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used by patients, and that entries are easily 
compared. 
‘‘(4) DATA SUBMISSION.—The responsible party 
for an applicable clinical trial shall submit to the Di-
rector of NIH for inclusion in the registry database 
the clinical trial information described in paragraph 
(2). 
‘‘(5) TRUTHFUL
CLINICAL
TRIAL
INFORMA-
TION.— 
‘‘(A) IN GENERAL.—The clinical trial in-
formation submitted by a responsible party 
under this subsection shall not be false or mis-
leading. 
‘‘(B) EFFECT.—Subparagraph (A) shall 
not have the effect of requiring clinical trial in-
formation to include information from any 
source other than the clinical trial involved. 
‘‘(6) TIMING OF SUBMISSION.—Except as pro-
vided in paragraph (7), the clinical trial information 
for a clinical trial required to be submitted under 
this subsection shall be submitted not later than 14 
days after the first patient is enrolled in such clin-
ical trial. 
‘‘(7) UPDATES.—The responsible party for an 
applicable clinical trial shall submit to the Director 
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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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‘‘(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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‘‘(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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‘‘(ii) A summary that is written in 
non-technical, understandable language for 
patients that includes the following: 
‘‘(I) The purpose of the clinical 
trial. 
‘‘(II) The sponsor of the clinical 
trial. 
‘‘(III) A point of contact for in-
formation about the clinical trial. 
‘‘(IV) A description of the patient 
population tested in the clinical trial. 
‘‘(V) A general description of the 
clinical trial and results, including a 
description of and the reasons for any 
changes in the clinical trial design 
that occurred since the date of sub-
mission of clinical trial information 
for inclusion in the registry database 
established under subsection (b) and a 
description of any significant safety 
information. 
‘‘(iii) A summary that is technical in 
nature that includes the following: 
‘‘(I) The purpose of the clinical 
trial. 
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‘‘(II) The sponsor of the clinical 
trial. 
‘‘(III) Each financial sponsor of 
the clinical trial. 
‘‘(IV) A point of contact for sci-
entific information about the clinical 
trial. 
‘‘(V) A description of the patient 
population tested in the clinical trial. 
‘‘(VI) A general description of 
the clinical trial and results, including 
a description of and the reasons for 
any changes in the clinical trial design 
that occurred since the date of sub-
mission of clinical trial information 
for the clinical trial in the registry 
database established under subsection 
(b). 
‘‘(VII) Summary data describing 
the results, including— 
‘‘(aa) whether the primary 
endpoint was achieved, including 
relevant statistics; 
‘‘(bb) an assessment of any 
secondary endpoints, if applica-
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ble, including relevant statistics; 
and 
‘‘(cc) any significant safety 
information, including a sum-
mary of the incidence of serious 
adverse events observed in the 
clinical trial and a summary of 
the most common adverse events 
observed in the clinical trial and 
the frequencies of such events. 
‘‘(iv) With respect to the group of 
subjects receiving the drug or device in-
volved, and each comparison group of sub-
jects, the percentage of individuals who 
ceased participation as subjects and the 
reasons for ceasing participation. 
‘‘(v) With respect to an individual who 
is not an employee of the responsible party 
for the clinical trial or of the manufacturer 
of the drug or device involved, information 
(to the extent not submitted under sub-
section (b)(2)(F)) on any agreement that 
the responsible party or manufacturer has 
entered into with such individual that re-
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