[Federal Register Volume 79, Number 223 (Wednesday, November 19, 2014)]
[Notices]
[Page 68890]
From the Federal Register Online via the Government Publishing 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:
[email protected].
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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