It would be nice to develop some testable conditions when defining when a versioned standard is ready for SHARE loading. This will help determine at what point the process will take place in COP-001.

Benefits for these readiness tests:

  • Generate Diff for public review and publication
  • Make metadata ready for download via SHARE Exports and SHARE API
  • Detail the intricate relationships among CDISC standards

Ideas for testable conditions:

0%

Running List of Ideas

  1. handler

    For CDASH, SDTM, SEND, metadata follow the established hierarchical stack: Model, Class, Domain, Variable, Value Domain

    Priority MEDIUM
    achow
    Jun 18, 2018
  2. handler

    No meaningful metadata appear as a specification table's footnote

    Priority MEDIUM
    achow
    Jun 15, 2018
  3. handler

    Metadata table do not have vertical or horizontal merged cells

    Priority MEDIUM
    achow
    Jun 15, 2018
  4. handler

    Uniform, predictable structure

    Priority MEDIUM
    achow
    Jun 15, 2018
  5. handler

    Must have metadata QC macro developed & applied

    Priority MEDIUM
    achow
    Jun 15, 2018
  6. handler

    An IG must implement a Model, and only one version of it

    Priority MEDIUM
    achow
    Jun 15, 2018
  7. handler

    Compatible with Spec Grabber

    Priority MEDIUM
    achow
    Jun 15, 2018
  8. handler

    Domains need to have a version number, drafts included

    Priority MEDIUM
    achow
    Jun 15, 2018
  9. handler

    Domain metadata are present: abbreviation, label, structure, version #, description

    Priority MEDIUM
    achow
    Jun 18, 2018
  10. handler

    Domains are defined in CDISC CT

    Priority MEDIUM
    achow
    Jun 18, 2018
  11. handler

    Variables in an IG must be defined in the corresponding versioned Model

    Priority MEDIUM
    achow
    Jun 18, 2018
  12. handler

    All CDISC CT codelists referenced exist

    Priority MEDIUM
    achow
    Jun 18, 2018
  13. handler

    Classes are defined in CDISC CT

    Priority MEDIUM
    achow
    Jun 18, 2018
  14. handler

    Each foundational standard has a formal product description, short name, and label

    Priority MEDIUM
    achow
    Jun 18, 2018
  15. handler

    Variables beginning with "--" are not referenced in Role column of implementation guide.

    Priority MEDIUM
    achow
    Jun 18, 2018
  16. handler

    Datatype is populated

    Priority MEDIUM
    jchason
    Jun 18, 2018
  17. handler

    Domain specification tables are complete with variables and associated metadata

    Priority MEDIUM
    achow
    Jun 18, 2018
  18. handler

    Metadata used in annotated CRF are correct and reflective of the actual domain metadata

    Priority MEDIUM
    achow
    Jun 18, 2018
  19. handler

    For SENDIG and SDTMIG, role is populated

    Priority MEDIUM
    jchason
    Jun 19, 2018

Furthermore, additional tooling or enhancement to existing tools will help reduce manual curation work. In other words, below is a wish list from curators:

0%

Curator Wish List on Tools and Enhancement

  1. handler

    Domain description (ref: Section 6.1 Index - Page 1, Section 6.2 Index - Page 1, etc.) be added to the domain metadata content control (ref: SDTMIG 3.3 Content Control) to eliminate manually deducing the text from paragraph text

    Priority MEDIUM
    achow
    Jun 18, 2018
  2. handler

    Capture "Controlled Terms, Codelist or Format" separately to reduce manual parsing

    Priority MEDIUM
    achow
    Jun 18, 2018
  3. handler

    CDASH variables often have 1-to-many SDTM mappings. Would be nice these are captured as such instead of manually creating the relationships

    Priority MEDIUM
    achow
    Jun 18, 2018
  • No labels

8 Comments

  1. Anthony Chow

    Need to deduce "1-to-1 relationship" into something testable.

  2. Anthony Chow

    Need to say something about conditional codelist

  3. Anthony Chow

    Need to work with Standards Development to discuss versioning strategy

  4. Anthony Chow

    Need to formalize requirement for managing CDASH and SDTM models together, provided it is a direction we agree

  5. Anthony Chow

    Need to determine metadata for TAUG

  6. Anthony Chow

    Need to understand the impact of harmonizing standards is to the SHARE meta-model

  7. Darcy Wold

    "Capture 'Controlled Terms, Codelist or Format' separately to reduce manual parsing" sounds like Spec Grabber's link diving. It's disabled for SHARE 1.0 output format, and it may not be currently configured as desired (I was making things up as I went along), but it's possible and already exists in infancy. 

    What's needed:

    • A way to reliably distinguish controlled terms from codelists from formats, preferably without having to check against a list of known values
    • Clear output parameters – do we want to differentiate between external dictionaries and codelists? Do you want to capture codelist C-codes as well?

  8. Darcy Wold

    Domain descriptions are already part of the domain metadata content control. The indices pull from the form. It's the "Definition from Controlled Terminology" column.