Using OpenData Clinical

OpenData Clinical allows you to create a clean and compliant directory of clinical trial sites and investigators in your Vault by linking Institution-type Organization object records and Investigator-type Person object records to OpenData Clinical records.

All OpenData Clinical records have an associated OpenData ID. OpenData IDs are different from Veeva IDs associated with Vault users. Veeva manages OpenData IDs on investigators and utilizes the same ID as the corresponding Healthcare Provider in Veeva commercial data products. This facilitates Veeva Vault connections, such as the CTMS to Medical CRM connection. In Clinical Operations, assigning the OpenData ID to a Vault record links it to the OpenData Clinical records.

Creating OpenData Clinical Organization and Person Records

When OpenData Clinical is enabled in your Vault, you cannot create Institution-type Organization or Investigator-type Person records without using the OpenData Clinical database. However, you can still create all other Organization and Person record types.

To create a new Institution or Investigator record:

1. In the Global Directory tab, navigate to the Organization or Personnel tab and click Create.
2. Select either Institution from the Organization Type drop-down or Investigator from the Person Type drop-down and then click Continue.
3. In the OpenData Clinical application section, select the Set OpenData ID link in the OpenData ID field.
4. In the OpenData Sites or OpenData Investigators dialog, enter the organization’s or person’s name and select the magnifying glass to search.
5. Select the record that matches the site or person you are searching for and click Confirm.
6. Optional: In the new Institution or Investigator record, enter any additional information necessary in the fields OpenData Clinical does not control.
7. Click Save.

Once saved, Vault creates the record in the Global Directory and links it to the OpenData Clinical record.

OpenData Clinical manages specific fields on Vault Institution and Investigator records. These fields are read-only, and users cannot edit the populated information. However, you can edit any fields or sections in the page layout that OpenData Clinical does not control. To modify OpenData Clinical-managed fields, submit a Data Change Request to suggest changes to existing OpenData Clinical records.

When creating a new Institution or Investigator record with OpenData Clinical, you can submit a new site or investigator Data Change Request if you cannot locate a record that matches your search criteria.

Vault pulls in updates from the OpenData Clinical database daily. When Veeva curators update information in the OpenData Clinical database, Vault applies those changes to the OpenData Clinical-managed fields in Vault records linked to OpenData Clinical and creates or updates read-only records to track the prior values.

OpenData Clinical Institution Records

OpenData Clinical manages and populates the following fields on Institution records:

• Name
• Parent Organization
• Available as Study Site
• Timezone

You can create Institution type Organization records for both parent organizations, such as hospitals or research networks, and sites. OpenData Clinical differentiates parent organization Institution records from site Institution records by setting the Available as Study Site field value as Yes only on site Institution records. When creating Study Site records in Vault, you can only select Organization records with a Yes value for the Available as Study Site field.

When you create a new Institution record, OpenData Clinical creates a new primary Location record. On the primary Location record, OpenData Clinical manages the following fields:

• Location Name
• Address Line 1
• Address Line 2
• Town / City
• State / Province / Region
• Postal / Zip Code
• Country

Vault displays the following fields from the primary Location record as a single Address field in the OpenData Clinical section on Institution records: Address Line 1, Address Line 2, Town / City, State / Province / Region, Postal / Zip Code, and Country. You cannot edit the OpenData Clinical-managed primary Location record. However, you can create additional Location records for addresses associated with the Institution record.

Vault links the populated Parent Organization field to the matching Institution-type Organization record if one exists in the Global Directory. If your Vault does not contain an existing Institution record for the Parent Organization, you can click Add to Vault to create a new Institution record for the parent organization. After creating the record, Vault links the Parent Organization field to the record.

OpenData Clinical Investigator Records

OpenData Clinical manages and populates the following fields on Investigator records:

• First Name
• Middle Name
• Last Name
• Suffix
• Email
• Office Phone
• Address
• All Specialty Groups
• All Specialties

Vault displays the First Name, Middle Name, Last Name, and Suffix fields as a single Name field in the OpenData Clinical section on the Investigator record.

When you create an Investigator record, OpenData Clinical creates Contact Information records for the Investigator and manages the following fields:

• Address Line 1
• Address Line 2
• Town / City
• State / Province / Region
• Postal / Zip Code
• Country
• Email
• Office Phone
• Organization

An Investigator may have multiple OpenData Clinical-managed Contact Information records if they are affiliated with multiple Organizations. You cannot edit OpenData Clinical-managed Contact Information records. However, you can create additional Contact Information records for contact details associated with the Investigator record.

OpenData Clinical uses the Person Linked Contact Information record to populate the Name, Email, Office Phone, and Address fields in the OpenData Clinical section of the Investigator record. An Investigator record can only have one Person Linked Contact Information record. Select the Change Primary Affiliation action to select another OpenData Clinical-managed Contact Information record for the Person Linked Contact Information record.

When an Email is not available for the Investigator in the OpenData Clinical database and the Investigator is not linked to a VeevaID user, you can manually enter an email address, which is then synced to the Person Linked Contact Information record. If OpenData Clinical later provides an email, it overwrites the user entry. For Investigator records linked to VeevaID users, the Email field is managed entirely by VeevaID and is not controlled by OpenData Clinical.

When OpenClinical Data controls a Contact Information record, it populates the Organization field and links to the matching Institution record if one exists in the Global Directory. If your Vault does not contain an existing Institution record for the Organization, Vault does not provide a link. Once you create a record for the organization populated in the Organization field, Vault retroactively links the field to the new record.

OpenData Clinical Prior Records

Vault pulls in updates from the OpenData Clinical database daily. For any updates to OpenData Clinical-managed fields on Investigator, Contact Information, Institution, or Location records, Vault automatically creates or updates a read-only prior record:

• Changes to Investigator records create or update a Prior Person record
• Changes to Contact Information records create or update a Prior Contact Information record
• Changes to Institution records create or update a Prior Organization record
• Changes to Location records create or update a Prior Location record

For example, the VeePharm organization has rebranded to VeePharm Health, and Veeva curators have updated the organization’s name in the OpenData Clinical database from VeePharm to VeePharm Health to reflect the name change. During Vault’s daily OpenData Clinical database updates, Vault updates the Name field on the Institution record to VeePharm Health and creates a Prior Organization record that stores the organization’s previous name of VeePharm.

You can view prior records in the Prior Details sections for updated Investigator, Contact Information, Institution, and Location records. The Last Modified Method field on Prior Person records displays OpenData Clinical if the data was modified by an OpenData Clinical data update, or displays User Sync if the data was modified by a User-Person record sync.

Submitting Data Change Requests

The OpenData Clinical-managed fields on Institution and Investigator records are read-only. If the data OpenData Clinical provides in the record is incorrect, or if you cannot locate a record that matches the organization or person you are searching for, you can submit a Data Change Request.

When you submit a new Data Change Request, OpenData Clinical sends it to the Veeva curators for review, and Vault creates a Data Change Request record. Vault notifies you once a curator reviews your request. If the curators approve your Data Change Request, Vault updates the changed fields the next time it pulls in the updated OpenData Clinical database.

If configured, you can view Data Change Request records in the Data Change Request section of the related Institution or Investigator record or the Data Change Requests tab.

Requesting a New Site or Investigator

When you cannot locate a record that matches the organization or person you are searching for, you can submit a Data Change Request to request Veeva curators add a new site or investigator to the OpenData Clinical database.

To create a Data Change Request for a new site or investigator:

1. In the Global Directory tab, navigate to the Organization or Personnel tab and click Create.
2. Select either Institution from the Organization Type drop-down or Investigator from the Person Type drop-down and then click Continue.
3. In the OpenData Clinical application section, select the Set OpenData ID link in the OpenData ID field.
4. In the OpenData Sites or OpenData Investigators dialog, enter the organization’s or person’s name and select the magnifying glass to search.
5. If you cannot find a record that matches the organization or person you are searching for, select the Request New Site or Request New Investigator tab.
6. In the Request New Site or Request New Investigator tab, enter the information for the organization or person you want Veeva curators to add to the OpenData Clinical database.
7. Select the checkbox for the disclaimer at the bottom of the dialog.
8. Click Confirm. Once you select Confirm, OpenData Clinical performs a final search for records matching the information you entered.
9. OpenClinical Data suggests additional records that might match your search. If a suggested record matches your search, select the record. If none of the records match the organization or person you are searching for, select the Add new site or Add new investigator.
10. Click Confirm.

Once you submit the Data Change Request, Vault displays a dialog box confirming your submission. OpenData Clinical sends all Data Change Requests to the Veeva curators for review. When curators add the new record to the OpenData Clinical database and resolve your Data Change Request, select the Create Missing Record action on the Data Change Request record to create the new OpenData Clinical Institution or Investigator record in your Vault.

You can view Data Change Request records for new sites or investigators in the Data Change Requests tab if configured. These records display the information provided in the Data Change Request submission, as well as the Status and Resolution of the Data Change Request.

Select the Cancel Request user action on the Data Change Request record while the record is in the Pending state to cancel the request. This action updates the record status to Cancelled.

Requesting Changes to Existing Site or Investigator Data

If the information OpenData Clinical populates into your Vault Institution or Investigator record is incorrect, you can submit a Data Change Request to suggest updates to the existing data.

To create a Data Change Request for existing data:

1. Navigate to the Institution or Investigator record for which you would like to suggest changes.
2. On the record, select the Data Change Request user action.
3. Update the incorrect information in the Data Change Request dialog form. Vault populates the current record data into the form’s fields.
4. Enter a reason for the suggested changes in the Notes/Rationale for Change text box.
5. Select the checkbox for the disclaimer at the bottom of the dialog.
6. Click Review.

Once you submit the Data Change Request, Vault displays a dialog box confirming your submission. OpenData Clinical sends all Data Change Requests to Veeva curators for review.

On Institution and Investigator records, a highlighter icon appears next to OpenData Clinical-managed fields with pending Data Change Requests. The highlighter icon disappears once the Veeva curators review and resolve the Data Change Request. An existing record can only have one active Data Change Request at any given time.

Vault generates a new Data Change Request record for each Data Change Request submission. Vault Data Change Request records for changes to existing OpenData Clinical records display a Data Change Request Line record for each field changed in the Data Change Request submission. The Data Change Request Line records provide the Old Value, New Value, and Confirmed Value for each field a user modifies in the Data Change Request submission.

Select the Cancel Request user action on the Data Change Request record while the record is in the Pending state to cancel the request. This action updates the record status to Cancelled.

Using Excluded OpenData Clinical Records

In some cases, specific sites or investigators may be excluded from the OpenData Clinical data set. This data could be excluded by Investigator opt-out or removed when sites go out of business or investigators retire. However, you may still require the use of these records in your Vault.

When Veeva curators remove data linked to existing Institution and Investigator records, Vault updates the existing record. The system sets the Excluded from OpenData field to True and populates the Exclusion Reason field. Unlike the other OpenData Clinical-managed records, you can edit and update all the fields in these independent records apart from the OpenData Clinical-populated, read-only Excluded from OpenData and Exclusion Reason fields.

Creating a Missing Record from a Resolved Data Change Request

After Veeva curators have resolved a Data Change Request due to the record being removed or excluded from OpenData Clinical, you may still need a local record for the excluded Institution or Investigator. You can create this record directly from the rejected Data Change Request.

The option to create a missing record from a resolved Data Change Request for an Investigator or Institution is only available if all of the following conditions are true:

• Data Change Request Type is New Record
• Data Change Request Status is Resolved
• Result is Change Rejected, Out of Scope
• Investigator only: Person is blank
• Institution only: Organization is blank

In order to create the missing record, on the Data Change Request record details page, select All Actions > Create Missing Record. This opens a record creation dialog with fields automatically populated based on the values in the Data Change Request and any Data Change Request Items. Once created, you can edit fields in the newly created record as with other excluded records.