Other

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
  
  

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.
• NCT Number:  This is the clinicaltrials.gov number that is assigned at the time of clinicaltrials.gov registration.  Add the NCT number if available. If the study is a cancer-related (submitted to PRMC) interventional investigator-initiated clinical trial, please contact Allison Creekmore at creekmorea@wustl.edu and she will register the trial to clinicaltrials.gov.  She will also register any other types of investigator-initiated cancer-related clinical trials for investigators.  
  
• 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.
• Objectives:  The full list of objectives from the protocol.
  
• Phase: For interventional clinical trials evaluating drugs/biologics/vaccines, select the accurate Phase. For interventional clinical trials evaluating radiation therapy, devices, or assays select N/A.  For expanded access studies, select N/A.  For observational, ancillary, correlative, not applicable, or single patient DT4 studies, select N/A.
• Scope: Choose National if the study is taking place at other sites in addition to WashU.  Choose Local if the study is only taking place at WashU.
• Age:  If the study is enrolling participants who are ≥ 18 years of age, choose Adults.  If the study is enrolling participants who are < 18 years of age, choose Children.  If the study is enrolling participants who are both Adults and Children, choose Both. 
• Consent at Age of Majority:  When Adults is chosen for Age, this field is grayed out.  If Children or Both is chosen for Age, this field opens up.  If a child < 18 years of age is enrolled and then they turn 18 and become an adult (at the age of majority) while they are a participant, they are to be consented into the study using the main consent form and not just the assent form.  This field would be marked as “yes” if there is a formal consent for the study.
• 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
• Involves Therapy:   Used to indicate a therapeutic trial. If set to “Yes” a subject that is actively enrolled in the trial is prevented from being registered on another therapeutic trial. Do not use “N/A”.
• Exclude Protocol on Web:  PRMC will complete this field for studies in the Oncology library.
• Open For Affiliates Only:  This field must be marked as “No” or left blank in order for PRMC to review the submission.
• Summary Accrual Info. Only:  For studies in the Oncology library, the New Studies Review Committee completes this field.  Contact the Siteman Cancer Center (SCC) Protocol Office at protocoloffice@wudosis.wustl.edu for questions regarding this field.
  
• Protocol Type: Indicates the type of protocol, and is used in reports.
  • Basic Science: designed to examine the basic mechanisms of actions (e.g., physiology, biomechanics) on an intervention.
  • Device Feasibility: an intervention of a device product is being evaluated in a small clinical trial (generally fewer than 10 participants) to determine the feasibility of the product; or a clinical trial to test a prototype device for feasibility and not health outcomes. 
  • Diagnostic: evaluating one or more interventions aimed at identifying a disease or health condition
  • Health Services Research: designed to evaluate the delivery, processes, management, organization, or financing of health care
  • Other: not identified by any other categories, if the study is an expanded access study, the protocol type will be classified as “other”
  • Prevention: designed to assess one or more interventions aimed at preventing the development of a specific disease or health condition
  • Screening: designed to assess or examine methods of identifying a condition (or risk factor for a condition) in people not yet known to have the condition (or risk factor)
  • Single Patient:  Only select this if the study is being conducted on one patient.
  • Supportive Care: designed to evaluate one or more interventions where the primary intent is to maximize comfort, minimize side effects, or work against a decline in participant health or function (not curative). 
  • Treatment: designed to evaluate one or more interventions for treatment of a disease, syndrome or condition (therapeutic)
• Data Table 4 Report Type: (Oncology Library only) Indicates the type of study and is used in reports.  The New Studies Review Committee will review for accuracy:
  • Ancillary/Correlative:
    • Ancillary:  Hypothesis-driven studies that are stimulated by, but are not a required part of, a main clinical trial/study, and that utilize patient or other resources of the main trial/study to generate information relevant to it. Ancillary studies must be linked to an active clinical research study and should include only patients accrued to that clinical research study. Only studies that can be linked to individual patient or participant data should be reported.
    • Correlative:  Hypothesis-driven laboratory-based studies using specimens to assess cancer risk, clinical outcomes, response to therapies, etc. Only studies that can be linked to individual patient or participant data should be reported.
  • Interventional:  Hypothesis-driven studies where individuals are assigned prospectively by an investigator based on a protocol to receive specific intervention(s). The participants may receive diagnostic, treatment, behavioral, or other types of intervention(s). The assignment of the intervention(s) may or may not be random. The participants are followed so that effects of the intervention(s) on biomedical and/or health outcomes are evaluated.
  • Not Applicable:  Not identified by the other categories.
  • Observational:  Hypothesis-driven studies that focus on cancer patients and healthy populations and involve no prospective intervention or alteration in the status of the participants. Biomedical and/or health outcome(s) are assessed in pre-defined groups of participants. The participants in the study may receive diagnostic, therapeutic, or other interventions, but the investigator of the observational study is not responsible for assigning specific interventions to the participants of the study.
• Registration Center: 
  • Research Center: Select if the study is sponsored by WashU.
  • External:  Select if the study has an industry sponsor or if another institution is the principal sponsor.
• Data Monitoring: (Use for Oncology Only) Indicates the party responsible for monitoring the protocol data. For lines below denoted with QASMC: Audits are required for any institutional (WashU and non-WashU) and interventional studies.  Check with the coordinating center to determine what tasks they will be performing for the study, and this will guide what category below to select.
  • External:  Pharmaceutical (industry)  sponsor or Cooperative Group sponsor
  • PI: The Principal Investigator monitors the data for non-interventional studies (e.g. Banking/Registry studies and Retrospective Chart Reviews)
  • QASMC - External Audit, External DSM : Study is sponsored by another institution (the coordinating center) which will be conducting the audits and will also be preparing the data safety monitoring (DSM) reports for the WashU patients. These reports are then submitted to SCC’s Quality Assurance and Safety Monitoring Committee (QASMC) for review.
  • QASMC – External Audit, Internal DSM: Study is sponsored by another institution (the coordinating center) which will be conducting the audits of our patients, but the DSM reports are not being provided by the coordinating center and will be prepared by the WashU study team.
  • QASMC – External Audit, Internal DSMB: Study is sponsored by another institution (the coordinating center) which will be conducting the audits, and an internal WashU Data Safety Monitoring Board (DSMB) is needed.
  • QASMC – Internal Audit, External DSM: If WashU is the primary sponsor (the coordinating center) or WashU is the secondary center and our patients are not already being audited by the main coordinating center, then the WashU QASMC will conduct the audits and the other institution will only be preparing the DSM reports.
  • QASMC – Internal Audit, Internal DSM: If WashU is the primary sponsor (the coordinating center) or WashU is the secondary center and our patients are not already being audited by the main coordinating center, then the WashU QASMC will conduct the audits, and the DSM reports are not being provided by the coordinating center and will be prepared by the WashU study team.
  • QASMC – Internal Audit, Internal DSMB: If WashU is the primary sponsor (the coordinating center) or WashU is the secondary center and our patients are not already being audited by the main coordinating center, then the WashU QASMC will conduct the audit.  A WashU Data Safety Monitoring Board (DSMB) is required for any institutional clinical trial where WashU is the primary center, there is treatment involved, AND one of the following: the target accrual is > 300, it is a double blinded treatment trial, the trial is multicenter, the trial is Phase III, or the study is “high risk” as determined by PRMC.
  • QASMC – No audit, Internal DSM only: Low risk studies where no auditing is required but the WashU study team prepares the DSM reports (e.g. Imaging studies)
  • QASMC – Internal Audit, Standing DSMB - If WashU is the primary sponsor (the coordinating center) or WashU is the secondary center and our patients are not already being audited by the main coordinating center, then the WashU QASMC will conduct the audit.  For studies activated after April 2021, the SCC Standing Data and Safety Monitoring Board (DSMB) is required for any institutional clinical trial where WashU is the primary center, there is treatment involved, AND one of the following: the target accrual is > 300, it is a double blinded treatment trial, the trial is multicenter, the trial is Phase III, or the study is “high risk” as determined by PRMC.
  • QASMC – no audit, Standing DSMB – Studies where audit is determined not to be required by PRMC or QASMC but the SCC Standing Data and Safety Monitoring Board (DSMB) is still required (e.g. CTEP study where the study chair is a WUSM investigator).
• Includes Specimen Banking?: 
  • • Yes:  The study is banking specimens
    • No:  The study is not banking specimens
• Companion Study?:  Select this box if the protocol is a companion to another study, i.e. the data and/or specimens to be used for the current study are gathered from a previously-approved study
• Multi-site Trial: 
  • • Yes:  There are other sites besides WashU participating in the study
    • No:  Only WashU is participating in the study
• 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.
• Pilot : 
  • Yes:  The study is a pilot study and the protocol indicates it is a pilot study.
  • No:  The study is not a pilot study and the protocol does not indicate it is a pilot study.
• Rare Disease: (Oncology library- the Siteman Protocol Office will document Rare Disease on the Protocol Annotations page, so need to complete this field) . 
  • Yes:  Select if the study population meets any of the following criteria: 
    • (a) A rare cancer defined by the NCI as < 6 / 1000,000 cases; 
    • (b) A narrow molecular subtype (e.g. rare mutations, targeted therapies); or 
    • (c) An uncommon clinical presentation (e.g. comorbidities, prior therapies).
  • No:  Select if the definition listed under Yes does not apply. 
• Protocol Target Accrual: The total number of subjects to enroll for the whole study. The target accrual number entered displays in the top header of most screens within OnCore.
• RC Total Accrual Goal (Lower): RC stands for “Research Center” which is WashU. The minimum number of subjects planned to be enrolled at WashU. The Low Accrual Report utilizes this field.  This number should never be lower than the accrual to date.  Usually this field is only lower than the Protocol Target Accrual if it is a Phase I or Phase I/II study. 
• RC Total Accrual Goal (Upper): RC stands for "Research Center" which is WashU. This field is populated with the maximum number of subjects the IRB has approved to be consented at WashU.
• RC Annual Accrual Goal: This is the number of subjects expected to be enrolled each year and is calculated using the RC Total Accrual Goal (Lower) and Accrual Duration (Months). 
• Affiliate Accrual Goal: The number of subjects to enroll at participating sites (not including WashU). The Affiliate Accrual Goal plus the RC Total Accrual Goal (Lower) should equal the Protocol Target Accrual.
• Accrual Duration (Months): The estimated number of months it will take to reach the Protocol Target Accrual. For retrospective chart review or specimen studies, this will be the estimated number of months it will take to collect all of the data needed for the study.
• 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.
• 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, sex, 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

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. 
  • 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.

Other Protocol Setup Topics:

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