OnCore Enterprise Research. Exercises: Subject Calendars and Visit Tracking

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1 OnCore Enterprise Research Exercises: Subject Calendars and Visit Tracking Clinical Research Coordinator June 2017

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3 P a g e 2 Exercises: Subject Calendars and Visit Tracking Contents OnCore Navigation Tips... 4 Subject Calendar Exercises... 6 Viewing the Subject Calendar... 6 Visit Tracking Exercises... 8 Indicate a Referral Channel... 8 Verify the Visit Date and Enter Details... 8 Enter Procedures Enter Additional Procedures Enter Additional Subject Visits... 12

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5 P a g e 4 OnCore Navigation Tips Open Only One Session of OnCore at a Time Only one session (web browser window) of OnCore should ever be open at one time. Multiple sessions of OnCore will result in program misbehavior, could result in data loss, and can only be resolved by closing the additional sessions. Turn Off Any Pop-Up Blockers in Your Web Browser There are times that OnCore will use pop-up windows for data entry/selection. Pop-up blockers will prevent these windows from displaying; please ensure that your web browser s pop-up blocker is disabled. Avoid Using the Back Button in Your Web Browser Avoid using the back button within your web browser while working in OnCore. Instead, use the navigation buttons, tabs, and menus within the OnCore Application to navigate. Using the browser s toolbar is outside the OnCore application and may lead to unexpected results and unsaved data. Do Not Change or Reset the Password for Your Account Users cannot reset their password in OnCore. Even though it appears that the Change Password option within your Profile will work, it has been disabled for University at Buffalo faculty and staff. Please use your UBIT Name and Password, or an assigned training account, to log into the system. Users can access their UBIT Password by calling the UBIT Help Desk at or by completing the UBIT Help Center form found on the website: Be Aware of Hyperlinks Throughout OnCore, any information presented in blue underlined text will allow the user to short cut to other areas of the system without utilizing a menu. Utilize CTRL+F to Find Items in Lists Utilizing the CTRL Key with the F key provides a quick search within a list. Select the list, document, or screen desired to be searched, then hold down the CTRL Key while also pressing the F key (Use the Command key, +F, on a Mac). Log off properly to Ensure Data Security To properly exit OnCore, please click the Log Off link at the top right of the screen. Simply closing your browser window may not log you off the site, leaving patient data insecure. Use Keyboard Shortcuts When Entering Dates Date fields in OnCore also accept a variety of keyboard shortcuts, or dates that are calculated relative to another date, as opposed to a specific date.

6 P a g e 5 Shortcut Resulting entry t Inserts the current date t + n t - n (where n is a number) Inserts a date n days from today: t +3 is three days from today t-1 inserts yesterday s date (1 day ago) w n w + n Inserts the current date plus/minus n number of weeks w 6 will insert a date 6 weeks ago w + 2 will insert a date 2 weeks from today m + n m n Inserts the current date plus/minus n number of months y + n y n Inserts the current date plus/minus n number of years mb or me Inserts the beginning or end of the month respectively; it can be used alone, or with + or with a number yb or ye Inserts the beginning or end of the year, respectively; it can be used alone or with + or with a number

7 P a g e 6 Subject Calendar Exercises Viewing the Subject Calendar Steps Notes To track subject visits or financial information for a protocol, the protocol must have a calendar attached to it. 1. Navigate to Subjects > CRA Console. 2. Enter a search term in the Select Protocol field to locate and open the desired protocol. 3. Click the Accrual tab, and then click the subject s OnCore Subject ID. Because subjects accrue to the protocol at different times, the protocol schedule cannot contain specific dates such as March 15. Instead, schedules are based upon subject milestone dates, such as the subject s Consent Signed and On Study date. 4. The Subject Console will open. Click the Calendar vertical tab. 5. On the Calendar tab, note the following columns: Procedure - In the first column, each row following Visit Date displays the name of a lab, panel, or procedure. Forms - The second column displays the names of the ecrfs (forms) that will be used to capture data from the corresponding lab, panel, or procedure. At present, the University at Buffalo will not be using the ecrfs within the OnCore system. 6. On the Calendar tab, note the following rows: Planned Date - This row displays the subject s scheduled visit dates. Hovering your cursor over the date in this row reveals the day of the week (and any visit tolerances). Once the subject has consented and is put on study, a personalized Subject Calendar with specific dates for that patient is generated, complete with specific dates for visits. It serves as a personalized visit schedule for the subject. Clicking the Freeze Panes button at the top of the tab allows you to scroll through the calendar without losing the column and row heading information.

8 P a g e 7 Visit Dates The row displays the subjects actual visit dates; this row will remain blank until the subject s visits have been tracked within the OnCore system. 7. Scroll to the bottom of the calendar to view the Calendar Foot Notes. Notice also that there is a Printable Subject Calendar link at the bottom of the console; the calendar can be generated in a monthly format and exported. 8. Click on the Orphaned Visits horizontal tab. This tab displays any visits that were checked in on an older version of the subject s calendar, but aren t on the current Subject Calendar. Scheduled visit dates may have a visit tolerance a number of days +/- the scheduled date wherein the procedure(s) can be scheduled. The calendar creator added the Calendar Notes within the Foot Notes; they indicate which statuses will trigger the display of the different sections of the calendar.

9 P a g e 8 Visit Tracking Exercises Indicate a Referral Channel Steps The University at Buffalo is collecting data regarding referral channels for study subjects. When you first open a Subject Calendar you will see a form labeled Referral Channel V3 in the Forms column. Notes Please complete the form during a subject s consent process. 1. To navigate to the form, click the Forms by Status tab on the left, and then click the To Do Forms tab. Click on the Referral Channel V3 link to open the form. 2. Select the appropriate Referral Channel option from the drop-down menu. 3. Click Save, and then click the Complete link within the top section of the tab. 4. Once you complete the form, it will be located on the Completed Forms tab. Verify the Visit Date and Enter Details Steps Notes The links shown immediately above each Planned Date on the Subject Calendar are links to pages where you can enter visit information to verify the visit. 1. Click the desired visit link. The Subject Visit Update page will open. 2. The first field on this page is the Visit Date. The date in this field defaults to the Planned date shown on the calendar. You can change this date as necessary. The date in the Visit Date field defaults to the Planned date shown on the calendar. You can change this date as necessary. Marking a visit as N/A indicates that the Visit does not apply to this subject. It will also create

10 P a g e 9 3. Next to the Visit Date is the Visit Status box. By default, Planned is selected. Click Occurred to verify the visit. a visit variation in the Financials Console. Planned The subject visit is planned for the date specified. Occurred The visit occurred. Missed The subject missed the visit. NA This visit does not apply for this specific subject. 4. Enter information into the additional fields, as necessary. Visit Description Details regarding the visit. Reset Calendar - Select whether, and by which means, future visit dates should be adjusted if the Visit Date was not the same as the Planned Date. Future visit dates will be adjusted on the Subject Calendar. Data Collection Completed Date - When the data collection for the visit is complete, the Data Monitor will enter the completion date. Monitored Date - When the data has been monitored, the Data Monitor will enter the monitored date. Submitted Date - When the data has been submitted to the sponsor, the Data Monitor will enter the submitted date. Locked Date - The date the data is locked, meaning no more changes/alterations are allowed to the data. By moving the mouse over the (C), the comments preceded by the title Clinical Comments

11 P a g e 10 will be visible. The Locked Date is informational only; it does not prevent a user from changing data. Clinical Comments - When clinical comments are entered, a (C) will display on the subject calendar next to the visit number. Data Comments - When data comments are entered, a (C) will display on the subject calendar next to the visit number. By moving the mouse over the (C), the comments preceded by the title Data Comments will be visible. 5. Click Submit And Close to return to the Subject Calendar. On the Subject Calendar, the Visit Status will change to Occurred and the Visit Date field will appear. Enter Procedures Steps The Procedures table for a visit lists the labs, panels, and procedures that are scheduled for that visit. Each procedure has a set of data entry fields. 1. Scroll to the Procedures table. Each procedure has a set of data entry fields: Procedure Date Enter a date only if it is different than the Visit Date. SOC - If the procedure is standard-of-care (as defined in the Financials portion of OnCore), the SOC checkbox will be selected by default. Changing the state of this checkbox has implications for Financials functionality. You will be asked to supply a reason if you add or remove a checkbox in this column. Notes Unless they are marked as Missed or N/A, it is assumed that if the visit has occurred, the procedures have been performed on that Visit Date, unless otherwise indicated by the Procedure Date. SOC Modifier - Indicate whether the SOC procedure is Q0, Q1, or Unknown. This is an indicator used by the Financial Coordinator.

12 P a g e 11 Missed Select this checkbox if the procedure was missed during the visit. Missed Count - You can have the calendar schedule a procedure to happen multiple times during a visit. If some of those procedures were missed, indicate how many. N/A - Check the N/A (not applicable) checkbox if the procedure does not apply for this visit. Location - The Location field indicates which clinic location was used if the procedure can be performed at different locations; the cost of the procedure may vary dependent upon the location it was performed at. This field is only available when the Cost Center configuration is enabled in the Financials Console. Enter Additional Procedures Steps If a procedure is done during the visit that was not planned as part of the calendar, you would click the Additional Procedures button to record the procedure. 1. Click the Additional Procedures button. Protocol Procedures - This tab lists the labs, panels, and procedures that have been assigned to the protocol. To add these events to the visit record, select the appropriate checkboxes and click the Submit button. Charge Master - The Charge Master provides a means to search for and add events. Search using the Event Description field, and then click the Add button. Once the event is added click the Submit button. Free-Text Procedures - The Free-Text Procedures tabs provides a means to create a new free-text procedure. Enter the name of the procedure in the Clinical Procedure field, and then click the Add button. Once the procedure is added click the Submit button. Notes Once the additional procedure(s) are added, you may return to the Subject Visit Update window by clicking the Close button.

13 P a g e Click the Close button to return to the Subject Calendar. 3. Add the Procedure Date and any additional information necessary to track the visit. Enter Additional Subject Visits Steps At times, subjects will be seen for visits that are not on the standard schedule. These visits can be recorded on the Additional Visits vertical tab. 1. Click the Additional Visits vertical tab. 2. Click New. The Subject Visit Update page will open. 3. Enter a Visit Date. 4. Click the Submit button. 5. Click the Additional Procedures button at the bottom of the page. 6. Add a Procedure using the steps outlined in Enter Additional Procedures above. 7. Finish the process by completing and necessary information in the Visit Details and Procedures sections of the Subject Visit Update page, and then click the Submit and Close button. Notes An Additional Visit may be more commonly referred to as an unscheduled visit. Additional visits do not appear on the Subject Calendar.

14 P a g e 13 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