207 
‘‘(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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stricts in any manner the ability of the in-
dividual— 
‘‘(I) to discuss the results of the 
trial at a scientific meeting or any 
other public or private forum; or 
‘‘(II) to publish the results of the 
trial, or a description or discussion of 
the results of the trial, in a scientific 
or academic journal. 
‘‘(vi) The completion date of the clin-
ical trial. 
‘‘(vii) A link to the Internet web post-
ing of any adverse regulatory actions taken 
by the Food and Drug Administration, 
such as a warning letter, that was sub-
stantively based on the clinical trial design, 
outcome, or representation made by the 
applicant about the design or outcome of 
the clinical trial. 
‘‘(C) LINKS IN DATABASE.—The Director 
of NIH shall ensure that the results database 
includes the following: 
‘‘(i) Links to Medline citations to pub-
lications reporting results from each appli-
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cable drug clinical trial and applicable de-
vice clinical trial. 
‘‘(ii) Links to the entry for the prod-
uct that is the subject of an applicable 
drug clinical trial in the National Library 
of Medicine database of structured product 
labels, if available. 
‘‘(iii) Links described in clauses (i) 
and (ii) for data bank entries for clinical 
trials submitted to the data bank prior to 
enactment of this section, as available. 
‘‘(4) TIMING.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraphs (B) and (C), a responsible party 
shall submit to the Director of NIH for inclu-
sion in the results database clinical trial infor-
mation for an applicable clinical trial not later 
than 1 year after the earlier of— 
‘‘(i) the estimated completion date of 
the trial, as submitted under subsection 
(b)(2); or 
‘‘(ii) the actual date of the completion, 
or termination before completion, of the 
trial, as applicable. 
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‘‘(B) EXTENSIONS.—The Director of NIH 
may provide an extension of the deadline for 
submission of clinical trial information under 
subparagraph (A) if the responsible party for 
the trial submits to the Director a written re-
quest that demonstrates good cause for the ex-
tension and provides an estimate of the date on 
which the information will be submitted. The 
Director of NIH may grant more than one such 
extension for the clinical trial involved. 
‘‘(C) UPDATES.—The responsible party for 
an applicable clinical trial shall submit to the 
Director of NIH for inclusion in the results 
database periodic updates to reflect changes in 
the clinical trial information submitted under 
this subsection. Such updates— 
‘‘(i) shall be provided not less fre-
quently than once every 6 months during 
the 10-year period beginning on the date 
on which information is due under sub-
paragraph (A); 
‘‘(ii) shall identify the dates on which 
the changes were made; and 
‘‘(iii) shall include, not later than 30 
days after any change in the regulatory 
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