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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, Amanda Gibson, 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.hopkins
medicine.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. The revised Supplemental Information Sheet for Corporate
Agreements is posted online at: http://www.hopkins 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.
Last month ORA announced the arrival of a sixth
director, Nicole Leonard, with expertise in devices and intellectual property.
Effective 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.hopkins
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
The SOM will offer additional training sessions
and Powerpoint presentations on the SOM submission process using PureEdge
Software and a "How To" complete the SF424 forms in October.
Please visit http://www.hopkinsmedicine.org/Research/ora/
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