Permissions: ODR Read: Provides read-only access to the Operational Data Repository module.

ODR Analytics: Provides read-only access to the Operational Data Repository module and access to the Operational Oversight app in Analytics.

ODR Read Write: Provides read and write access to the Operational Data Repository module, including the ability to create issues. (Cannot access Field Configuration, manage Picklists, or access the Operational Oversight app in Analytics.)

ODR Configure: Provides read and write access to the Operational Data Repository module, including the ability to create issues, manage picklists, and configure fields (show / hide). (Cannot access the Operational Oversight app in Analytics.)

elluminate’s Operational Data Repository, or ODR, provides the ability to import or manually add your operational data into elluminate.

Important: Imported data overwrites currently entered data.

Access the Operational Data Repository

The Operational Data Repository is accessed using the 9-dot icon in the master header and selecting Operational Data Repository under Operational Insights. 

The Home page displaying Study Alerts is the default view when you first access ODR. Users have the option to change their view to display studies by status or phase.

Users can use the left navigation to access any of the panels listed.

A blue badge next to each panel name in the left navigation indicates the number of records in that panel. 

The blue badge in the header next to the Study Alerts, or the name of the study status or study phase indicates the number of studies in view. 

Toolbar Actions

Use the toolbar at the top right in the master header.

• Search: Use the Search field by entering any part of a Protocol Name or Protocol ID and the studies shown will update. 
• Study Status icon: By default, view by Study Status is turned on. Click the icon to turn it off and view by Study Phase.
• Select Status icon: Use the drop-down to select the study status or study phase you want to view.
• Toggle Favorites icon: Use the Toggle Favorites icon (the star) to display only study cards marked as your favorites. To mark a study as a favorite, click the Favorite icon (the star) in a study card. 
• Picklists icon: Click to open the Picklists window.
• Open Dashboard icon: Click to open the Operational Oversight app in Analytics. Only users with the ODR Analytics privilege will see this icon.
• Open Fields Config icon: Click to open the Fields Config window. Only users with the ODR Configure privilege will see this icon.
• Audit Trail icon: Click to open the Audit Trail prompts. 
• Question mark: Click to open the drop-down with access to the Help Center, Community, Learning Portal, Support contact information, Privacy Policy, Legal Notices, and About version #.

View by Study Alerts

Studies that have met criteria based on default calculations will be added to Study Alerts.

• Draft Protocol Date is Approaching: If Draft Protocol Date Actual is missing and Draft Protocol Date Planned is within the next 30 days
• Final Protocol is Approaching: If Final Protocol Date Actual is missing and Final Protocol Date Planned is within the next 30 days
• Screening Failure Rate (%) Is Exceeding Planned: If Screening Failure Rate (%) Actual is higher than Screening Failure Rate (%) Planned
• Enrollment Rate is Low: If Enrollment Rate Actual is Lower than Enrolment Rate Planned
• Number of Screen Failures is High: If Number of Screen Failures Actual is higher than Number of Screen Failures Planned
• First Site Activated Is Approaching: If First Site Activated Actual Date is missing and First Site Activated Date Planned is within the next 30 days
• First Subject Screened Is Approaching: If the First Subject Screened Actual Date is missing and First Subject Screened Planned is within the next 30 days
• First Subject In Is Approaching: If the First Subject In Actual is Missing and the First Subject in Planned is within the next 30 days

View by Study Status

Study status is retrieved from the information entered in the Study form. In the example above, the status of 'completed' was selected. The header shows that you are viewing by Study Status > Completed, and the study card displays the study name (link to access the study top-level form), study status, the number of total actual sites, total actual screened subjects, and total actual enrolled subjects. Study statuses are defined in the Study Status picklist.

View by Study Phase

Studies can be displayed by Study Phase, categorized based on the data imported or entered into the system, such as different fields within Rates and Milestones. 

Study phases include Planning, Active Pre-Enrollment, Active Enrollment, Completed, and Undefined. 

Tip: If the Study Status field is not completed for a study, it will be in the Undefined study phase.

Change Your Home Page View

Users can change their view of the Home page using the Study Status and Select Status icons in the master header.

By default, the view by Study Status is turned on. Therefore, the Select Status drop-down will include all study statuses and phases, as well as study alerts. When the Study Status icon is turned off, the Select Status drop-down will include Study Alerts, and all study phases (Planning, Active Pre-Enrollment, Active Enrollment, Completed, and Undefined). 

Change the View by Study Status / Study Phase

1. The Study Status icon is shaded, indicating it is turned on. Click the icon to turn it off and view by Study Phase.
2. Click the Select Status icon.
3. From the drop-down, select either Study Alerts, the study status, or the study phase.

Study Cards

The items displayed on study cards will vary depending on whether you are viewing them by study alerts, study status, or study phase.

Study cards on the Study Alerts page.

Study cards on the Study Status page.

Study cards on the Study Phase page.

Items include:

• Hyperlinked Study Name: Click to open the Edit Study window (form).
• Study Details icon: Click to open the Study Details window displaying the Milestones timeline (if data are available) and Metrics by Phase.
• Favorites icon: Click to mark as a favorite.
• Protocol Name: The Study ID (Protocol ID) from the study's top-level form.
• Study Status: The study status retrieved from the study's top-level form.
• Total Actual Sites
• Total Actual Screened Patients
• Total Actual Enrolled Patients
• Study Phase specific metrics: The metrics displayed vary based on the study phase.

Navigation

Click any of the panels from the left to navigate to another panel. Data you see listed have either been manually entered or has come in through an import. The Operational Data Repository holds data for Investigational Products, Programs, Studies, Study Sites, Sites, Organizations, Investigators, Personnel, Sponsors, Clinical Development Plans, Regulatory Submissions, Ethical Review Boards, Preferred Providers, and Protocol Deviations. The orange sideline indicates which panel you are viewing.

Icons are available at the top right of the master header. Regardless of which panel you have open, the same icons display. See the ODR Icons table below for details.

Grid (Listing) Functionality

Selecting a panel in the left navigation opens the associated grid (listing). For example, clicking on Investigators opens the Investigators listing. Most columns can be sorted, filtered, fixed, and moved. 

Set a Column Filter

1. Click the column header. A drop-down opens with sort options and Filter. 
2. Click Filter.
3. Select and add your filter options.
   
   
   1. Select either Include Selections (defaulted) or Exclude Selections. 
      Include Selections will filter for all records in which the selected values appear. 
      Exclude Selections will filter for all records in which the selected values do not appear. 
   2. Optionally, select Blank Values. 
      Blank Values will allow selection of records in which the filtered column contains blank or null values. This can be used with the Include or Exclude radio button to include blank/null data or exclude it from the filtered results. 
      Note: When applying the Include Selections or Exclude Selections criteria on a numeric or date range, the Includes option will include the minimum and maximum values in the results and the Excludes option will exclude the minimum and maximum values from the search results.
   3. Select from the list by checking the boxes, or enter text. You can enter a letter or number string, and items with that string will display after selecting Filter Rows.
4.  Select Filter Rows or Clear. Note that these buttons become active after filter conditions are selected.

After a column filter has been applied and Filter Rows selected, the Filters icon in the toolbar becomes shaded, indicating that at least one column filter has been applied to all rows within the listing. Filtered columns have a filter icon at the right in the column header.

Clear Filter Conditions

In the listing with an existing row filter applied:

1. Click column header.
2. In the drop-down click Filter.
3. In the filter selection window, select Clear.

This clears all filters for that column.

OR

1. Click the active (shaded) Filters icon in the master header. This opens a drop-down with the following options:
   1. Clear (all) Filters.
   2. See items that are filtered. Click the red minus circle icon to remove individual filters.

Sort Columns

Most columns can be sorted in ascending or descending order. Columns that have been sorted display an arrow (facing up for ascending, facing down for descending) under the header, for easy identification.

1. Click the column header.
2. Select Sort Ascending or Sort Descending.
3. To sort additional columns, hold the SHIFT key and click the column header, then select Sort Ascending or Sort Descending.

Fix and Unfix Columns

Columns can be fixed, or locked, to the left or right of a panel so the columns remain on the screen as the user scrolls right or left. Fixing columns is helpful when reviewing data and retaining specific fields for easier identification of each record.

1. To fix a column, right-click the column header and select Fix, then select To the left or To the right.
2. To Unfix a column, right-click the column header and select Unfix.
   

Tip: It is best to first fix columns to the left or right, then sort.

Adjust Column Width

When hovering over the header row, a grab bar appears, use this to adjust the width of a column. 

Move Columns

Columns can be reordered by clicking on the column header and dragging it to a new location. The reordered columns remain until the user closes out of their session.

Access Open Issues

Records with open issues will have a hyperlinked number in the Open Issues column. Click the hyperlinked number to open the Related Issues window. For more details on managing issues in the ODR  see the article Create and Manage Issues in the Operational Data Repository.

ODR Icons

Panel Summaries

Investigational Products

The Investigational Product panel contains information around an investigational product (IP). This panel is set up to allow the end users to add and edit IPs. This panel will not limit the type of IP created. Therefore, different products may be entered or ingested, such as drugs, compound drugs, devices, software, etc. The panel has built in flexibility to manage most types of IPs and will be updated as new types enter clinical trials.

Programs

The Programs panel is used to bridge an individual study and a group of studies which may be used to test for an indication or group of indications. The end user can assign studies to a program within this panel. All studies available will be listed. In addition, all IPs entered into the system will also be listed. These may also be associated with the program.

Studies

The Studies panel is used to enter details of any study in the Operational Data Repository. As with all panels, this data may also be ingested from outside systems. In either case, the user will be allowed to edit and add data as needed. Due to the amount of information needed for studies, additional sections are listed on the left of the new or edit windows. Clicking on a section title opens the associated window on the right with ingested / entered details. 

Also, note that Role Histories is generated by the system when someone’s role changes. This tracks changes to an individual’s role in the study.

Study Sites

The Study Sites panel is where the sites are associated with studies; that is, the site has been approved to participate in the identified study. Details can be added to complete the data associating the study with a site. As there is a lot of data associated with the pairing of the site with a study, additional sections are listed on the left of the new or edit windows. 

Sites

The Sites panel holds the site information. This data can be added (manually or ingested), or current data can be edited. This panel contains the details of the site’s physical address and contact information, as well as any specialties. Finally, the sponsor approvals are for the site itself and indicates that the site has been approved to be used in a study.

Organizations

This panel is used for information on organizations and can be associated to one or more sites.

Investigators

This panel is used for detailed information on the Investigator, such as contact information and accreditations. Investigators can be associated with a study in other forms.

Personnel

This panel is used to record information for all the personnel in the study and / or site other than the Primary Investigator. Again, contact information and degrees / certifications can be added here.

Sponsors

This panel is used to record information about sponsors. This especially useful if there are multiple sponsors or a cosponsor.

Clinical Development Plans

This panel is used to collect details of the Clinical Development Plan.

Regulatory Submissions

This panel is used to collect the information on any regulatory submission to allow tracking of it.

Ethical Review Boards

This panel is used to keep track of all ERBs in use for the sponsor.

Preferred Providers

This panel is used to track any preferred provider used by the sponsor. These can be associated with a study in other forms.

Protocol Deviations

This panel is used to track protocol deviations. 

Note: Protocol Deviation data entered in the topform and Protocol Deviation Tracking subform (within Studies) is synchronized. Data entered into the Protocol Deviation Tracking subform will be accessible in the Protocol Deviations top-level form data, with the addition of new data being one-directional. Data editing is allowed in both forms, and the synchronization is bi-directional. Data synchronization is limited to pre-defined fields in the form and does not include custom fields.