Sponsored Programs News Archives

(July 1, 2007)
CLINICAL TRIALS PROTOCOL REGISTRATION UPDATE

Beginning July 1, 2008, the International Committee of Medical Journal Editors (ICMJE) will adopt the World Health Organization’s (WHO) definition of a “clinical trial”; thereby expanding the current scope of trials which are required to be pre-registered, to include Phase I studies. The WHO defines a clinical trial as “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.” For further details, please visit http://content.nejm.org/cgi/content/full/NEJMe078110?query=TOC

(May 1, 2007)
Western Institutional Review Board (WIRB) Fees Increased

WIRB increased its fees effective April 1, 2007. The new fee schedule is available here

(May 1, 2007)
Eli Lilly Grant Office Still Accepting Applications for 2007

Lilly’s Grant Program Supports healthcare professional education, and patient advocacy and consumer education programs. To learn more about the program and the application process, visit http://www.lillygrantoffice.com/index.jsp.

(May 1, 2007)
OIP Now Requires Completed Internal Documentation Before Initiating Clinical Trial Agreement Negotiations

The number of clinical trial agreements received by OIP continues to increase, which is good. However, the number of studies cancelled in the middle of contract negotiations has also increased. These aborted negotiations correlate with an absence of completed internal documentation, e.g., signed Internal Approval Form, Conflict of Interest Disclosure, and internal budget. In an effort to ensure that the greatest number of agreements is executed in a timely manner, we are adopting the practice of Sponsored Programs and can no longer begin contract negotiations for clinical trials until completed internal documentation is received.

(March 2007)
Western Institutional Review Board (WIRB) Fee Schedule

Western Institutional Review Board is adjusting its fee schedule effective April 1, 2007. Please be advised that all services provided on or after April 1, 2007, will be billed at the new rates. The new fee schedule of rateswill be available on the ORSP website as well as the OIP website on March 16, 2007.

(February 1, 2007)
WIRB Study Closure

WIRB considers the study open at the site until a study closure report is received. Please complete the study closure form when:

All subjects have finished their final visits and follow-up and
The sponsor or sponsor representative has indicated the study is closed at your site and
If the study was conducted under a Federalwide Assurance, all data analysis at the site is completed.

WIRB will close the study upon receipt of the closure report.

(August 2005)
WIRB Study Closure

WIRB considers the study open at the site until a study closure report is received. Please complete the study closure form when:

All subjects have finished their final visits and follow-up and
The sponsor or sponsor representative has indicated the study is closed at your site and
If the study was conducted under a Federalwide Assurance, all data analysis at the site is completed.

WIRB will close the study upon receipt of the closure report.

(June 2005)
Clinical trials must be registered before study subjects are enrolled to ensure your right to publish your findings.

The International Committee of Medical Journal Editors (ICMJE) now requires that all clinical trials must be registered on a publicly accessible internet site if you want a journal that adheres to the ICMJE policy to consider your manuscript for publication. As of July 1, 2005, registration must occur prior to enrollment of the first study subject. If you are the Principal Investigator for a clinical trial that enrolled a patient prior to July 1, you must ensure that your clinical trial is registered prior to submission for publication.

Beginning September 13, 2005, the ICMJE will no longer accept for publication, any clinical trials which have not been registered in accordance with this policy. For additional information on registration deadlines, please refer to the Frequently Asked Questions on the ICMJE website at http://www.icmje.org/faq.pdf.

Registration at ClinicalTrials.gov meets the requirements of the ICMJE. The Office of Industry Partnerships will help ensure that your clinical trial is properly registered. Details of the requirement, including the definition of "clinical trial," and other frequently asked questions about the registration process are now available at http://www.research.vcu.edu/p_and_g/clinicaltrials.htm