About Disclosure Data Prepopulation

Vault 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, or its related Metric records, or selected Protocol records. The table below lists the prepopulated Disclosure Form fields and the field the data populates from. For example, Vault will populate the Protocol Identification Number field using the value from the Study Number field on the selected Study record.

CTMS Object	CTMS Field	Prepopulated US Disclosures Field
Study	Study Number	Protocol Identification Number
Study	Protocol Title	Official Title
Study	Study Design Type	Study Type
Study	Study Start Date	Study Start Date
Metrics	Planned Total Enrollment	Enrollment
Protocol Design Groups	Title	Arm Title
Protocol Design Groups	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 of Focus of Study
Protocol Medical Conditions	Medical Conditions	Conditions of Focus of Study
Protocol	Interventional Study Model	Interventional Study Model
Protocol	Sampling Method	Sampling Method
Protocol	Allocation	Allocation
Protocol	Sex	Sex
Protocol	Gender Based	Gender Based
Protocol	Gender Description	Gender Eligibility Description
Protocol	Minimum Age and Units	Minimum Age and Units
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

Site List

Vault populates the Site List section with Study Sites data from the selected Study. The Study Sites data is not editable 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 CTMS records. The following table lists the populated Disclosure Form record fields and the CTMS object and fields from which the data populates:

CTMS Object	CTMS 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/Providence/Region	State/Providence/Region
Primary Study Site Location	Postal/Zip Code	Postal/Zip Code
Primary Study Site Location	Country	Country
Principal Investigator Study Person	First Name	First Name
Principal Investigator Study Person	Last Name	Last Name
Principal Investigator Contact Info	Phone Number	Phone Number
Principal Investigator Contact Info	Email	Email