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.
Note: Veeva Support must enable OpenData Clinical in your Vault. OpenData Clinical is part of the Clinical Operations application family. You must have Veeva CTMS and/or Veeva eTMF to use OpenData Clinical. Contact your Veeva representative for more information.
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:
- In the Global Directory tab, navigate to the Organization or Personnel tab and click Create.
- Select either Institution from the Organization Type drop-down or Investigator from the Person Type drop-down and then click Continue.
- In the OpenData Clinical application section, select the Set OpenData ID link in the OpenData ID field.
- In the OpenData Sites or OpenData Investigators dialog, enter the organization’s or person’s name and select the magnifying glass to search.
- Select the record that matches the site or person you are searching for and click Confirm.
- Optional: In the new Institution or Investigator record, enter any additional information necessary in the fields OpenData Clinical does not control.
- 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.
OpenData Clinical Institution Records
OpenData Clinical manages and populates the following fields on Institution records:
- Name
- Parent Organization
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, Vault does not provide a link. Once you create a record for the organization populated in the Parent Organization field, Vault retroactively links the field to the new record.
OpenData Clinical Investigator Records
OpenData Clinical manages and populates the following fields on Investigator records:
- First Name
- Middle Name
- Last Name
- Suffix
- Office Phone
- 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.
OpenData Clinical creates a new Person Linked Contact Information record when you create a new Investigator record. On the Person Linked Contact Information record, OpenData Clinical manages the following fields:
- Address Line 1
- Address Line 2
- Town / City
- State / Province / Region
- Postal / Zip Code
- Country
- Office Phone
- Organization
You cannot edit the OpenData Clinical-managed Person Linked Contact Information record. However, you can create additional Contact Information records for contact details associated with the Investigator record.
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.
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:
- In the Global Directory tab, navigate to the Organization or Personnel tab and click Create.
- Select either Institution from the Organization Type drop-down or Investigator from the Person Type drop-down and then click Continue.
- In the OpenData Clinical application section, select the Set OpenData ID link in the OpenData ID field.
- In the OpenData Sites or OpenData Investigators dialog, enter the organization’s or person’s name and select the magnifying glass to search.
- 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.
- 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.
- Select the checkbox for the disclaimer at the bottom of the dialog.
- Click Confirm. Once you select Confirm, OpenData Clinical performs a final search for records matching the information you entered.
- 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.
- 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 a new record to the OpenData Clinical database, you must create the Institution or Investigator record in your Vault and link it to the new OpenData Clinical record.
Note: If you submit a Data Change Request to add a site or investigator record that already exists in the OpenData Clinical database, Veeva curators will reject the Data Change Request and refer you to the existing OpenData Clinical record.
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.
You can cancel a request by selecting the Cancel Request user action on the Data Change Request record when the record is in the Pending status. 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:
- Navigate to the Institution or Investigator record for which you would like to suggest changes.
- On the record, select the Data Change Request user action.
- Update the incorrect information in the Data Change Request dialog form. Vault populates the current record data into the form’s fields.
- Enter a reason for the suggested changes in the Notes/Rationale for Change text box.
- Select the checkbox for the disclaimer at the bottom of the dialog.
- 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.
You can cancel a request by selecting the Cancel Request user action on the Data Change Request record when the record is in the Pending status. This action updates the record status to Cancelled.