EventTracker User Guide

Revised July 2016 by Robin Richardson

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Contents 1.0. EventTracker Dashboard ...................................................................................................................... 3

2.0. Searching for a Study Protocol .......................................................................................................... 4

2.1. Searching for a Study Protocol ...................................................................................................... 4

2.2. Searching for a Pre-Study ............................................................................................................... 5

3.0. Adding Data to a Protocol .................................................................................................................. 6

3.1. Basic Details .......................................................................................................................................... 7

3.1.1. Protocol Status ............................................................................................................................. 8

3.1.2. Pop-Out Menus .......................................................................................................................... 8

3.1.3. Service Line, Group, and Subgroup ...................................................................................... 9

3.1.4. ICD 10 Code ................................................................................................................................ 10

3.1.5. Significant Dates and CLARA Logs ...................................................................................... 11

3.2. Delegation .......................................................................................................................................... 12

3.3. Services ................................................................................................................................................ 15

3.3.1. Adding a Service ........................................................................................................................ 15

3.3.2. Managing Services ................................................................................................................... 16

3.4. Submissions ........................................................................................................................................ 16

3.4.1. Adding Submissions to an Existing Group Type ............................................................. 17

3.4.2. Adding Submissions to New Group Types ....................................................................... 18

3.4.3. Printing and Exporting Submissions ................................................................................... 18

3.5. Notifications ....................................................................................................................................... 18

4.0. Viewing Reports .................................................................................................................................... 19

5.0. Tracking Documents ............................................................................................................................ 19

5.1. Document Tracker for Users .......................................................................................................... 19

5.2. Document Tracker for Managers ............................................................................................... 20

6.0. Viewing Release Notes ....................................................................................................................... 20

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1.0. EventTracker Dashboard EventTracker (ET) was developed for UAMS regulatory staff to track updates, changes, and events within a study. Studies are pulled from CLARA, and users may add extra data elements that CLARA doesn’t track. Users may also track events such as when the study opens for enrollment, submissions that are made, and services that are performed for the study. When you first open ET, you will see this dashboard (Figure ____).

Figure 1. The EventTracker dashboard (home page) has five main features.

There are four links and one field on the dashboard. All will be covered in this guide.

• Search by IRB or title: This field is where you will generally start by searching for a study (2.1. Searching for a Study).

• Pre-Study List: These are pre-studies listed in DOC groups by category (2.2. Searching for a Pre-Study)

• Reports: This section is where you can find Research Nurse Reports (4.0. Viewing Reports).

• Document Tracking: Document Tracking is a separate application that is embedded in ET for tracking user training for a study (5.0. Tracking Documents).

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• Release Notes: This section lists the changes that have been made to ET as it has been developed (6.0. Viewing Release Notes).

This guide will take you through the general workflow of using ET and will explain the various sections of the application.

2.0. Searching for a Study Protocol When you open ET, the first thing you will most likely do is search for a study protocol.

2.1. Searching for a Study Protocol To locate a protocol, simply enter an IRB number or study title in the search box and press Enter (Figure 2).

Figure 2. To see details of the study, click the study IRB in the search results box.

Click the study IRB in the search results to open the study’s Basic Details page (see Figure 3). You may then edit the study if needed. (See 3.1. Basic Details for more information about this page.)

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Figure 3. The study may be edited starting from the study Basic Details page.

2.2. Searching for a Pre-Study To locate a pre-study, first click the Pre-Study List link in the top right corner. A list of all of the pre-studies will display (Figure 4).

Figure 4. The Pre-Study List is arranged by DOC group.

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The studies are arranged by DOC (Disease Oriented Committee) groups, each containing studies about a particular area of the body or a certain type of disease. Under each DOC group, you can see a list of studies that are not categorized, and below that list are three expandable sections:

• IRB Processing: Study is in the process of being reviewed by the IRB.

• Opened: Study has been approved or does not require an IRB review.

• Declined: Study was submitted but declined by either UAMS or the IRB.

• Uncategorized: Study does not fall into one of the above categories.

The study protocols are also color coded, with the following meanings:

• Purple: Study has been assigned to budget staff.

• Pink: Study has not been assigned to budget staff and does not have an IRB.

• Blue: Study has not been assigned to budget staff and does have an IRB.

Click a study protocol to view details about it, add to it, or edit it. Be sure to save your changes.

3.0. Adding Data to a Protocol Once you have opened a study protocol, you can add information about it. There are five main sections where you can add or edit data. Here is the general order you will follow as you go through them:

• Basic Details: Contains information such as status, significant dates, contacts, and more information pertaining to the protocol (3.1. Basic Details).

• Delegation: Contains information on who has been assigned to the different duties pertaining to the study (3.2. Delegation).

• Services: Shows services that have been performed for the study and how many minutes were spent on each (3.3. Services).

• Submissions: Displays all documents that have been submitted pertaining to the study (3.4. Submissions).

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• Notifications: Shows any notifications about the study (rarely used) (3.5. Notifications).

3.1. Basic Details The Basic Details page contains information about the status, purpose, contacts, and other information related to the study protocol (see Figure 5). The fields may be added to or edited as needed.

Figure 5. Some of the fields on the Basic Details page, such as DOC Group, Sub Category, and Primary Purpose, are not obviously links.

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3.1.1. Protocol Status The top of the Basic Details shows the status of the protocol. It also contains links to Change status and to View status history of the study (Figure 6).

Figure 6. You may change the study status or view the status history on the Basic Details page.

3.1.2. Pop-Out Menus A few fields on the Basic Details are not obvious links but contain pop-out menus for you to select the relevant information for that field. There are three fields on the Basic Details page with pop-out menus you should be aware of:

• DOC Group (Figure 7):

Figure 7. Check the DOC Group your protocol belongs to and click Select.

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• Sub Category (Figure 8):

Figure 8. Check the DOC Sub Category your study belongs to and click Select.

• Primary Purpose (Figure 9):

Figure 9. Check the Primary Purpose of your study and click Select.

3.1.3. Service Line, Group, and Subgroup If you click on Service Line, Group, or Subgroup, a list of service lines will open with checkboxes (see Figure 10). When you check a box, if there is a group related to the service line, a sub-list will display for you to select from. If that group has any subgroups, they will display as well.

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Figure 10. Each time you check a box, any groups and/or subgroups will display.

Be sure to click Save after you have made your selection(s).

3.1.4. ICD 10 Code The ICD 10 codes are hidden by default, but you can view the ICD 10 codes that have been applied to your study by clicking View/Hide ICD Codes (see Figure 11). You may also delete codes here by clicking the red X.

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Figure 11. Click the View/Hide ICD Codes link to view the codes applied to the protocol.

To add ICD 10 codes, enter a code or code name (or partial code or code name) in the ICD_10 code/name field, select from the list that displays, and click Add (Figure 12).

Figure 12. Select the codes you want to add to your protocol and click Add.

3.1.5. Significant Dates and CLARA Logs The bottom section of the Basic Details page shows significant dates, such as the date the protocol was created in CLARA, IRB submission and approval dates, continuing review dates, and committee approvals.

You may also click Show CLARA Logs to view the CLARA history of the study (Figure 13).

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Figure 13. Click Show CLARA Logs to view the history of the study and what has been happening with it.

3.2. Delegation The Delegation section is a valuable resource for tracking study responsibilities and training of nurses and researchers assigned to a study. The page contains a list of the staff, the various areas of study, a record of who has completed training, and a link to TrialSearch where training documents can be downloaded (Figure 14).

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Figure 14. The Delegation page helps keep track of training responsibilities.

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The following is a typical workflow when delegating training responsibilities:

1. The principal investigator (PI) sets up a staff member for training (see Figure 15):

a. Click the name of the staff member from the Protocol staff list, and it will automatically fill the Staff Name field (1).

b. Click all of the Study Responsibilities that apply to the staff member, and the letters that represent them will automatically fill the Code field (2).

c. Click in the Start Date field and select a date from the calendar pop-up (3).

d. If applicable, enter a Stop Date.

e. Click Save, then OK when the Add new assignment? dialog box opens.

Figure 15. The Staff Name and Code fields auto-populate when you click a name from the Protocol staff and Study Responsibilities lists.

2. The staff member then goes to the Training Documents link, which takes him or her to TrialSearch where there are links to the training documents.

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3. Once training is completed, the staff member will go back into EventTracker, click the Delegate tab, and enter his or her initials in the Staff Initial & Training Log column.

The delegation lists may also be printed or exported by clicking the links at the top right of the Delegation tab screen.

3.3. Services Click the Services tab, and you will see what services the research nurses have performed in relation to the study, as well as how many minutes they spent performing the services (Figure 16).

Figure 16. The Services tab shows what has been done and how long it took.

3.3.1. Adding a Service You may also Add Service by clicking the link, filling out the following information, and clicking Save (Figure 17):

Figure 17. Fill out the Core Service box and click Save to add a service.

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3.3.2. Managing Services You may Manage services by clicking view/edit in the row of the service of interest, then making the needed changes (including deleting the service) and clicking Save (Figure 18).

Figure 18. View/edit services allows you to make changes to or delete a service.

3.4. Submissions Submissions are documents submitted to certain parties as part of the study protocol. When you click the Submissions tab, you will see all of the documents that have been submitted for the protocol to date grouped by type of report (Figure 19).

Figure 19. Three types of reports have been submitted for this study: Progress Report to Committee, Death, and Complex Safety Reports.

If you expand a submission, you will see information about the submission, as well as a link to remove the submission or add a new submission to the group type (Figure 20).

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Figure 20. Click Remove to delete a submission from a group type.

3.4.1. Adding Submissions to an Existing Group Type Once you have expanded a group type, you may click New Date to add a submission to the group of that type (Figure 21).

Figure 21. Expand the group and click New Date to add a submission to that group type.

Select a Committee, Event, Date, and optionally, a Note about the submission and click Save.

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3.4.2. Adding Submissions to New Group Types Click the Add Submission link to add a new submission of a new type not already listed. The screen will contain several fields for you to fill out regarding the submission (Figure 22).

Figure 22. Choose a submission type from the drop-down menu, then enter the date and number of events being reported.

From the drop-down menu, select the Type of submission you are creating. You must also enter the Date, and you may enter the Number of events and any Notes about the submission. Click Save.

3.4.3. Printing and Exporting Submissions To print the details of all submission, simple click the Print link below the navigation bar. If you want to export the submissions, click Export, and the file will export as a Microsoft Excel spreadsheet.

3.5. Notifications Notifications are generally entered by the research nurses, and they cannot be entered unless the study is in OpenClinica. To add a notification, click Add Notification on the Notifications tab (Figure 23).

Figure 23. You may add a notification if the study is in OpenClinica.

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4.0. Viewing Reports The Reports link on the ET dashboard will take you to any reports that have been submitted to ET. Click Reports then click the name of the report you would like to view.

5.0. Tracking Documents The Document Tracking link takes you to Document Tracker, a separate application that is embedded in ET. In Document Tracker, custom forms are created by UAMS IT Research that display whatever information is requested. The forms may contain any of four data types: date, checkbox, drop-down menu, or free text. The form(s) created are to be filled out by users, then managers may view the information.

The following sections show one example of a Document Tracking form. In practice, the information collected could be just about anything.

5.1. Document Tracker for Users To enter Document Tracker for users, click Start Document Tracker for User on the welcome page.

Here you will see your User Information as well as information about whether you have uploaded your CV, when your next TB test is due, your user type, and any comments (Figure 24).

Figure 24. You may change your own information by clicking in each field. A history of your changes can also be seen by clicking in the field.

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You may view the various versions of each and/or change the information in the field by clicking in it (Figure 25).

Figure 25. You may view the different versions as well as change the information in the fields.

5.2. Document Tracker for Managers Document Tracker for managers allows managers to view all of their site’s staff information as entered into the custom form. To enter Document Tracker for managers, click Start Document Tracker for Manager on the welcome page. Managers may also delete staff and add new staff for their site(s) from the Document Tracker (Figure 26).

Figure 26. Managers may delete staff and add staff for their site(s) in Document Tracker for Managers.

6.0. Viewing Release Notes The Release Notes link on the dashboard will take you to a list of the New Features and Bug Fixes for EventTracker as they have occurred over time (Figure 27).

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Figure 27. Release Notes is a list of New Features and Bug Fixes in EventTracker.