Grants Bulletin

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December 24, 2007

New law expands clinical trial registration requirements

The Food and Drug Administration Amendments Act (U.S. Public Law 110-085 pdf, 156 pages) enacted in September 2007, expands the types of clinical trials that must be registered in ClinicalTrials.gov. The law dictates deadlines for registration of drug and device trials, designates who is responsible for registering a trial, and identifies the categories of trials which must be registered. In addition, it requires certain results information to be included and sets penalties for noncompliance. Some of these requirements must be met by December 26, 2007, and necessitate prompt compliance by responsible parties as there are monetary fines for noncompliance with this law.

Scope of requirement:
Trials that must be registered generally include:

• Phase 2 - 4 trials of drugs and biologics (controlled clinical investigations other than Phase 1 investigations, of a product subject to FDA regulation)
• Trials of devices (controlled trials with health outcomes, other than small feasibility studies and pediatric postmarketing surveillance).

If you have questions specific to your trial meeting the scope of this requirement, refer to the statutory definition of “applicable clinical trial” in the law (U.S. Public Law 110-085 pdf, 156 pages). However, the National Institutes of Health (NIH), Association of American Medical Colleges (AAMC) encourages registration of all trials.

In addition, the International Committee of Medical Journal Editors (ICMJE) who has since 2005 required registration as a condition of publication, are expanding their requirements scope. The ICMJE will begin to implement the WHO definition of clinical trials for all trials that begin enrollment on or after 1 July 2008. This definition states that a clinical trial is “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.”

Who is responsible:
The registration responsibilities fall on the sponsors and PIs of the clinical trials.

• The individual/entity defined by the FDA as the “sponsor” (e.g., the IND/IDE holder) is responsible to register “applicable clinical trials.”
• A PI is responsible for registering clinical trial information “when the PI 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.” U.S. Public Law 110-085 or if they have been delegated registration duties by a sponsor.
• 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.
• Sponsors of industry funded trials are designated as the responsible party for trial registration in the final clinical trial agreement.

Registration Deadlines:
Key deadlines are December 26, 2007 and September 27, 2008.

• Trials initiated after 9/27/07 or ongoing as of 12/26/07 must be registered in full by the later of 12/26/07 or 21 days after the first patient is enrolled.
• Trials that were ongoing as of 9/27/07 and do not involve serious or life threatening diseases or conditions must be registered by 9/27/08.
• Trials that were “ongoing” as of as of 9/27/2007, do involve a serious or life threatening disease or condition, and are completed by 12/26/2007 are not subject to these requirements, though they may be subject to pre-existing registering requirement.
• Any trial registered before September 27th must be updated in ClinicalTrials.gov as specified in the law to include the expanded data elements.

Penalties:
Consequences for failing 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.

The following guidance documents and other information can be found at the following UK website: Registering Trials on ClinicalTrials.gov

• Guidance on New Law (Public Law 110-85) Enacted to Expand the Scope of ClinicalTrials.gov: Registration
• Association of American Medical Colleges Action Memo Re Clinical Trials Education Requirement 11/19/07 (1-page pdf)
• ClinicalTrails.gov Data Element Definitions (22-page pdf)

Obtaining a code/password to register trials:
To obtain an access code to the UK Organizational Account on ClinicalTrials.gov, send a request with Name Department and Email address to
Belinda Smith, MS, CCRC
Sr. Research Administrative Coordinator/ Education
UK Clinical Research Development & Operations Center (CR-DOC)
Phone: 859-323-8150
belinda.smith@uky.edu

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December 14, 2007

December Holiday Schedule for Research Administration Offices

The Office of Sponsored Projects Administration (257-9420), the Proposal Development Office (257-2861), the Office of Research Integrity–IRB & IACUC– (257-9428), and the Survey Research Center (257-4684) will be closed Tuesday, December 25 through Tuesday, January 1 and will reopen on Wednesday, January 2, 2008.

If you anticipate a need for services provided by any of these offices during this time, please call the appropriate office(s) before Tuesday, December 18 so that we may assist you prior to the holiday break.

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December 10, 2007

NIH Reduces Temporary “Error Correction Window” for Electronic Grant Applications from Five Business Days to Two

Notice Number: NOT-OD-08-018
The National Institutes of Health will reduce the “error correction window” (i.e. the time allowed after the submission deadline to address NIH system identified errors/warnings) from five (5) business days to two (2) business days for all electronically submitted grant applications with submission deadlines on or after January 8, 2008.
This change will mean that electronic applications will be considered “on-time” if all of the following criteria are met:

• All required registrations must be complete prior to the initial submission.
• Initial successful submission to Grants.gov must have a timestamp on/before 5 p.m. local time of the applicant organization on the receipt date.
• Applicants must correct errors and/or warnings within the two business days following the receipt date (referred to as the “error correction window”).
• All application corrections must be in response to a system-identified error/warning (application submissions with additional changes may be refused).
• If final submission is sent after the receipt date, a cover letter attachment must be included identifying the system-identified errors/warnings that have been corrected.

The two business days provided to view the assembled application image in eRA Commons will remain unchanged. It is NIH’s ultimate goal to define “on-time” submission as having an error-free application (i.e., passes Grants.gov and eRA Commons system-enforced business rules without errors) with a Grants.gov timestamp on/before 5 p.m. local time of the applicant organization on the receipt date. NIH temporarily relaxed the definition of “on-time” submission by allowing a five business day “error correction window” for the first six electronic application receipt cycles following the initial transitions to electronic applications. The “error correction window” allowed applicants to adjust to the system-enforced business rules and ensured that Grants.gov and NIH system processing times did not interfere with successful submission. Progress on both fronts allows us to close this window which helps speed up the process of getting the applications in to review and ultimately award.
Full text of notice: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-018.html

Please remember the university's internal proposal deadline: the final version of a proposal should be delivered to the Office of Sponsored Projects Administration (OSPA) three business days prior to the sponsor's deadline. If you have questions about the NIH notice or UK policy, please contact OSPA at 7-9420.