Stream: research
Topic: Domain Terminology for Trial Management
Gustav Vella (May 04 2019 at 15:21):
Hi There, This is sort of an edge case but the goal is FHIR related. So I'll ask here.
For interoperability purposes I'm exposing certain information in our CTMS such as the legal basis of the trial, the trial group, the electronic site delegation log as FHIR resources. For modelling & interoperability purposes I'd like to refer to a) whatever seems to be normative and b) to terminologies - where possible. The closest I get to anything normative are the schemata defined by EMA http://esubmission.ema.europa.eu/index.htm. But schemas are structure definitions and not code systems, even though they contain more or less normative value sets.
Gustav Vella (May 04 2019 at 15:21):
The quickest option would be to define CodeSystem resources + corresponding ValueSet resources and stuff the value sets extracted from the EMA schemas in there.
The better option would be have these ValueSets in a proper terminology. I've looked at the CARELEX eTMF ontology http://purl.bioontology.org/ontology/CARELEX?conceptid=http%3A%2F%2Fwww.CareLex.org%2F2012%2Fcarelex.owl%23eTMF
The issue there: it's quite rudimentary describes the artefacts related to a trial and not key concepts themselves. For instance: The legal basis of the trial and the members of the trial group are missing.
Gustav Vella (May 04 2019 at 15:21):
Does anyone here know of an appropriate domain terminology/ontology or of anyone working on a terminology covering the Trial Management domain?
Gustav Vella (May 04 2019 at 16:01):
For completeness: I've been through the CDISC Standards in RDF created by PhUSE CS Semantic Technology WG and can't find anything related to legal bases of trials and the trial group as specified for individual legal bases.
Lloyd McKenzie (May 04 2019 at 17:30):
Can you give examples of the types of codes you'd expect to see as "legal basis for a trial"?
Gustav Vella (May 04 2019 at 18:39):
We only manage trials taking place at German Study sites so the models reflect German pharmaceutical law.
https://simplifier.net/clinicalsite.org/rechtsgrundlage-duplicate-2
AMG > Current German Pharmaceutical Law
AMG vor August 2004 > German Pharmaceutical Law prior to 2004
MPG > Medical Device Law
MPG nach §23b > Medical Device Law pertaining to §23b
nicht-AMG nicht-MPG > Other
The most important members of the Trial group on site are:
Principal Investigator
Deputy Investigator
Subinvestigator
Primary Contact on Site
Other Members of the Trial Group
...
Gustav Vella (May 04 2019 at 18:39):
Depending on the legal basis, the Trial Group would be set up differently. In trials Prior to 2004 for instance there would not be a Deputy Investigator. The legal basis of the trial changes the structure and validation rules of the trial management record.
As ever, in Europe this all percolates up to the EU /EMA or rather their submission forms point to EU Law which is implemented via several levels of indirection in German law.
Here is an excerpt from the schema of one of their submission forms:
Gustav Vella (May 04 2019 at 18:40):
<xs:simpleType name="legalBaseHumanType" final="restriction">
<xs:restriction base="xs:string">
<xs:enumeration value="article-8-3"/>
<xs:enumeration value="article-10-1"/>
<xs:enumeration value="article-10-3"/>
<xs:enumeration value="article-10-1And10-3"/>
<xs:enumeration value="article-10-4"/>
<xs:enumeration value="article-10a"/>
<xs:enumeration value="article-10b"/>
<xs:enumeration value="article-10c"/>
<xs:enumeration value="article-16a"/>
</xs:restriction>
</xs:simpleType>
<xs:simpleType name="legalBaseVeterinaryType" final="restriction">
<xs:restriction base="xs:string">
<xs:enumeration value="article-12-3"/>
<xs:enumeration value="article-13-1"/>
<xs:enumeration value="article-13-3"/>
<xs:enumeration value="article-13-1And13-3"/>
<xs:enumeration value="article-13-4"/>
<xs:enumeration value="article-13a"/>
<xs:enumeration value="article-13b"/>
<xs:enumeration value="article-13c"/>
<xs:enumeration value="article-13d"/>
</xs:restriction>
</xs:simpleType>
<xs:simpleType name="authorisationGrantedByType" final="restriction">
<xs:restriction base="xs:string">
<xs:enumeration value="union"/>
<xs:enumeration value="memberState"/>
</xs:restriction>
</xs:simpleType>
<xs:simpleType name="applicationConsiderationHumanType" final="restriction">
<xs:restriction base="xs:string">
<xs:enumeration value="conditionalApproval"/>
<xs:enumeration value="exceptionalCircumstances"/>
<xs:enumeration value="article-10-1"/>
<xs:enumeration value="article-10-5"/>
<xs:enumeration value="article-74a"/>
</xs:restriction>
</xs:simpleType>
<xs:simpleType name="applicationConsiderationVeterinaryType" final="restriction">
<xs:restriction base="xs:string">
<xs:enumeration value="exceptionalCircumstances"/>
<xs:enumeration value="article-13-5"/>
<xs:enumeration value="article-77-5"/>
</xs:restriction>
</xs:simpleType>
Gustav Vella (May 04 2019 at 18:40):
https://ec.europa.eu/health/documents/eudralex/vol-1_de
Lloyd McKenzie (May 04 2019 at 18:54):
Interesting. That sounds like it would be country-specific terminologies?
Gustav Vella (May 04 2019 at 18:56):
Interesting.
.. a nightmare ;-)
That sounds like it would be country-specific terminologies?
Yes!
Lloyd McKenzie (May 04 2019 at 20:39):
You might raise the question on the #german/terminologien stream - if a standard German terminology exists, the folks who hang out there might be more likely to know.
Gustav Vella (May 04 2019 at 21:58):
Got some feedback from @Stefan Lang who pointed me to http://ncimeta.nci.nih.gov/ . Indeed I can find most of the roles there. The descriptions point to ICH.
Also got some feedback from people working on the The European Legislation Identifier framework (ELI) with some promising leads.
I'll follow up. Thanks!
Last updated: Apr 12 2022 at 19:14 UTC
