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Summary

Adds the Participant extension to the CTC AE extractor.

New behavior

The CTC AE extractor extractors two new values (actor and functionCode) that make up the two pieces of the Participant complex extension. If functionCode is included, actor must be included as well per the Ig.

Code changes

  1. Updated example values in docs and sample-client-data. New fields referenced in the CSV_Templates sheet as well.
  2. Added the Participant Function Value Set to the valueSets directory for use in fetching display values for the functionCode column.
  3. Added support for the new columns to the CTC AE Template and Extractor.
  4. Updated unit tests for the CTC AE Template and Extractor.

Testing guidance

Ensure tests pass and extracted data looks good.

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@dmendelowitz dmendelowitz left a comment

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This works great! I just had one tiny comment about some wording

if (!(adverseEventCode && effectiveDate && grade)) {
throw new Error('The adverse event is missing an expected attribute. Adverse event code, effective date, and grade are all required.');
} else if (functionCode && !actor) {
throw new Error('The adverse event is missing an expected attribute. Adverse event actor is a required element within the Participation extension');
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This error message kind of makes it feel like actor is 100% required, not just conditionally required. I wonder if there's a better way to word it? Like would someone necessarily know what the participation extension is if they're just dumping a CSV into the client?

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This is a really good point. I've changed this message to be a little more specific about the relationship between the actor and functionCode columns.

@dmendelowitz dmendelowitz merged commit 469efde into develop Dec 17, 2021
@dmendelowitz dmendelowitz deleted the ctcae-complex-extension branch December 17, 2021 20:04
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3 participants