The
PI has appointed a 3-member Data Monitoring
and Safety board (DMSB) at the request of the
Foundation. This three-member panel will interface
with the Steering Committee and Data Management
Center at least once a year. It will receive
progress reports as well. The committee consists
of one pediatric orthopedic physician (MD),
one physical therapist clinical scientist and
administrator, and one disability consumer advocate.
The PI has determined that the primary roles
of this committee are to: (1) advise the Steering
committee on matters related to safety, project
execution, project cessation, public relations,
or other activities deemed appropriate by either
the Lead investigators or the Foundation. It
is not answerable to the Foundation, but is
advisory to the Steering Committee.
Members
are:
Nancy
N. Byl,
PhD, PT
University of California San Francisco
Professor and Chair
Department of Physical Therapy and Rehabilitation
Science
San Francisco, CA
June
Issacson Kailes,
MSW
Director of Training
Center for Disability Issues and the Health
Professions
Western University of Health Sciences
Pomona, CA
Hugh
G. Watts,
MD
Pediatric Orthopedic Surgeon, Retired
Shriners Hospitals for Children, Los Angeles
Unit
Los Angeles, CA
Anny
Xiang,
PhD
University of Southern California
Assistant Professor of Research
Department of Preventive Medicine
Los Angeles, CA
PTClinResNet
will follow the NIH Guidance on reporting adverse
events to institutional review boards for NIH-supported
Multicenter Clinical Trails. See Appendix E
for details of this plan. The IRB for University
of Southern California Health Sciences Campus,
LAC+USC Medical Center and Health Research Association
has an approved standard IRB Report of an Internal
Adverse Event (for USC site events and IRB report
of an External Adverse Event (for Satellite
site events). These forms are accessible on
the web at the following URL: IRB forms: http://ccnt.hsc.usc.edu/irb/irb.html.
We will link this site to our PTClinResNet website
for Data Monitoring Procedures.
