[mla-nynj] FW: [mla-grc] Fwd: ClinicalTrials.gov Info

Robb Mackes rmackes at delamed.org
Tue Nov 20 18:38:48 UTC 2007

Posting for Mahnaz...





From: Mary Langman [mailto:mlaedo2 at mlahq.org] 
Sent: Tuesday, 20 November, 2007 13:25
To: MLA-GRC at mlahq.org; mla-legis-tf at mlahq.org; janeblum at umich.edu;
lwatson at umn.edu
Subject: [mla-grc] Fwd: ClinicalTrials.gov Info


GRC and Legislative Task Force Members:

Dane Christensen has forwarded the following information regarding  PL:
110-85, the new law that expands ClinicalTrials.gov. Dane has provided
information regarding registration requirements and other related


Guidance on New Law (Public Law 110-85) Enacted to Expand the Scope of
ClinicalTrials.gov: Registration 


Notice Number: NOT-OD-08-014

Key Dates
Release Date: November 16, 2007

Issued by
National Institutes of Health (NIH), (http://www.nih.gov
<http://www.nih.gov/> )

A new law has been enacted to expand the scope of ClinicalTrials.gov.
This notice provides information for NIH grantees on new
responsibilities related to the first part of the law, the registration
of clinical trials.  

New Law Enacted to Expand ClinicalTrials.gov:

Public Law 110-85, which was enacted on September 27, 2007 [
ic_laws&docid=f:publ085.110.pdf>  ] amends the Public Health Service Act
to expand the scope of clinical trials that must be registered in
ClinicalTrials.gov.  It also increases the number of registration fields
that must be submitted, requires certain results information to be
included and sets penalties for noncompliance. This notice provides
information for NIH grantees and contractors on new responsibilities
related to the first part of the law, the registration of clinical
trials.    Additional information will be forthcoming.

Which Trials Must be Registered?

The trials that must be registered are called "applicable clinical
trials."  Under the statute, these trials generally include:  (1) Trials
of Drugs and Biologics:  Controlled, clinical investigations, other than
Phase 1 investigations, of a product subject to FDA regulation; and (2)
Trials of Devices:  Controlled trials with health outcomes, other than
small feasibility studies, and pediatric postmarket surveillance. You
should review the statutory definition of applicable clinical trial to
identify if any of your trials must be registered to comply with the law
] See PL 110-85, Section 801(a), (adding new 42 U.S.C. 282(j)(1)(A)).
NIH encourages registration of ALL trials whether required under the law
or not.

Who is responsible?

The entity responsible for registering is the "responsible party."  The
statute defines the responsible party as: 

(1) the sponsor of the clinical trial (as defined in 21 C.F.R. 50.3) [
.gov/cfr_2003/aprqtr/pdf/21cfr50.3.pdf ], or 

(2) the principal investigator of such clinical trial if so designated
by a sponsor, grantee, contractor, or awardee (provided that "the
principal investigator is responsible for conducting the trial, has
access to and control over the data from the clinical trial, has the
right to publish the results of the trial, and has the ability to meet
all of the requirements" for submitting information under the law.)  [
c_laws&docid=f:publ085.110.pdf ] See PL 110-85, Section 801(a), (adding
new 42 U.S.C. 282(j)(1)(A)(ix)).  

How do you determine if you are a responsible party?

Investigators are encouraged to consult with their sponsored research
office, institutional counsel, or other partners to determine if they
are the "responsible party" for registering a trial.  It is your
responsibility to determine if you are obligated to register any of your
clinical trials.

1) If you are the Investigational New Drug Application (IND) or
Investigational Device Exemption (IDE) holder, you may be the "sponsor"
as that term is defined in the FDA regulations found at 21 C.F.R. 50.3.
For studies that are conducted under an IND or IDE, the "sponsor" is
identified in the course of filing the IND (commonly called the "IND
holder" or the "part 812 sponsor") OR

2) You may not be the sponsor, but if you are the Principal Investigator
you may have been delegated registration duties by the sponsor provided
the other conditions for access and control over information are met.

3)  For extramural trials, where there is no IND or IDE holder, NIH
would not be the responsible party.  The funding recipient may be a
"responsible party" as that term is defined in the Act, depending on the
unique circumstances of the trial. 

When Must I Register My Trial?

1) Trials initiated after 9/27/2007, or trials that are ongoing as of
12/26/2007 must be registered in full by:  The later of 12/26/2007 or21
days after the first patient is enrolled. 

2) Trials that were "ongoing" as of as of 9/27/2007 and do not involve a
"serious or life threatening disease or condition," must be registered
by 9/27/2008.   

3) Trials that were "ongoing" as of as of 9/27/2007, do involve a
"serious or life threatening disease or condition," and are completed
(meaning, not "ongoing") by 12/26/2007 are not subject to these
requirements, though they may be subject to pre-existing registering

("Ongoing" in this context means a trial had one or more patients
enrolled, but had not examined the final subject or provided the final
subject an intervention for the purposes of final collection of data for
the primary outcome as of 9/27/2007.)

What are the penalties for failing to register an "applicable clinical
Penalties for responsible parties who fail to register, or provide false
or misleading information in connection with, applicable clinical trials
are significant  and may include civil monetary penalties and, for
federally-funded trials, the withholding or recovery of grant funds.
See PL 110-85, Sections 801(a), (b), (adding new 42 U.S.C. 282(j), and
new 21 U.S.C. 331(jj)).

Obtaining Assistance from NIH:

Existing mechanisms established by NIH ICs to assist funding recipients
in registering trials with ClinicalTrials.gov can continue to be used to
assist responsible parties with the new registration requirements. A
list of IC liaisons is provided below.  While the NIH anticipates the
continuation of this service, it is important to remember that the IC
cannot in any way substitute for the responsible party in fulfilling its
statutory duties. When requesting registration assistance from an IC,
you are responsible for ensuring that all necessary information is
provided to the IC in sufficient time to review and coordinate before
the statutory deadlines described above for submission to
ClinicalTrials.gov are triggered.  You will need to stay in contact with
the IC liaison to ensure that your information has been registered
properly.  Submission of registration information to an IC is not
sufficient to satisfy the statutory obligations for submission to
ClinicalTrials.gov.  Alternatively, you may register your trial directly
by following the procedures outlined at

Additional information on the new registration requirements is available
on the PRS Web site http://prsinfo.clinicaltrials.gov/. 

Mary M. Langman, Coordinator
Information Issues and Policy
Medical Library Association
65 E. Wacker Pl., Ste. 1900
Chicago, Illinois 60601-7246

ph  312/419-9094, ext. 27
fax  312/419-8950
mlaedo2 at mlahq.org

Plan to attend MLA'08 Connections: BridgingtheGaps
                                            May 16-21 Chicago

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