203 
of NIH for inclusion in the registry database peri-
odic updates to reflect changes to the clinical trial 
information submitted under this subsection. Such 
updates— 
‘‘(A) shall be provided not less than once 
every 6 months until information on the results 
of the trial is submitted under subsection (c); 
‘‘(B) shall include identification of the 
dates of any such changes; 
‘‘(C) not later than 30 days after the en-
rollment status of such clinical trial changes, 
shall include an update of the enrollment sta-
tus; and 
‘‘(D) not later than 30 days after the com-
pletion date of the clinical trial, shall include a 
report to the Director that such clinical trial is 
complete. 
‘‘(8) APPLICABILITY
OF
DEVICE
TRIALS.—In 
the case of an applicable clinical trial regarding a 
device, the responsible person for the trial shall sub-
mit to the Director of NIH the clinical trial informa-
tion as required in paragraph (4), but the Director 
may not make the information publicly available 
through the registry database until the device is ap-
proved or cleared (as the case may be). 
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204 
‘‘(c) CLINICAL TRIALS RESULTS DATABASE.— 
‘‘(1) ESTABLISHMENT.—To ensure that results 
of clinical trials are made public and that patients 
and providers have current information regarding 
the results of clinical trials, the Secretary, acting 
through the Director of NIH, shall establish and ad-
minister a clinical trial results database in accord-
ance with this section (referred to in this section as 
the ‘results database’). The Director of NIH shall 
ensure that the results database is made publicly 
available through the Internet. 
‘‘(2) SEARCHABLE CATEGORIES.—The Director 
of NIH shall ensure that the public may search the 
entries in the results database by 1 or more of the 
following: 
‘‘(A) The indication studied in the clinical 
trial, using Medical Subject Headers (MeSH) 
descriptors. 
‘‘(B) The safety issue studied in the clin-
ical trial. 
‘‘(C) Whether an application for the tested 
indication is approved, pending approval, with-
drawn, or not submitted. 
‘‘(D) The phase of the clinical trial. 
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205 
‘‘(E) The name of the drug or device that 
is the subject of the clinical trial. 
‘‘(F) Within the documents described in 
clauses (i) and (ii) of paragraph (3)(B), the fol-
lowing information, as applicable: 
‘‘(i) The sponsor of the clinical trial. 
‘‘(ii) Each financial sponsor of the 
clinical trial. 
‘‘(3) CONTENTS.— 
‘‘(A) IN GENERAL.—The responsible party 
for an applicable clinical trial shall submit to 
the Director of NIH for inclusion in the results 
database the clinical trial information described 
in subparagraph (B). 
‘‘(B) REQUIRED
ELEMENTS.—In submit-
ting clinical trial information for a clinical trial 
to the Director of NIH for inclusion in the re-
sults database, the responsible party shall in-
clude, with respect to such clinical trial, the fol-
lowing information: 
‘‘(i) The information described in sub-
paragraphs (A) through (E) of subsection 
(b)(2). 
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