Page Comparison

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1. From the Menu, navigate to ePRMS > Submission Console.
2. If the submission is not currently displayed, search for it by entering the protocol number in the Submission No./Protocol No./PRMC No. field. This is not a predictive field and will not populate as you type. You must enter the number exactly and then click enter. A list of submissions will appear from which you can click the hyperlinked submission.
3. To respond to the query:
   1. Make all necessary changes to the submission per the query details.
      1. Scroll to the bottom of the page and click Update.
      2. If the query is due to missing or incomplete documentation, attach all relevant documents.
      3. Make any other adjustments to the information on the page per the query details.
      4. Click Save and Close.
   2. Respond to the query and resend the submission.
      1. At the bottom of the page, click Query Detail.
      2. In Query Detail block, click Edit.
      3. In Response text box, list the changes you made.
      4. Click Submit and Respond.
4. As with the initial submission, you will receive notification of committee decision.
   1. If approved, you may now proceed with IRB Submission.
   2. If contingent or deferred, repeat the steps outlined above.

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Definitions

PC Console > Main > Details tab

The PC Console > Main > Details tab is where basic information about a protocol is recorded. This page is the first page populated when creating a new protocol in OnCore.

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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.
• 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.