Version 1.0 of the Asthma Therapeutic Area User Guide (TAUG-Asthma) was developed under the CFAST program and the CDISC Standards Development Process. TAUG-Asthma describes the most common biomedical concepts relevant to asthma studies, and the necessary metadata to represent such data consistently with Terminology and SDTM.
TA Standards extend the Foundational Standards to represent data that pertain to specific indications within disease areas. CDISC Standards specify how to structure the data; they do not specify what data should be collected or how to conduct clinical trials, assessments or endpoints.
Public Review Comments
CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.
Errata
- Page 5 / Section 1, Introduction:
- Second paragraph: The final sentence of this paragraph should be replaced with "See http://cdisc.org/cfast for a list of CFAST participating organizations."
- Figure 1: This outdated figure should be removed.
- Page 8 / Section 1.4 and throughout: Concept maps and their keys should be updated to the current coding style.
-
Page 38 / Section 3.1.6, Example 1:
-
first paragraph: "the Device-in-Use (DI) domain" is a typo; the domain code should be DU
-
re.xpt: the value in the "RETESTCD" for Row 3 should be renamed from "PPFEV1" to "FEV1PP"; for Row 4 should be renamed from "PPFVC" to "FVCPP"
-
-
Pages 41-42 / Section 3.1.6: Example 4 is updated as follows:
-
- Page 67 / Appendix B: This appendix should be removed.
- Page 68 / Appendix C: The title of this appendix should be changed from "Workgroup" to "CFAST Asthma Team"
- Page 72 / Appendix F:
- This appendix should be moved from the TAUG-Asthma itself to a separate document as a ReadMe for Prototype SHARE Metadata for Asthma.
- Worksheets for Pulmonary Function Tests should be renamed as follows:
- "PPFVC" to "FVCPP"
- "PPFEV1" to "FEV1PP"
- "PPFEF" to "FEF25_75PP"
- "PPPEF" to "PEFPP"
Supplementary Material
SDTMIG Draft Domains
The outdated copies of the draft domains included with the TAUG-Asthma (AG and RE) should be disregarded in favor of Procedure Agents (AG) and Respiratory System Findings (RE), respectively.
Prototype CDISC Library Metadata: Pulmonary Function Tests
- Bookmarks should be renamed as follows:
- "PPFVC" to "FVCPP"
- "PPFEV1" to "FEV1PP"
- "PPFEF25-75" to "FEF25-75PP"
- "PPPEF" to "PEFPP"
- Page 1 / Introduction: Short names for pulmonary function tests should be renamed as follows:
- "PPFVC" to "FVCPP"
- "PPFEV1" to "FEV1PP"
- "PPFEF25-75" to "FEF25-75PP"
- "PPPEF" to "PEFPP"
- Page 2 / Key to Layout: TESTCD should be renamed from "PPFVC" to "FVCPP"
- Page 5: Title and TESTCD should be renamed from "PPFVC" to "FVCPP"
- Page 5: The first part of the name for each BRIDG-based concept variable should be renamed from "PPFVC_OBS" and "PPFVC_RES" to "FVCPP_OBS" and "FVCPP_RES"
- Page 7: Title and TESTCD should be renamed from "PPFEV1" to "FEV1PP"
- Page 7: The first part of the name for each BRIDG-based concept variable should be renamed from "PPFEV1_OBS" and "PPFEV1_RES" to "FEV1PP_OBS" and "FEV1PP_RES"
- Page 10: Title and TESTCD should be renamed from "PPFEF25-75" to "FEF25-75PP"
- Page 10: The first part of the name for each BRIDG-based concept variable should be renamed from "PPFEV1_OBS" and "PPFEV1_RES" to "FEF25-75PP_OBS" and "FEF25-75PP_RES"
- Page 12: Title and TESTCD should be renamed from "PPPEF" to "PEFPP"
- Page 12: The first part of the name for each BRIDG-based concept variable should be renamed from "PPPEF_OBS" and "PPPEF_RES" to "PEFPP_OBS" and PEFPP_RES"