Other

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TABLE OF CONTENTS

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1. From the Menu, navigate to Protocols > PC Console
   1. If you are creating a new protocol, click New Protocol in the vertical toolbar.**
      
   2. If you are reviewing an existing protocol:
      1. Type the HRPO Number in the Select Protocol field and select from the drop down.
         
      2. Click Update in the bottom right side of the page to open the fields for revisions.
         
         
         

2. In the Protocol Details block, review or enter the following highlighted fields that make up the WashU Minimum Footprint:

   Yellow = Shell
   Green = Minimum Footprint

   
   
   

3. When all required and desired fields have been entered on the  PC Console > Main > Details tab, click Submit.

   1. The Accrual Information fields highlighted above must have values entered for any type of study, including retrospective chart reviews and specimen collection studies

4. Completion Dates are not required when the study has ended but this info may be helpful for PRMC. Estimated dates are fine for use. 

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• For reviews conducted by the WashU IRB, most review info is automatically added, but you may need to add details.  
  Instructions: IRB Initial Submission.
• When an external/central IRB submission is approved, you will need to add the information. 
  Instructions: External IRB Reviews - Request to Rely Process.
  
  

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Definitions

PC Console > Main > Details tab 

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• Role(s): roles that the sponsor will play for the protocol.
  • Agent Source - will provide the drug/agent. 
  • CRO (Contract Research Organization) - an organization contracted by the sponsor to perform research functions.
  • Data Analysis - will conduct data analysis. 
  • Design - responsible for trial design. 
  • Funding Source - provides funding
• Principal Sponsor: Sponsor who is funding the study.  This is the sponsor that will appear in the protocol header. 
  • Guidelines for studies in the Oncology Library:
    • For cooperative group studies, the Principal Sponsor will be the cooperative group.
    • For WashU institutional studies, the Principal Sponsor will be:
      • The Federal funding agency (e.g. National Cancer Institute, National Institutes of Health, etc.) if the grant was specifically obtained for the study.
      • BJC Healthcare if the principal investigator is a Barnes employee and the study doesn’t have a federally-funded grant that was specifically obtained for the study.
      • For all other studies, Washington University will be the Principal Sponsor.
    • For secondary institutional studies, the Principal Sponsor will be the academic organization that is leading the study.
    • For industrial (pharma) studies, the Principal Sponsor will be the pharmaceutical company funding the study. 
    • The New Studies Review Committee (NSR) will review all new studies for accuracy on sponsor listings.  If any questions, please contact the PRMC office at protocoloffice@wudosis.wustl.edu.
      
• Sponsor Protocol No.: The protocol number assigned by the sponsor; this must match information submitted to myIRB. For Investigator Initiated Trials, use the HRPO number.  This field is optional, but departments may have specific requirements.

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