FIBROID

All SIR members performing UAE are encouraged to participate. In order to contribute data to the registry, you will need internet access [Netscape™ and Internet Explorer™ browsers (version 4.0 and higher) running on Microsoft Windows 95, 98 NT4, or 2000 operating systems are required to support the UAE Registry web-based interface] and to complete the following three steps:

1). Fax a site registration form to Diane Minshall-Liu at the Duke Clinical Research Institute (DCRI), (919) 668-7027.

2). Obtain institutional review board (IRB) approval (please see below for assistance in your application process). Fax this approval, along with a sample informed consent, to Diane Minshall-Liu at DCRI, (919) 668-7027.

3) Agree to abide by the terms and conditions set forth in a site agreement between your institution and CIRREF.

Once these steps are completed, DCRI will then contact you with your username and password so that you may submit data to the registry via the web-based interface. We suggest that you submit the necessary documents to your IRB as soon as possible, as this can be a lengthy process.

If you have any questions, please feel free to contact Carolyn Strain or Nella Bloom at 703-691-1805. If you need assistance or have any questions regarding your IRB submission and registration, please contact DCRI: Diane Minshall-Liu at 919-668-8221.

The deadline to enroll as a participating site in the Uterine Artery Embolization FIBROID Registry is July 1, 2002. We regret that we will be unable to accept applications after this date.

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IRB submission

Documentation of IRB (Institutional Review Board) approval is required prior to submitting data to the registry. Every hospital and academic institution that conducts research has an IRB designed to protect the rights of patients and ensure that those participating in research studies are aware of the risks involved. Many IRBs have developed standard language and/or a standard format for IRB submission. Standard language may be used in consent documents and is typically developed for those elements that deal with confidentiality, compensation, answers to questions, and the voluntary nature of participation. Each investigator should determine their local IRB's requirements before submitting.

For those who are unfamiliar with submitting an application to their IRB , the process may seem intimidating at first, however submitting most applications is a relatively straightforward process. Many IRBs have a standard Research Review Application that you will submit along with the study protocol and patient informed consent. Feel free to use the provided template for submission which is addressed to the head of your local IRB and provides the purpose of the study and the study procedures.

The following documents should be included with your IRB submission:

	Registry synopsis
	Protocol
	Sample informed consent (please note that the informed consent may be used as provided or may be modified to comply with institutional requirements/preferences)
	FIBROID Registry Case Report Form (CRF)
	Baseline
	30 day follow-up

In addition, the FDA Web site: http://www.fda.gov/oc/oha/IRB/toc.html provides comprehensive information on the IRB process and clinical investigation requirements. This site used in conjunction with guidance from your local IRB should provide all of the necessary details. Additional materials that you may need to provide your IRB include the CV of the lead investigator and a précis on UAE.

The study protocol and informed consent must be reviewed and approved by the IRB at each center before subjects are enrolled in the study. Patients must sign an informed consent prior to registry enrollment. (Signed informed consent must be retained with the study records.) Evidence of IRB approval will be required on an annual basis.

Please fax a copy of your IRB approval and sample informed consent to Diane Minshall-Liu at the Duke Clinical Research Institute (DCRI) at (919) 668-7027.

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Patient Informed Consent

Along with IRB approval, a copy of your site's patient informed consent for the Registry must be submitted to DCRI in order to participate in the Registry. A sample informed consent is provided for your reference, but may need to be modified to comply with your institutional requirements/preferences. If your site does modify the informed consent provided, please ensure that the final copy contains the basic elements detailed in the link. For more detailed guidelines, please visit the National Institutes of Health Office of Human Subjects Research site: http://ohsr.od.nih.gov/info/finfo_6.php3.

Training Manual

The FIBROID Registry Training Manual provides comprehensive information on all aspects of the registry, including detailed information on collecting baseline data. It is highly recommended that all sites review the manual before beginning data collection and use the manual for reference throughout the study.

Click here for a printable version of the entire document:

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Core Sites

Lead Investigator	Institution	City	State	Country
James Benenati, MD	Miami Cardiac and Vascular Institute	Miami	FL	USA
Joseph Bonn, MD	Thomas Jefferson University Hospital	Philadelphia	PA	USA
David Brophy,MD	Mount Auburn Hospital	Boston	MA	USA
Jeffrey Dieden, MD	Kaiser Medical Center Oakland	Oakland	CA	USA
Karen Ehrman, MD	Methodist Hospital of Indiana	Indianapolis	IN	USA
Mark Garcia, MD	Christiana Care Health Systems	Newark	DE	USA
Joseph Gemmete, MD	University of Michigan	Ann Arbor	MI	USA
Michael Hines, MD	Kaiser Hospital Vallejo	Vallejo	CA	USA
David Hovsepian, MD	Mallinckrodt Institute of Radiology	St. Louis	MO	USA
Kevin Kim, MD	Johns Hopkins University	Baltimore	MD	USA
John Lipman, MD	Radiology Associates of Atlanta	Atlanta	GA	USA
Robert Min, MD	Cornell Vascular-- New York Presbyterian	New York	NY	USA
James Newman, MD, PhD	Cleveland Clinic Foundation	Cleveland	OH	USA
Gerald Niedwiecki, MD	Mease Countryside Hospital	Safety Harbor	FL	USA
Mahmood Razavi, MD	Stanford University Hospital	Palo Alto	CA	USA
Anne Roberts, MD	UCSD Medical Center	San Diego	CA	USA
William Romano, MD	William Beaumont Hospital	Royal Oak	MI	USA
Rajinder Sharma, MD	Henry Ford Hospital	Detroit	MI	USA
Richard Shlansky-Goldberg, MD	University of Pennsylvania	Philadelphia	PA	USA
David Siegel, MD	Long Island Jewish Medical Center	New Hyde Park	NY	USA
Gary Siskin, MD	Albany Medical Center	Albany	NY	USA
Steven Smith, MD	LaGrange Memorial Hospital	LaGrange	IL	USA
James Spies, MD	Georgetown University Hospital	Washington	DC	USA
Keith Sterling, MD	INVOA Alexandria Hospital	Alexandria	VA	USA
Robert Vogelzang, MD	Northwestern Memorial Hospital	Chicago	IL	USA
Robert Worthington-Kirsch, MD	Delaware Valley Imaging	Philadelphia	PA	USA
Moises Yoselevitz, MD	Ochsner Clinic Foundation	New Orleans	LA	USA

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Participating Sites

Lead Investigator	Institution	City	State	Country
Philip Amatulle, MD	Vassar Brothers	Poughkeepsie	NY	USA
Raymond Ashleigh, MD	South Manchester University Hospitals NHS Trust	Manchester		England
Brian Baghdady, MD	Spartanburg Radiologic Associates	Spartanburg	SC	USA
Steven D.Brantley, MD	Quantum Radiology	Atlanta	GA	USA
Abbas Chamsuddin, MD	University of Tennessee Medical Group	Memphis	TN	USA
Man-kwong Chan, MD	Queen Elizabeth Hospital	Hong Kong		HK-SAR
Lee R. Christensen, MD	St. Francis Hospital and Medical Center	Blue Island	IL	USA
John Clouston, FRACR	Wesley Hospital	Brisbane		Australia
Mark Cockerill, MD	Sentara Virginia Beach General Hospital	Norfolk	VA	USA
Gregory J. Dubel, MD	Rhode Island Hospital	Providence	RI	USA
Simon Girling, MRCP, FRCR	Norfolk & Norwich University Hospital	Norwich		England
Jackeline Gomez-Jorge, MD	University of Miami/Jackson Memorial Medical Center	Miami	FL	USA
Gregory Gordon, MD	St. Luke's	Lincoln	NE	USA
Brian Hardy, MD	The University of Manitoba	Winnipeg	MB	Canada
Peter B. Hathaway, MD	St. Mark's Hospital	Salt Lake City	UT	USA
David A. Henry, MD	St. Francis Hospital	Milwaukee	WI	USA
Laura J. Hodges, MD	Greenwich Hospital	Greenwich	CT	USA
Trevor N. Hooper, MD	Gainesville Radiology Group	Gainesville	FL	USA
Keith Horton, MD	Washington Hospital Center	Washington	DC	USA
Linda Hughes, MD	Holy Cross Hospital	Ft. Lauderdale	FL	USA
Darren Hurst, MD	St. Elizabeth Medical Center	Edgewood	KY	USA
Gregory Karnaze, MD	Austin Radiological Associates	Austin	TX	USA
David J. Kastan, MD	St. Joseph Mercy Hospital	Ann Arbor	MI	USA
Chad G. Kelman, MD	West Boca Medical Center	Boca Raton	FL	USA
Paull M. Kiproff, MD	Allegheny General Hospital	Pittsburgh	PA	USA
Brian McInroy, MD	Holy Spirit Hospital	Lewisberry	PA	USA
Steven Meranze, MD	Vanderbilt University Medical Center	Nashville	TN	USA
Michael Miller, Jr., MD	Latrobe Area Hospital	Latrobe	PA	USA
Adrian Moger, MD	Mercy Hospital	Portland	ME	USA
J.G.Moss, MD	Gartnavel Hospital	Glasgow		Scotland
Tony Nicholson, MD	Hull and East Yorkshire Hospitals	Hull		England
John L. Nosher, MD	UMDNJ-Robert Wood Johnson	New Brunswick	NJ	USA
Carroll C. Overton, MD	Wake Medical Center	Raleigh	NC	USA
Steven H. Peck, MD	Rose Medical Center	Denver	CO	USA
Stuart Pollack, MD	Thunderbird Samaritan Medical Center	Glendale	AZ	USA
Donald Ponec, MD	Tri-City Medical Center	Oceanside	CA	USA
Douglas Powell, MD	Hillcrest Medical Center	Tulsa	OK	USA
Howard M. Richard, MD	University of Maryland Medical System	Baltimore	MD	USA
Marcos Roffe, MD	St. Agnes Healthcare	Baltimore	MD	USA
Folco Scappaticci, MD	Bristol Hospital	Bristol	CT	USA
Douglas C. Smith, MD	Loma Linda University Medical Center	Loma Linda	CA	USA
Efstathios Spinos, MD	Chippenham	Richmond	VA	USA
Brett Storm, MD	Tallahassee Memorial Hospital	Tallahassee	FL	USA
John Sunderland , MD	Caritas Hospital	Louisville	KY	USA
Joel Tennenhouse, MD	St. John's Hospital	Springfield	IL	USA
Corito S. Tolentino, MD	El Camino Hospital	Mountain View	CA	USA
Grant D.K. Urquhart, MD	Southern General Hospital	Glasgow		Scotland
Jonathan Uy, MD	Franciscan Skemp Health Care	La Crosse	WI	USA
Thomas Velling, MD	Hoag Memorial Hospital Presbyterian	Newport Beach	CA	USA
Evert-Jan Verschuyl, MD	Providence St. Peter Hospital	Olympia	WA	USA
Anthony Watkinson, MBBS	Royal Free Hospital	Hampstead		England
Kurt Wetzler, MD	Eastern Radiologists	Greenville	NC	USA
Bret N. Wiechmann, MD	North Florida Regional Medical Center	Gainesville	FL	USA
James A. York, MD	Gwinett Medical Center	Lawrenceville	GA	USA
Alan Zakheim, MD	Englewood Hospital and Medical Center	Englewood	NJ	USA
Darryl A. Zuckerman, MD	University Hospital	Cincinnati	OH	USA

For information on becoming a participating site, please go to the top of this page.

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Site Newsletter

Click here for the UAE FIBROID Registry newsletter*:

Archives

*Note to participating sites: These editions of the UAE FIBROID Registry newsletter have been targeted toward Core Sites. Information on longitudinal follow-up does not apply to participating sites.

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