Veeva Disclosures utilizes CTMS, eTMF, and Study Startup Vaults shared objects to populate fields within the Disclosure Form layout of the Disclosure records. These populated fields ensure data consistency across objects during the disclosure process for manually and automatically created Disclosure records.
Note: Vault prepopulates fields on the Disclosure Form when a user or Vault creates the Disclosure record. The fields remain unchanged unless manually updated, even if the original data changes.
Disclosure Form Data Prepopulation
Vault prepopulates specific Disclosure Form fields with values from fields based on the selected Study record, selected Protocol record, or other related records. Vault displays a (p) indicator next to each field name that Vault can prepopulate. Prepopulated Disclosure fields remain blank when the corresponding Clinical Operations field is blank.
The table below lists the prepopulated Disclosure Form fields and the field the data populates from. For example, Vault will populate the Unique Protocol Identification Number field using the value from the Study Number field on the selected Study record.
| Clinical Operations Object | Clinical Operations Field | Prepopulated US Disclosures Field |
|---|---|---|
| Study | Study Number | Unique Protocol Identification Number |
| Study | Protocol Title | Official Title |
| Protocol | Brief Title | Brief Title |
| Study | Study Design Type | Study Type |
| Study | Study Name | Acronym |
| Study | EUCT Number | Secondary ID |
| Study | NIH Grant Number | Secondary ID |
| Study | Study Start Date | Study Start Date |
| Study | Study Recruitment Status | Overall Recruitment Status |
| Primary Outcome Completed Milestone | Actual or Planned Finish Date | Primary Completion Date |
| Last Subject Out Milestone | Actual or Planned Finish Date | Study Completion Date |
| Study | IND/IDE | US Food and Drug Administration IND or IDE |
| Study | IND/IDE Number | IND/IDE Number |
| Protocol | Brief Summary | Brief Summary |
| Protocol | Plan to Share IPD | Plan to Share IPD |
| Protocol | Plan Description | Plan Description |
| Metrics | Actual Total Enrollment | Enrollment (actual) |
| Metrics | Planned Total Enrollment | Enrollment (estimated) |
| Protocol Group Design | Title | Arm Title |
| Protocol Group Design | Description | Arm Description |
| Protocol Interventions | Intervention Names | Intervention Names |
| Protocol Intervention Other Name | Intervention Other Name(s) | Intervention Other Name(s) |
| Protocol Medical Conditions | Medical Conditions | Conditions or Focus of Study |
| Protocol | Interventional Study Model | Interventional Study Model |
| Protocol | Observational Study Model | Observational Study Model |
| Protocol | Observational Time Perspective | Time Perspective |
| Protocol | Biospecimen Retention | Biospecimen Retention |
| Protocol | Biospecimen Description | Biospecimen Description |
| Protocol | Purpose | Primary Purpose |
| Protocol | Model Description | Model Description |
| Protocol | Masking Description | Masking Description |
| Protocol | Phase | Study Phase* |
| Protocol | Number of Groups | Number of Groups/Cohorts |
| Protocol | Number of Groups | Number of Arms |
| Protocol | Protocol Group Design | Arm Type |
| Protocol | Protocol Group Design | Group Type |
| Protocol | Roles Masked | Masking |
| Protocol | Allocation | Allocation |
| Protocol | Gender | Sex |
| Protocol | Gender Based | Gender Based |
| Protocol | Gender Description | Gender Eligibility Description |
| Protocol | Minimum Age and Units | Minimum Age and Units |
| Protocol | Maximum Age and Units | Maximum Age and Units |
| Protocol | Healthy Volunteers | Accepts Healthy Volunteers |
| Protocol | Sampling Method | Sampling Method |
| Protocol Eligibility Criteria | Eligibility Criteria Type and Description | Eligibility Criteria |
| Protocol Outcome Measures | Type | Type |
| Protocol Outcome Measures | Title | Title |
| Protocol Outcome Measures | Time Frame | Time Frame |
| Protocol Outcome Measures | Description | Description |
| Citation | PubMed Identifier | PubMed Identifier |
| Citation | Citation | Citation |
| Citation | Results Reference | Results Reference |
| Link | Description | Description |
| Link | URL | URL |
* The Study Phase field on US Registration Disclosures only prepopulates from the corresponding Protocol record when configured in your Vault.
EU Disclosure Form Data Prepopulation
Vault automatically populates Disclosure Form fields on EU Initial Applications, Substantial Modifications, and Additional MSC Disclosures using data from CTMS records.
The table below lists the prepopulated EU Disclosure Form fields and their Clinical Operations source fields:
| Clinical Operations Object | Clinical Operations Field | Prepopulated EU Disclosures Field |
|---|---|---|
| Study | Protocol Title | Full title (English) |
| Study | Study Name (name__v)(often renamed in Vaults) |
Protocol code |
| Study | WHO ID | WHO universal trial number (UTN) |
| Study | NCT ID | ClinicalTrials.gov identifier (NCT number) |
| Study | ISRCTN ID | ISRCTN number |
| Study | Study Phase | Trial Phase |
| Study Country | Country Name (within EEA Jurisdiction) | Member States Concerned (Rows)* |
| Study Country Enrollment Metric | Planned Total Enrollment | Member States Concerned: Subjects |
| Study Country | Country (Non-EEA Jurisdiction) | Member States Concerned: Countries Outside the EEA |
| Study Country Metrics (EEA) | Planned Total Enrollment (Sum) | Estimated Total Population: Estimated EEA Subjects |
| Study Country Metrics (Non-EEA) | Planned Total Enrollment (Sum) | Estimated Total Population: Estimated Rest of the World Subjects |
| Study Metric | Planned Total Enrollment | Estimated Total Population: Estimated Total Subjects |
| First Country Subject Screened Milestone (EEA) | Earliest Planned Finish Date (in EEA) | Estimated Recruitment Start Date in EEA |
| Last Country Subject Out Milestone (EEA) | Latest Planned Finish Date (in EEA) | Estimated End of Trial Date in EEA |
| Last Study Subject Out Milestone (Study) | Planned Finish Date | Estimated Global End of Trial Date |
| Protocol | Public Title | Public Title (English) |
| Medical Condition | Medical Condition | Medical condition(s) (English) |
| Medical Condition | Rare Disease | Rare disease? |
| Protocol | Trial Scope | Trial Scope |
| Objectives | Objective (Type: Main) | Main objective (English)** |
| Objectives | Number | Number |
| Objectives | Objective (Type: Secondary) | Secondary objective (English) |
| Eligibility Criteria | Number (Type: Inclusion) | Inclusion Criteria Number |
| Eligibility Criteria | Eligibility Criteria (Type: Inclusion) | Principal inclusion criteria (English) |
| Eligibility Criteria | Number (Type: Exclusion) | Exclusion Criteria Number (ID) |
| Eligibility Criteria | Eligibility Criteria (Type: Exclusion) | Principal exclusion criteria (English) |
| End Points | Number (Type: Primary) | Primary end point Number (ID) |
| End Points | Endpoint (Type: Primary) | Primary end point (English) |
| End Points | Number (Type: Secondary) | Secondary End Point Number (ID) |
| End Points | Endpoint (Type: Secondary) | Secondary end point (English) |
| Protocol | Gender | Gender (Are subjects male?) |
| Protocol | Gender | Gender (Are subjects female?) |
| Protocol | Healthy Volunteers | Clinical trial group |
| Protocol | Age Range | Age range |
| Protocol | Plan to Share IPD | Plan to Share IPD |
| Protocol | Plan Description | Plan Description |
| Citation | PMID | Reference to Publication |
* When configured by an Admin, Member States Concerned rows prepopulate automatically for study countries joined to the EEA jurisdiction.
**Note: When more than one main objective exists for a protocol, the main objective field will not prepopulate.
Site List
Vault populates the Site List section with Study Site data from the selected Study. The Study Site data is read-only in the Site List section. You can locate the Site List in the More Info section of the Disclosure Form.
Study Sites populate into the Site List based on the sites marked as Include for Disclosure. Vault automatically selects the Include in Disclosures checkbox on all new Study Site objects. To have a Study Site populate into the Disclosure record, ensure the Include in Disclosures checkbox is selected while creating or editing a Study Site.
Principal Investigator data for disclosed Study Sites also populates into the Site List. Unlike Study Sites, Vault does not automatically select the Include in Disclosure checkbox on the Study Person record for the selected Principal Investigator. Select the Include in Disclosures checkbox when editing the Study Person record for the Principal Investigator to ensure Vault populates the data in the Disclosure record.
Vault populates the Site List section from Clinical Operations records. The following table lists the populated Disclosure Form record fields and the Clinical Operations object and fields from which the data populates:
| Clinical Operations Object | Clinical Operations Field | Prepopulated Disclosures Field |
|---|---|---|
| Study Site | Study Site Number | Site Number |
| Study Site | Recruitment Status | Site Status (US only) |
| Organization | OMS Organization ID | Organisation ID (EU only) |
| Organization | Name | Facility Name (US) Site Location (EU) |
| Primary Study Site Location | OMS Location ID | OMS LOC ID (EU only) |
| Primary Study Site Location | Address Line 1 | Site Street Address (EU only) |
| Primary Study Site Location | Town/City | Town/City |
| Primary Study Site Location | State/Province/Region | State/Province (US only) |
| Primary Study Site Location | Postal/Zip Code | Zip/Postal Code |
| Primary Study Site Location | Country | Country |
| Principal Investigator Study Person | Title | Title (EU only) |
| Principal Investigator Study Person | First Name | Facility Contact First Name |
| Principal Investigator Study Person | Middle Name | Facility Contact Middle Initial* (US only) |
| Principal Investigator Study Person | Last Name | Facility Contact Last Name |
| Principal Investigator Study Person | Therapeutic Expertise | Department (EU only) |
| Principal Investigator Contact Info | Phone Number | Phone Number |
| Principal Investigator Contact Info |
* Vault truncates middle names to a single middle initial on the Site List layout and in generated submission XML files.
Populating Form Fields from the Global Directory
Users with Read permissions for Global Directory can quickly populate data from the global directory while editing supported Disclosure forms. You can search the global directory to automatically fill multiple related fields for a supported Organization record, Address, or Person by clicking the Directory icon. Use the radio button to select a matching record, and click Confirm. Vault automatically populates the table or Disclosure Form with the corresponding data from the directory record.
Note: If OpenData Clinical is enabled in the Vault, directory fields are locked for editing and are automatically updated by OpenData Clinical instead.