Sec. 1121. Clinical Trial Data System
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The Secretary, acting through the Commissioner of Food and Drugs and the Director of the National Institutes of Health, shall enter into a cooperative agreement, contract, or grant for a period of 7 years, to be known as the Clinical Trial Data System Agreement, with one or more eligible entities to implement a pilot program with respect to all clinical trial data obtained from qualified clinical trials for purposes of registered users conducting further research on such data.
Eligible entities seeking to enter into a cooperative agreement, contract, or grant with the Secretary under this section shall submit to the Secretary an application in such time and manner, and containing such information, as the Secretary may require in accordance with this section. The Secretary shall not enter into a cooperative agreement, contract, or grant with an eligible entity unless such entity submits an application including the following: A certification that the eligible entity is not currently and does not plan to be involved in sponsoring, operating, or participating in a clinical trial nor collaborating with another entity for the purposes of sponsoring, operating, or participating in a clinical trial.
Information demonstrating that the eligible entity can compile clinical trial data in standardized formats using terminologies and standards that have been developed by recognized standards developing organizations with input from diverse stakeholder groups, and information demonstrating that the eligible entity can de-identify clinical trial data consistent with the requirements of section 164.514 of title 45, Code of Federal Regulations (or successor regulations). A description of the system the eligible entity will use to store and maintain such data, and information demonstrating that this system will comply with applicable standards and requirements for ensuring the security of the clinical trial data.
A certification that the eligible entity will allow only registered users to access and use de-identified clinical trial data, gathered from qualified clinical trials, and that the eligible entity will allow each registered user to access and use such data only after such registered user agrees in writing to the terms described in (e)(4)(B), and such other carefully controlled contractual terms as may be defined by the Secretary. Evidence demonstrating the ability of the eligible entity to ensure that registered users disseminate the results of the research conducted in accordance with this section to interested parties to serve as a guide to future medical product development or scientific research.
The plan of the eligible entity for securing funding for the activities it would conduct under the clinical trial data system agreement from governmental sources and private foundations, entities, and individuals. Evidence demonstrating a proven track record of— being a neutral third party in working with medical product manufacturers, academic institutions, and the Food and Drug Administration; and having the ability to protect confidential data. An agreement that the eligible entity will work with the Comptroller General of the United States for purposes of the study and report in subsection (d).
The Secretary, acting through the Commissioner of Food and Drugs and the Director of the National Institutes of Health, upon the expiration of the 7-year period referred to in subsection (a), may extend (including permanently), expand, or terminate the pilot program established under such subsection, in whole, or in part. The Secretary shall conduct a study and issue a report to the Congress, with respect to the pilot program established under subsection (a), not later than 6 years after the date on which the pilot program is established under subsection (a).
The study under paragraph
(1)shall— review the effectiveness of the pilot program established under subsection (a); and be designed to formulate recommendations on improvements to the program. The report under paragraph
(1)shall contain at least the following information: The new discoveries, research inquiries, or clinical trials that have resulted from accessing clinical trial data under the pilot program established under subsection (a). The number of times scientists have accessed such data, disaggregated by research area and clinical trial phase. An analysis of whether the program has helped reduce adverse events in clinical trials. An analysis of whether scientists have raised any concerns about the burden of having to share data with the system established under the program and a description, if any, of such burden. An emphasis of privacy and data integrity practices used in the program. In this section: The term eligible entity means an entity that has experienced personnel with clinical and other technical expertise in the biomedical sciences and biomedical ethics and that is— an institution of higher education (as such term is defined in section 1001 of the Higher Education Act of 1965 ( 20 U.S.C. 1001 )) or a consortium of such institutions; or an organization described in section 501(c)(3) of title 26 of the Internal Revenue Code of 1986 and exempt from tax under section 501(a) of such title. The term medical product means a drug (as defined in subsection
(g)of section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 )), a device (as defined in subsection
(h)of such section), a biological product (as defined in section 351 of the Public Health Service Act ( 42 U.S.C. 262 )), or any combination thereof. The term qualified clinical trial means a clinical trial sponsored solely by an agency of the Department of Health and Human Services with respect to a medical product— that was— approved or cleared under section 505, 510(k), or 515, or has an exemption for investigational use in effect under section 505 or 520(m), of the Federal Food, Drug, and Cosmetic Act ( 42 U.S.C. 301 et seq. ); or licensed under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) or has an exemption for investigational use in effect under such section 351; or that is an investigational product for which the original development was discontinued and with respect to which— no additional work to support approval, licensure, or clearance of such medical product is being or is planned to be undertaken by the sponsor of the original development program, its successors, assigns, or collaborators; and the sponsor of the original investigational development program has provided its consent to the Secretary for inclusion of data regarding such product in the system established under this section. The term registered user means a scientific or medical researcher who has— a legitimate biomedical research purpose for accessing information from the clinical trials data system and has appropriate qualifications to conduct such research; and agreed in writing not to transfer to any other person that is not a registered user de-identified clinical trial data from qualified clinical trials accessed through an eligible entity, use such data for reasons not specified in the research proposal, or seek to re-identify qualified clinical trial participants. The term Secretary means the Secretary of Health and Human Services.
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