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94TH GENERAL ASSEMBLY
State of Illinois
2005 and 2006
SB1517
Introduced 2/23/2005, by Sen. Jacqueline Y. Collins - Miguel del Valle SYNOPSIS AS INTRODUCED:
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20 ILCS 2310/2310-367 new |
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Amends the Department of Public Health Powers and Duties Law. Provides that any entity conducting a clinical drug trial on a human person in this State must register with the Department. Sets forth certain minimum requirements for the registration. Provides that the information so gathered shall be collected in a clinical trials data bank administered by the Department. Requires the Department to publish aggregates of the clinical trials data collected, at least annually, and with personal identifiers redacted. Sets forth the purposes for the publication of clinical trials data and provides that the Department shall take all steps necessary under State and federal law to protect patient confidentiality. Provides that the Department shall adopt rules as necessary to implement the requirements.
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| FISCAL NOTE ACT MAY APPLY | |
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A BILL FOR
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SB1517 |
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LRB094 08104 RSP 38289 b |
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| AN ACT concerning State government.
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| Be it enacted by the People of the State of Illinois,
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| represented in the General Assembly:
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| Section 5. The Department of Public Health Powers and |
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| Duties Law of the
Civil Administrative Code of Illinois is |
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| amended by adding Section 2310-367 as follows:
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| (20 ILCS 2310/2310-367 new) |
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| Sec. 2310-367. Clinical drug trial registry; data bank. The |
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| Department shall require that every hospital, laboratory, |
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| person, or facility conducting a clinical drug trial on a human |
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| person in this State must register with the Department. The |
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| Department shall specify the form and content of the |
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| registration, which shall at a minimum require the entity |
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| conducting the clinical drug trial to disclose: (i) the name |
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| and U.S. patent number of the drug or drugs being used in the |
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| clinical drug trial and (ii) the result or results of the |
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| clinical drug trial. |
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| The information so gathered shall be stored, categorized, |
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| and collected in a clinical trials data bank to be administered |
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| by the Department. The Department shall ensure, at least |
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| annually, the publication of clinical trials data bank |
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| information with personal identifiers redacted and focusing on |
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| the aggregate data collected and the results of the trials. The |
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| purpose of publicizing data bank information is to provide |
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| relevant information about the drugs involved to patients and |
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| physicians and to educate the public by providing relevant |
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| information in language readily comprehensible by the general |
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| public. The Department shall undertake all steps necessary |
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| under State and federal law to protect patient confidentiality |
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| in order to prevent the identification of individual patients. |
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| The Department shall adopt rules as necessary to implement |
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| this Section pursuant to the Illinois Administrative Procedure |
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