• Protocol Search
• Sections
• Subject Search
• Sections
• Search Results
• 7.Protocol and Subject Searches

Protocol Search

From the Menu, navigate to Protocols > Protocol Search.

Create a Protocol Search based on the various criteria related to the protocol. Tailor your search by inputting any parameters you wish to use to narrow down your results.

• Entering parameters in the available fields will search by that criteria.
• Checking the box under Results Column will list that criteria as a column in your results "report."

Some parameters are hard-coded to appear in the results, but for the most part, you may search by a field without including it as a results column, or you may include a column in your results even if you do not filter by it.

For example: Under Age Group, you may wish to filter your search to Adult age groups only, but since all your resulting protocols will be for Adult age groups, you do not need to include this column in your results. Alternatively, you may wish to check the box to include the protocol title in your results, even though you are not narrowing your search by title.

Sections

The sections and fields by which you can search directly correspond to the fields in the vertical and horizontal tabs in the PC Console. Click the blue plus sign next to a section to open it up and use the fields therein. The sections are as follows:

1. Protocol Status
   1. If you search by Status or Status Change, you must include a date range for your search.
      1. Status: the protocol had the selected status at any point during the specified date range.
      2. Status Change: the protocol was changed to the selected status at any point during the specified date range.
   2. Pay attention to the "Filter Type" option so you can search multiple things at once. Filter Types include:
      1. Contains Any
      2. Contains All
      3. Does Not Contain
   3. Pending Studies include:
      1. New
      2. PRMC Approval
      3. IRB Initial Approval
      4. On Hold
      5. Any Signoffs still need to be completed (CRC signoff, Regulatory signoff)
   4. Active Studies include:
      1. Open to Accrual
      2. Suspended
      3. Closed to Accrual
   5. Completed Studies include:
      1. Abandoned
      2. Terminated
      3. IRB Closure
   6. Example: If you only want to search for Open to Accrual studies
      1. Click the Active check box
      2. Put the following into Status: Suspended, Closed to Accrual
         1. click on Dose Not Contain below the status search bar.
      3. Include your date range.
      4. Click Search.
2. Participating Institution: You can search for protocols based on which institutions are participating in the study.
3. Staff
   1. You can search for protocols that have a certain staff member listed as staff.
   2. You can even specify at which level (Protocol or Subject) the staff member should be listed.
4. Main: These fields correspond to the information provided on the Main page of the PC Console. Things like the Phase of the study, whether it is a Multi-Site Trial, what the Scope is, and what the Age Group is can be filtered.
5. Management: The fields under Management can help you search for protocols based on which departments, study teams, or sponsors are associated with them.
6. Treatment: You can use this to search for protocols with specific drugs, devices, or modalities connected with its treatment.
7. Protocol Annotations: This page has been set up within the PC console to identify certain parameters of Oncology protocols operating at Washington University. These parameters include Authorized Study Sites, Protocol Types, and Accrual Information.
8. Accrual: Based on the other parameters you set for your protocol search, you can include results for various Accrual Goals related to the protocols that are defined by your search.
9. LTFU: You can search for protocols that are strictly Long Term Follow Up protocols.

Subject Search

From the Menu, navigate to Subjects > Subject Search.

The functionality and process for running Subject Searches is very similar to that of Protocol Searches. See the Protocol Search information above for more details.

Sections

The sections and fields by which you can search directly correspond to the fields in the vertical tabs on the Subject Console, also referred to as the Subject Lifecycle. Click the blue plus sign next to a section to open it up and use the fields therein. The sections are as follows:

1. Subject Demographics: this section is useful for identifying specific subjects or groups of subjects based on demographic information.
2. Subject Status:
   1. Status: subjects with the selected status at any point during the specified date range.
   2. Status Change To: subjects whose status was changed to the selected status at any point during the specified date range.
3. Consent and Eligibility: search for subjects who signed consent or met specific eligibility statuses during certain date ranges
4. On Study: search for subject based on any of the information entered in the On Study tab, including sequence number, study site, disease sites, staff, and many other options
   1. Be aware that subjects will not result in the search unless the CRC has entered this date into the subject's On Study tab. The more data that you put into the system, the more data you can get out of it.
5. Protocol: The fields in this section refer to data stored in various PC Console > Main tabs. Subjects associated with the protocols that meet the specified criteria are matched.
6. Follow Up: search for subjects based on various Off Treatment, Off Study, or On Follow Up data.

Search Results

The search result "report" can be sorted by the various columns and filtered to identify specific data. Results can be exported as PDF or Excel.

Saved Searched

When you find a Protocol or Subject Search that works well for your needs and you want to run it again in the future, you can save your search.

• Click Save As at the top of the search screen.
• Enter a name for your search.
• Click Save.

To access a saved search in the future, click the drop down arrow next to Saved Searches and click on the search you wish to run. You can adjust parameters such as date, if needed, before running.

If you frequently use the Protocol Search function and have Saved Searches you think might be helpful to others, please let the OnCore Support Team know!

Protocol Search

From the Menu, navigate to Protocols > Protocol Search.

Create a Protocol Search based on the various criteria related to the protocol. Tailor your search by inputting any parameters you wish to use to narrow down your results.

• Entering parameters in the available fields will search by that criteria.
• Checking the box under Results Column will list that criteria as a column in your results "report."

Some parameters are hard-coded to appear in the results, but for the most part, you may search by a field without including it as a results column, or you may include a column in your results even if you do not filter by it.

For example: Under Age Group, you may wish to filter your search to Adult age groups only, but since all your resulting protocols will be for Adult age groups, you do not need to include this column in your results. Alternatively, you may wish to check the box to include the protocol title in your results, even though you are not narrowing your search by title.

1. You can create a protocol search based on various criteria related to the protocol
   1. The search criteria directly corresponds to the information present in the different vertical tabs within the PC Console
   2. You can tailor your search by inputting any parameters you wish to use to narrow down your results
   3. The parameters fall within these available categories:
      
      1. Protocol Status Search
         1. If you search by Protocol Status, you must include a date range for your search
         2. Pay attention to the "Filter Type" option so you can search multiple things at once
            1. Filter Types:
               1. Contains Any
               2. Contains All
               3. Does Not Contain
         3. Pending Studies include:
            1. New
            2. PRMC Approval
            3. IRB Initial Approval
            4. On Hold
            5. Any Signoffs still need to be completed (CRC signoff, Regulatory signoff)
         4. Active Studies include:
            1. Open to Accrual
            2. Suspended
            3. Closed to Accrual
         5. Completed Studies include:
            1. Abandoned
            2. Terminated
            3. IRB Closure
         6. Example: If you only want to search for Open to Accrual studies, click the "Active" check box and put the following into "Status": Suspended, Closed to Accrual and click on "Dose Not Contain" below the status search bar. Include your date range and click "Search"
      2. Participating Institution Search
         1. You can search for protocols based which institutions are participating in the study
      3. Staff
         1. You can search for protocols that have a certain staff member listed as staff
         2. You can even specify at which level (Protocol or Subject) the staff member should be listed
      4. Main
         1. These fields correspond to the information provided on the main page of the PC Console. Things like the Phase of the study, whether it is a Multi-Site Trial, what the Scope is, and what the Age Group is can be filtered
      5. Management
         1. The fields under Management can help you search for protocols based on which departments, study teams, or sponsors are associated with them
      6. Treatment
         1. You can use this to search for protocols with specific drugs, devices, or modalities connected with its treatment
      7. Protocol Annotations
         1. This page has been set up within the PC console to identify certain parameters of Oncology protocols operating at Washington University. These parameters include Authorized Study Sites, Protocol Types, and Accrual Information
      8. Accrual
         1. Based on the other parameters you set for your protocol search, you can include results for various Accrual Goals related to the protocols that are defined by your search
      9. LTFU
         1. You can search for protocols that are strictly Long Term Follow Up protocols
2. If you are an individual who frequently utilizes the Protocol Search function and have Saved Searches you think might be helpful to others, please let the OnCore Support Team know!