Archetype Review Checklist

The following components or attributes of an archetype need to be considered at each stage of development. In this way, at final publication, we will have a consistent and high quality archetype. At all times, remember that the archetype is designed for a universal use case, and specific details that are appropriate for a particular health domain or clinical purpose can and should be constrained and represented in a template.

The approach to design scope is intended to be broad and as inclusive as is deemed sensible. The intent for a maximum data set in an archetype is ideal but may be overwhelming for some clinical concepts, and a more pragmatic decision may be to keep the scope based on what most users will require in the first instance, with slots for specialised content elements or those for other peripheral purposes, such as reporting, that can be used wherever needed.. This will help to keep the focus of the archetype on the most commonly used and core clinical concepts and not be overloaded with data elements that are uncommonly used.

Consider each of the following details when submitting an archetype to CKM - whether for the initial archetype upload, or submitting archetypes for review or publication:

Archetype Detail	Check for:
Concept name	Is this appropriate?
Data - data elements	Are these complete? Is there any content missing? Are the datatypes appropriate?
Data - normal statements	Should normal statements be included in this archetype? If present, are the normal statements appropriate? What normal statements should be added?
Events	Should any event be available? Are the specific point-in-time or interval events appropriate? What specific events should be added? Are events present that only apply in limited use cases and should be left to a template?
Protocol	Are the Protocol data elements appropriate? What other data elements should be added?
State	Are the State data elements appropriate? Are the assumed values correct? What other data elements should be added?
Slots	Are the slots named appropriately? Are the ITEM archetypes selected as inclusions correct? Are the ITEM archetypes selected as exclusions correct?
Comments	Check the correctness of any comments per data element
Cardinality	Check that cardinality is correct for Compositions, Sections, Clusters and Slots
Occurrences	Check the occurrences of data elements is correct
Metadata	Check completion and correctness of: Concept Description - a definition of the clinical concept being modelled. Purpose - the aim and intent of this archetype. What are the key aspects about this concept that will be covered by the scope of the archetype? For example, the adverse reaction EVALUATION will include both data elements that support the documentation of both the propensity of future reactions plus recording summary information about adverse reaction events that have occurred. Use - desciption of how this archetype might be used in implementations. Misuse - description about how this archetype should not be used in implementations. References Keywords Primary Author Contributors
Punctuation and spelling	Check for correctness and consistency of punctuation and spelling. Data element names - no full stop All descriptions require a full stop at the end of the sentence.
Phrasing and expression	Check for consistency of phrasing and expression, especially in data element naming and descriptions