...
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 |