CDISC recommends the data element "Serious Adverse Event" be considered for promotion in USCDI v5.
The rationale is that it will aid in drug safety, patient safety and clinical research. HL7 Vulcan Adverse Event working group is close to publishing two implementation guides to clarify how the data element would be used: http://hl7.org/fhir/uv/ae-research-ig/2023Sep/StructureDefinition-AdverseEvent-clinical-research.html https://build.fhir.org/ig/HL7/fhir-ae-research-backport-ig/index.html
The FHIR AdverseEvent Resource is Maturity Level 2 http://build.fhir.org/adverseevent.html
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Fig 1 The "Data Class" and "Data Element" dropdown menus allow users to specify the exact content they wish to comment on.
4. Optional: Propose New Data Class or Element
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This will redirect you to the ONDEC (ONC New Data Element and Class) Submission System.
In the ONDEC system, follow the provided instructions to submit your proposal for a new data class or element.
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Fig 2 The "Propose a New Data Class or Data Element" button redirects users to the ONDEC Submission System for proposing new data elements not currently available in the system.
5. Complete the Comment Form
Fill out the required fields in the comment form:
Subject: Enter a brief, descriptive title that summarizes your comment. This helps reviewers quickly understand the nature of your feedback.
Comment: In this field, provide the full details of your comment or feedback. Be as clear and specific as possible about your suggestions, concerns, or observations. Include any relevant details that support your position.
6. Optional: Add Additional Comments
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Complete the Subject and Comment fields for your additional comment.
Repeat this process for each additional comment you wish to submit.
Fig 3 The "Comment on another data element" link enables users to create multiple comments addressing different elements within a single submission.
7. Optional: Upload Supporting Files
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Locate the "File Upload" section at the bottom of the comment form.
Click to upload any files (such as PDFs or documents) that provide additional context, evidence, or clarification for your comment.
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Fig 4 The "File Upload" section permits users to attach supporting documentation that supplements their written comments.
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Fig 5 A red triangle with exclamation mark indicator appears next to the “Return to saved Comment” button when draft comments are saved in the system.
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Click the "Review and Submit" button at the bottom of the form.
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Review all information for accuracy and completeness.
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If you choose to submit, your comment will be recorded in the system and made available for review by the appropriate stakeholders.
Fig 6 The review screen allows users to verify comment content and make any necessary modifications before final submission.
Submitted by rbaker@cdisc.org on
CDISC recommends Serious Adverse Event promotion in v5
CDISC recommends the data element "Serious Adverse Event" be considered for promotion in USCDI v5.
The rationale is that it will aid in drug safety, patient safety and clinical research. HL7 Vulcan Adverse Event working group is close to publishing two implementation guides to clarify how the data element would be used:
http://hl7.org/fhir/uv/ae-research-ig/2023Sep/StructureDefinition-AdverseEvent-clinical-research.html
https://build.fhir.org/ig/HL7/fhir-ae-research-backport-ig/index.html
The FHIR AdverseEvent Resource is Maturity Level 2
http://build.fhir.org/adverseevent.html
Thank you for the opportunity to comment.