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
'''New Items'''
 
*
 
'''Outstanding Items'''
 
*
 
'''Completed Items'''
 
# There are a number of Marketing Authorization Dates: First Authorization Date, Renewal Date, Variation Date, Withdrawal Date, Expiry Date.  This can be solved by providing 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?
 
#::DONE: 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. --[[User:Jduteau|Jduteau]] 23:06, 18 November 2010 (UTC)
 
#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)
 
#::CLARIFICATION: 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.
 
#:::DONE: Relates to a specific product with form, etc. all part of the product description. Now, if you say the authorization relates to a "classification" then I think you really mean "indication", or "purpose" for which the product is approved. Currently this is held together by the product document, the label, that is approved. I have added the subjectOf participation to the specializedKind role. [[User:Gschadow|Gunther]] 14:09, 29 November 2010 (UTC)
 
#We need to have the address of the governing agency address.
 
#:DONE [[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 and country where a measurement was made.
 
#: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.
 
#::CLARIFICATION:  In the US there is an inhaler that is measured by dose that reaches the mouth whereas in Europe exactly the same product is measured at the point the dose leaves the spray.  The values are simiilar but different so there effectivly 2 different strengths which are equivalent if you use common measurement measures.  Hence a need to express measurement point and countrry.  After rethinking this, I believe that I can map this as a characteristic of the ingredient.
 
#:::DONE: I agree with you, these fine details can be done with those characteristics. [[User:Gschadow|Gunther]] 14:09, 29 November 2010 (UTC)
 
  
=== R_Substance (POCP_RM080300UV) ===
+
The SVN repository is at http://gforge.hl7.org/svn/hl7v3/trunk/cpm
'''New Items'''
+
 
*
+
== CPM Technical Corrections ==
'''Outstanding Items'''
+
 
#Need to indicate a substance that is related to a characteristic (antigen ID for cells)
+
Details of Current Technical Corrections and Archived Technical Corrections can be found on separate pages by clicking on the links below.
#:ANSWER: this is what Interaction is for: antibody - interactsIn - Interaction[Ab-Ag-binding] - interactor - antigen
+
 
#::CLARIFICATION: antigen ID was one example - the generic use case is "Substance related to a property that is not the substance being described"And the problem with your solution is that I have a property of the substance and this property is related to an antigen and I need to provide the antigen ID.
+
[[Current Technical Corrections]]
#:::QUESTION: this clarification does not show any additional need. Your antigen ID is supported. "Substance related to a property" -- there are many ways by which substances can relate to properties of other substances. You need to be specific on the use cases. Give all the examples that you have, likely they are modeled in a few different patterns.
+
 
#::::CLARIFICATION:
+
[[Archived CPM Technical Corrections]]
#::::#If the substance being described is a T-cell, for example, which would be classified as a “structurally diverse substance”, then the auxiliary substance would be CD4 glycoprotein which would itself have a substance IDSo we’re not describing CD4 here as an interactant, we’re describing it as an auxiliary in the description of a property.
+
 
#::::#In describing a polymer, the defining property might be the degree of binding to a dye that occurs (a bit like titration) and the particular dye would be the auxiliary substance.
+
[[Deprecating Lot Number Text]]
#::::#To describe a nanoparticle, which would be another “structurally diverse substance”, there may be a particular protein that would bind to the nanoparticle, the protein would be the auxiliary substance.
+
 
#::::#To describe a low molecular weight heparin (bemeparin, dalteparin, enoxaparin), which would be considered a polymer substance, the amount of binding (again a bit like titration) of Factor IIA and/or Factor X could be used as a defining property.  The Factor IIA or Factor X would be the auxiliary substances.
+
[[Storage Conditions and Shelf Life]]
#The Moiety has a mandatory link to the played entity. For Subunits, I have no entity to reference, so this link should not be mandatory. I could just hang an entity since none of the attributes are mandatory, but that seems wrong.
+
 
#:ANSWER: of course you must have an Entity, the subunit itself. The subunit must be something. Typically a protein subunit is coded on a different gene, so you would even have a different protein id (say if you use UniProt). Even if by "subunit" you mean "domain", such an entity can have and should have an identification, for instance, the UniProt sub-sequences (chains) have feature identifiers.
+
== Meeting Minutes ==
#::REBUTTAL: Well yes I have the subunit, but I have no attributes about the subunit, i.e no ID.
+
===June 7, 2012===
#(Related to Completed #7) I have Glycosylation which has a number of characteristics (Type, N, O, C) and they can all repeat. So I still feel that the ability to have a parent characteristic (Glycosylation) with children (Type, N, O, C) is needed.
+
Attendees: Hugh Glover, Julie James, Keith Thomas, Erin Fitzsimmons, Hans Buitendijk, Gunther Schadow
#:ANSWER: still no, glycosylation type should not be a characteristic. It should be a code specified in the Moiety.code or Bond.code, see the document on page 31f (Posttranslational Modification).
+
*
#::REBUTTAL: From what I understand about Glycosylation, it is a defining type of the Protein - Human, Other mammal, Yeast, Plant, Insect - they all produce completely different substances even if everything else about the protein is the sameSo it does not belong in the Moiety.code or Bond.code as it is specific to the overall substance.
+
===March 22, 2012===
'''Completed Items'''
+
Attendees: Julie James, Keith Thomas, Hans Buitendijk, Gunther Schadow
#How to indicate the Gene and the specific Gene element that a Substance is derived from?
+
* Gunther distributed Substance Mapping spreadsheet on 2.3.A, but unclear current stateJulie/Hugh submitted 6.1.5 mapping but had not heard until earlier this week.
#:ANSWER: IdentifiedSubstance - productOf - DerivationProcess - interactor - IdentifiedSubstance [[User:Gschadow|Gunther]] 00:51, 18 November 2010 (UTC)
+
** At this time, everybody hoping the way it works.
#::DONE --[[User:Jduteau|Jduteau]] 23:07, 18 November 2010 (UTC)
+
** Anticipate ICH may start a set of testing. Based on that will get better feedback.
#We have a status and domain of names.
+
* Lot Number Text
#:ANSWER: for domain: NamedEntity - subjectOf - Policy [[User:Gschadow|Gunther]] 00:51, 18 November 2010 (UTC)
+
** Enough support to remove from model, and then deprecate from RIM in next harmonization.
#::QUESTION: for "status", what are those statuses?
+
 
#:::CLARIFICATION: current, alternate, superceded
+
===March 8, 2012===
#::::DONE: The specification of what name you need to use under what circumstances is carried by the Policy that you can associate with the Identified(Named)Entity role. If these policies are outdated, or say that you can use a name as an alternative or not any more, would all be handled by Policy. Also added statusCode and effectiveTime into NamedEntity and IdentifiedEntity roles, with a note to use Policy for fine control. [[User:Gschadow|Gunther]] 14:09, 29 November 2010 (UTC)
+
Attendees: Julie James, Keith Thomas, Norman Gregory, Gunther Schadow, Rob Savage, Hans Buitendijk
#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.
+
*[[Storage Conditions and Shelf Life]]
#: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.
+
**eStability focuses on new products and their storage conditions
#::DONE--[[User:Jduteau|Jduteau]] 23:07, 18 November 2010 (UTC)
+
**eStability does not have shelf life, only expirationTimeWould not use shelf live. 
#We need a "SubjectOf" relationship on the NamedEntity to indicate reference information for the names.
+
**The Storage act contains the storage conditions as observations.
#:DONE [[User:Gschadow|Gunther]] 00:51, 18 November 2010 (UTC)
+
**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.
#Need to provide documentation of a characteristic.
+
***Against: 0; Abstain: 0; In favor: 3
#:QUESTION: use case please? Do you mean the subjectOf relationship to Document should be added?
+
**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.
#::CLARIFICATION: Yes, there is a need to provide the reference documentation for a characteristic value, so subjectOf relationship to Document.
+
*[[Deprecating Lot Number Text]]
#:::DONE [[User:Gschadow|Gunther]] 14:09, 29 November 2010 (UTC)
+
**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".  
#We have processSteps that have sub-processStepsSubstanceSpecification does not allow this.
+
***No one has picked up on this?
#:DONE [[User:Gschadow|Gunther]] 00:51, 18 November 2010 (UTC)
+
***Is it right that there are two alternative approaches?
#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.
+
**Lots are a product instance.
#:QUESTION: It's easy to add this, but there should be at least one use case. What is it?
+
**Ingredients used for mixed lots, while part is used for combinations such as kits.
#::CLARIFICATION: I have a Protein Substance that has information about the sequenceThere 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 characteristicsSo 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.
+
**Looks like we have what we need and moving towards concensus.
#:::ANSWER: Subunits are different Moieties. You put characteristics onto the molecular part that they pertain to, not on the higher order molecular complex. So, it is actually good that you do not have these characteristics structures, because they make you focus on modeling the molecule, not the information about it. [[User:Gschadow|Gunther]] 14:09, 29 November 2010 (UTC)
+
 
#Many codes have a status and change date of the code.
+
===February 23, 2012===
#: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.
+
Attendees: Gunther Schadow, Keith Thomas, Hans Buitendijk, Julie James, Myron Finseth, Hugh Glover
#R_SubstancePresence - the scoper is not actually attached to the choice box.
+
*Harmonization Proposals
#:DONE [[User:Gschadow|Gunther]] 12:49, 3 December 2010 (UTC)
+
**Reconstitution Procedure - CPM24
#Need to provide documentation of the derivation process - need a link to Document.
+
***[[File:HL7 Harmonization Proposal Reconstitution Procedure CPM24.doc]]
#:DONE [[User:Gschadow|Gunther]] 12:49, 3 December 2010 (UTC)
+
***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 MaterialA 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 GloverAgainst: 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