The Clinical Trials Office has been renamed to the Office of Clinical Research Administration (OCRA) with expanded functions to support externally funded clinical research activity. The Clinical Research Administration functions within the Office of the Senior Vice President of Research and Strategic Initiatives. The mission of the office is to facilitate clinical research at Temple University throughout the Health Science Campus by provideing services aimed to:
Identify and/or support development of new clinical research opportunities in collaboration with our clinical research teams
Complete the contractual and clinical trial budget process for clinical research to ensure consistency, efficiency, and compliance with local and federal requirements. Currently efforts are primarily directed at industry funded research, however the office can provide insight with all externally funded clinical research contracts and grants.
Promote collaboration of clinical research services at the Health Science Campus and incorporate available resources throughout the University.
Support continuing education opportunities for research professionals and the public about the clinical research process to promote efficiency, quality, and integrity that will enhance protection for research volunteers.
IMPORTANT CHANGES WITH BANNER FINANCIAL SYSTEM
Updated Grant Participant Registration (GPR) Form Now Available with FOAPAL - Use the new form for the correct registration of research subjects to ensure all services are billed according to the terms of the Grant. Study Coordinators must complete a GPR Form each time a Research Subject has a research procedure or test.
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.
