20R1.4 Data Model Changes

As part of the 20R1.4 release, we’ve made the following changes to standard configuration in all CDMS vaults:

In Support of New Features

Override the Review Plan for a Form Using Rules:

• Added the Override Review Plan (override_review_plan__v) value to the Rule Action Type (rule_action_type__v) picklist
• Added the Review Plan Private Key (review_plan_private_key__v) field to the Rule Action (rule_action__v) object
• Added the Review Plan Private Key (review_plan_private_key__v) and Form (form__v) fields to the Rule Result (rule_result__v) object

New System Tools Area & Enhancements to Vault-level Deployments:

• Added the System Tools Tab (system_tools_tab__v) field to the Application Role Function (application_role_function__v) object
• Removed the Role Management Tab (role_management_tab__v) field from the Application Role Function (application_role_function__v) object
• Removed the Study (study__v) field from the Deployment Whitelist (deployment_whitelist__v) object

Study Closeout PDFs:

• Added the Site Closeout Status (site_closeout_status__v), Site Closeout Action (site_closeout_action__v), and Signature Type (signature_type__v) picklists
• Added the Site Closeout (site_closeout__v), Site Closeout Generation (site_closeout_generation__v), and _Site Closeout Activity (site_closeout_activity__v) objects
• Added the Type (type__v) field to the Signature Definition (signature_definition__v) object
• Removed the Subject (subject__v) field from the Signature Binding (signature_binding__v) object
• Added the Site Closeout Generation (site_closeout_generation__v) field to the Signature State (signature_state__v) object
• Added the following fields to the Application Role Function (application_role_function__v) object:
  • Generate Closeout PDF (generate_closeout_pdf__v)
  • Notify Sites of Closeout PDF (notify_sites_of_closeout_pdf__v)
  • Review Closeout PDF (review_closeout_pdf__v)
  • Accept Closeout PDF (accept_closeout_pdf__v)

Enhancements to Event Date Queries:

• Added the Out of Window (out_of_window__v) field to the Rule Definition (rule definition__v) object
• Added the Out of Window (out_of_window__v) field to the Study Configuration (study_config__v) object

Template Vaults:

• Added the Vault Type (vault_type__v) picklist
• Added the Vault Type (vault_type__v) field to the Study Vault (study_vault__v) object

Freeze/Sign/Lock Propagation Changes:

• Added the Signature State (signature_state__v) object
• Added Signature State (signature_state__v) field on the Signature Binding (signature_binding__v) object
• Added the following fields to the Study Configuration (study_config__v) object:
  • Dynamic Status Calculation (dynamic_status_calculation__v)
  • Item Value Modified Date Blank on Create (item_value_modified_date_blank_on_create__v)
  • Signature State Version (signature_state_version__v)
• Added the Casebook Operational Summary (casebook_operational_summary__v) object
• Added the following fields ot the Event Operational Summary (event_operational_summary__v) object:
  • Event Group (event_group__v)
  • Event Signed (event_signed__v)
  • Event Signed Date (event_signed_date__v)
  • Event Frozen (event_frozen__v)
  • Event Frozen Date (event_frozen_date__v)
  • Event Locked (event_locked__v)
  • Event Locked Date (event_locked_date__v)
• Added the following fields to the Form Operational Summary (form_operational_summary__v) object:
  • Subject (subject__v)
  • Event Group (event_group__v)
  • Form Definition (form_definition__v)
  • Form Signed (form_signed__v)
  • Form Signed Date (form_signed_date__v)
  • Form Frozen (form_frozen__v)
  • Form Frozen Date (form_frozen_date__v)
  • Form Locked (form_locked__v)
  • Form Locked Date (form_locked_date__v)

Casebook Variables for Rules:

• Added the Casebook Variable Definition (casebook_variable_def__v) object

Change Reasons for Event Reset:

• Added the Reset (reset__v) value to the Change Reason Subtype (change_reason_subtype__v) picklist

Data-driven Review Plans:

• Added SDV Review Plan (sdv_plan__v) and DMR Review Plan (dmr_plan__v) fields to the Form Operational Summary (form_summary__v) object

Restricted Data:

• Added the Restricted Data Access (restricted_data_access__v) field to the Application Role Function (application_role_function__v) object
• Added the Marked for Removal (marked_for_removal__v) field to the Event (event__v) and Form (form__v) objects
• Added the Restricted (restricted__v) field to the Subject (subject__v), Casebook (casebook__v), Event Group (event_group__v), Event (event__v), Form (form__v), Item Group (item_group__v) and Item (item__v) objects

Reconstitute

In Support of Future Enhancements

New objects:

• Randomization Action History (rand_action_history__v)
• Randomization Config - Email Group (rand_config_email_group__v)
• Randomization Config Related Data (rand_config_related_data__v)
• Randomization Configuration (rand_config__v)
• Randomization Enrollment (rand_enrollment__v)
• Randomization List Item (rand_list_item__v)
• Randomization Related Data (rand_related_data__v)
• Randomization Strata Group Definition (rand_strata_group_def__v)
• Randomization Strata Vars Definition (rand_strata_vars_def__v)
• Randomization Treatment Assignment (rand_treatment_assign__v)
• Randomization Treatment Definition(rand_treatment_def__v)
• Randomization Upload History (rand_upload_history__v)

New fields on existing objects:

• Added Enable Randomization (enable_randomization__v) on Study Configuration (study_config__v)
• Added the following fields to Application Role Function (application_role_function__v):
  • Configure Randomization (configure_randomization__v)
  • Manage Randomization List (manage_randomization_list__v)
  • Randomization List Actions (randomization_lista_actions__v)
  • Randomization Tab (randomization_tab__v)
  • Randomize Subject (randomize_subject__v)
  • Unrestrict Randomization Data (unrestrict_randomization_data__v)
  • View Randomization Enrollment (view_randomization_enrollment__v)
  • View Randomization Kit/Device (view_randomization_kit_device__v)
  • View Restricted Randomization Enrollment (view_restricted_randomization_enrollment__v)

New picklists and picklist values:

• Added the following picklists:
  • Randomization Action Type (rand_type__v)
  • Randomization Enrollment Status (rand_enrollment_status__v)
  • Randomization File Action Type (rand_file_action_type__v)
  • Randomization ID Type (rand_id_type__v)
  • Randomization Level (rand_level__v)
  • Randomization Related Data Input Method (rand_related_data_input_method__v)
  • Randomization Status (rand_status__v)
  • Randomization Type (rand_type__v)