19R1.4 Data Model Changes

Pre-Release Date: July 2, 2019 | Release Date: August 2, 2019

As part of the 19R1.4 release, we’ve made the following changes to standard configuration in all CDMS vaults:

Changes to Support New Features

We made the following changes to standard configuration in all CDMS vaults in support of new features with 19R1.4:

  • Added the following items as part of the Custom Role Management feature:
    • Added the Role Management Tab Access (role_management_tab_access__v) and Role Management Access (role_management_access__v) permission sets and assigned those permission sets to the Lead Data Manager (lead_data_manager__v) and User Administrator (user_administrator__v) security profiles
    • Added the standard Role Management (role_management__v) tab
    • Added the following new objects:
      • Application Role Security Profile Rel (application_role_security_profile_rel__v)
      • Function Object Lifecycle Rel (function_object_lifecycle_rel__v)
      • Function Permission Set Rel (function_permission_set_rel__v) *
  • Added the following items as part of the Site Review Plan Assignment feature:
    • Added the Review Plan Casebook (review_plan_casebook__v) object
    • Added the Subject Ordinal (subject_ordinal__v) field to the Review Plan Site (review_plan_site__v) object
    • Added the Review Plan Site (review_plan_site__v) object lifecycle
    • Added the following fields to the Study Configuration (study_config__v) object:
      • DMR Override Plan (dmr_override_plan__v)
      • DMR Review Plan (dmr_review_plan__v)
      • DMR Subject Ordinals (dmr_subject_ordinals__v)
      • SDV Override Plan (sdv_override_plan__v)
      • SDV Review Plan (sdv_review_plan__v)
      • SDV Subject Ordinals (sdv_subject_ordinals__v)
      • Review Plan Override (review_plan_override__v)
    • Added the Manage Review Plan Assignment (manage_review_plans_assignment__v) field to the Application Role Function (application_role_function__v) object

Changes to Support Future Enhancements

We made the following changes to standard configuration in all CDMS vaults in support of future enhancements:

  • Two standard Application Roles: CDMS Clinical Assessments Editor (cdms_clinical_assessments_editor__v) and CDMS Clinical Assessments Reader (cdms_clinical_assessments_reader__v)
  • Added the following fields to the Application Role Function (application_role_function__v) object:
    • Assessments Tab (assessments_tab__v)
    • Edit Clinical Assessments (edit_clinical_assessments__v)
    • Manage Assessments (manage_assessments__v)
    • View Clinical Assessments (view_clinical_assessments__v)
  • Added the Assessment Editor (assessment_editor__v) and Assessment Reader (assessment_reader__v) security profiles
  • Added the Assessments Tab Access (assessments_tab_access__v) permission set
  • Added the CDM Key (cdm_key__v) field to the following objects:
    • Review Plan (review_plan__v)
    • Review Plan Object Definition (review_plan_object_definition__v)
    • Signature Definition (signature_definition__v)
  • Added the Last Coded Date (last_coded_date__v) field to the Medical Coding Request (mc_request__v) object