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 you wish to add or edit a record.

To create a new record in a panel, click the Create icon ( the plus sign) 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 will open a subform where you can enter details in each field. 

Note: The Schedule of Events subsection (within Studies) is a 3-part subform. You must enter the required fields in the first two subforms and click the Next button. The third form is a grid format to enter the appropriate 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 in 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. Click in 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. Click Save to save your changes, or Cancel to cancel your entry / updates.

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 have multi-select checklists to select from, e.g., the user selects which Programs that the Investigational Product is used in (0). The number in the blue badge indicates the number of selected items in the list. The count will be displayed in a panel listing. If the list is long, you may use the Search by typing in the text field. As you enter text, the list displays any names with that text. Items that are checked display at the top of the list.

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

Archive a Record

Users with the ODR Configure privilege can archive records. Archived record details are available in the Audit Log. 

1. From a panel listing, click to highlight the record you wish to archive. Or you can 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 used elsewhere in the Operational Data Repository).
   

   Note: If the record you are trying to archive is used elsewhere in the Operational Data Repository a pop-up message will display with details of where it is being used. Make note of where the record is being used, click the x in the top right corner of the pop-up to close it, and then archive the record from the other panels where it is being used. The record is not archived until you see the confirmation message stating it has been archived successfully.

3. Enter your Reason for Archiving the Record.
4. Click Save to proceed. A confirmation message displays briefly.

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 will show '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

From any panel in the left navigation, users can export data using the Exporter module. Clicking the Export icon directs the user to the Exporter module and uses the contents of the ODRViews. The export includes the return of lookups to associated tables so that the export includes the name of the related item in addition to the ID. Data from all fields, top-level forms, and sub-level forms, are included.

1. From the panel grid you wish to export, click the Export icon in the toolbar.
   
   The Exporter module opens in a separate tab displaying Global Data Stores, ODRViews.
   
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 you selected the Export icon. 
4. By default, the Format is Excel. Click the drop-down to select a different format: CSV, SAS, SAS XPORT, or Delimited. Depending on your selection, the options may change. 
   

   Tip: The next steps are for exporting to Excel and then downloading to your computer. For more details on using the Exporter module see the Export Data article in the Exporter section.

5. Select Add CheckSum when you want to ensure the data you are exporting has not been altered when opening it. When you check this, an .md5 file will be created with your export. Be sure to save the .md5 file with your exported file(s). The consumer of the file must have the appropriate software to match the checksum file to the excel file and prove that it has not been altered. This is available for any type of export.
   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 your export with the one provided by the source of the file, 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 will display Names. Select Labels if appropriate.
8. By default, the Export to and Extract Files checkboxes are not checked. 
9. Click Export. The export will be listed under Recent Exports in the lower section of the window.
10. Click the Download button at the right of export to download to your computer.

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, if Study is selected as the Top-Level Form, the Entity drop-down will include a list of Protocol IDs. The top-level audit trail displays based on your selections.

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. Within the Top-Level Form audit trail listing you can:
   1. Sort and filter columns from the column headers (using 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.