Document ID: FDA-2014-N-1840-0001
Agency: fda
Document Type: Notice
Title: Electronic Study Data Submission;nData Standards; Validation Rules for
Study Data Tabulation ModelnFormatted Studies; Availability
Posted Date: 2014-11-19T05:00Z

[Federal Register Volume 79, Number 223 (Wednesday, November 19, 2014)]
[Notices]
[Page 68890]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-27384]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1840]

Electronic Study Data Submission; Data Standards; Validation 
Rules for Study Data Tabulation Model Formatted Studies; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA) Center for Drug 
Evaluation and Research (CDER) is announcing the availability of a 
document entitled ``Validation Rules for Study Data Tabulation Model 
(SDTM) Formatted Studies.'' CDER is making this document available to 
improve the standardization and quality of clinical data submitted to 
CDER, as well as to improve the predictability of data quality and 
usefulness.

FOR FURTHER INFORMATION CONTACT: Office of Strategic Programs, Center 
for Drug Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993, email: 
edata@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: CDER supports the regulatory submission of 
standardized clinical study data based on the Clinical Data Interchange 
Standards Consortium SDTM. Upon receipt of the data, CDER validates the 
data using a set of validation rules. The ``Validation Rules for SDTM 
Formatted Studies'' is an Excel file that provides a human readable 
description of a rule set for validation. Submitters of clinical study 
data can use this information to understand how FDA validates the data. 
The file is available on FDA's Study Data Standards Resources Web page 
at http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm. It contains a combination of conformance rules (i.e., how 
well the data conform to the standard) and business rules (i.e., 
quality checks; how well the data may support useful analysis). The 
rules may be updated periodically as new or updated validation rules 
are developed. The Change History tab will provide a descriptive change 
history of the document.

    Dated: November 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-27384 Filed 11-18-14; 8:45 am]
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