Office Of Clinical Research - OCR
USF Health · Office of Research
 
 

For Industry-Sponsored Clinical Trials



The OCR supports clinical investigators and their research staff throughout the project life cycle. To enhance the timely processing of study startup documents, the OCR recommends adherence to the following steps in the routing process workflow. 



Confidentiality Disclosure Agreement received at site from sponsor. Site sends electronic copy of CDA to USF Division of Patents and Licensing for review and negotiation. Negotiations completed, P&L will route CDA for signatures and submit to sponsor. Click here for the P&L Website

 

 

 

Site sends an electronic copy of the proposed contract and budget to  Corinne Walters in the OCR to begin contract negotiations. Site staff negotiates budget with sponsor.

 

 

 

Site staff completes USF IRB Application packet (or WIRB Initial Review

Submission Form packet) and routes for Departmental Scientific Review.


 

 

Site staff completes Conflict of Interest Financial Relationships Disclosure Form if applicable and routes for departmental Chairperson for signature.  Site staff completes USF Health Reporting Outside Activities Database (ROAD) if applicable.


   

Site staff completes USF IRB Application packet or WIRB Initial Review Submission Form packet and routes for departmental Chairperson signature.
 

  

 

Site staff completes the USF Division of Sponsored Research electronic Internal Form via the web-based Research Online Internal Form system. Click here for the Research Online site.


 

 

Site staff attaches the following to the electronic Internal Form via the File Attachments functionality found within the form:

  • Research protocol
  • Budget
  • USF IRB or WIRB Application packet, including Scientific Review
  • Financial Relationships Disclosure Form, if applicable
  • FDA 1572 form or other documentation of the location(s) where the participants will be seen for study visits.

 

  

Site staff notifies the Principal Investigator that the electronic Internal Form is ready for review and signature.  Principal Investigator reviews, edits as needed, and signs the Internal Form via electronic signature.

 

The Internal Form is then automatically routed to the departmental Chairperson who reviews and signs the Internal Form via electronic signature.



The Internal Form is then automatically routed to the Dean for signature who reviews the attachments and the Internal Form prior to signing via electronic signature.  

Site staff submits completed IRB Application packet to USF IRB. If planning WIRB submission, site staff submits a copy of the WIRB Initial Review Submission Form packet to Henry Zych at USF IRB.  The following forms are required to be submitted to USF IRB for all WIRB studies:
  • Protocol
  • Investigator Brochure
  • WIRB Application
  • Scientific Reviewer signature
  • Chairperson signature
  • Mandatory Human Subjects Protections education
  • COI management, if applicable

     



OCR staff forwards the fully executed Internal Form to USF IRB for all WIRB studies.



If for USF IRB review, study is placed on an agenda by USF IRB staff.  If for WIRB review, USF IRB staff generates a WIRB Approval to Proceed letter and electronically sends it to WIRB, PI, site contact, and OCR staff.



Site staff submits WIRB packet to WIRB.



Site staff submits USF IRB or WIRB Approval letter to OCR.




Site staff posts new study information on the Clinical Studies Online Database. Click here.

The purpose of the Clinical Studies Online Database is to increase the public profile of clinical studies performed by investigators at USF Health.  This website allows the public easy navigation through a list of current clinical studies as well as the ability to provide contact information to volunteer as a research participant.  Investigators and site staff post their current projects in the database and update the information as necessary.  Research site staff can search the password protected database for volunteers with an interest in specific medical conditions or for healthy volunteers for control groups.  To obtain information on how to access the Clinical Studies Online Database, please contact Catherine Jahrsdorfer or Charmaine Disimile. The USF Health Clinical Studies Online Database is not intended to substitute for the mandatory registration of clinical trials on the ClinicalTrials.gov registry.