You are viewing an old version of this page. View the current version.
Compare with Current
View Page History
« Previous
Version 6
Next »
Date
25 March 2014
Attendees
Goals
- Continue terminology process discussion
- Begin mapping the process into TaskMap
Discussion Items
| Time | Item | Who | Notes |
|---|
| Process Proposal | | - Proposal
- to move 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 out of scope and not part of the 10-12 month project duration
- Other Terminology requests - use the New Term Request form on the EVS website
- TA terminology requests for TA project would be managed by the Terminology TA Specialist
- 6 week administrative publication process performed by Erin and Jordan is outside this process and TA project timeline
- Terminology included as part of the TAUG package will be considered provisional until publication on the EVS website.
- Process
- The goal is 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.
- The benefits of this approach are two-fold. It would afford a view of both the list format (to spot redundancies and ensure consistency within the list) and allow for a full definition view that includes the questions, and relationships CDASH, SDTM, ADaM, etc..
- We need to be aware that there may be cases where complete terminology is not developed. BERNICE - can you expand - the LOC example.
|
| | Proposed Pilot | | Agreed to consider trying this new process on the Hepatitis-C and Breast Ca projects. Rhonda Facile to contact the respective PMs and inform this of this 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 | | Terminology TA Specialist - see below Discussed 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. |
| | CDISC Terminology UG & 1-page "Cheat Sheet" | | - The Terminology Governance and Implementation document, is in need of updating. Wayne has provided some comments registered over a year ago on this document. He asks that the team consider these.
- The document should also conform to the current CDISC style guide which is posted at http://portal.cdisc.org/Teams%20Projects/default.aspx
- Rhonda suggested that the team also develop a 1-page "cheat sheet" that can be given to TA team members that are not directly involved in terminology development but can benefit from knowing the main steps and principles. Bernice replied that she thought this was indeed a good idea but expressed concern regarding workload.
|
Terminology TA Specialist (CFAST Resource) | A member of the terminology team | - Works with the TA teams to determine terminology needs.
- Works with the CDISC terminology team and the NCI-EVS rep team to develop the needed new/modified/retired terms.
- Ensures alignment with existing terminology
| - Therapeutic area domain expertise
- Protocol and clinical study experience
- Collaboration and teamwork skills
- Experience working with volunteers is useful
- Familiarity with CDISC standards is useful
|
Action Items