# Case Data Entry Overview After promoting an _Inbox Item_ to a _Case_, Vault copies all data from the source _Inbox Item_ to the appropriate fields on the _Case_ and child records. Consider the following when processing _Cases_: * If your Admin has configured your Vault to isolate blinded _Product_ information on Clinical Trial _Study Cases_, see Isolate Blinded Clinical Trial Information for additional considerations during _Case_ processing. * _Cases_ involving pregnancy, parents, and children include additional sections and fields. For more information, see Process Pregnancy Cases, Child Information & Parent Information. * When processing _Cases_ that may be reportable to the PMDA, see Complete Intake and Process Cases for the PMDA for regionally specific features in Vault. * When entering data, picklist field values are accent-sensitive. Entering a value with an accent prioritizes results with accents. Within many sections of a _Case_ record, you can select _Create_ to manually add related records. For information on specific _Case_ fields, including in sections not described on this page, see Case Field Reference. ### Prerequisites To support _Case_ processing, your Admin can enable the following: * For some [device detail fields][1] to appear for _Cases_ with _Combination Products_, see Enable Combination Products. * To enter remedial actions and malfunctions on _Cases_ with one or more device constituents, see Enable Remedial Actions and Malfunction for Combination Products. * To lock _Cases_ to prevent changes, see Enable Manual Case Locking: User Check In and Check Out. * For Vault to consider _Case Products_ with a _Drug Role_ of _Drug Not Administered_ as suspect, see Enable Extend Definition of Suspect to Drug Not Administered. * To code device-specific adverse events using the International Medical Device Regulators Forum (IMDRF) dictionary, see Enable the IMDRF Dictionary for Maintenance, Case Processing, and Submissions. * For clearer study product blinding labels, see Enable Product Masking Selection for Study Products. * To capture substance data for EMA E2B(R3) section D.8.r.EU, update the _Case Drug History Substance_ layout. ## Report Details Section {#device-details} For some device fields to appear, the _Case_ must have a _Case Product_ that is a _Combination Product_. Use the following _Report Details_ fields to specify this information about device-type _Case Products_: * _Device Report Type_ * _Device Report Type (Status)_ * _Malfunction Only_ * _Device Follow-Up Type_ * _Remedial Action_ * _Remedial Action-Other_ When you enter _Remedial Action_ and _Malfunction_ at the _Case Product_ level, Vault syncs this device-specific information to the _Case_ level. This is useful for _Cases_ that involve multiple _Combination Products_ or _Combination Products_ with multiple device constituents. ## Study Section {#study-section} When the _Report Type_ of the _Case_ is _Study_, the _Study_ section appears on the layout for entering information about the _Study_ the patient is enrolled in. If a _Study_ was selected on the initial _Inbox Item_, the _Study_ section fields are automatically populated with any available _Study_ data configured in _Business Admin_.
### Blinding Details {#blinding-details} The following _Study_ section fields describe the blinding settings active on a _Case Product_: * _Study Blinded_ * _Case Blinded_ * _Blind Protection_ * _Masking_ These values are informational and read-only. By default, these fields appear only if the _Study_ associated with the _Case_ is double-blinded. Manage Case Blinding provides information about unblinding _Cases_. ## Study Registrations Section {#study-registration-section} When the _Report Type_ of the _Case_ is _Study_, the _Study Registrations_ section appears on the layout for entering registration information about the _Study_ the patient is enrolled in. When you select a _Study_ in the _Study_ section and save the page, Vault adds each registration configured under the associated _Study_ in _Business Admin_. Vault may update or populate _Case Study Registration_ data in the following scenarios: * When you create a follow-up _Case_ from a _Case_ or non-E2B-imported _Inbox Item_, Vault populates the _Study Registrations_ section on the follow-up _Case_ with the latest registration data from the _Study_ library. * When you merge an E2B-imported _Inbox Item_ to an in-flight _Case_ or promote it to a follow-up _Case_, Vault maps the _Inbox Item_'s _Study_ registration data to the _Study Registrations_ section on the in-flight _Case_. * After automated _Case_ promotion for _Inbox Items_ imported from E2B or JSON, Vault populates the _Study Registrations_ section on the follow-up _Case_ with the _Inbox Item_ _Study_ registration data. ## Contacts Section {#case-contacts} When you promote an _Inbox Item_ to a _Case_, Vault copies the reporter and patient information to create _Case Contacts_. ### Types of Case Contacts The following list describes the types of _Case Contacts_: * **Reporter**: Captures information about the person who reported the _Case_. A _Reporter_ type of contact is created for patients or health care professionals who are also the reporter. * **Patient**: Captures information about the patient. * **Health Care Professional**: Captures information about the health care professional who treated the patient for the adverse event that resulted in hospitalization or treatment. * **Base Case Contact**: Captures information about contacts who are not reporters, patients, or health care professionals who have information relevant to the adverse event. * **Facility**: Captures information about the facility where a vaccine dosage was administered. A _Case Product Dosage_ can then reference a _Facility_ record using the _Administration Facility_ field. * From _Inbox Item_ promotion, the _Facility_ type of _Case Contacts_ are created only through the Intake Vault API from JSON files. When imported _Inbox Items_ include sender information, Vault adds those details to the _Inbound Transmission_. ### How Vault Creates and Updates Case Contacts {#case-contact-auto-creation} On each new _Case_, Vault creates a _Reporter_ type of _Case Contact_, using data from the _Inbox Item_ contact information. Vault also copies patient information to the _Reporter_ type of contact when the patient is also the reporter. If the patient was not the reporter, Vault creates a separate _Patient_ type of _Case Contact_. Vault determines whether the patient is also the reporter using the _Patient_ value specified in the _Reporter Qualification_ field on the _Inbox Item_.
#### When the Patient is the Reporter
If the _Reporter Qualification_ is _Patient_, Vault: * Considers the patient the primary reporter. * Does not create a _Patient_ type of _Case Contact_. * Populates the patient information fields on the primary _Reporter Case Contact_.
Patient Reporter * Updates the corresponding fields on the primary _Reporter Case Contact_ any time the _Patient_ name fields are updated on the _Case_. #### When the Patient is Not the Reporter If the _Reporter Qualification_ is not _Patient_, Vault: * Creates a _Patient_ type of _Case Contact_ record in addition to the _Reporter Case Contact_. * Populates the patient information fields on the _Patient Case Contact_
Patient Contact * Updates the corresponding fields on the _Patient Contact_ any time the _Patient_ name fields are updated on the _Case_. You can have only one _Patient Contact_ per _Case_. If the _Inbox Item_ did not specify these fields and they are later added to the _Case_ directly, Vault copies the patient name fields from the _Inbox Item_ to create a new _Patient Contact_. ## Products Section {#products-section} Use the _Products_ section to enter information about suspect and concomitant medications, including products suspected to have an interaction. For _Cases_ under a _Study_, this section label appears as _Products (Study)_. When you promote an _Inbox Item_ to a _Case_, Vault copies the product information to create the primary _Case Product_ record using the appropriate product type: * **Company Product** (_Drug_, _Biologic_, _Device_, _Vaccine_, or _Company Product_): If a _Product_ from the company library was selected on the source _Inbox Item_, then Vault creates the _Case Product_ of that type. * **Study Product**: If the _Inbox Item_ specified a _Study_, then Vault copies the _Study Products_ to the _Case_. * **External Product**: If the _Inbox Item_ does not link to a preconfigured _Product_, Vault adds the product details as an _External Product_. * **Combination Product**: If a _Combination Product_ was selected on the _Inbox Item_, its constituents are automatically downloaded and added as separate _Case Products_ when the _Case_ is promoted. Each constituent _Product_ inherits the _Combination Product Drug Role_.
When you add a _Product_ that is configured in the _Product_ Library, Vault populates the _Product_ details on the _Case_. For information on coding products based on the reported _Product_, see Auto-Code and Browse Products. ### About Company Products The _Company Product_ type of _Company Product_ is used when a product has multiple _Product Type_ registrations to meet agency reporting requirements. When _Company Product_ is selected, the _Transmission Product Type_ on the _Registered As_ field from the _Product Registration_ is copied to the _Product Globally Registered As_ field. Available _Transmission Product Types_ include the following: * _Drug_ * _Biologic_ * _Device_ * _Vaccine_ * _Nutritional_ * _Cosmetic_ * _OTC Drug_ * _OTC Device_ * _Combination Product_
When you create a _Company Product_ record, the sections and fields included are based on the _Product Types_ in the associated _Product Registrations_. For example, the _Device Information_ section appears only when the _Company Product_ is registered as a device in at least one jurisdiction. ### Delete a Case Product {#delete-cp} If configured by your Admin, when you delete individual _Case Products_, Vault also deletes the following related records: * _Case Product Dosage_ * _Case Product Indication_ * _Case Product Device Code_ * _Case Product Similar Incident_ * _Case Product Substance_ * _Case Assessment_ * _Case Assessment Result_ * _Case Assessment Expectedness_ * _Signal Individual Case Review_ (applies only to Safety Signal) Each _Case_ must have a primary _Case Product_. As such, you cannot delete a primary _Case Product_. If you have to delete a primary _Case Product_, you can designate a different _Case Product_ as primary using the _Rank_ field, and then delete the non-primary _Case Product_. If configured by your Admin, when you delete a _Case Product_ on a _Case_ with a _Localized Case_, Vault deletes the related _Localized Case Product_ and its related records. For Japan _Localized Cases_, Vault follows the same process as when deleting _Case Product Registrations_ and the related records.
#### Dosages Subsection {#dosages-section} Use the _Dosages_ subsection to add, edit, or delete dosage and route of administration regimens for a _Case Product_. By default, this section does not display for _Device_ type of _Case Products_ or _Study Products_ associated with a double-blinded Study. When there are no _Dosage_ records, the _Case Product Dosage_ section appears blank. To create a _Dosage_, select **Edit** on the _Case Product_ page. To create additional dosages for a _Case Product_, select the _Add Dosages_ button. After saving the page, Vault displays dosages in order of the earliest to latest _First Admin Date_. You can also copy a _Dosage_ record and any inputted data by selecting the **Copy** (Copy Button) icon. To mark a _Dosage_ record for deletion, select the **Delete** (Delete Button) icon.
### Substances Section {#substances-section} Use the _Substances_ subsection to add _Substances_ under a _Case Product_. _Substance_ records specify the active substance and strength in the product. By default, this section appears only for _External Products_ and open or single-blinded _Study Products_. ### Case Product Similar Incident Section {#cp-similar-incident} When generating reports in the EU MIR format, the _Case Product Similar Incident_ subsection captures information about similar incidents based on region and time period. Depending on your Admin's configuration, _Case Product Similar Incident_ records may be generated automatically or manually. To generate them manually, from the **All Actions** menu, select **Generate Similar Incident Records**. If no other _Case Product Similar Incident_ records exist, after running the action, Vault generates twelve records, one for each region and time period pair. After record generation, you can enter the market and similar incident data on each record. ### Registration Subsection {#registration-section} Use the _Registration_ subsection to add license and registration details for a _Case Product_. By default, this section does not appear for blinded _Study Products_. If the registration details are already configured in the _Product_ library and you select that _Product Registration_ in the _Case Product Details_ section, Vault automatically populates data in the _Registration_ section. The following related sections are available only for processing _Cases_ that may be reportable to the PMDA: * _Case Product Registrations_ * _Local Reporting Details_ * _PMDA Reportable Products_ * _Case Comments_ For information on these sections, see Complete Intake and Process Cases for the PMDA. ## Events Section {#ae-section} Use the _Events_ section to add _Case Adverse Events_ with details of each adverse event. For _Cases_ with SAEs transferred from the Safety-EDC Connection, you can run the _Add Relevant Subject Information_ action to add the applicable subject information to the _Case_. ### Delete a Case Adverse Event When you delete individual _Case Adverse Events_, Vault also deletes the following related records: * _Case Assessment_ * _Case Assessment Result_ * _Case Assessment Expectedness_ Each _Case_ must have a primary _Case Adverse Event_. As such, you cannot delete a primary _Case Adverse Event_. If you must delete a primary _Case Adverse Event_, you can designate a different _Case Adverse Event_ as primary using the _Rank_ field, and then delete the non-primary _Case Adverse Event_. If configured by your Admin, when you delete a _Case Adverse Event_ on a _Case_ with a _Localized Case_, Vault deletes the related _Localized Case Adverse Event_ and its related records.
## Diagnoses Section {#case-diagnoses} Use the _Diagnoses_ section to combine signs and symptoms that were reported into a single _Case Diagnosis_, if required. By default, the _Diagnoses_ section does not appear until the _Case_ is in the _Medical Review_ state. ## Causes of Death Section {#death-section} Use the _Causes of Death_ section to enter the details about the reported and autopsy-determined causes of death. The _Causes of Death_ section appears if at least one of the following conditions are met: * The _Date of Death_ field has a value * A _Seriousness_ field value on a _Case Adverse Event_ for the _Case_ contains _Results in Death_ ## Medical Assessments Section {#med-assessments} The _Medical Assessments_ section provides a centralized view of all assessment data for a _Case_. Use this section to review and update: * _Case Assessment_ fields: Display the assessed relationship between _Case Adverse Events_ and _Case Products_ with an eligible _Drug Role_ and assessments of Product Quality Complaints (PQCs). * _Case Assessment Result_ fields: Support entering the assessed relationship between the adverse event and product pair from individual sources. * You can enter additional comments about the assessment in the _Company Comments_ field in the _Narrative_ section. * _Case Assessment Expectedness_ fields: Display the evaluated expectedness of _Case Adverse Events_.
For more information on _Case Assessments_, _Case Assessment Results_, and _Case Assessment Expectedness_, see Generate Assessments. ## Documents Section {#documents-section} Use the _Documents_ section to add and manage documents linked to the _Case_, including the source report, narrative, attachments, literature, and other relevant documents. ### E2B Transmission Document Setup To be included in E2B transmissions, _Case_ documents must: * Be classified with the _Case › Source › Attachment_ or _Case › Source › Literature_ document type. * Include _Yes_ in the _Retransmit_ field. When sending FDA E2B(R2) or FDA FAERS E2B(R3) transmissions through an AS2 Connection for _Cases_ with over-the-counter (OTC) drugs, you can also attach OTC carton images. To include images, files must: * Be classified with the _Case › Source › Attachment_ document type. * Include _FDA Carton Attachment_ in the _Attachment Type_ field. ### Add a Case Attachment or Literature Document {#add-a-case-attachment-or-literature-document} When adding a _Case Attachment_ or _Literature Document_, classify the document type with either of the following options, as appropriate: * _Case › Source › Attachment_ * _Case › Source › Literature_ During E2B generation, included documents map to the: * C.1.6 and C.4.r sections of E2B(R3) files. * A.1.8.1-2 and A.2.2 sections of E2B(R2) files. [1]: #device-details