Welcome To Temple University's
Office of Clinical Trials Web-site!
The Office of Clinical Trials (OCT) is based on the Temple University Health Science Campus and operates to serve as a link between Temple’s clinical investigators and the pharmaceutical biotechnology and medical device industries. The OCT functions at the core of clinical research by providing value-added services to the development and conduct of clinical research at Temple University. OCT is responsible for all Contract and Budget negotiations for Industry sponsored trials. In addition, OCT provides a variety of educational initiatives for faculty, physicians and clinical research professionals.
For more information and
general inquiries, please contact us at 215 707
9190 or OCT@temple.edu
Topic: IRB Communications during the trial after IRB Approval
Time: Tuesday February 26, 2008 12:00 – 1:00
Location Health Science Campus Student Faculty Center - 4th Floor Room C
Presenters: Richard Throm -Temple University IRB
Craig Pfister, CCRP
The goal of this seminar series is to facilitate regulatory compliance for the protection of human subjects and enhance clinical trial activity. Clinical Research OWLS will focus on the operational complexities and regulatory compliance when conducting medical intervention research at the Health Science Campus.
The Food and Drug Administration Amendments Act of 2007 codified into law the requirements for registration of clinical trials on CLINICALTRIALS.GOV. The National Institute of Health also provides guidance on the requirement of the law. The law is consistent with the previous registration requirements issued by International Committee of Journal Medical Editors (ICMJE) for publication rights. The U.S. Government does now mandate additional data elements (that were previously optional) and has enhanced the clinicaltrials.gov site to facilitate full compliance.
The IRB Application Forms for Medical Intervention protocols (especially WIRB) have been updated and are available on the WEB! The Initial Submission Form (which is the long IRB Questionnaire form) for WIRB has changed and so is the Temple IRB form. The newest version of the form is 11/2007!
It is imperative that you use the updated Western IRB Form for all submissions!!! The Western IRB will not accept the previous version (11/2006) after January 1, 2008! Since there is processing time prior to WIRB receiving the form it is recommended you use this updated version now!
Please be sure to only use forms available on the Temple IRB Decision Tree and use a new form each time - as they are subject to minor change
On November 7, 2007, the University announced that it was switching from DHL to UPS as its preferred shipping vendor. EHRS would like to provide some information to shippers of dangerous goods to help facilitate your shipments.
Topic: Obesity A National Epidemic? - Understanding and Treating Obesity and its consequences
Time: Thursday December 6, 2007 4:00-5:00 PM
Location: Temple University Hospital Erny Auditorium (First Floor)
Presenters: Gary Foster , PhD. – Department of Public Health
Guenther Boden, M.D.–Department of Public Health
Eva Surmacz, PhD.–School of Medicine
The goal of this seminar series is to showcase ongoing clinical and translational research at Temple Health Science Campus and to stimulate new research opportunities among our basic science and clinical faculty. Participants will learn how other HSC faculty engaged in translational research is productively embracing a multidisciplinary team approach to answering important scientific questions related to human health.
