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TABLE OF CONTENTS

Minimum Footprint

The protocol Shell will be completed or reviewed by Clinical Research Billing Support (CRBS) shortly after IRB submission in the myIRB system.  These fields that will be completed by CRBS are highlighted in Yellow on screenshots throughout this page. The rest of the required fields complete the WashU Minimum Footprint and are to be entered by the protocol Regulatory Coordinator.  These fields are highlighted in Green on screenshots throughout this page.  Study teams are responsible for reviewing all highlighted fields, both Yellow and Green.

There may be additional required fields for protocols that require review by PRMC (i.e. protocols in the Oncology library).  These are also outlined below.

Protocol Details

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. 

Management

1. From the PC Console, navigate to the Management horizontal tab from the Main tab in the vertical toolbar.
2. 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 > Management tab, click Submit.

Staff

1. From the PC Console, navigate to the Staff horizontal tab from the Main tab in the vertical toolbar.
2. Select the Role from the dropdown menu.  The following protocol staff roles are required for the WashU Minimum Footprint:
   1. Principal Investigator
   2. Regulatory Coordinator - Primary
   3. Financial Coordinator
   4. Clinical Research Coordinator - Primary
3. In the Staff Name field, start typing the name and select from the drop down.
4. Click Add (bottom right).
   Yellow = Shell                                                              
   Green = Minimum Footprint 
   
   
   
5. If a staff member needs access to multiple institutions, once a staff member has been added, click Edit next to their name.
   
   
   
   
   1. A pop-up will generate. Under Can Access All Protocol Organizations:
      1. Yes: Provides staff member with access to all subjects enrolled at all participating institutions.
      2. No: (Default selection) Staff member may only access subjects enrolled under their Organization and additional organizations, as selected.
   2. Click in the Select Organizations box to see a list of all organizations associated with the protocol. Select only the institutions to which the staff needs access, as this will allow them to see subject data for the institution. Ensure that the staff has proper permissions and training to see PHI from other institutions before granting this access.
      
   3. Click Submit to save changes.

Sponsor

The PC Console > Main > Sponsor page is where the protocol sponsor information is managed and displayed.

1. From the PC Console, navigate to the Sponsor horizontal tab from the Main tab in the vertical toolbar.
2. If the protocol shell was created for you, the sponsor(s) listed in IRB will be entered.
   1. Make sure the sponsor(s) are accurate.
   2. Make sure one sponsor is marked the Principal Sponsor.
3. If there are no sponsors entered, complete the following to enter these required fields:
   
   1. Click Add Sponsor. Search within the Search for existing sponsors to add field. This is a predictive field and will populate as you type. 
      1. If the sponsor you need does not populate, please email the OnCore Support Team to have the sponsor added to the OnCore system. 
      2. Once you have selected the sponsor, click Add. Repeat this process for any additional sponsors.
   2. Role(s): Click Edit and check the box to select all applicable roles that the sponsor will play for the protocol.
   3. Principal Sponsor: Click this checkbox for sponsor who is funding the study. 
4. After completing these fields, press Submit.
   

Yellow = Shell                                                                                    
Green = Minimum Footprint

Disease 

The PC Console > Treatment > Disease/Diagnosis tab is required only for protocols in the Oncology library.
See DT3 Disease Codes for entry requirements prior to submitting to PRMC.

Institution

The PC Console > Institution page is used to display, add, and delete the institutions and study sites that are participating in the protocol.  All participating institutions who will be reporting their enrollments in OnCore are required to be added. WashU is required at minimum upon creation of the protocol shell.

1. From the PC Console, navigate to the Institution tab in the vertical toolbar.

2. In the Participating Institutions block, click Add.

3. Search within the Institution field. 

   1. This is a predictive field and will populate as you type. 

   2. If the institution you need does not populate, please email the OnCore Support Team to have the institution added to the OnCore system.

4. For sites other than WashU, be sure to select Uses Research Center IRB if the institution will be using WashU as its IRB of record.

5. Once you have selected the institution, click Save.

   

6. If the institution has sites nested under it, indicate which sites are participating. If all nested sites are participating, no additional action is required. If only some are participating, please complete the following steps:

   1. Once you have added the institution, click the hyperlinked name of the institution.
      
   2. Click Study Sites in the vertical tool bar.
   3. Click Update.
   4. Every nested study site will be selected by default. Uncheck the box for any site that will not be enrolling subjects on this protocol.
   5. Click Submit and the click PC Console in the vertical tool bar. You will see only the sites you left checked listed under the institution.

IRB Reviews

All internal/external IRB reviews for the protocol need to be maintained in OnCore.  For details on what is required and how to enter this in OnCore, select the appropriate link(s) below:

• 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.
  
  

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.

• Protocol No.: This is the main identifier for a protocol and will appear in reports and searches.
  • OnCore integrates with myIRB to link the study across the two systems, allowing select review and status information to flow from myIRB into OnCore. Therefore, you must enter the protocol number as assigned by HRPO in the Protocol No. field.
  • If you create the protocol shell in advance of IRB submission and you do not yet have a HRPO number assigned, please enter the PRMC number (for oncology studies) or the short title on your HRPO application.
• Library: The library you select determines which set of configurations are made accessible for the protocol in OnCore.  Select Oncology if PRMC review is required. For guidance on which studies require PRMC review, please visit the PRMC website.
• Department: In myIRB, Department is defaulted based on the PI; this may differ from Management Group. Department identifies the group responsible for managing study financials, determines privileges, and routes information for financial reports.
• Organizational Unit: This will default to WUMC as there is only 1 Organizational Unit in OnCore.
• Title: Identifies the full-length name of the protocol. The title populates to other pages within the OnCore application and is displayed in some reports. 
• Short Title: An abbreviated version of the protocol title with 100 character maximum, the short title populates throughout OnCore and in some reports
  • Through the OnCore-Epic integration, the short title in OnCore populates as the study title in Epic.
• Phase: For Clinical Trials, select the accurate Phase.  For non-Clinical Trials, select N/A.
• Protocol Type: Indicates the type of protocol, and is used in reports.
  • Basic Science: studying basic mechanism of an intervention
  • Device Feasibility: device is being evaluated for the feasibility of the product or of a test prototype device and not health outcomes
  • Diagnostic: studying intervention aimed at identifying a disease/condition
  • Health Services Research: studying delivery, process, management, organization, or financing of health care management, organization, or financing of health care
  • Other: not identified by any other categories
  • Prevention: studying intervention(s) aimed at preventing development of disease/health condition
  • Screening: studying methods of identifying a condition/risk factor for a condition in people not yet known to have it
  • Single Patient - Non DT4: Compassionate use / expanded access / emergency use of a investigational drug on a single patient
  • Supportive Care: evaluating intervention(s) where primary intent is to maximize comfort, minimize side effects, or work against a decline in participant health (not curative)
  • Treatment: evaluating intervention(s) for treatment of disease, syndrome or condition (therapeutic)
• Investigational Drug: This field sets the value of the Investigational Drug field in the IND/IDE horizontal tab in the PC Console Main tab. 
  • Yes: There is an IND or IND exemption.
    
  • No: There is no IND.
  • N/A: IND designation does not apply.
• Investigational Device: This field sets the value of the Investigation Device field in the IND/IDE horizontal tab in the PC Console Main tab.
  • Yes: There is an IDE.
  • No: There is no IDE.
  • N/A: IDE designation does not apply.
• RC Total Accrual Goal (Upper): RC stands for "Research Center" which is WashU. This field is populated with the number of subjects the IRB has approved. 
• Investigator Initiated Protocol: This field indicates if the Principal Investigator for the study initiated the protocol.
  • Yes: The trial originated and/or is sponsored at WashU
  • No: The trial originated and/or is sponsored outside of WashU
• Protocol Target Accrual: The number of subjects to enroll for the protocol. The target accrual number entered displays in the top header of most screens within OnCore and will populate in some reports. 
• RC Total Accrual Goal (Lower): The minimum number of subjects to enroll at WashU. The Low Accrual Report utilizes this field.   
• Primary Completion Date: Estimated date that the final subject will receive an intervention for the purposes of final collection of data for the primary outcome measure(s) (use Anticipated).
  • This field is only required for interventional investigator-initiated trials.
• Study Completion Date: Final date that data is expected to be collected for the remaining outcome measure(s) (use Anticipated).
  • This field is only required for interventional investigator-initiated trials.

PC Console > Main > Management tab

 The PC Console > Main > Management tab is where administrative information about the protocol is tracked.   Some departments may have their own requirements beyond the Minimum Footprint requirements.

• 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.
• 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, gender, 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.
• 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

PC Console > Main > Staff

The PC Console > Main > Staff tab is where staff members associated with the protocol are managed.

PC Console > Main > Sponsor tab

The PC Console > Main > Sponsor page is where the protocol sponsor information is managed and displayed.

• 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. 
• 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.

Other Protocol Setup Topics:

• DT3 Disease Codes (Oncology Only)
• Add Protocol Staff
• Updating Protocol Statuses
• PRMC Initial Submission (Oncology Only)
• Local IRB Reviews
• External IRB Initial Reviews