1.  Revise the archetype prior to sending out for a first review. Check the following:

  2.  Identify potential members and create a team that will be assigned to reviewing this archetype:

  3. Initiate the review:

 4.  CKM Notifications.

 5. Once the review deadline has passed, the editor can collate the feedback and revise the archetype based on the reviewer comments:

 6.  The editor can initiate the next round of review on the revised archetype, and sending out the collated feedback, including the editorial response to each comment. 

 7. Steps 3 to 6 can be repeated as many times as is required until consensus is reached on the clinical content.

 8.  Once agreement is reached on the clinical content ie all (or the majority of, if consensus cannot be reached) reviewers 'Accept' the archetype, the status of the archetype can be set to 'Published'.

 9. Other reviewers can be added at any time in the review process, even in the middle of an existing review.

 10. Once the clinical content is agreed and fixed and thus effectively published, then additional work to incorporate translations and terminology coding can commence.

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In addition, consider the the same list provided to the reviewers, below.  In particular it will largely fall to the responsibility of the editor to ensure that the descriptions and options within the archetype are represented consistently, with similar phrasing, expression, grammar etc.

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
  • Purpose
  • Use
  • Misuse
  • References - Citation style
  • Keywords
  • Primary Author
  • Contributors

Punctuation and spelling

Check for correctness and consistency of punctuation and spelling

Phrasing and expression

Check for consistency of phrasing and expression, especially in data element naming and descriptions