# About the Safety-EDC Connection Using the Safety-EDC Connection, organizations with both a Safety Vault and a Clinical Data EDC Vault can exchange data about serious adverse events (SAEs) discovered by study sites from your EDC Vault to your Safety Vault for Case processing, helping you to avoid delays and compliance issues. Site Investigators can enter and update _Safety Case Initiation Event_ forms in your EDC Vault and Vault automatically transfers the SAE data, along with the applicable subject and _Case_ information, to your Safety Vault. Case Processors and Medical Reviewers can then triage, review, and process the _Case_ according to the submission requirements of the relevant regional health authorities for a particular study. This allows your organization to minimize the risk of data entry mistakes and respond to SAEs in the designated time period, avoiding delays and compliance problems. When a site user creates an SAE in their EDC Vault, Vault generates an initial _Inbox Item_ in the Safety Vault in the _New_ lifecycle state. You can review the new _Inbox Item_ and promote it to an Initial _Case_ or Follow-up _Case_, when applicable. If your Admin has configured automated _Case_ promotion and a site user later updates that SAE in their EDC Vault, Vault generates a new _Inbox Item_ in the _Marked as Follow-up_ lifecycle state in the Safety Vault and links it to the appropriate _Case_, which you can review and optionally merge into the existing _Case_. For _Cases_ created or updated based on SAE data from the connection, you can [review and adjust][3] all relevant subject information. For more information, see Managing Safety Integrations in Veeva Clinical Data Help.
## How the Safety-EDC Connection Works The Safety-EDC Connection creates new records and updates existing records across Vaults in the following situations: * When an EDC user creates or updates SAE subject data, Vault creates or updates the corresponding _Inbox Item_, _Case_, and [EDC subject information records][2] in the Safety Vault based on Admin-defined field mapping. When an EDC user creates or updates SAE case data, Vault creates an _Inbox Item_ in the Safety Vault. If a _Case_ does not yet exist in the Safety Vault, the _Inbox Item_ is created in _New_ state, which you can review and promote as appropriate. When applicable, Vault [promotes the _Inbox Item_ or marks it for follow-up][4]. For _Inbox Items_ generated by the connection: * When the SAE is for a [child subject][9], the _Inbox Item_ includes parent information. The connection also generates an _Inbox Item_ when parent information changes in EDC. * When configured by your Admin, Vault [assigns a _Significance_ value][5], allowing you to prioritize follow-up _Cases_ for processing. You can recalculate _Significance_ when necessary. * When an EDC user clears the SAE by clicking the _Mark as Blank_ button, the generated _Inbox Item_ has an _EDC Reason_ value of _Form cleared by the EDC user, representing a void or nullification scenario_. If a relevant _Case_ exists, it updates to _Marked as Follow-up_ state. * When an EDC user downgrades an adverse event from serious to not serious, the change is reflected on the _Inbox Item to Case Compare_ page, and the _Case_ updates to _Marked as Follow-up_ state. * For any _Inbox Items_ in _New_ state for which the connection generates a follow-up _Inbox Item_ for the same _Case_ (indicated by matching _Link_ values), Vault moves the previous _Inbox Item_ to _Superseded_, making it safe to ignore. * Vault links the _Superseded_ records to the new _Inbox Item_. * Vault populates the _New Info Date_ on the new _Inbox Item_ with the value from the oldest existing record, supporting accurate due date calculation. You can review the original date in the _Source Data_ pane of the new record. * When a Safety user updates [subject-related information][3], Vault tracks those changes so that future updates from EDC consider those [Safety decisions][6]. * When an EDC user deletes subject data related to an SAE, Vault marks the corresponding [EDC subject information records][2] in the Safety Vault as deleted and creates an _Inbox Item_ for each nullified _Case_ associated with the deleted subject. The _EDC Reason_ value on these _Inbox Items_ is _Subject Deleted on Vault EDC_. Vault does not delete the associated _Inbox Item_ or _Case_ when deleting subject information records. * Any EDC Local Lab results integrated into the EDC subject casebook in the EDC Vault transfer to the _Inbox Item_ and corresponding lab section in the _Case_ in your Safety Vault. You can also review the data on the _Test Results_ tab of the [_Add Relevant Subject Information_ dialog][3]. When an EDC user populates any _Analyte_ value for a specific lab panel, all available _Analytes_ for the panel display in your Safety Vault, including any _Analytes_ without values. In Safety Vaults, you cannot run the following actions on _Inbox Items_ generated by the connection: * _Promote to Multiple Cases_ * _New Case - Copy Patient Info_ ### Automated Classification of Inbox Item Significance {#significance} Vault may assign a _Significance_ value to _Inbox Items_ generated by the connection based on your Admin's configuration, allowing you to prioritize follow-up _Cases_ for processing by referencing the following assigned values: * _Initial Case_ * _Non-Significant Follow-Up_ * _Significant Follow-Up_ * _Urgent Significant Follow-Up_ This determination is typically based on updates to the seriousness, expectedness, or relatedness details. For _Inbox Items_ related to existing _Cases_, you can review changes on the _Inbox Item to Case Compare_ page. You can review which _Significance Criteria_ Vault evaluated to determine _Significance_ in the _Significance Results_ section of an _Inbox Item_. Vault recalculates _Significance_ every time it detects an associated follow-up _Inbox Item_. You can also [manually recalculate _Significance_][7]. #### Recalculate Significance Criteria {#rerun} If you make changes that may impact seriousness, expectedness, or relatedness, you can recalculate the significance by running the **Rerun Significance Criteria** action from the **All Actions** menu of an _Inbox Item_ in _Marked as Follow-up_ state. ### Promotion & Follow-Up {#promote-follow-up} You can review generated _Inbox Items_ in your Safety Vault and promote them to initial or follow-up _Cases_, or merge to in-flight _Cases_ as appropriate. Vault does not assign incoming primary adverse events a _Rank_ value when promoting _Inbox Items_ generated by the connection to follow-up or merging them to in-flight _Cases_. Vault promotes _Inbox Items_ to initial or follow-up _Cases_ depending on if your Admin has configured Automated Case Promotion. When configured, Vault promotes the _Inbox Item_ to _Case_ based on the Automated Case Promotion process. Otherwise, Vault moves the _Inbox Item_ to the _Marked as Follow-up_ state and links it to the _Case_, so long as the matching initial _Case_ is not in an Admin-defined prohibited state. #### Follow-Up Cases {#follow-up} When marking an _Inbox Item_ for follow-up, Vault checks for any previously marked _Inbox Items_ that are related to the same initial _Case_ and updates them to _Marked as Follow-up (not current)_ state with a link to the newer _Inbox Item_, allowing you to prioritize the most up-to-date _Inbox Item_ for promotion. Vault makes the following updates based on the _New Info Date_ values of the existing related _Cases_: * The most recently created _Inbox Item_ moves to the _Marked as Follow-up_ state with a _New Info Date_ value based on the oldest related _Marked as Follow-up (Not Current)_ record. You can review the original date below the populated field value and in the _Source Data_ pane of the record. * All other applicable _Inbox Items_ move to the _Marked as Follow-up (Not Current)_ state. When you manually promote an _Inbox Item_ to a follow-up _Case_ (using the _Create Follow-Up_ action or the manual merge method), all other _Inbox Items_ related to the same initial _Case_ move to the _Superseded_ state. #### Pregnancy Cases, Child & Parent Information {#pregnancy-cases} Upon promotion of _Inbox Items_ generated from EDC _Casebooks_ for pregnant and child subject SAEs, including cases with birth outcomes, Vault creates and updates the applicable _Pregnancy Cases_, _Child Information_, and _Parent Information_ for processing in Safety. Vault does the following: * Maps the parent's subject information to the child's _Case_ and links the _Cases_. * When multiple _Cases_ exist for the parent, links the child's _Case_ to the parent's most-recent pregnancy _Case_. * If no pregnancy _Case_ exists, links the child's _Case_ to the parent's most-recent _Case_. * Links the _Cases_ so that any new versions retain links to the applicable first version, even if a more-recent follow-up version exists in either Vault. * Generates an _Inbox Item_ to promote to a _Case_ each time parent information is updated in EDC. For _Inbox Items_ generated for child information-related updates in EDC, Vault maps source data that may not appear on the _Inbox Item to Case Compare_ page but does appear on the _Case_ upon merge or promotion. Once a day, Safety Vault checks for any parent _Cases_ that are not already linked to child _Cases_ and, when applicable, links those _Cases_. Vault also checks for any changes made to parent subject information and, when applicable, updates the parent's _Case_.
## About Record Creation & Updates {#records} When creating a record through the connection, Vault populates certain standard fields based on your Admin's mapping. Vault also populates the _Link_ (`link__sys`) field on the target record with the source record's _Global ID_ (`global_id__sys`), which lets Vault know which records to update in the target Vault when data is updated in the source Vault. When Vault creates a _Case_ in your Safety Vault through the connection, Vault populates fields on the source _Safety Case_ to reference the name and ID of the target record. Vault populates the _Study_ and _Study Product_ fields on generated _Inbox Items_ if there are [matching records](/en/lr/679352/#study-and-study-product-matching) in your Safety Vault. If no matches are found, the _Inbox Item_ will be in _Missing Information_ state. You can then manually populate the blank fields. Vault creates all new records in their lifecycles' initial states except generated _Inbox Items_, which may be in _Missing Information_ state if required fields are blank. ### EDC Subject Information Records {#cdms-subject-records} Vault transfers clinical subject data from an EDC Vault to subject information records in your Safety Vault, which includes a parent _CDMS Subject Information_ record and the following child records: * _CDMS Subject Adverse Event_ * _CDMS Subject Case Product_ * _CDMS Subject Case Product Dosage_ * _CDMS Subject Case Product Indication_ * _CDMS Subject Cause of Death_ * _CDMS Subject Drug History_ * _CDMS Subject Event Product Assessment_ * _CDMS Subject Height History_ * _CDMS Subject Last Menstruations_ * _CDMS Subject Links_ * _CDMS Subject Medical History_ * _CDMS Subject Pregnancy Child_ * _CDMS Subject Pregnancy Information_ * _CDMS Subject Test Results_ * _CDMS Subject Weight History_ ## Reviewing & Adding Relevant Subject Information {#reviewing-adding-subject-information} For SAEs transferred from an EDC Vault, you can run the _Add Relevant Subject Information_ action on the applicable _Case_ to review all relevant subject data, including medical and drug history, test results, and adverse events. You can then select which relevant subject data you want to add to the _Case_.
To add data based on subject information received from your EDC Vault and automatically create and relate the applicable records: 1. Navigate to the applicable _Case_. 2. From the **All Actions** menu, select **Add Relevant Subject Information**. 3. In the _Add Relevant Subject Information_ dialog, select the applicable items you want to add to the _Case_. * Optional: Use the search bar and filters to help find the items you want to add. Search results are case-sensitive. Any column that references a [raw object](/en/lr/15298/#object-data-store-options) will sort all values starting with capital letters before all values starting with lowercase letters. * Optional: Click the **Actions** menu and select **Edit Columns** to select which columns to display in the dialog. * Click the tabs to navigate between the options: * **Medical History** * **Drug History** * **Test Results** * **Products**: You cannot remove the study's _Products_ in this dialog. * **Adverse Events**: You can only add _Adverse Events_ not already linked to another SAE. 4. When you've made your selections, click **Confirm**. Vault adds the applicable records to the appropriate sections in the _Case_ based on the items you selected in the dialog. When you add a product, Vault includes any associated dosage and study or concomitant indication details. add-relevant-subject-information-dialog
### Reviewing Subject Information {#reviewing-subject-information} When configured by your Admin, you can review subject-specific information on a _CDMS Subject Information_ record's details page using the following [layouts](/en/lr/44069/#object-record-layouts) on any record generated after running the _Add Relevant Subject Information_ action on a _Case_: * **Triage**: Overview of all pending _Inbox Items_ and any additional _Cases_ for the subject. * **Subject Information**: Comprehensive view of the subject, allowing you to identify and review any unexpected data. ## Safety Decisions {#decisions} When a Safety user [adds subject information][3] or removes subject-related information (_Medical History_, _Drug History_, _Test Results_, _Products_, and _Adverse Events_) from a _Case_ promoted from an _Inbox Item_ generated by the connection, Vault tracks those changes so that future updates from EDC consider those Safety decisions. This allows Vault to generate appropriate follow-ups for the most applicable _Case_, ensuring Safety teams are notified of any developments for ongoing evaluation and regulatory compliance. Vault does not assign incoming primary adverse events a _Rank_ value when promoting _Inbox Items_ generated by the connection to follow-up or merging them to in-flight _Cases_. Vault generates _Inbox Items_ for follow-up for the most recent _Case_, providing it is not in a voided state, with the following exceptions: * When multiple _Cases_ have the same _Case Number_, Vault generates an _Inbox Item_ only for the most recent _Case Version_. * When a _Case_ splits into multiple _Cases_: * If the [_Link_][8] value is the same, Vault generates an _Inbox Item_ only for the _Case_ with the highest _Case Number_. * If the primary _Case Adverse Event_ is the same on both _Cases_, Vault generates an _Inbox Item_ only for the _Case_ with the highest _Case Number_. In this scenario, we recommend adding relevant subject information from the lowest _Case Number_ to the other _Case_. * If either of the primary _Case Adverse Events_ was manually added by a user, Vault ignores the associated _Case_. * When users in EDC and Safety update subject information on different _Cases_ linked to the same study subject in EDC, all updated _Cases_ updated in EDC result in follow-ups in the Safety Vault. If users make the same change in both Vaults, the connection generates an _Inbox Item_ so users can review and determine next steps. When an EDC user changes subject information previously-related to the _Case_ or changes previously captured in another _Inbox Item_ for the same _Case_, Vault may generate an empty _Inbox Item_ for review. [2]: #cdms-subject-records [3]: #reviewing-adding-subject-information [4]: #promote-follow-up [5]: #significance [6]: #decisions [7]: #rerun [8]: #records [9]: #pregnancy-cases