OnCore Enterprise Research. Basics: Reporting and Searching

Transcription

1 OnCore Enterprise Research Basics: Reporting and Searching All Access Roles June 2017

2 P a g e 1 This page is intentionally blank.

3 P a g e 2 Table of Contents What is the OnCore Enterprise Research System?... 3 Using Protocol Search... 6 Conduct a Protocol Search... 6 Understanding the Protocol Search Results Page Add Result Columns to Your Protocol Search Save a Protocol Search Using Subject Search Search for a Subject Add Search Columns to Your Subject Search Save a Subject Search OnCore Reports Run the Planned Visits Report Using Document Search Document Search Criteria Understanding the Document Search Results page Using My Console Explore My Console... 26

4 P a g e 3 This page is intentionally blank.

5 P a g e 4 What is the OnCore Enterprise Research System? OnCore stands for Online Collaborative Research Environment. It is a Clinical Trial Management System (CTMS) developed by Forte Research Systems that supports academic medical centers, cancer centers, and healthcare systems around the country. OnCore has been purchased by the University at Buffalo to support research activities and compliance, which will allow for enhanced trial management, robust reporting, enrollment tracking, and accurate clinical research billing. Integration between OnCore and the Click portal will ensure that protocols submitted and reviewed by the IRB within Click are seamlessly transitioned to the OnCore system. The combined systems will manage the entire lifecycle of a research project, from protocol creation to project closeout.

6 P a g e 5 This page is intentionally blank.

7 P a g e 6 NOTE: Access to OnCore reporting features is dependent upon the role(s) you have been assigned within the system; you may not have access to all of the reporting tools described within this guide. Using Protocol Search Protocol Search is a robust searching tool that allows you to specify a wide variety of search criteria and to choose additional protocol data to appear in the search results. You can export those results to a PDF report or Excel spreadsheet. Conduct a Protocol Search 1. Navigate to Protocols > Protocol Search. The Protocol Search page provides dozens of data fields, allowing for complex and detailed searches. You can enter information in any of the page sections to narrow your search. 2. In the Protocol Status section, select the protocol statuses to search for, and then use the corresponding From Date and Thru Date fields to specify a date range. To match protocols having the selected status within a specified date range, enter both a From Date and a Thru Date. To match protocols having the selected status at any time after the From Date, leave the Thru Date blank. To match protocols having the selected status at any time prior to the Thru Date, leave the From Date blank.

8 P a g e 7 Status Matches are found for protocols with the selected statuses at any point during the specified date range. Status Change Matches are found for protocols that were changed to the selected statuses at any point during the date range. Checkboxes: o Pending - The search will include protocols with the statuses of New, PRMC Approval, IRB Initial Approval, On Hold, and all Protocol Signoffs. o Active - The search will include protocols with the statuses of Open to Accrual, Suspended, and Closed to Accrual. o Completed - The search will include protocols with the statuses of Abandoned, Terminated, and IRB Study Closure. 3. In the Participating Institution section, select the institutions and study sites to search for. Institution - Matches are found for protocols with the selected institutions. Protocol No. - Matches protocols with the supplied value in any of the 'protocol number' fields: Protocol No, IRB No., Pharmacy No., and Sponsor No.

9 P a g e 8 Summary Accrual Only - Matches protocols where the Summary Accrual Info Only field has been set to Yes on the PC Console > Main > Details tab. Open For - A drop-down field to match all protocols ('All' option), protocols that may only be open at affiliate institutions (Affiliates Only option), or protocols that may be open at the Research/Cancer Center (CC option). Title - Matches protocols with the supplied value in the protocol Title or Short Title fields. Institution - Matches protocols with the selected institution(s) assigned on the PC Console > Institution tab. Study Site - Matches study sites listed as active for the protocol on the PC Console > Institution tab. 4. In the Staff section, select the staff members or roles to search for. Staff Name - Matches protocols with the selected staff member(s) assigned as Protocol Staff or Subject Staff, based on the selected Scope. Staff Role - Selecting a Staff Role without entering a Staff Name will limit matches to protocols with staff assigned to that role as Protocol Staff or Subject Staff.

10 P a g e 9 Only Active Protocol Staff - For this checkbox, the phrase "active protocol staff" refers to whether a staff member is actively assigned to a protocol. Scope - This field is used to determine whether the Staff Name and Staff Role search criteria should be applied to Protocol Staff, Subject Staff, or both. When the field is blank, OnCore searches both Protocol Staff and Subject Staff. 5. There are additional sections available for searching; to aid visibility, some of them have been collapsed. Click on the plus sign (+) to open any collapsed fields. In the Main section, search for field data stored on the PC Console >Main > Details tab. In the Management section, search for field data stored in the PC Console > Main > Management tab. In the Treatment section, search for field data stored in the PC Console > Treatment > Details and the PC Console > Treatment > Disease/Diagnosis tabs. In the Annotations section, search for field data stored in the PC Console > Annotations tab. In the Accrual section, search for field data stored in the PC Console > Main > Details tab. In the LTFU section, search for Long Term Follow-Up (LTFU) protocols. 6. Once you have made selections from any combination of the sections listed above, click the Search button.

11 P a g e 10 Understanding the Protocol Search Results Page The Protocol Search Results page always includes the following features: Search criteria Filter and navigational aids Results table Protocol No. column Your search criteria are always listed in the page header. If you export the results via Excel or PDF, the search criteria are included in the export. The Filter field allows you to limit the results; type a search term and press Enter to show only protocols with matching criteria in any of the columns. The Page number drop-down allows you to open a specific page of the results, and the arrows allow you to navigate between pages. The search results are shown in a table that includes a standard set of results fields along with any additional results columns you have selected. To sort the data, click a column header; click again to sort in the opposite order. For users with access to the PC Console, the protocol numbers are links to the corresponding protocol.

12 P a g e 11 Protocol Count View Excel View PDF Add Staff button At the bottom left of the search results page, the total number of results found is shown. Generates an Excel spreadsheet of the search results. Generates a PDF document of the search results. Allows you to add staff to a protocol directly from the protocol search results. Select the corresponding checkbox in the Add Staff? Column, and then click Add Staff. A pop-up window opens with fields for Staff Name, Staff Role, and Start Date. Add Result Columns to Your Protocol Search The Protocol Search page is divided into expandable sections. Each section has a header with an expand icon [+] and a section name; when you click [+], additional options appear. On the left of each section is a column of checkboxes labeled Result Column? Selected fields are included as columns on the search results page. The following steps will allow you to add criteria to your previous search of protocols. 1. Click Back to Search to return to the Protocol Search page. NOTE: The criteria used in the last protocol search are automatically entered in the data fields. If you wanted to clear all criteria used in your previous search, you would click Clear. 2. Locate a section that contains Result Column? checkboxes. 3. Select the criteria you desire to add to your search, and then select the Result Column? checkbox that field. 4. Click Search.

13 P a g e An additional column containing your specified criteria will be included in the results table. Save a Protocol Search You can save protocol search criteria to perform search more efficiently. After you have developed and tested searches that you know you will use frequently, you can save the search to run it again without having to re-enter all the search criteria. NOTE: Any dates that have been entered as part of the saved search are saved as the calendar date and not a relative date. You will need to edit your dates as necessary. 1. Navigate to Protocols > Protocol Search, and enter your search criteria. 2. At the top of the Protocol Search page, click the Save As button. 3. In the pop-up window, type a name for your search in the Name field and click Save. Your saved searches will be available in the drop-down list attached to the Saved Searches field. They will also appear in the Saved Searches widget on the Home page.

14 P a g e 13 This page is intentionally blank.

15 P a g e 14 Using Subject Search Subject Search is a robust searching tool. This search option allows you to specify the search criteria and the kind of subject data to display in the search results. Search results can be exported to a PDF report or Excel spreadsheet. Subject Search is structured in the same way as Protocol Search, which was discussed previously. Search for a Subject The Subject Search page provides dozens of data fields, allowing you to find one or more subjects based on a variety of search criteria. Searching for subjects is an easy process: simply enter data into fields indicating the subject data you wish to match, and then click the Search button. Add additional search values to further refine your search. 1. Navigate to Subjects > Subject Search. The Subject Search page provides dozens of data fields, allowing for complex and detailed searches. You can enter information in any of the page sections to narrow your search. 2. In the Subject Demographics section, select the demographics to search for, and then use the corresponding From Date and Thru Date fields to specify a date range, if needed. To match subjects having the selected demographics within a specified date range, enter both a From Date and a Thru Date. To match subjects having the selected demographics at any time after the From Date, leave the Thru Date blank. To match subjects having the selected demographics at any time prior to the Thru Date, leave the From Date blank.

16 P a g e 15 OnCore Subject ID The identification number for this subject. Last Name The subject s last name. First Name The subject s first name. Birth Date The subject s birth date. Expired Date The date on which the subject passed away. Race The subject s race. Ethnicity The subject s ethnicity. Gender The subject s gender. Last Known Date Alive - This is the last date that institutional personnel knew the subject was alive. 3. In the Subject Status section, select the status to search for, and then use the corresponding From Date and Thru Date fields to specify a date range.

17 P a g e 16 Status Matches are found for protocols with the selected statuses at any point during the specified date range. Status Change To Matches are found for protocols that were changed to the selected statuses at any point during the date range. 4. There are additional sections available for searching; to aid visibility, some of them have been collapsed. Click on the plus sign (+) to open any collapsed fields. In the Consent and Eligibility section, search for subjects who have consented or became eligible within a specified date range. In the On Study section, search for field data stored in the Subject > Subject Console > On Study tab. In the Protocol section, search for field data stored in the various PC Console > Main tabs. In the Follow Up section, search for subjects that held a status within a specified date range (e.g., Off Treatment, Off Study, etc.). 5. Once you have made selections from any combination of the sections listed above, click the Search button.

18 P a g e 17 The Subject Search Results page opens. Note that the header at the top of the page lists the criteria used in the search, and the bottom of the page displays the number of subjects found. The Subject Search Results page always includes the following features: Search criteria Filter and navigational aids Results table OnCore Subject ID View Excel View PDF Your search criteria are always listed in the page header. If you export the results via Excel or PDF, the search criteria are included in the export. The Filter field allows you to limit the results; type a search term and press Enter to show only subjects with matching criteria in any of the columns. The Page Size drop-down allows you to specify the number of search results per page, and the arrows allow you to navigate between pages. The search results are shown in a table that includes a standard set of results fields along with any additional results columns you have selected. To sort the data, click a column header; click again to sort in the opposite order. The OnCore Subject ID numbers are links to the corresponding subject in the Subject Console. Generates an Excel spreadsheet of the search results. Generates a PDF document of the search results.

19 P a g e 18 Add Staff Allows you to add staff to a subject directly from the subject search results. Select the corresponding checkbox in the Add Staff? Column, and then click Add Staff. A pop-up window opens with fields for Staff Name, Staff Role, and Start Date. Add Search Columns to Your Subject Search The Subject Search page is divided into expandable sections. Each section has a header with an [+] expand icon and a section name. To open a section, click the [+] expand icon. The following steps will allow you to add criteria to your previous search of subjects. 1. Click Back to Search to return to the Subject Search page. NOTE: The criteria used in the last subject search are automatically entered in the data fields. If you wanted to clear all criteria used in your previous search, you would click Clear. 2. Locate a section that contains Result Column? checkboxes. 3. Select the criteria you desire to add to your search, and then select the Result Column? checkbox that field. 4. Click Search. 5. An additional column containing your specified criteria will be included in the results table.

20 P a g e 19 Save a Subject Search You can save protocol search criteria to perform search more efficiently. After you have developed and tested searches that you know you will use frequently, you can save the search to run it again without having to re-enter all the search criteria. NOTE: Any dates that have been entered as part of the saved search are saved as the calendar date and not a relative date. You will need to edit your dates as necessary. 1. Navigate to Subjects > Subject Search, and enter your search criteria. 2. At the top of the Subject Search page, click the Save As button. 3. In the pop-up window, type a name for your search in the Name field and click Save. Your saved searches will be available in the drop-down list attached to the Saved Searches field. They will also appear in the Saved Searches widget on the Home page.

21 P a g e 20 OnCore Reports OnCore provides many standard reports that have been developed in collaboration with our customers. In this section, we will discuss how to run one of the most common reports, the Planned Visits Report. Run the Planned Visits Report The Planned Visits Report displays a list of subject visits for a date range and can be filtered by Protocol, Procedure, Subject Staff, Organizational Unit, and Management Group. 1. Navigate to Reports > Reports and click the Planned Visits tab. 2. In the Standard Reports section, click the Planned Visits Report link. The Planned Visits Report criteria page opens:

22 P a g e Enter the Reporting Period. Select dates in both the Visit Dates From and the Visit Dates Thru fields. 4. Enter or select the criteria in the additional fields to narrow your search. Protocol No. Limits the results to visits for a specific protocol. Procedure Limits the results to those visits with the specified procedure as a standard or additional procedure. Subject Staff Limits the results to subjects who have the specified staff listed as their Subject Staff. Organizational Unit Limits the results to those protocols associated with the specified organizational unit. Management Group - Limits the results to those protocols associated with the specified management group. Include in Results? If selected, this includes a Management Group column in the report results. Visit Status Limits the results to the selected status(es). 5. Click Submit. 6. The results display all visits for the protocol during the specified date range. The link in the Visit Info column opens the Subject Visit Update page, where you can verify the visit and enter visit information.

23 P a g e 22 Using Document Search Document Search allows you to easily locate protocol documents. Document Search locates files that have been attached in one of the following locations: PC Console > Documents/Info > Attachments tab IRB or PRMC/SRC Reviews (if marked as Released) PC Console > Institution > selected institution > Documents Note: Document Search displays documents only from active protocols; that is, protocols with a status of Open to Accrual, Closed to Accrual, or Suspended. Documents associated with inactive protocols cannot be found using Document Search. Document Search Criteria Search criteria are entered in Protocols > Document Search. You can use any of the options, alone or in combination, to narrow results. Protocol No. - Searches only active protocols (status of Open to Accrual, Closed to Accrual, or Suspended). Keyword - Text entered in this field will look for matches in the Title, Short Title, or Objective fields in the PC Console > Main > Details tab. Investigator - Matches protocols with the specified Investigator listed in the PC Console > Main > Staff tab > Protocol Staff section.

24 P a g e 23 Institution - Matches protocols having the specified institution as a Participating Institution in PC Console > Institution. NOTE: Insititution is required and will default to the instititution to which your user account is associated. You can only select those institutions to which you have access. Display All Documents - A protocol can have multiple versions of a document. By default, only the most recent version of a document appears in the search results. When the Display All Documents checkbox is selected, all versions of matching protocol documents will be listed. Once you have entered your search criteria, click the Submit button. Understanding the Document Search Results page Document Search Results show only protocols that have documents matching the search criteria. Search results are sorted by Protocol No., Document Type, and then by Version Date in reverse chronological order. The Alt. Protocol No. column displays the protocol s IRB, PRMC, and Sponsor Protocol numbers. The File Name is a link that, when clicked, downloads a copy of the attached document. When a consent attachment has been uploaded as a combined consent, the File Name

25 P a g e 24 column shows text that references the original document. The original document appears as a link, from which all parts of the combined consent can be downloaded. NOTE: The Version Date column will show the dates for expired documents in red.

26 P a g e 25 This page is intentionally blank.

27 P a g e 26 Using My Console My Console is designed to assist subject staff in managing subject visits. It provides a means to view and verify visits without accessing each subject individually from the CRA and Subject Consoles. My Console provides a personalized view of OnCore data, displaying information that is relevant to the current OnCore user. Explore My Console 1. Navigate to My Console > My Console. The My Console page contains four vertical tabs: Protocols, Subjects, Subject Visits, and My Calendar. 2. My Console opens on the Protocols tab. This tab displays all protocols to which you have been assigned as part of the protocol staff, regardless of role. Each protocol has a linked protocol number shown in the Protocol No. column. Clicking the link opens the protocol within the PC Console. NOTE: A protocol must have an Active status of Open to Accrual, Closed to Accrual, or Suspended to appear in My Console. My Console will not display protocols that have been terminated or had an IRB Study Closure.

28 P a g e Click the Subjects tab. The Subjects tab displays all subjects you have been assigned as part of the subject staff. Initially, only active subjects on active protocols are shown on the page; however, you can change this default by using the filter controls in the page header. Unselecting the Show Active Protocols Only checkbox causes all subjects from all protocols to display on the page. You can also select a different Subject Status from the drop-down menu, which will allow subjects of one of the following statuses: Active - Includes the statuses of Consented, Eligible, Eligible (O), On Study, On Treatment, Consent Waived On Follow Up - Includes the statuses Off Treatment, On Follow Up All - Displays all subjects from all of your currently assigned protocols Subjects are displayed in a table with linked column headers. Clicking a column header sorts in ascending or descending order. Each subject has a linked OnCore Subject ID in the OnCore Subject ID column. Clicking the link will open the selected subject in the Subject Console.

29 P a g e Click the Subject Visits tab. The Subject Visits tab contains two horizontal tabs: Occurred Visits and Pending Visits. Occurred Visits - This tab allows you to see if the forms for each visit were completed, submitted, and monitored. These columns correspond to the Data Collection Completed Date, Submitted Date, and Monitored Date fields on the Subject Visit Update page. Pending Visits: This tab provides a way for you to quickly update information regarding subject visits without having to navigate to each subject visit individually. Within the Subject Visits tab, you can export the Occurred Visits or Pending Visits tabs to both Excel and PDF. Additionally, you can sort each column in the output by clicking on the column headers. a. Click the Occurred Visits tab. To update the dates for these visits, enter the following: Select each checkbox Enter the corresponding date in the date fields Click Submit NOTE: When the CRF Completed date has an entry and either the CRF Submitted date or the CRF Monitored date also has an entry, the visit will no longer appear in the list.

30 P a g e 29 b. Click the Pending Visits tab. The Pending Visits tab allows you to view all non-occurred visits within a given timeframe. The From Date field defaults to a week prior to the current day and the Thru Date field defaults to a week after the current day. These dates quickly provide you a view of any recent visits that you still need to verify and some upcoming visits for which you might need to plan. In addition, subject visits can be filtered by a particular protocol or a particular subject by selecting values in the Protocol Filter and Subject Filter find-as-you-type fields. Note: If a protocol is selected in the Protocol Filter field, the Subject Filter will only supply subjects assigned to the selected protocol. The Pending Visits page displays all the pending visits for a protocol or a subject. Visit - Each Pending Visit has a link in the Visit column. Clicking the link opens the Subject Visit Update page, where you can enter details about the visit. Planned Visit Date - The Visit Date in the subject s calendar. Actual Visit Date - Making an entry in this field and clicking Submit will mark the visit as Occurred, which you can do if you don t have extra details to record for a visit.

31 P a g e 30 Missed checkbox - You can mark a visit as Missed by selecting its checkbox and clicking the Submit button. Multiple visits can be verified simultaneously in this way. Future visits cannot be marked as Missed. Clinical Comments - This is a read-only field, displaying the clinical comments from the Subject Visit Update page. 5. Click the My Calendar tab. The My Calendar page displays your subject visits in a month-format calendar. Initially it shows visits for subjects to whom you are assigned as subject staff, and visits for subjects on protocols to which you are assigned as protocol staff. On the calendar, the subject name, protocol number, and visit description are links that will open the Subject Console, PC Console, and Subject Visit Update page, respectively. NOTE: The checkboxes located at the bottom of the calendar allow you to change the display defaults. Simply unselect one or both of the Include Subject From Assigned Protocols and Include Assigned Subjects checkboxes. You can change the calendar view by using the icons below the month title at the top of the calendar. Click on the icons in the middle of the header to change the calendar view to display the visits for a single day, a week, or one month.

32 P a g e 31 Click on the month and year in the center of the header to quickly select a new month or year from the attached drop-down list. Clicking dates located at the sides of the header allows you to page forward or backwards one month at a time.

33 P a g e 32 This page is intentionally blank.

34 P a g e 33 OnCore Support Team Clinical and Translational Research Center 875 Ellicott Street Buffalo, NY CTMS@buffalo.edu Electronic Research Administration (era) UB Commons, Suite 114 University at Buffalo North Campus Buffalo, NY support@research.buffalo.edu