# 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](/en/lr/548356/) 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](/en/lr/495381/#clinops-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 name, person's name, or OpenData ID, and click **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](/en/lr/845021/#requesting-a-new-site-or-investigator) 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](/en/lr/845021/#requesting-changes-to-existing-data) 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][1]. ### OpenData Clinical Institution Records {#odc-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_](/en/lr/4345/#study_sites) 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 {#odc-investigator-records} OpenData Clinical manages and populates the following fields on _Investigator_ records: * _First Name_ * _Middle Name_ * _Last Name_ * _Suffix_ * _Email_ * _Office Phone_ * _Address_ * _Primary Country_ * _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 sometimes delivers _Investigator_ records that do not have a confirmed affiliated OpenData Clinical _Institution_. If Veeva cannot source an affiliation for an _Investigator_, OpenData Clinical delivers the _Investigator_ record without _Contact Information_ records or affiliations. You can submit a [Data Change Request](/en/lr/845021/#requesting-a-new-site-or-investigator) for the _Investigator_ to suggest the affiliated OpenData Clinical _Site_. 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. From the _Contact Information_ section, set **Is Primary** to **Yes** to display another _Contact Information_ record as the preferred affiliation in the _OpenData Clinical Details_ section for the _Investigator_ 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](/en/lr/548356/), 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 {#odc-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](/en/lr/46534/). ## Submitting Data Change Requests {#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](/en/lr/845621/), 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 {#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 name, person's name, or OpenData ID, and click **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](/en/lr/845621/). 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 {#requesting-changes-to-existing-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. [1]: #odc-prior-records