The Office of Research Administration (ORA) is pleased to report the following significant changes to our services and staffing effective September 18th, 2006:
New Clinical Trials Office at Brown’s Wharf in Fells Point
Effective September 18th, 2006, all new commercial clinical trial agreements and any subsequent modifications thereto will be reviewed, negotiated and approved by a dedicated clinical trials staff at the Brown’s Wharf ORA. In future editions of Research WebNotes you will be introduced to a staff with clinical research, law and clinical trial contracting expertise. Keith Weiner, Rose Previte and Keisha Nwaigwe have been reassigned from the BRB (Broadway Research Building) staff to the new office. At this time, the Clinical Trials group is not making departmental assignments to specific staff. Contact information for the Clinical Trials group is posted online at http://www.hopkinsmedicine.org/Research/ora/FP_Contact.html The Supplemental Information Sheet for Corporate Agreements has been revised. There are 3 request designations for corporate agreements: 1) clinical trials, 2) research other than clinical trials or 3) some other purpose. We have selected the International Committee of Medical Journal Editors (ICMJE) definition of clinical trials (“Any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome.”) to define which agreements (including Phase I and II treatment trials) will be handled by the Clinical Trials Office. All proposed agreements should continue to be submitted to the Broadway Research Building , Suite 117 ORA office. Those with a correct Clinical Trial designation on the Supplemental Information Sheet will be picked up by the Brown’s Wharf staff on a daily basis. Other clinical research agreements, not qualifying as clinical trials (e.g. an observational study) will continue to be reviewed by the BRB office.
New Departmental Delegation for agreements other than Clinical Trials
Last month ORA announced the arrival of a sixth director, Nicole Leonard, with expertise in devices and intellectual property. Effective on September 18th, we are revising the departmental delegations to assign Nicole to departments that work the most with biomedical devices. The new delegations are available at: http://www.hopkinsmedicine.org/Research/ora/ORA_Deptl_Assignments.html
New Clinical Research Services
ORA has also assembled a team of experts to provide a research patient care insurance coverage analysis and budgeting assistance for clinical research. Karen Roz has joined us from the Oncology Clinical Research Office as the Associate Director for this group. Currently their services are available to interested investigators, while we coordinate and provide the prospective coverage review department by department. Contact information for the Clinical Research Services group is posted online at http://www.hopkinsmedicine.org/Research/ora/FP_Contact.html | 
