OnCore Enterprise Research Exercises: Subject Administration Clinical Research Coordinator August 2018
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P a g e 2 Exercises: Subject Administration Contents OnCore Navigation Tips... 4 Date Shortcuts... 5 Summary Accrual Only Exercises... 6 Locate a Summary Accrual Only Protocol... 6 Add a Summary Accrual... 6 Documents/Info Exercises... 8 Locate Archive/... 8 Create an Archive... 8 Create a Note... 9 Annotations Exercises... 10 Locate Annotations... 10 Notate Pre-Screening Efforts... 10 Notate Re-Consents... 11 Notate Safety Letters IND/IDE... 11 Notate Sponsor Monitoring Visits... 12 Notate Audits... 12 Notate Mid-Study Sponsor Monitor Change... 13 Notate Mid-Study Clinical Research Organization Change... 13
P a g e 3 Notate Required Study Training... 13 Notate Other Invoiceable Items... 14 Subject Registration Exercises... 16 Register an Existing Patient... 16 Create a New Patient... 16 Update Subject Demographics... 17 Subject Management Exercises... 18 Enter Subject Consent... 18 Determine Subject Eligibility... 18 Place a Subject On Study... 19 Add Subject Staff... 20 Place a Subject On Treatment... 20 Enter Off Treatment, On Follow Up, and Off Study Statuses... 21 Subject Deviation Exercises... 24 Create a Serious Adverse Event (SAE)... 24 Create a Follow-Up SAE... 25 Create a Subject Deviation... 26
P a g e 4 OnCore Navigation Tips Use only one instance of OnCore at a time Only one session (browser window or browser tab) of the OnCore Enterprise Research system website should be open at a time on your computer. Multiple sessions of OnCore could result in duplicate data and application misbehavior. Use a computer with a keyboard and a mouse OnCore stores large volumes of complex information about the protocols, subjects, calendars, and budgets in your research portfolio. When using the application, use a keyboard and a mouse for efficient data entry. Using a tablet or a touchscreen can make data entry feel cumbersome or time-consuming, while using a keyboard and mouse can speed up your workflows significantly. Avoid using the browser s back button Use OnCore s buttons, tabs, and menus to navigate within the program; do not use the browser s navigation buttons. Using the browser toolbar to navigate might lead to unexpected results, such as unsaved data or webpage errors. Single-click buttons and links Especially when clicking Save or Submit to create a new record, click once so that only one record is created and duplicate data is not saved in the database. Avoid double-clicking the mouse when working in OnCore. Disable pop-up blockers on your web browser OnCore uses many pop-up windows that allow you to make selections and enter data. If your browser is set to prevent pop-up windows from opening, it will also prevent OnCore s pop-up windows from opening.
P a g e 5 Date Shortcuts 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 NOTE: When entering a keyboard shortcut into a Date Widget field, you can press Enter, Tab, or click anywhere outside the Date Widget to calculate the appropriate date in MM/DD/YYYY format.
P a g e 6 Summary Accrual Only Exercises Locate a Summary Accrual Only Protocol The Summary Accrual Info. Only tab is marked Yes when only summary subject data will be collected for a protocol. 1. Navigate to Menu > Protocols > PC Console. 2. Enter a search term in the Select Protocol field to locate and open the desired protocol. 3. Within the Protocol Details section on the Main tab, notice that the field Summary Accrual Info. Only is marked Yes. This setting disables the Subjects > CRA Console > Register Subject page. This setting cannot be changed once subjects are accrued to the protocol. Add a Summary Accrual Summary accrual information is updated on the Accrual tab of the PC Console. 1. On the Accrual tab, click the Update button. 2. Enter the following into the Add Protocol Accrual section: From Date start of the accrual period Thru Date end of the accrual period (must be from the same calendar year as the From Date) Accrual number of subjects in the accrual group Institution select the appropriate institution from the drop-down menu The required fields are From Date, Thru Date, Accrual, and Institution Type. Consider what types of reports you wish to generate regarding subject demographics when you are selecting additional fields in this area. If you are adding multiple accruals at the same time, you will need to group them according to some common characteristics.
P a g e 7 Institution Type select the appropriate choice from the drop-down menu Gender gender of the accrual group Age Group age range of the group Ethnicity ethnicity of the accrual group Race race of the accrual group Disease Site disease site of the accrual group Recruited By name or initials of the recruiter Zip Code zip code of the accrual group 3. Click the Add button to add the accrual to the protocol. 4. The accrual will be added to the list at the bottom of the tab; use the Edit button to make any changes necessary, and the Copy button to make a copy of an accrual. 5. Repeat steps 2-3 to add additional acrrual groups, if necessary. Click the Close button when finished.
P a g e 8 Documents/Info Exercises Locate Archive/ Locate the FAQs tab in the PC Console to see important notes regarding the Protocol Calendar. 1. Navigate to Menu > Protocols > PC Console. 2. Click on the Documents/Info tab, which lists all attachments to the protocol. 3. Click the Archive/ horizontal tab. The Documents/Info > Archive/ tab allows you to create and post that are of interest to the Study Team. It also allows you to Archive study records for storage once the protocol has been completed. Create an Archive 1. From the Archive/ tab, click Add in the Archive Details section. 2. Enter the following information: Archive Date Archive Type Location Where the box will be stored. Box The number on the box. Contents regarding the contents of the box. 3. Click Save to save your Archived item, and then click the Submit button. Follow the steps above to Archive additional items.
P a g e 9 To remove a FAQ, check the Delete option and Save your changes. Create a Note 4. From the Archive/ tab, click Add in the Details section. 5. Enter the following information: will appear in the PC Console header, as a page icon. Date Note Text 6. Click Save to save your Note, and then click the Submit button. Follow the steps above to add additional. To remove a Note, check the Delete option and Save your changes.
P a g e 10 Annotations Exercises Locate Annotations Locate the Annotations tab in the PC Console to log general protocol-related billable items for the selected protocol. 1. Navigate to Menu > Protocols > PC Console. 2. Click on the Annotations tab. 3. Click the Update button. Protocol Annotations are used to collect protocol data that is not accounted for by standard OnCore fields. We will use this page to log general protocolrelated billable items on a quarterly basis. Notate Pre-Screening Efforts 1. Enter the following information: Number of Subjects Pre-Screened Today s Date Comments 2. Click Apply. To edit an entry, click the Edit icon ( ) in the right column. To remove an entry, click the Remove ( ) icon in the right column, and then click Delete.
P a g e 11 Notate Re-Consents 1. Enter the following information: Number of Subjects Re-Consented Today s Date Comments 2. Click Apply. To edit an entry, click the Edit icon ( ) in the right column. To remove an entry, click the Remove ( ) icon in the right column, and then click Delete. Notate Safety Letters IND/IDE 1. Enter the following information: Number of New Letters Today s Date Comments 2. Click Apply. To edit an entry, click the Edit icon ( ) in the right column. To remove an entry, click the Remove ( ) icon in the right column, and then click Delete.
P a g e 12 Notate Sponsor Monitoring Visits 1. Select the appropriate Type of Monitoring Visit from the dropdown menu. 2. Enter the following information: Date of Monitoring Hours of Monitoring Comments 3. Click Apply. To edit an entry, click the Edit icon ( ) in the right column. To remove an entry, click the Remove ( )icon in the right column, and then click Delete. Notate Audits 1. Select the appropriate Audit Type from the dropdown menu. 2. Enter the following information: Date of Audit Hours Auditor on Site Comments 3. Click Apply. To edit an entry, click the Edit icon ( ) in the right column. To remove an entry, click the Remove ( )icon in the right column, and then click Delete.
P a g e 13 Notate Mid-Study Sponsor Monitor Change 1. Enter the following information: Date of Monitor Change Comments 2. Click Apply. To edit an entry, click the Edit icon ( ) in the right column. To remove an entry, click the Remove ( ) icon in the right column, and then click Delete. Notate Mid-Study Clinical Research Organization Change 1. Enter the following information: Date of CRO Change Comments 2. Click Apply. To edit an entry, click the Edit icon ( ) in the right column. To remove an entry, click the Remove ( )icon in the right column, and then click Delete. Notate Required Study Training 1. Enter the following information: Type of Training Date of Training
P a g e 14 Hours Spent Training Comments 2. Click Apply. To edit an entry, click the Edit icon ( ) in the right column. To remove an entry, click the Remove ( )icon in the right column, and then click Delete. Notate Other Invoiceable Items 1. Enter the following information: Date Comments 2. Click Apply. To edit an entry, click the Edit icon ( ) in the right column. To remove an entry, click the Remove ( )icon in the right column, and then click Delete. 3. Click the Save button in the bottom-right corner of the page.
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P a g e 16 Subject Registration Exercises Register an Existing Patient 1. Navigate to Menu > Subjects > CRA Console. 2. Enter a search term in the Select Protocol field to locate and open the desired protocol. 3. Click the Register Subject tab. 4. Choose a location from the Study Site drop-down menu. This field indicates the location where the subject is enrolled, or where they are seen most by the study staff. 5. In the Find Fields section on the left, enter the subject s last name in the Last Name field and click the Find button. 6. The Subject Find Results table shows all subjects matching the search criteria. Click the OnCore Subject ID to populate the fields in the New Subject Details screen with the selected subject s data. 7. Click the Add button to add the subject to the protocol. Create a New Patient If the patient does not yet exist in OnCore, you must create a new patient record. 1. On the Register Subject tab, click Clear All. 2. Choose a location from the Study Site drop-down menu. A subject cannot be entered into OnCore without an association to a protocol. When entering a new subject, first check to see whether they have already been entered into OnCore, in order to avoid duplicate subject entries. The Subject Find Results table shows subject records that already exist in OnCore. These subjects are already associated with another protocol. If you want to know if they are currently active in another study, please contact CTMS@buffalo.edu If there is a duplicate subject created or you need to have a subject record deleted, please contact CTMS@buffalo.edu
P a g e 17 3. Click the Generate button to create an OnCore Subject ID for the patient. This number will identify this subject across all protocols in the OnCore system. You will add an identification number for this subject in relation to this specific protocol in another area within the system. If a patient will be seen at multiple Study Sites, pick the one that the patient will be seen at most of the time. 4. Enter the following into the New Subject Details section: Last Name First Name Birth Date Gender Ethnicity Race 5. Click the Add button to add the subject to the protocol. Update Subject Demographics Subject demographic information is updated on the Demographics tab of the Subject Console. 1. Click the Update button, if necessary. 2. Enter information into the additional areas and then Add your changes: Contact Information - Contact information, such as address, phone number, and e-mail address. Subject s Emergency Contacts Contact information for the subject s emergency contacts. Do not enter a patient s Social Security number in OnCore as an Additional Subject Identifier. An example of an appropriate Additional Subject Identifier is a Hospital ID from another system. Additional Subject Identifiers - Identifiers for the subject other than the OnCore System ID. Information in the Identifier Type field is selected from a pre-defined list; free text can be entered in both the Identifier and Identifier Owner fields.
P a g e 18 Subject Management Exercises Enter Subject Consent The Consents section will list signed consent forms for this subject. 1. Click the Consent vertical tab. 2. Click the Update button. 3. Enter the date that the subject signed a consent in the Signed Date field and then click Select Consents. 4. A list of available Consents opens, showing consent forms for the subject that have been approved at the subject s Study Site. If a subject was consented on an older version of a consent form, an RR superscript ( RR ) will appear next to the OnCore Subject ID for the patient in the CRA Console indicating that the subject needs to reconsent on a newer version of the form. 5. Select Accepted for the appropriate document, and then click Save. 6. Click the Close button. The Subject Status (at the top of the console) changes to CONSENTED. Determine Subject Eligibility Confirming a subject s eligibility is not required by OnCore prior to placing that subject On Study, but it is generally done. 1. Click on the Eligibility vertical tab. 2. To record the subject s eligibility, click the Update button. 3. Enter the following information:
P a g e 19 Eligibility Status Verified By your initials Status Date 4. Click the Submit button. 5. Click the Close button. The Subject Status (at the top of the console) changes to ELIGIBLE. Place a Subject On Study Once a subject has been deemed eligible for the study, they need to be placed On Study. 1. Click on the On Study vertical tab, and then click Update. 2. Enter a Sequence Number; this is the patient s ID number related to the study. 3. Enter an On Study Date; this is usually the date that the patient is randomized in the study to receive treatment, a device, or other therapy. 4. Make selections for the Primary and Secondary Diagnosis fields as appropriate: 5. Enter a Zip at Registration. 6. Additional Protocol Subject Identifiers, such as the Subject Screening ID #, can be added. Select Subject Screening ID # from the Identifier Type drop-down menu. The On Study date is typically the date of the subject s first treatment; in many cases the On Study and On Treatment date will be the same. The Sequence Number is normally the patient s ID number related to the study. It is a number assigned by the sponsor or study team. The system will not allow a duplicate Sequence Number. Zip at Registration and Insurance are mandatory fields, and are needed to generate accurate reports from the system. 7. Enter a value (any value using a combination of letters and numbers) in the Identifier field, and click the Add link.
P a g e 20 8. Click the Select button in the Insurance section of the page. Place checkmark(s) next to the type(s) of insurance the subject has, and then click the Add button. It is not necessary to enter a Group or Participant Number at this point. 9. Click the Submit button. The Subject Status (at the top of the console) changes to ON STUDY. Add Subject Staff The Subject Staff section on the Menu > Subject Console > On Study page holds information about the treatment staff assigned to the subject. Add Individual Staff: 1. Select a Role from the drop-down menu. This subject and their visits will appear in My Console and in the Subjects widget on the home screen for the assigned staff members. 2. Begin typing a name in the Staff Name field to search for and select a staff member. 3. Click Add. Add Study Team Members: 1. Click the Team button to create Subject Staff from the already-defined Protocol Staff list. 2. To add study team member(s), simply place checkmarks in the Select column. To add all members at once, choose Select All. 3. Click the Submit and Close buttons. Place a Subject On Treatment The Treatment tab allows you to begin scheduling subject visits. When the protocol was set up in the OnCore system, a Subject
P a g e 21 1. Click the Treatment vertical tab, and then click Add. 2. Select an Arm from the drop-down menu. 3. Select the On Arm Date. This is the date the subject was randomized or assigned to a specific arm of a study. For example, this could be the date the patient goes on the Randomized arm or the Open-Label arm of a study. 4. Select the On Treatment Date; this date activates the Treatment section of the Subject Calendar. 5. Click the Save button. The Subject Status (at the top of the console) changes to ON TREATMENT. Calendar was developed with milestone dates for each visit and procedure. As you ve been doing these steps, visits have been populating on the subject s calendar. The planned dates for the visits in the calendar are relative to the dates entered for each individual subject. Enter Off Treatment, On Follow Up, and Off Study Statuses Off Treatment 1. Click the Follow-Up vertical tab, and then click Update. 2. Select an Off Treatment Date; this is typically the last date the patient is receiving study treatment, and can be specific to each protocol. 3. Select an Off Treatment Reason. 4. Add comments to the Explain field, if necessary. 5. Click the Submit button. The Subject Status (at the top of the console) changes to OFF TREATMENT. These statuses are typically triggers for visits in the Subject Calendar. The statuses would not be changed all at once, as written in this exercise. Normally, these statuses would be updated / changed at the points where the subject has completed all visits for a certain portion of the Subject Calendar (e.g., completing all Treatment visits would trigger the need to change the status to OFF TREATMENT).
P a g e 22 On Follow Up 1. Select a Follow-Up Start Date; this is the date the patient has completed study treatment visits or the last day of treatment, and is now being followed up per protocol. 2. Edit the Transferred To (Study Site) by clicking on the search icon ( ) to locate the site where the subject will be seen for follow-up visits, if different from current location. The On Follow-Up date is typically the last date of treatment; in the case of the sample protocols, the date the last pill was taken, or the date the device was put in place. 3. Enter information in the additional fields, as necessary: Alternate MRN The MRN for the subject at the follow-up site when the follow-up will be performed at another study site, if applicable Last Follow-Up Date - The last date verified from the Follow-Up section of the subject calendar can be entered here when the patient completes the study. Next Follow-Up Date - Date of the next follow-up visit can be entered here. Last Known Survival Status The patient s survival status. Expired Date - The date of death reported to institution personnel. The Approx? checkbox can be used if the reported date is not exact. Last Known Date Alive - This is the last date that institution personnel knew the subject was alive. QA Date - The date the subject s record was reviewed for accurate and complete data.
P a g e 23 Comments A free-text entry field for comments related to the subject follow-up. 4. Click the Submit button. The Subject Status (at the top of the console) changes to ON FOLLOW UP. Off Study 1. Enter an Off Study Date; this is the very last visit date for the subject. 2. Select an Off-Study Reason, and add comments to the Explain field, if necessary. 3. Click the Submit button. The Subject Status (at the top of the console) changes to OFF STUDY.
P a g e 24 Subject Deviation Exercises Create a Serious Adverse Event (SAE) The SAEs tab records any Serious Adverse Events associated with a subject. 1. Click the SAEs vertical tab. 2. Click New. 3. Enter the following information for this Serious Adverse Event (SAE): Event Date Enter the date the SAE occurred (required) SAEs must be entered at the subject level; however, SAEs can be viewed across all subjects at the protocol level in the CRA Console. The Event Date for a SAE must be on or after a subject s Consent Date. Reported Date Enter the date that the SAE was reported (required) Reported By Enter your name/initials Upon submission, an Event Number will be assigned to the SAE. This unique number appears at the top of the page. Outcome - Select from the dropdown menu (required) Event Narrative Enter a brief description of the adverse event SAEs can be locked when you are finished to prevent edits to all but the Tracking Details section. Protocol Attribution Select from the drop-down menu 4. The following optional sections of an SAE allow you to track additional details, if desired: SAE Classification - Allows you to select one or multiple SAE classifications from a drop-down list.
P a g e 25 Adverse Event Details - This section is optional, but if information is entered in this section, all required fields must be filled before clicking Add. Tracking Details - Records the dissemination of information regarding the SAE. Additional SAE Identifiers - Records other identifiers for the SAE, such as a number assigned by the IRB. An Identifier Type can be selected from the drop-down list and free text can be entered into the Identifier and Identifier Owner fields. Supporting Documents - Allows you to upload files relevant to the SAE 5. Click the Submit button. Upon submission, an Event Number will be assigned to the SAE. 6. Click Complete and Lock. Even though the SAE has been locked, you have the ability to update the Tracking Details section of the SAE and to create a follow-up SAE. Create a Follow-Up SAE 1. Select the SAEs tab and click on the SAE s Event No. link. 2. Click Create Follow-Up. 3. Enter the required information for this follow-up SAE, as well as any other appropriate details. The Follow-Up SAE copies most of the parent record s information; you can then make modifications as needed (most commonly this involves changes to the Outcome field). 4. Click Submit to save your entries, and then click the SAEs vertical tab. The Event No. of the Follow-Up SAE will show its relationship to the parent (in parentheses). The Follow-Up SAE has a Delete link in the Delete column but its parent SAE does not. When
P a g e 26 SAEs are deleted, they must be deleted in reverse order of creation (the child SAE must be deleted before the parent SAE). Create a Subject Deviation A Subject Deviation is a variance from the approved protocol procedures, specific to an individual subject. 1. Click the Deviations vertical tab. 2. Click the New button. 3. Enter the required information for this Subject Deviation and complete additional fields as appropriate. Date Discovered - Enter the date that the deviation was detected Deviation Date - Enter the date that the deviation occurred Category Select the type of deviation Description of Deviation - Enter a brief description of what occurred Action Taken Enter a description of the action taken by the research team 4. Click the Submit button. 5. Click the Deviations vertical tab to see the updated page. Visits that fall outside the Tolerance window for the Planned Dates on the Subject Calendar will be recorded automatically by the system. The Date Discovered and Reported By fields default to the current date and user, but they can be changed. The Delete link allows you to delete a Deviation record entered in error. You can also print out or save a PDF of the deviation that can be used for your records or to send to the PI or sponsor.
P a g e 27 OnCore Support Team Clinical and Translational Research Center 875 Ellicott Street Buffalo, NY 14203 716.888.4713 CTMS@buffalo.edu Electronic Research Administration (era) UB Commons, Suite 114 University at Buffalo North Campus Buffalo, NY 716.829.3457 support@research.buffalo.edu