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 |
| Study | Study Design Type | Study Type |
| 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 | Planned or Actual Finish Date | Primary Completion Date |
| Study | IND/IDE | US Food and Drug Administration IND or IDE |
| Study | IND/IDE Number | IND/IDE Number |
| 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 | 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 |
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 US Disclosures Field |
|---|---|---|
| Study Site | Site ID | Site ID |
| Study Site | Recruitment Status | Site Status |
| Organization | Name | Study Site Name |
| Primary Study Site Location | Town/City | Town/City |
| Primary Study Site Location | State/Province/Region | State/Province |
| Primary Study Site Location | Postal/Zip Code | Postal/Zip Code |
| Primary Study Site Location | Country | Country |
| Principal Investigator Study Person | First Name | Facility Contact First Name |
| Principal Investigator Study Person | Last Name | Facility Contact Last Name |
| Principal Investigator Contact Info | Phone Number | Phone Number |
| Principal Investigator Contact Info |