Configuring the Vault Safety EDC Connection Connection

The Vault Safety EDC Connection is an integration between your CDMS vault and your Safety vault. Vault transfers data between CDMS and Safety with the Vault Safety EDC Connector. This integration automates the reporting of all serious adverse events (SAEs) and related information for hte safety case to the safety system.

Any time a site completes or updates the SAE form, or any related forms, CDMS automatically generates a first-send or follow-up and sends it to Vault Safety. Study designers can define item mappings, case duration rules, and linking by the site to determine which subject data is included in the safety case. The integration and message statuses can be tracked in the Safety Cases Report.

The integration also supports the automated nulliofication of a safety case due to a change to non-serious or a form reset.

Vault Safety sends back case decisions and status updates to CDMS.

Create the Connection

Once this feature is enabled in your vault, you can begin configuration. First, you must connect your CDMS and Safety vaults.

1. Navigate to Tools > System Tools > Connections > Safety.
2. Click + New Connection.
3. Enter a Name for the Connection.
4. Select Active for Status.
5. Select Vault Safety for Type.
6. Enter a comma-separated list of email addresses for Notification Emails. These are the users that will receive email notifications related to the connection’s status.
7. Select Vault Safety-EDC Connection for Vault Safety Inbox Type.
8. Click Save.

Notification Emails

You can set your configuration so that up to five (5) users receive notifications when the following events occur:

• Transmission of a Safety Case or Safety Message fails via the Safety to CDMS Connector or via the AS2 Gateway to a third party safety system
• Safety to CDMS or AS2 Gateway connection becomes inactive
• Gateway Profile becomes inactive
• AS2 Gateway Encryption Certificate expires:
  • 3 months before expiration
  • 1 month before expiration
  • Day of expiration

Scan Vault Safety

You can run a job from the Connections page that scans Vault Safety for its design elements relative to CDMS-to-Safety transfers over the connnector (non E2B).

To run a scan:

1. Navigate to your Connection.
2. Hover over the connection’s Name to show the Scan button.

3. Click Scan.

4. In the Scan Vault Safety dialog, click Run Job.

Set Safety Integrations Type

Next, you must set your study’s Safety Integration Type to Vault Safety-EDC Connection.

To set the integration type:

1. Navigate to Studio > Study Settings for your Study.
2. Click Edit.

3. For Safety Integrations Type, select Vault Safety-EDC Connection.

4. Click Save.

Safety Integration Setup

Now that you’ve enabled the feature for your Study, you can perform integration setup from Tools > Safety Integrations.

1. Navigate to Tools > Safety Integrations.
2. Select your Study.
3. In Safety Settings, click Edit.
4. Select your Connection for Safety System Connection Profile.
5. Make your setup selections. The table below describes the settings available.
6. Click Save.

Setting	Description
Safety System Connection Profile	Select the Connection you created in System Tools that connects your CDMS vault to the safety system.
Study Transmission Status	Set this to Active to indicate that your study is ready to transmit data to Safety. Otherwise, leave this set to Inactive.
Alerting on Unsubmitted Forms	Select Yes to activate a job that will alert selected users about unsubmitted SAE forms. This option sends an alert when a site user creates a new SAE form, enters data to mark it as Serious, and doesn’t submit the Form. This option also sends an alert if the user submits the Form but doesn’t enter a value for the mapped AE term item. These scenarios prevent the initial sending of safety data. The reporting deadline will also be set when seriousness is set to Yes. You can choose alert recipients from Tools > Safety Integrations. From Safety Integrations, you can choose a specific list of users or email groups and limit recipients by country. Vault sends a notification to the selected users and to the site user one hour after form creation.
Acknowledgement File Late Behavior	This setting applies when an E2B XML is sent to the safety system, but no acknowledgement file is received yet. Vault sets the message with the chosen status and text to indicate the action. An ack file can be still received later, but this action will put the case back in a status where it is eligible for additional follow-ups. You can choose to always wait for the ack file (None - Always Wait for Ack), or you can choose to accept or reject after waiting a number of days.
Data Synchronization Period (days)	Enter the number of days after the SAE End Date when new data will no longer be synchronized with Vault Safety. All data already included in the case will continue to be synchronized.

Case Settings

To set the integration type:

1. Navigate to Studio > Safety Settings for your Study.
2. Click Edit.
3. Make your changes. The table below lists the available case settings.
4. Click Save.

The following settings are available:

Setting	Description
Subject ID Location	Select the location of the Subject ID value that you want to send to the safety system
Subject ID Format	Define the format for the Subject ID. You can choose from the following: Subject Only, Site-Subject, Country ISO-Site-Subject.
Primary Source Qualification Value	Select the value for the Primary Source Qualification.
Study Drug Classify when ConMed Suspect	Select the classification for the Concomitant Medication when the site user chooses Suspect. This is for cases when a user is classifying a Concomitant Medication via an Item to Form link, and user chooses SUSPECT, then this classification is to be instead used for Study Drug classification(s) of the send/case.
Study Name Value	Optional: You can define a Study Name to send to the safety system. When left blank, Vault sends the Study Label.
Sponsor Study Number Value	Optional: You can define a Sponsor Study Number to send to the safety system. When left blank, Vault sends the Study Label.
Study Type	Select the Study Type of the Reaction (C.5.4). Select from “Clinical trials”, “Individual patient use” or “Other studies”.
Reporter	Select, Full Site Information, Principal Investigator, or None. If you choose Principal Investigator, Vault uses the Principal Investigator assigned to the Site. This is the value for the Reporter field on the Safety Case.
NullFlavor for Coding	Select how to handle null values for coding: “None”, “10067482”, or “99999999”. If you choose “None”, Vault won’t include the E2Bs below in the Safety Case. If you choose “99999999” or “10067482”, CDMS sends that as the value for the E2Bs below. Coding E2Bs: SAE - E.i.2.1b: Reaction / Event (MedDRA code) AE - E.i.2.1b: Reaction / Event (MedDRA code) MH - D.7.1.r.1b: Medical History (disease / surgical procedure / etc.) (MedDRA code)
Mute Coding Follow-ups	When set to Yes, this setting stops Vault from sending follow-ups when the only change is the coding of the AE term (coded, uncoded, or a change to the dictionary version). When set to No, Vault sends follow-ups for all changes, including coding. If your study primarily performs coding in the safety system, Vault recommends setting this option to Yes to prevent unnecessary follow-ups to the safety system.
Datetime Value Behavior	When configuring safety data against datetime fields on an EDC form, this option indicates which value to send. You can choose from Use Screen / Entered Value to use the value as entered by the site, or you can choose Use Normalized (UTC) Value to use the datetime normalized to UTC using the site time zone relative to the screen value.
Auto Set Medically Confirmed	This setting determines the inclusion of “Medical Confirmation by Healthcare Professionals” (E.i.8) in the safety case. Select Yes to include.

Configure Forms for Send to Safety

You must create a Form Configuration for your Serious Adverse Event form and any other Form that you want to use to send data to the safety system. Create Form Configurations from Studio > Form Configurations.

For each Form Configuration, there are three steps:

1. Form Properties: Define the Form Properties, including the form type and the key item.
2. Item Configurations: Map Safety Fields to their corresponding Items.
3. Inclusion Criteria: Define the inclusion criteria Vault will use to determine the form data included in the send to the safety system.

How to Map Safety Fields

For each Form Configuration, you will map Safety Fields to their corresponding Items on the Form.

1. Proceed to the Item Configurations step of your Form Configuration.
2. For each Safety Field row, click in the Configured Item cell.
3. Select the Item you want to map to the Safety Field.
4. For your Serious Adverse Event form configuration, select Required for First Send to require a value in this item field for the first-send to occur.
5. When finished with your mappings, click Save. Then you can proceed to the Inclusion Criteria step.

Serious Adverse Events

To configure your Serious Adverse Event form:

1. Navigate to Studio > Form Configurations for your Study.
2. Click + New Form Configuration.
3. Select Serious Adverse Events for Safety Form Type.
4. Select the Form.
5. For Each Entry In, select which method to determine individual SAEs:
   • Form: Select this option to treat each instance of the Form as its own SAE
   • Repeating item group in form: Select this option to treat each instance of the repeating Item Group as its own SAE.
6. Optional: Enter a Description.
7. Select the Safety Key Item. This is typically the Item that indicates seriousness.
8. Define the Safety Key Item Value:
   • Select Specify value and enter a specific value to match on.
   • Select Any non empty value to consider any non-empty value a match.
9. Click Save and Next.
10. For each Safety Field, you must map it to a Configured Item on your Form. For reference, see the Adverse Event Safety Fields table.
11. Click Save and Next.
12. To define Inclusion Criteria, select Yes for Include Related Adverse Event Forms in Safety Case.Otherwise, leave this set to No.
13. Select your inclusion method:
    • Include Related Adverse Event Forms Linked by Site Users: Select Yes to include related Adverse Events that are linked by sit4 users in the Safety Case. Otherwise, leave this set to No.
    • Include Related Adverse Event Forms by Date Matching: Select Yes to include related Adverse Events by date matching in the Safety Case. Otherwise, leave this set to No.
14. If you selected Yes for Include Related Adverse Event Forms by Date Matching, enter your date ranges.
15. Click Save.

CDMS Form Type	Safety Field	Data Type	Inbox Item/Case Object	Inbox Item/Case Field
Serious Adverse Event	Event Reported	Text (250)	case_adverse_event__v	event_reported__v
Serious Adverse Event	Event Reported (Coding LLT)	Text (8)	case_adverse_event__v	event_meddra__v
Serious Adverse Event	Start / Onset Date	Date/Datetime	case_adverse_event__v	onset_idate__v
Serious Adverse Event	End / Resolved Date	Date	case_adverse_event__v	resolved_idate__v
Serious Adverse Event	Outcome	Mapped Value	case_adverse_event__v	outcome__v
Serious Adverse Event	Serious	Mapped Value	case_adverse_event__v	highlighted_term__v
Serious Adverse Event	Adverse Event of Special Interest	Boolean	N/A	N/A
Serious Adverse Event	Seriousness Criteria	Mapped Value	case_adverse_event__v	seriousness__v
Serious Adverse Event	CTCAE Grade	Mapped Value	case_adverse_event__v	ctcae_grade__v
Serious Adverse Event	Severity	Mapped Value	case_adverse_event__v	severity__v
Serious Adverse Event	Age at Onset	Numeric (3)	case_version__v	age_value__v (with age_calculation_status__v set to “Yes”)
Serious Adverse Event	Age at Onset Unit	Mapped Value	case_version__v	age_unit__v
Serious Adverse Event	Country Event Occurred	Text (2)	case_adverse_event__v	event_country__v
Serious Adverse Event	Symptom / Diagnosis	Mapped Value	case_adverse_event__v	symptom_diagnosis__v
Serious Adverse Event	Expedited Event	Boolean	case_adverse_event__v	expedited_flag__v
Serious Adverse Event	Healthcare Professional Confirmed	Boolean	case_adverse_event__v	hcp_confirmed
Serious Adverse Event	Hospital Admission Date	Date	case_adverse_event__v	hospital_admission_date__v
Serious Adverse Event	Hospital Discharge Date	Date	case_adverse_event__v	hospital_discharge_date__v
Serious Adverse Event	Days Hospitalized	Numeric (4)	case_adverse_event__v	days_hospitalized__v
Serious Adverse Event	Hospital Name	Text (200)	case_adverse_event__v	hospital_name__v
Serious Adverse Event	Hospital City	Text (35)	case_adverse_event__v	hospital_city__v
Serious Adverse Event	Hospital State	Text (40)	case_adverse_event__v	hospital_state__v
Serious Adverse Event	Narrative	Text (30000)	case_version__v	narrative_text__v
Serious Adverse Event	Reporter Commments	Text (20000)	case_version__v	reporters_comments__v
Serious Adverse Event	Sender Comments	Text (20000)	case_version__v	sender_comments__v
Serious Adverse Event	Nullification Reason	Text (200)	inbox_item__v	edc_reason__v (This only is avialable in the Inbox Item to indicate to the user that this is a nullification case and why. There’s no impact on Case data model.)
Serious Adverse Event	Reporter Qualification	Mapped Value	case_contact__v	qualificiation__v
Serious Adverse Event	Reported Language	Text (20)	case_adverse_event__v	event_reported_language__v
Serious Adverse Event	Reporter First Name	Text (50)	case_contact__v	firstname_value__v
Serious Adverse Event	Reporter Last Name	Text (50)	case_contact__v	lastname_value__v
Serious Adverse Event	Overall Action Taken	Mapped Value	N/A	N/A
Serious Adverse Event	Concomitant Medication Drug Role	Mapped Value	N/A	N/A
Serious Adverse Event	Action Taken with Study Product	Mapped Value	case_assessment_result__v	action_taken__v
Serious Adverse Event	Did Reaction / Event Recur when Study Drug Resumed	Mapped Value	case_assessment__v	reaction_recurrence__v
Serious Adverse Event	Method of Assessment to Study Drug	Text (60)	case_assessment_result__v	method_of_assessment__v or method_text__v
Serious Adverse Event	Result of Assessment to Study Drug	Mapped Value	case_assessment_result__v	assessment_result__v or result_text__v
Serious Adverse Event	Source of Assessment to Study Drug	Text (60)	case_assessment_result__v	source_type__v or source_text__v

Concomitant Medications

To include Concomitant Medications:

1. Navigate to Studio > Form Configurations for your Study.
2. Click + New Form Configuration.
3. Select Concomitant Medication for Safety Form Type.
4. For Each Entry In, select which method to determine individual ConMeds:
   • Form: Select this option to treat each instance of the Form as its own ConMed.
   • Repeating item group in form: Select this option to treat each instance of the repeating Item Group as its own ConMed.
5. Optional: Enter a Description.
6. Click Save and Next.
7. Select the Item for each CM Field that you include in your form. Note that the Item must have the correct data type. See the table below for a list of Items and their expected Data Type.
8. Optional: (If enabled) By Default, CDMS uses Always Interacting for G.k.1 (Study Drug Classify when ConMed Suspect) when classifying a Concomitant Medication via an Item to Form Link, in which a user chose Subject. You can choose instead to use Always Suspect.
9. Click Save and Next.
10. To include all Forms in the Safety Case, select Yes for Include All Forms in Safety Case. Otherwise, leave this set to No and define inclusion criteria.
11. Select your inclusion method:
    • Include Forms Linked by Site Users: Select Yes to include related Adverse Events that are linked by sit4 users in the Safety Case. Otherwise, leave this set to No.
    • Include Forms by Date Matching: Select Yes to include related Adverse Events by date matching in the Safety Case. Otherwise, leave this set to No.
12. If you selected Yes for Include Forms by Date Matching, enter your date ranges.
13. Click Save.

CDMS Form Type	Safety Field	Data Type	Inbox Item/Case Object	Inbox Item/Case Field
Concomitant Medication	Product / Medication Reported	Text (250)	case_product__v	product_reported__v
Concomitant Medication	Country Obtained	Text (2)	case_product__v	country_obtained__v
Concomitant Medication	Gestation Exposure Number	Numeric with Precision (3,3)	case_product__v	gestation_exposure_number__v
Concomitant Medication	Gestation Exposure Unit	Mapped Value	case_product__v	gestation_exposure_unit__v
Concomitant Medication	Device Name	Text (1000)	case_product__v	device_name_part__v
Concomitant Medication	Device Evaluated	Mapped Value	case_product__v	device_evaluated__v
Concomitant Medication	Device Usage Type	Mapped Value	case_product__v	device_usage_type__v
Concomitant Medication	Device Implanted Date	Date/Datetime	case_product__v	date_implanted_idate__v
Concomitant Medication	Device Explanted Date	Date/Datetime	case_product__v	date_explanted_idate__v
Concomitant Medication	Device Age	Numeric with Precision (5,4)	case_product__v	date_age__v
Concomitant Medication	Device Age Unit	Mapped Value	case_product__v	device_age_unit__v
Concomitant Medication	Additional Information Coded	Mapped Value	N/A	N/A
Concomitant Medication	Start Date	Date/Datetime	case_product_dosage__v	firstadmin_idate__v
Concomitant Medication	End Date	Date/Datetime	case_product_dosage__v	lastadmin_idate__v
Concomitant Medication	Duration of Dispense Value	Numeric with Precision (5,3)	case_product_dosage__v	duration_number__v
Concomitant Medication	Duration of Dispense Unit	Mapped Value	case_product_dosage__v	duration_unit__v
Concomitant Medication	Dose Value (Number)	Numeric with Precision (9,3)	case_product_dosage__v	dose_number__v
Concomitant Medication	Dose Value (Text)	Text (2000)	case_product_dosage__v	dose_text__v
Concomitant Medication	Dose Unit (Code)	Mapped Value	case_product_dosage__v	dose_unit__v
Concomitant Medication	Dose Unit (Text)	Text (50)	case_product_dosage__v	dose_unit_text__v
Concomitant Medication	Frequency Value	Numeric with Precision (4,8)	case_product_dosage__v	frequency_number__v
Concomitant Medication	Frequency Unit	Mapped Value	case_product_dosage__v	frequency_unit__v
Concomitant Medication	Route (Code)	Mapped Value	case_product_dosage__v	patient_adminroute__v
Concomitant Medication	Route (Text)	Text (60)	case_product_dosage__v	patient_adminroute_text__v
Concomitant Medication	Route Term ID	Text (50)	case_product_dosage__v	patient_adminroute_termid__v
Concomitant Medication	Route Term ID Version	Text (50)	case_product_dosage__v	patient_adminroute_termid_version__v
Concomitant Medication	Site of Dispense	Mapped Value	case_product_dosage__v	anatomical_site__v
Concomitant Medication	Batch / Lot Number	Text (35)	case_product_dosage__v	batchlot_number__v
Concomitant Medication	Dose Form (Text)	Text (50)	case_product_dosage__v	dose_form_text__v
Concomitant Medication	Dose Form Term ID	Text (50)	case_product_dosage__v	dose_form_termid__v
Concomitant Medication	Dose Form Term ID Version	Text (50)	case_product_dosage__v	dose_form_termid_version__v
Concomitant Medication	Parent Route (Text)	Text (60)	case_product_dosage__v	parent_adminroute_text__v
Concomitant Medication	Parent Route (Code)	Mapped Value	case_product_dosage__v	parent_adminroute__v
Concomitant Medication	Parent Route Term ID	Text (50)	case_product_dosage__v	parent_adminroute_termid__v
Concomitant Medication	Parent Route Term ID Version	Text (50)	case_product_dosage__v	parent_adminroute_termid_version__v

Characterization of Drug Role

If this Concomitant Medication is suspected to have caused the related Serious Adverse Event, this element captures the relationship between the ConMed and SAE. Map this element to the Item that indicates the drug role. This is typically a codelist-type Item. Then, you can translate the codelist to the appropriate coded values for the mapped field.

To use this element, your Study must have a configured Item to Form linking relationship between the appropriate Item on the Concomitant Medication form and the Serious Adverse Event form.

Medical History

To include Medical History:

1. Navigate to Studio > Form Configurations for your Study.
2. Click + New Form Configuration.
3. Select Medical History for Safety Form Type.
4. For Each Entry In, select which method to determine individual medical history events:
   • Form: Select this option to treat each instance of the Form as its own history
   • Repeating item group in form: Select this option to treat each instance of the repeating Item Group as its own history.
5. Optional: Enter a Description.
6. Click Save and Next.
7. Select the Item for each MH Field that you include in your form. Note that the Item must have the correct data type. See the table below for a list of Items and their expected Data Type.
8. Click Save and Next.
9. To include all Forms in the Safety Case, select Yes for Include All Forms in Safety Case. Otherwise, leave this set to No and define inclusion criteria.
10. Select your inclusion method:
    • Include Forms Linked by Site Users: Select Yes to include related Adverse Events that are linked by site users in the Safety Case. Otherwise, leave this set to No.
    • Include Forms by Date Matching: Select Yes to include related Adverse Events by date matching in the Safety Case. Otherwise, leave this set to No.
11. If you selected Yes for Include Forms by Date Matching, enter your date ranges.
12. Click Save.

CDMS Form Type	Safety Field	Data Type	Inbox Item/Case Object	Inbox Item/Case Field
Medical History	Medical History Reported	Text (250)	case_medical_history__v	name_reported__v
Medical History	Medical History Reported (Coding LLT)	Text (8)	case_medical_history__v	name_meddra__v
Medical History	Start Date	Date/Datetime	case_medical_history__v	startdate_idate__v
Medical History	Continuing	Boolean	case_medical_history__v	continuing_value__v
Medical History	End Date	Date/Datetime	case_medical_history__v	enddate_idate__v
Medical History	Comments	Text (2000)	case_medical_history__v	comments__v
Medical History	Family History	Boolean	case_medical_history__v	family_history__v
Medical History	Illness at Vaccination	Boolean	case_medical_history__v	illness_at_vaccination__v

Patient Characteristics

To include Patient Characteristics:

1. Navigate to Studio > Form Configurations for your Study.
2. Click + New Form Configuration.
3. Select Patient Characteristics for Safety Form Type.
4. Optional: Enter a Description.
5. Click Save and Next.
6. Select the Item for each CM Field that you include in your form. Note that the Item must have the correct data type. See the table below for a list of Items and their expected Data Type.
7. Click Save and Next.
8. For Patient Characteristics, Include All Forms in Safety Case is automatically enabled.
9. Click Save.

CDMS Form Type	Safety Field	Data Type	Inbox Item/Case Object	Inbox Item/Case Field
Patient Characteristics	Gender	Mapped Value	case_version__v	gender_value__v
Patient Characteristics	Date of Birth	Date / Numeric / Text	case_version__v	dob_idate__v
Patient Characteristics	Race	Mapped Value	case_version__v	race__v
Patient Characteristics	Ethnicity	Mapped Value	case_version__v	ethnicity__v
Patient Characteristics	Age Group	Mapped Value	case_version__v	age_group__v
Patient Characteristics	Age at SAE	Numeric (3)	case_version__v	age_value__v
Patient Characteristics	Age at SAE Unit	Mapped Value	case_version__v	age_unit__v
Patient Characteristics	Age at Vaccination	Numeric (3)	case_version__v	age_at_vaccination_number__v
Patient Characteristics	Age Unit at Vaccination	Mapped Value	case_version__v	age_at_vaccination_unit__v
Patient Characteristics	Gestation Value	Numeric (3)	case_version__v	gestation_value__v
Patient Characteristics	Gestation Unit	Mapped Value	case_version__v	gestation_unit__v
Patient Characteristics	Weight (kg)	Numeric with Precision (4,4)	case_version__v	weight_normalized__kg__v
Patient Characteristics	Height (cm)	Numeric with Precision (4,3)	case_version__v	height_normalized__cm__v
Patient Characteristics	Patient Name or Initials	Text (60)	case_version__v	patient_id_value__v
Patient Characteristics	GP Medical Record Number	Text (20)	case_version__v	mrn_gp_value__v
Patient Characteristics	Hospital Record Number	Text (20)	case_version__v	mrn_hospital_value__v
Patient Characteristics	Investigational Record Number	Text (20)	case_version__v	mrn_investigation_value__v
Patient Characteristics	Specialist Record Number	Text (20)	case_version__v	mrn_specialist__value
Patient Characteristics	Randomization Number	Text (20)	case_version__v	patient_randomization_number__v
Patient Characteristics	Last Menstrual Date	Date	case_version__v	last_menstrual_date
Patient Characteristics	Pregnancy Occurrences	Numeric (2)	case_version__v	gravida_gravidity__v
Patient Characteristics	Number Given Birth	Numeric (2)	case_version__v	para_parity__v
Patient Characteristics	Pregnant at SAE	Boolean	case_version__v	pregnancy_case__v
Patient Characteristics	Pregnant at Vaccination	Boolean	case_version__v	pregnant_at_vaccination__v
Patient Characteristics	Pregnancy Conception Date	Date	case_version__v	pregnancy_conception_date__v
Patient Characteristics	Pregnancy Due Date	Date	case_version__v	pregnancy_due_date__v
Patient Characteristics	Pregnancy Outcome	Mapped Value	case_version__v	pregnancy_outcome__v
Patient Characteristics	Delivery Method	Mapped Value	case_version__v	delivery_method__v
Patient Characteristics	Date of Pregnancy Outcome	Date	case_version__v	date_of_pregnancy_outcome__v
Patient Characteristics	Parent Subject Number	Text (128)	case_version__v	parent_subject_number__v
Patient Characteristics	General Medical History	Text (10000)	case_version__v	medical_history_text__v
Patient Characteristics	Subject had Concomitant Therapies	Boolean	N/A	N/A

In Case of Death

To include data from an In Case of Death form:

1. Navigate to Studio > Form Configurations for your Study.
2. Click + New Form Configuration.
3. Select In Case of Death for Safety Form Type.
4. Optional: Enter a Description.
5. Click Save and Next.
6. Select the Item for each Field that you include in your form. Note that the Item must have the correct data type. See the table below for a list of Items and their expected Data Type.
7. Click Save and Next.
8. For In Case of Death, Include All Forms in Safety Case is automatically enabled.
9. Click Save.

CDMS Form Type	Safety Field	Data Type	Inbox Item/Case Object	Inbox Item/Case Field
In Case of Death	Date of Death	Date	case_version__v	dod_idate__v
In Case of Death	Autopsy Result Available	Boolean	case_version__v	autopsy_value__v
In Case of Death	Reason Autopsy Result Omitted	Mapped Value	case_version__v	autopsy_reason_omitted__v
In Case of Death	Cause of Death - Type	Mapped Value	case_cause_of_death__v	type__v
In Case of Death	Cause of Death - Reported	Text (250)	case_cause_of_death__v	name_reported__v
In Case of Death	Cause of Death - Reported (Coding LLT)	Text (8)	case_cause_of_death__v	name_meddra__v

External Labs

To include data from External Labs:

1. Click Edit if you aren’t already in Edit mode.
2. Click External Labs to expand that section.
3. For Include External Labs, select Yes.
4. Select the External Labs Form.
5. Select the Item for each field that you include in your form. Note that the Item must have the correct data type. See the table below for a list of Items and their expected Data Type.
6. Click Save.

CDMS Form Type	Safety Field	Data Type	Inbox Item/Case Object	Inbox Item/Case Field
External Labs	Test Date	Date/Datetime	case_test_result__v	date_idate__v
External Labs	Test Name	Text (250)	case_test_result__v	name_reported__v
External Labs	Test Name (Coding LLT)	Text (8)	case_test_result__v	name_meddra__v
External Labs	Test Result (Numeric)	Numeric with Precision (14,3)	case_test_result__v	result_value__v
External Labs	Test Result (Code)	Mapped Value	case_test_result__v	result_code__v
External Labs	Test Unit	Mapped Value	case_test_result__v	result_unit__v
External Labs	Test Result (Text)	Text (2000)	case_test_result__v	restult_text__v
External Labs	Test Result (Qualifier)	Mapped Value	case_test_result__v	result_qualifier__v
External Labs	Test Normal Low Value	Text (50)	case_test_result__v	normal_low_value__v
External Labs	Test Normal High Value	Text (50)	case_test_result__v	normal_high_value__v
External Labs	Test Comments	Text (2000)	case_test_result__v	comments__v
External Labs	More Information Available	Boolean	case_test_result__v	more_information_available__v

Study Drug

To include data from a Study Drug form (formerly labeled Treatment):

1. Navigate to Studio > Form Configurations for your Study.
2. Click + New Form Configuration.
3. Select Study Drug for Safety Form Type.
4. For Each Entry In, select which method to determine individual study drugs:
   • Form: Select this option to treat each instance of the Form as its own study drug.
   • Repeating item group in form: Select this option to treat each instance of the repeating Item Group as its own study drug.
5. Enter the Study Drug Name.
6. Select Yes or No for Blinding.
7. Optional: You can choose to only include this form in the case when the Subject is in a certain Subject Group. Select a Group for Only Include When Subject Group Is to do so. When this field is blank, Vault includes the form for all subjects when the inclusion criteria are met.
8. Optional: Enter a Description.
9. Select the Safety Key Item. This is typically the Item indicating that the dispense was performed.
10. Define the Safety Key Item Value:
    • Select Specify value and enter a specific value to match on.
    • Select Any non empty value to consider any non-empty value a match.
11. Click Save and Next.
12. Select the Item for each Field that you include in your form. Note that the Item must have the correct data type. See the table below for a list of Items and their expected Data Type.
13. Click Save and Next.
14. To include all Forms in the Safety Case, select Yes for Include All Forms in Safety Case. Otherwise, leave this set to No and define inclusion criteria.
15. Select your inclusion method:
    • All: Include all Forms in the Safety Case.
    • Closest dispense on/before SAE start
    • Advanced date matching
16. If you selected Advanced date matching, enter your date ranges.
17. Click Save.

CDMS Form Type	Safety Field	Data Type	Inbox Item/Case Object	Inbox Item/Case Field
Study Drug	Start Date	Date/Datetime	case_product_dosage__v	firstadmin_idate__v
Study Drug	End Date	Date/Datetime	case_product_dosage__v	lastadmin_idate__v
Study Drug	Duration of Dispense Value	Numeric with Precision (5,3)	case_product_dosage__v	duration_number__v
Study Drug	Duration of Dispense Unit	Mapped Value	case_product_dosage__v	duration_unit__v
Study Drug	Dose Value (Number)	Numeric with Precision (9,3)	case_product_dosage__v	dose_number__v
Study Drug	Dose Value (Text)	Text (2000)	case_product_dosage__v	dose_text_long_text__v
Study Drug	Dose Unit (Code)	Mapped Value	case_product_dosage__v	dose_unit__v
Study Drug	Dose Unit (Text)	Text (50)	case_product_dosage__v	dose_unit_text__v
Study Drug	Frequency Value	Numeric with Precision (4,8)	case_product_dosage__v	frequency_number__v
Study Drug	Frequency Unit	Mapped Value	case_product_dosage__v	frequency_unit__v
Study Drug	Route (Code)	Mapped Value	case_product_dosage__v	patient_adminroute__v
Study Drug	Route (Text)	Text (60)	case_product_dosage__v	patient_adminroute_text__v
Study Drug	Route Term ID	Text (50)	case_product_dosage__v	patient_adminroute_termid__v
Study Drug	Route Term ID Version	Text (50)	case_product_dosage__v	patient_adminroute_termid_version__v
Study Drug	Site of Dispense	Mapped Value	case_product_dosage__v	anatomical_site__v
Study Drug	Batch / Lot Number	Text (35)	case_product_dosage__v	batchlot_number__v
Study Drug	Dose Form Term ID	Text (50)	case_product_dosage__v	dose_form_termid__v
Study Drug	Dose Form Term ID Version	Text (50)	case_product_dosage__v	dose_form_termid_version__v
Study Drug	Dose Form Text	Text (128)	case_product_dosage__v	dose_form_text__v
Study Drug	Parent Route (Text)	Text (60)	case_product_dosage__v	parent_adminroute_text__v
Study Drug	Parent Route (Code)	Mapped Value	case_product_dosage__v	parent_adminroute__v
Study Drug	Parent Route Term ID	Text (50)	case_product_dosage__v	parent_adminroute_termid__v
Study Drug	Parent Route Term ID Version	Text (50)	case_product_dosage__v	parent_adminroute_termid_version__v

Drug History

To include data from a Drug History form:

1. Navigate to Studio > Form Configurations for your Study.
2. Click + New Form Configuration.
3. Select Drug History for Safety Form Type.
4. For Each Entry In, select which method to determine individual drug histories:
   • Form: Select this option to treat each instance of the Form as its own drug history.
   • Repeating item group in form: Select this option to treat each instance of the repeating Item Group as its own drug history.
5. Optional: Enter a Description.
6. Click Save and Next.
7. Select the Item for each Field that you include in your form. Note that the Item must have the correct data type. See the table below for a list of Items and their expected Data Type.
8. Click Save and Next.
9. To include all Forms in the Safety Case, select Yes for Include All Forms in Safety Case. Otherwise, leave this set to No and define inclusion criteria.
10. Select your inclusion method:
    • All: Include all Forms in the Safety Case.
    • Closest dispense on/before SAE start
    • Advanced date matching
11. If you selected Advanced date matching, enter your date ranges.
12. Click Save.

CDMS Form Type	Safety Field	Data Type	Inbox Item/Case Object	Inbox Item/Case Field
Drug History	Drug History Reported	Text (250)	case_drug_history__v	name_reported__v
Drug History	Start Date	Date/Datetime	case_drug_history__v	startdate_idate__v
Drug History	End Date	Date/Datetime	case_drug_history__v	enddate_idate__v
Drug History	Age at Vaccination / Use	Numeric (3)	case_drug_history__v	age_at_vaccination_number__v
Drug History	Age At Vaccination / Use Unit	Mapped Value	case_drug_history__v	age_at_vaccination_unit__v
Drug History	Product Type	Mapped Value	case_drug_history__v	product_type__v
Drug History	Indication Reported	Text (250)	case_drug_history__v	indication_reported__v
Drug History	Reaction Reported	Text (250)	case_drug_history__v	reaction_reported__v

Inclusion Criteria

You can choose to include a related Form based on it’s date in relation to the SAE form.

General Notes

1. Allows site linking for inclusion. This is an option for any section except Study Drug.
2. Compare dates - SAE Start / End to the related form Start / End
3. Both date comparison and allowance of site linking can be configured within a section, i.e. any are true, the form data is included in the safety case / transfer.
4. For fields where date only field is compared to full datetime, both are considered date for the comparison purpose
5. For datetime to datetime comparison where one of the time values is set unknown, both are considered date for the comparison purpose
6. Study Drug is a special section that contains several options that are specific only to that section.
7. When a start date is not set on a related form (or the primary SAE), duration inclusion rules are ignored
8. For forms with no end date (yet, or ongoing), the end date is considered far in the future for comparison purposes of the two durations. As such, those forms are included as the conservative default.
9. For partial dates (e.g. unknown day), comparisons are done with respect to the year first, then month.
10. When a form has no end date map (common with study drug or external labs), then the end date is considered equal to the start date.

Options / Related Section Availability

X = ‘Can be used in the section’

Options	AE	CM	MH	Labs	Study Drug	Notes
All	X	X	X	X	X	Disables any other option in that section
Linked by Site User	X	X	X	X		When this option is used, Form to Form or Item to Form linking must be configured and site must perform the link
Duration overlaps any part of SAE	X	X	X	X	X	The start to end range of the related form overlaps the start to end date range of the primary SAE
Duration overlaps X days on/before SAE start	X	X	X	X	X	The start to end range of the related form overlaps the following range: SAE Start - X days → SAE Start
Duration overlaps X days on/after SAE start	X	X	X	X	X	The start to end range of the related form overlaps the following range: SAE Start → SAE Start + X days
Duration overlaps any X days on/before SAE end	X	X	X	X	X	The start to end range of the related form overlaps the following range: SAE End - X days → End Start
Duration overlaps any X days on/after SAE end	X	X	X	X	X	The start to end range of the related form overlaps the following range: SAE End → SAE End + X days
Duration ends before the SAE start	X	X	X	X	X	The end date of the related form is before the SAE start
Study drug start date prior to the SAE start					X	The start date of the study drug form is before the SAE start
Closest On Before SAE Start					X	This is a special option only for Study Drug. When set, no other option can be used. This option includes one dispense of the study drug that is closest to the SAE start (on/before)

Duration Rule Examples

Here are some common examples for use of duration rules:

Section	Intent	Configuration	Include/Exclude Examples
Adverse Events	Include any other Adverse Event, serious or not, that occurred within 2 days of the start of the serious adverse event.	Select Duration overlaps X days on/before SAE Start and enter "2" for Value. Select Duration overlaps X days on/after SAE Start and enter "2" for Value. Multiple Cases: This example creates multiple cases in the safety system with the same events. Use the safety system to mark one closed as duplicate and work with the other.	If the primary SAE form's SAE Start Date and End Date is January 15th: SAE #1, start date January 14th: Included SAE #2, start date January 17th: Included SAE #3, start date January 19th: Excluded
Concomitant Medications	Include any Concomitant Medication form that is ongoing at the SAE Start or that has ended within 3 days of the SAE Start.	Select Duration overlaps X days on/before SAE Start and enter "3" for Value. Select Duration overlaps any part of SAE	If the primary SAE form's SAE Start Date is January 15th and its SAE End Date is also January 15th: CM #1, start date January 10th, no end date (ongoing): Included CM #2, start date January 17th: Excluded CM #3, start date January 5th, end date January 13th: Included

Remove Form Configurations

You can remove a single Form Configuration or remove all Form Configurations at once to start over. If you have Safety Cases associated with a Form Configuration, Vault disables the delete option.

To remove a single Form Configuration:

1. Navigate to Studio > Form Configurations for your Study.
2. Hover over the Form Configuration Name to show the Actions menu.
3. Select Delete.
4. In the confirmation dialog, click Delete.

To remove all Form Configurations:

1. Navigate to Studio > Safety Settings for your Study.
2. From the Actions menu, select Delete All Safety Configurations.
3. In the confirmation dialog, click Delete.

Custom Safety Fields

You can configure the connection to send data to custom fields in Vault Safety, in addition to those defined by default.

You must first create the object fields in your Safety vault.

Then, you can add the field metadata to your CDMS vault. Then, you can map these fields as you do standard fields in the form configuration. Once you’ve performed these tasks, Vault CDMS sends data from these fields in the same way as standard fields.

Configuration in Vault Safety

Before you can configure your custom fields in CDMS, you must first do so in Vault Safety.

See Mapping Custom Fields in the Vault Safety documentation.

Import Custom Fields

You use Vault Loader to load these fields in bulk using a CSV file.

Prepare the CSV File

The following columns are required in the CSV file:

• name__v
• grouping_property__v
• system_field_only__v
• display_order__v
• label__v
• hover_text__v
• json_parent__v
• json_node_name__v
• field_data_type__v
• field_max_length__v
• field_max_precision__v
• common_field__v
• allow_static_value__v
• needs_value_for_related_eligible__v
• multi_picklist_destination__v
• multi_value_with_date__v
• system_managed__v
• answer_each_study_drug__v
• definition_status__v
• vocab_synch_type__v
• vocab_synch_info__v
• cross_vault_unique_id__v
• item_to_form_link_paired__v

Import Using Vault Loader

To load object records:

1. In the left panel of the Loader tab, click Load.
2. For the CSV File, click Choose and select the CSV input file.
3. In the Object Type drop-down, select the object on which to perform bulk actions.
4. In the Action Type drop-down, select Create, Update, Upsert, or Delete.
5. In the Key Field drop-down, select any unique fields from the specified object. This option is only required for the Delete, Upsert, and Update actions.
6. Optional: Select the Record Migration Mode checkbox to allow the creation or update of object records in any lifecycle state or state type. Additionally, Vault bypasses entry criteria, entry actions, validation rules, event actions and reference constraints when creating or updating records in migration mode.
7. Optional: Select the Include updated field values in the output log for verification checkbox to include supported VQL fields in the output logs. VQL query validation will impact performance.
8. Optional: Click Map Fields to access the field mapping grid. You can also load a previously saved mapping by clicking the Map Fields drop-down button and selecting Load Saved Mapping.
9. Click Start Load.

Before processing the request, Vault validates the selected CSV file. If the file is valid, Vault begins processing the request. When finished, you’ll receive a Vault notification and email with request details and CSV output files.

For additional information about Vault Loader, see Vault Loader: Create, Update & Delete Object Records in the Vault Platform help.

Scan Vault Safety for Design Elements

You can run a job from the Connections page that scans Vault Safety for its design elements relative to CDMS-to-Safety transfers over the connector (non E2B).

To run a scan:

1. Navigate to your Connection.
2. Hover over the connection’s Name to show the Scan button.
3. Click Scan.
4. In the Scan Vault Safety dialog, click Run Job.

Map Fields to their Safety Case Elements

Once you’ve imported the field information from Safety, those fields become available for mapping in Studio. This is the same process as mapping the standard fields.

See Configuring Forms for Send to Safety.

Download Specifications

You can download your safety configuration via the Study Design Specification or the All CRFs PDF export.

Deploying your Safety Configuration

Once you finish your configuration in your study’s DEV environment, you can deploy it to TST for testing, then onward into your training and production environments.

Your safety configuration, except for the Integration Setup and Connection, is automatically included in your study’s deployment package. When you deploy your study, Vault includes the current configuration in the package.

Because this configuration is managed as part of study deployments, you can only make changes in DEV type environment. To make changes, make them in the DEV environment and then deploy those changes to your other environments. This configuration is validated as part of casebook version publication. While validation is in progress, editing is disabled. A list of possible errors and warnings is available here.

Learn how to deploy a study.