved back in the FDIS.
      • Concept domain does not impact the model.
      • FDIS is in ballot, so cannot change this type of issue anymore given ISO ballot process only allows minor changes at this stage.
      • What happened to the CD Qualifier? Would have to be coordinated with the terminology. Suggestion was that post-coordination was to be done through implementation guidance.
      • No need to change the model to accommodate CD Data Type qualifier.
      • Motion to accept the proposal as is. Julie James, Gunther Schadow.
        • Should not result in and create a separate class in the CPM model to accommodate.
        • Suggestion to include: Terms would only be used with in post coordination within an existing CD. Concern that is too complex.
        • Gunther wants the proposal as-is.
        • Against: 0; Abstain: 0; In favor: 5
    • Storage & Shelf Live - CPM26

February 16, 2012

Attendees: Hugh Glover, Gunther Schadow, Myron Finseth, Keith Thomas, Hans Buitendijk, Rob Savage

  • Agenda:
    • How to tie IDMP back to CPM
    • Harmonization Proposals (9 total - 3 a week)
    • Technical Corrections
  • IDMP to CPM
    • So far we grew CPM to cover IDMP, but is becoming unwieldy.
    • Primary objection/concerns that if you unroll CPM people get schemas that are new to them.
    • Present CPM with CMETs, but include guidance on where things for IDMP, how to thread it together, serialization.
    • Should that information in CPM or IDMP implementation documentation? Should be in IDMP documentation.
    • We're reviewing it here as there will be adjustments likely.
    • IDMP is on same May Ballot Cycle.
  • Harmonization Proposals
    • Combined Dose Form Concept Domain - CPM-21
    • Material Form - CPM-22
      • File:Material Form.doc
      • Concern that this cannot be put above Material. A Combined Dose Form could consist of multiple materials of different forms.
      • Suggest to carry into OO discussion in next 2 weeks.
    • Container Form Concept Definition - CPM-23
  • RIM Proposals
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