With every release, we update the data model to better support evolving needs and new feature functionality. With this release, we’ve added the following components to the SiteVault Enterprise data model. These data model updates are automatically included in all SiteVault Enterprise Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see What’s New in 20R3.
Added the following components to support the Safety Distribution: SiteVault feature:
- Added the following fields to the Distribution Task (
distribution_task__v) object: - Action Status (
action_status__v) - Connection (
connection__v) - Error Message (
error_message__v) - Added the following multi-document workflows:
- Acknowledge Safety Distributions (
ack_safety__v) document workflow - Auto-Acknowledge Safety Distributions (
auto_ack_safety__v) document workflow
Added the following standard document types to support the Document Type Additions feature:
- Completed CRFs (
completed_crfs__v) - Invoice (
invoice__v) - Participant Adverse Event Log (
adverse_event_log__v) - Study Site Contact Info (
study_site_contact_info__v) - Equipment Log (
equipment_log__v)
Added the following components to support the Patient & Participant Data Model feature:
- Added the following objects:
- Patient (
patient__v) - Participant Visit (
participant_visit__v) - Added the following fields to the Patient (
patient__v) object: - First Name (
first_name__v) - Last Name (
last_name__v) - Middle Name (
middle_name__v) - Date of Birth (
date_of_birth__v) - Email (
email__v) - Phone Number (
phone_number__v) - Address Line 1 (
address_line_1__v) - Address Line 2 (
address_line_2__v) - City/Town (
city_town__v) - State/Province (
state_province__v) - Zip/Postal Code (
zip_postal_code__v) - Country (
country__v) - Gender (
gender__v) - Race (
race__v) - Ethnicity (
ethnicity__v) - Medical Record Number (
medical_record_number__v) - Universal Patient Number (
universal_patient_number__v) - Language (
language__v) - Locale (
locale__v) - Site (
research_site__v) - Added the following fields to the Participant Visit (
participant_visit__v) object: - Study (
study__v) - Site (
research_site__v) - Participant (
participant__v) - Planned Date (
planned_date__v) - Actual Date (
actual_date__v) - Visit Type (
visit_type__v) - Reason for Visit (
reason_for_visit__v) - Sequence (
sequence__v) - Added the following fields to the Participant (
subject__v) object: - Patient (
patient__v) - Consent Status (
consent_status__v) - MyVeeva Invitation Status (
myveeva_invitation_status__v) - Candidate Date (
candidate_date__v) - Completed Date (
completed_date__v) - Consent Failed Date (
consent_failed_date__v) - Consenting Date (
consenting_date__v) - End of Treatment Date (
end_of_treatment_date__v) - Enrolled Date (
enrolled_date__v) - In Follow-Up Date (
in_followup_date__v) - In Screening Date (
in_screening_date__v) - Lost to Follow-Up Date (
lost_to_followup_date__v) - Pre-Screening Date (
prescreening_date__v) - Pre-Screening Failed Date (
prescreening_failed_date__v) - Randomized Date (
randomized_date__v) - Reason for Screen Failure (
reason_for_screen_failure__v) - Recruitment Method (
recruitment_method__v) - Screen Failed Date (
screen_failed_date__v) - Withdrawn Date (
withdrawn_date__v) - Added the Participant Visit (
participant_visit__v) document field. - Added the following states to the Participant Lifecycle (
subject_lifecycle__v): - Candidate (
candidate_state__v) - Pre-Screening (
prescreening_state__v) - Pre-Screen Failed (
prescreen_failed_state__v) - Consenting (
consenting_state__v) - Consenting Failed (
consenting_failed_state__v) - First Visit Scheduled (
first_visit_scheduled__v) - In Screening (
in_screening_state__v) - Screen Failed (
screen_failed_state__v) - Enrolled (
enrolled_state__v) - Randomized (
randomized_state__v) - End of Treatment (
end_of_treatment_state__v) - Completed (
completed_state__v) - Lost to Follow-Up (
lost_to_followup_state__v) - Withdrawn (
withdrawn_state__v) - In Follow-Up (
in_followup_state__v) - Added the following picklists:
- Visit Type (
visit_type__v) - Race (
race__v) - Ethnicity (
ethnicity__v) - Reason for Visit (
reason_for_visit__v) - Consent Status (
consent_status__v) - Gender (
gender__v) - MyVeeva Invitation Status (
myveeva_invitiation_status__v) - Reason for Screen Failure (
reason_for_screen_failure__v) - Recruitment Method (
recruitment_method__v)
Added the following components to support the Research Organization Object feature:
- Added the Research Organization (
org__v) object - Added the Research Organization (
org_lifecycle__v) lifecycle - Added the Research Organization (
org__v) field to the Research Site (research_site__v) object