2014-03-24 CFAST PM Terminology Process Call #1 Meeting Notes

Bernice reviewed the current terminology process. Bernice's slides are attached below.

10 terminology teams:

1. 1. Lab
   2. PK
   3. Questionnaires
   4. SEND
   5. Oncology
   6. ECG
   7. Devices
   8. Virology
   9. Cardiovascular
   10. General - takes all the requests that don't fit a particular team.

• Each team must have a EVS, data management, clinical scientists, subject matter experts in the area
• Meets once a week
• Publishes terminology quarterly - see schedule in attached slide set.

Bernice - established new terminology teams by sending requests out to the CDISC community as needed.

RCRIM - no longer is involved in these calls.

Erin - Some teams have little coming in and other have lots of requests coming in. Steve - This happens on those projects that have CDEs as the basis, hence the "bolus". Erin - some teams are interested in controlling things but others not.

Bess - MS has a big component, they are working with the ophthalmology team. When is the best time to create terminology for a new draft domains? So they have been waiting until things are almost final. There needs to be better coordination between the term team and the SDS team. Modeling done in parts, list of clinical concepts, you need to know which domain it will go into, must understand WHERE they will fit. SRC comes back with comments that may change this. Concern, the modeling is not see until it goes to SRC. They have been creating terminology and then pulling it.

Proposal - perhaps add an SRC review at the end of the Stage 1

A decision was made by the SDS team - Findings About was overloaded, so you can have a Findings About with a specific TA code list.

Terminology Cheat Sheet

Suggestion to develop a terminology 1-page "cheat sheet". A list of areas that have terminology developed:

• What can be controlled and what cannot - a large topic
• What lists extensible and which are not
• A list of rules that apply to all projects that need terminology developed.
• Postnote: There is a terminology UG developed a while ago. This document needs to be revised and updated.

Bernice's note to Amy dated march 19 - suggested new process

I was trying to think of a way that we good accomplish what Amy was asking for: terminology review being released with user guide review.

I have a rough idea of a possible way to accomplish this:

- Controlled terminology publication will still be released at the end of every quarter ( 4 times a year)

- Controlled terminology public review will still be put out for comment 10 weeks before the official terminology publication release at the end of every quarter

- Therapeutic Area User Guides will still be released for public review at their current schedule

- TA team submits their terminology requests on the CDISC Controlled Terminology Multiple Term Request Spreadsheet

- The terms on this form will end up being divided among the different terminology teams and follow the usual process of review

- The original TA multiple term request spreadsheet can be updated as time goes on based on TA meetings and Terminology meetings

- When the User Guide goes out for public review, the updated TA terminology multiple term request spreadsheet can be attached as DRAFT

- Each term on that DRAFT multiple term request spreadsheet might be in different stages:  already published, reviewed and accepted/denied, or not reviewed yet by the term team

- When the public review for the User Guide is completed, the TA team can review the terminology comments

- If the TA team agrees with the public review comments, they can send updates to terminology (the details of this needs to be worked out)

- Obviously the TA team would need assistance in keeping the original Multiple Term Request Spreadsheet updated

- CFAST has offered part time TA terminology assistance, this person could attend the TA meetings and the terminology meetings and keep the spreadsheet updated