Permissions: Users must have the ODR Read Write or ODR Configure privilege to create and manage records in the Operational Data Repository (ODR).
Users with the ODR Read or ODR Analytics privilege have read-only access.

Data can be imported into the Operational Data Repository, or it can be added or edited directly within the Operational Data Repository. Toolbar icon actions and entry / edit form functionality is the same for all panels and forms.  

Create or Edit a Record

First, click the panel name from the left navigation where a record is to be added or edited.

To create a new record in a panel, click the Create (plus sign) icon in the master header.

To edit a record:

• Double-click the row,
• Highlight the row and click the Edit icon in the master header, or
• Right-click the row and select Edit.

Use Common Functionality

All new and edit forms have the similar functionality.

• Fields with a red asterisk are required.
• Fields with drop-down lists are associated to Picklists and may be modified using the Picklists icon. Some fields, such as Primary Contact, are drop-down lists containing names from Investigators and Personnel.
• Date fields have a drop-down to a calendar, or dates can be entered as ddmmmyyyy (e.g., 03JAN2023).
• Some fields include data populated from other panels or system auto filled.
• Use the scrollbars to access all fields.
• Use the tabs at the top of the form to access Basic Details or Rates and Milestones.
• Additional subsections are listed on the left side of the new / edit form. Most subsections have a plus sign at the right, indicating the user can open a subform to enter additional data.
• Create an issue from a panel listing or from an edit record window. The Create Issue icon is available in the panel listing and the edit record window at the top right (it is not available in the new record window).

Examples of field functionality are shown below.

A. In several panels (e.g., IP, Programs, Studies, Study Sites, and Sites) additional subsections are listed on the left side of the new / edit form.

• To view details already entered for a subsection, click the subsection name.
• To add details, click the plus sign to the right of the subsection name. This action opens a subform for detail entry in each field. 
  

Note: The Schedule of Events subsection (within Studies) is a 3-part subform. Completion of the required fields in the first two subforms is necessary before clicking Next. The third form presents a grid format for entering specific details.  

B. Some panels have tabs at the top: Basic Details, Rates and Milestones (or Milestones).

C. Fields with a red asterisk are required, e.g., the Protocol ID field.

D. Click an open field to enter free text (best practices are determined by client).

E. Click a drop-down to display the list of values, and then make a selection. 

F. Click the calendar icon to open the calendar picker. 

G. Hover over the 'i' icon for the Tooltip to display.

H. Select a checkbox for a question if Yes. For example, Are/will CROs be used? has a single checkbox, checking it identifies it as yes, CROs are used.

I. Use the scrollbar to access all the form fields.

J. To save changes, click Save. To discard an entry or updates, click Cancel.

Tabbed Forms

Some panels, i.e., Studies, Study Sites, and Regulatory Submissions, have tabs at the top of the form. Use the tabs to access basic details or rates and milestones. The selected tab is underlined in orange. 

Multi-Select Lists

Some sections include multi-select checklists where users can choose, for example, which Programs an Investigational Product is used in. The number within the blue badge indicates the quantity of selected items in the list, and this count also appears in the panel listing.

For longer lists, use the Search field by typing text. As text is entered, the list dynamically displays names containing that text. All checked items automatically display at the top of the list for easy review.

Some forms have many sections, be sure to use the scrollbars to access all sections of a form. 

Subsection Details

Entered details for each subsection display in the main window. 

Enter Subform Data

1. Click the Add / Create icon at the right of the subsection name in the left navigation or at the top right in the toolbar.
   
2. Enter the details into the subform.
   
3. Click Save.

Edit Subform Data

1. Select the record by checking the box at the left.
2. Click the Edit icon in the toolbar.
3. Make the updates in the Edit window.
4. Click Save.

Delete Subform Data

Use caution when deleting subform data. There is no warning message.

1. Select the record by checking the box at the left.
2. Click the Delete icon in the toolbar.

Save a New or Edited Record

1. Click Save in the subform to save entered / edited data; or click Cancel to cancel selections.
2. Click Save in the New / Edit form to save entered / edited data; or click Cancel to cancel selections.

Archive a Record

Users with ODR Configure privileges can archive records. Details of archived record are accessible in the Audit Log. 

1. From a panel listing, click to highlight the record to be archived, or highlight the record and open the edit window.
2. Click the Archive Record icon. The Archive a Record window opens if the record is not in use elsewhere in the Operational Data Repository.
   • If the record is in use elsewhere, a pop-up message displays listing the locations where the record is used. Review the listed locations, close the pop-up by clicking the X in the upper-right corner, and archive the record from those panels first. The record is archived only after a confirmation message indicates successful archiving.
3. Enter a Reason for Archiving the Record.
4. Click Save to proceed. A confirmation message displays.

Access Archived Records

Archived records do not initially appear in a panel listing, however, from a panel listing, a user can select the 'Show Archived Records' icon to see them in the panel listing.

1. From a panel listing, click the Show Archived Records icon in the master header. Three additional columns display at the right of the listing, 'Is Archived,' 'Archival Reason,' and 'Restore Archival Reason.'

Restore an Archived Record

Archived records can be restored from a panel listing. 

1. Click the Show Archived Records icon. The three additional archival columns display at the right of the listing.
2. Highlight the row of an archived record. Archived records display Yes in the Is Archived column.
3. Click the Restore Archived Record icon in the master header.
   
4. Enter the reason in the Reason for Restoring the Archived Record textbox.
5. Click Save.

Export Panel Data

Panel data can be exported using the Export icon in the master header and selecting either Export this data or Open in Exporter. Select the desired panel from the left navigation.

Export to Excel

A filtered panel grid can be exported to Excel. 

1. Optionally, filter the panel grid.
2. Click the Export icon in the toolbar, then select Export this data.

The Excel file downloads to the computer.

Open in Exporter

Using the Open in Exporter option directs users to the Exporter module. The Exporter module then opens and utilizes the contents of the ODRViews. The export includes the return of lookups to associated tables, ensuring that the name of the related item, in addition to its ID, is included in the export. Data from all fields, including top-level and sub-level forms, is incorporated.  

1. From the desired panel grid, click the Export icon in the toolbar, then select Open in Exporter.
   
   The Exporter module opens in a separate tab, displaying the available domains from the ODRViews Global Data Store.
   
2. By default, the Domain file naming is Do not change case of file name. Select the drop-down to update if appropriate: Change file names to uppercase, or Change file names to lowercase.
3. By default, the Available Domains is populated with the appropriate tables (top and sub levels) preselected based on where the Export icon was selected.

4. By default, the Format is Excel. Click the drop-down to select a different format: CSV, SAS, SAS XPORT, or Delimited. Options may change depending on the selection. 

   Tip: The following steps describe exporting to Excel and downloading the file. For more information on using the Exporter module, refer to the Export Data article in the Exporter section.

5. Select Add CheckSum to verify that exported data has not been altered when opened. When selected, an .md5 file is generated with the export. Be sure to save the .md5 file with the exported file. The file recipient must have the appropriate software to compare the checksum file with the exported file and prove that it has not been altered. This option is available for all export types.

   Tip: CheckSum: The outcome of running an algorithm, or a cryptographic hash function, on a piece of data, usually a single file. Comparing the checksum generated from an export with the one provided by the file's source helps to ensure that the copy of the file has not been altered. A checksum may also be referred to as a hash sum.

6. By default, the Output Type is Workbook Per Domain (the zip file includes a separate file for each domain selected). Select Sheet Per Domain for one file with individual sheets for each selected domain.
7. By default, the Field Headers displays Names. Select Labels if appropriate.
8. By default, the Export to and Extract Files checkboxes are not checked.
9. Click Export. The export is listed under Recent Exports in the lower section of the window.
10. Click the Download button to the right of export to download the file.

Access the ODR Audit Trail

The ODR Audit Trail tracks every action of inserted or altered data. Users can include or exclude archived records, filter, and sort the data in the column headers, and export the table.

1. Click the Audit Trail icon in the master header.
   
2. Select the Top-Level Form from the drop-down.
   
3. Select the Entity from the drop-down. For example, when Study is selected as the Top-Level Form, the Entity drop-down displays a list of Protocol IDs. The top-level audit trail displays based on the selected values.

Tip: To Include archived objects, first check the box, then select from the Entity drop-down. The Reason For Change is populated in the listing for archived records only.

1. Use the Audit Trail's convenient functionalities to:
   1. Sort and filter columns directly from the column headers, leveraging typical elluminate functionality.
   2. Move from one page to the next using the Previous / Next Page icons in the master header.
   3. Export the list using the Export icon in the master header.
2. To access the audit trail for a Sub Level Form for the selected Top-Level Form, select the Sub Level Form from the drop-down.
   
3. Click the Entities button. The Sub Level Form audit trail opens in a separate window.
4. Click Ok, Cancel, or the x in the top right corner to close the window.