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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• IRB No.: Like Protocol No. in the Details page, IRB No. is searchable in Select Protocol fields
  • For studies using HRPO, this number is the same as the protocol number.
  • For studies using an external IRB, this is the IRB number as assigned by the IRB of record.
• PRMC Review Required:  
  • Yes: The study is a cancer-related study
  • No: The study is not a cancer-related study 
• NCI Trial ID: (Oncology library only) This field is for CTRP tracking purposes only and will be completed by the Siteman Cancer Center CTRP Coordinator.
• Automated Sequence No.: If marked Yes, subject sequence numbers will be automatically generated based on rules you set up. Once a subject becomes eligible and is put On Study in the On Study tab of the Subject Console, the next available sequence number will be assigned to that subject and will auto-populate in the Sequence Number field.  If the study has different accrual goals based on arm or subject demographic factors such as age, gendersex, ethnicity, etc., different accrual goals can be set by selecting Stratified Block.  Complete instructions can be found on the Stratification Blocks page.
  
• Internal Account No: This is required for the Workday-OnCore integration for Financials. After the study team creates the project in Workday, the Center for Clinical Studies (CCS) will review, approve and enter the Workday Project No. as the Internal Account No.  This needs to be entered prior to the first invoice creation in OnCore.
• Allow Duplicate Enrollment: 
  • Yes: If the study allows previously screen failed subjects to re-screen and re-enroll, this field must be set to yes in order to allow a single subject to be enrolled on the protocol multiple times. 
    
  • No: When set to no, a single subject may only be enrolled on the protocol once. If you attempt to enroll a subject who has already been added to the protocol, the system will not allow this action.
• Management Group: The team responsible for enrolling/managing study participants and/or collecting data for primary research endpoints. This field defines access privileges and shows up in reports. Select all that apply and select one Primary.  Study teams should never select the CRBS Management Group, as only the CRBS Team should add that when applicable.
• Program Areas: (Oncology Library Only) These selections will be used in the Data Table 4 Report and will be completed by the New Studies Review Committee.
• Oncology Group: (Oncology Library Only) These are internal reporting groups. The Oncology Group marked as Primary will become the default value for the Oncology Group field on the Subject Console > On Study 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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• DT3 Disease Codes (Oncology Only)
• 2. Add Protocol Staff
• 3. Updating Protocol Statuses
• 5. PRMC Initial Submission (Oncology Only)
• Local IRB Reviews
• External IRB Initial Reviews

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