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question-circle Indications in SPL

  • Posts: 114
6 years 9 months ago #3620 by Jean Duteau
Replied by Jean Duteau on topic Indications in SPL
Ah, you can get to Indications another way as well via the subject relationship off the section (as opposed to the subject2 I used in my earlier response). I missed that the easy way I gave didn't actually reference a specific product or substance.

For indications on a specific product:
.../section/subject/manufacturedProduct/consumedIn/substanceAdministration1/reason/indicationObservationCriterion

For indications on a substance, I don't see how you can do that directly. You can say Substance X is an ingredient of Product Y and Product Y has the following indications for administering it:

.../section/subject/ingredient/ingredientOfProduct/asManufacturedProduct/consumedIn/substanceAdministration1/reason/indicationObservationCriterion

Jean

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  • Posts: 15
6 years 9 months ago #3619 by Peter Bomberg
Replied by Peter Bomberg on topic Indications in SPL
Thanks Jean, I am specifically looking at a mechanism of relating indications to either the substance or product.

I may have no choice but to use the section approach, however the issue is that there is no link to products (in the case that the document has more than a single product) or substances (when there is more than one product).

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  • Posts: 114
6 years 9 months ago #3618 by Jean Duteau
Replied by Jean Duteau on topic Indications in SPL
Peter,

From the SPL model, the ProductUseGuidelines has a reason relationship to the Indication choice which contains a IndicationObservationCriterion as one of the choices and that is where the indications for a given product would be specified.

Starting with the SPL schema, the XML path to the Indications is:

Document/component/structuredBody/component/section/subject2/substanceAdministration/reason/indicationObservationCriterion

This observation takes a code (text is allowed) that would be the indication.

Hope this helps,

Jean Duteau

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  • Posts: 15
6 years 9 months ago #3579 by Peter Bomberg
Is there any metadata (ie element contained within the SPL product data elements section) that captures indications?

There is a separate section, but looking at the SPL schema I do not see any reference to the otherIndication element. What am I missing or is it that SPL as currently defined does not capture indications at the product or substance level?

Help or assistance would be welcome, or even point me in the right direction.

Peter Bomberg

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