Page History

• Proposal 
  • To move the TA terminology development out of the existing process and develop with the other metadata as part of a TAUG and go out for public review with the draft TAUG. The purpose of this call was to explore how that would look and what would be needed.
  • Alana drafted the terminology Process for TAs based on input from assembled group. See attached TaskMap.
• Scope
  • Questionnaires are out of scope and not part of the 10-12 month CFAST project duration.
  • 6 week administrative publication process performed by Erin and Jordan at the NCI-EVS is considered outside the process and the TA 10-12 CFAST project duration. TA terminology will be clearly marked provisional until publication on the EVS website.
  • TA terminology requests for TA project would be managed by the Terminology TA Specialist.
  • Terminology TA Specialist will submit the TA team request in the New Term Request system which can be accessed from the CDISC Controlled Terminology Webpage
  • Other Terminology requests, outside the TA project will continue to use the New Term Request system
• Public Review
  • TA Terminology will be included as part of the TAUG package, considered provisional until publication on the EVS website.
  • Public review for TA terminology will be included with the TAUG package that goes out for public review.
  • TA team will review the public review comments on the terminology that was included with the TAUG package
• TA Process Changes
  • Agreed to identify and engage the Terminology TA Specialist at the end of Stage 0, and have this role as an active member that performs the terminology gap analysis with Erin Muhlbradt and functions as the liaison to the full terminology team. Definition description and new term development would occur within the TA team, with the review and advice of the full terminology team led by Bernice Yost.
• Benefits & Risks
  
  • The benefits:
    • It would allow a list view - to spot redundancies and ensure consistency within the list.
    • It would allow for a complete view that shows all related metadata, questions, answers (terminology), definitions, data types, and relationships to CDASH, SDTM, ADaM, etc..
  • The risks:
    • We need to be aware that there may be cases where complete terminology is not yet developed.   There may be terms on the list that have not yet completed their review in the existing terminology teams;   The TA terminology request may have terms that cross many therapeutic areas like Anatomical Location;   The General Terminology team handles these requests;
    • This proposal requires the ability to get Terminology Specialist Volunteers from TransCelerate
    
    

Agreed to consider trying this new process on the Hepatitis-C and Breast Ca projects.

Rhonda Facile - to contact the respective PMs (John Owen and Sarah Davis) and inform this them of this terminology piloting activity.

Pamela Harvey - to function as the Term TA Specialist with the assistance of Bernice and the TA Clinical Experts

Bernice Yost - to follow-up with Sam and Dave Jordan to request the appointment of a TA Terminology Specialist for Breast Ca.

Role Description

TA Terminology TA Specialist - see draft below

Discussed that there is a possibility that TCB can resource a terminology specialist for one of the TA projects. Bernice Yost to follow-up with Sam Hume.