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2015-08-18
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Electronic Study Data Submission; Data Standards; Support for Study Data Tabulation Model Implementation Guide Version 3.2
Notices
D09002ee1c180b6b3
D09002ee1c180b748
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) are announcing support for the 3.2 version (see section II. Exceptions) of Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model Implementation Guide (SDTM IG 3.2), an update to the FDA Data Standards Catalog (Catalog), and availability of validation rules for the 3.2 version. SDTM IG 3.2 has been available from CDISC since December 2013. FDA is encouraging sponsors and applicants to use SDTM IG 3.2 (see section II. Exceptions) in investigational study data provided in regulatory submissions to CBER and to CDER.
80 FR 50014
https://www.govinfo.gov/app/details/FR-2015-08-18/2015-20316
2015-20316
fr18au15-54
4164-01-P
Docket No. FDA-2015-N-2853
https://www.govinfo.gov/app/details/FR-2015-08-18/2015-20316
https://www.govinfo.gov/content/pkg/FR-2015-08-18/html/2015-20316.htm
https://www.govinfo.gov/content/pkg/FR-2015-08-18/pdf/2015-20316.pdf
2 p.
50014
50015
80 FR 50014
Electronic Study Data Submission; Data Standards; Support for Study Data Tabulation Model Implementation Guide Version 3.2; Federal Register Vol. 80, Issue
NOTICE
2015-20316
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2015-N-2853
4164-01-P
2015-20316
Notice.
The Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) are announcing support for the 3.2 version (see section II. Exceptions) of Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model Implementation Guide (SDTM IG 3.2), an update to the FDA Data Standards Catalog (Catalog), and availability of validation rules for the 3.2 version. SDTM IG 3.2 has been available from CDISC since December 2013. FDA is encouraging sponsors and applicants to use SDTM IG 3.2 (see section II. Exceptions) in investigational study data provided in regulatory submissions to CBER and to CDER.
Ron Fitzmartin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993-002, 301-796-5333, email: ronald.fitzmartin@fda.hhs.gov.
Guidance:
Electronic Study Data Submission; Data Standards; Support for Study Data Tabulation Model Implementation Guide Version 3.2
,
cber.cdisc@fda.hhs.gov
cder-edata@fda.hhs.gov
ronald.fitzmartin@fda.hhs.gov
http://www.cdisc.org/
http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm
http://www.regulations.gov
Federal Register
Vol. 80, no. 159
Office of the Federal Register, National Archives and Records Administration
2015-08-18
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311 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2015-08-18
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https://www.govinfo.gov/app/details/FR-2015-08-18
https://www.govinfo.gov/content/pkg/FR-2015-08-18/pdf/FR-2015-08-18.pdf
https://www.govinfo.gov/content/pkg/FR-2015-08-18/xml/FR-2015-08-18.xml
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2015-08-18
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FR-2015-08-18
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FR-2015-08-18
80
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