Sec. 1102. Standardization of data in Clinical Trial Registry Data Bank on eligibility for clinical trials
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/bill/114/hr/6/ih/section-1102A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 402(j) of the Public Health Service Act ( 42 U.S.C. 282(j) ) is amended— by redesignating paragraph
(7)as paragraph (8); and by inserting after paragraph
(6)the following: The Director of NIH shall— ensure that the registry and results data bank is easily used by the public; ensure that entries in the registry and results data bank are easily compared; ensure that information required to be submitted to the registry and results data bank, including recruitment information under paragraph (2)(A)(ii)(II), is submitted by persons and posted by the Director of NIH in a standardized format and shall include at least— the disease or indication being studied; inclusion criteria such as age, gender, diagnosis or diagnoses, lab values, or imaging results; and exclusion criteria such as specific diagnosis or diagnoses, lab values, or prohibited medications; and to the extent possible, in carrying out this paragraph, make use of standard health care terminologies, such as the International Classification of Diseases or the Current Procedural Terminology, that facilitate electronic matching to data in electronic health records or other relevant health information technologies. . Clause
(iv)of section 402(j)(2)(B) of the Public Health Service Act ( 42 U.S.C. 282(j)(2)(B) ) is hereby stricken. Not later than 90 days after the date of enactment of this Act, the Secretary of Health and Human Services shall consult with stakeholders (including patients, researchers, physicians, industry representatives, health information technology providers, the Food and Drug Administration, and standard setting organizations such as CDISC that have experience working with Federal agencies to standardize health data submissions) to receive advice on enhancements to the clinical trial registry data bank under section 402(j) of the Public Health Service Act ( 42 U.S.C. 282(j) ) (including enhancements to usability, functionality, and search capability) that are necessary to implement paragraph
(7)of section 402(j) of such Act, as added by subsection (a). Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services shall begin implementation of paragraph
(7)of section 402(j) of the Public Health Service Act, as added by subsection (a).
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Sec. 1102
Standardization of data in Clinical Trial Registry Data Bank on eligibility for clinical trials
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