Vault Loader
Vault Loader allows you to load data to your Vault or extract data from your Vault in bulk. Loader is particularly useful during migrations and on-boarding. Extracted information downloads to a CSV file, which you can load back into your Vault or into other systems.
General Loader Guidance
- Each loader file must remain in CSV format (not Excel)
- The column headers reflect each field you see when manually creating a record in the system. I populated the second row as an example in each file - be sure to delete this row!
- Non-required fields can be left blank
- If you’re unsure what fields are required, navigate to creating a record manually - the required fields are yellow and the non-required fields are white.
Available Bulk Actions
| Available Bulk Actions | File | Batch Size |
|---|---|---|
| Extract Document Metadata | CSV output | up to 1,000,000 |
| Extract Document Version Metadata | CSV output | up to 1,000,000 |
| Extract Document Source Files | CSV output with links to file staging | up to 10,000 |
| Extract Document Renditions | CSV output with links to file staging | up to 10,000 |
| Extract Document Relationships | CSV output | up to 1,000,000 |
| Extract Object Record Metadata | CSV output | up to 1,000,000 |
| Extract Users | CSV output | up to 1,000,000 |
| Extract Groups | CSV output | up to 1,000,000 |
| Create & Update Documents | CSV input | unlimited; CSV must be under 1GB |
| Create & Delete Document Relationships | CSV input | unlimited; CSV must be under 1GB |
| Create & Delete Document Attachments | CSV input | unlimited; CSV must be under 1GB |
| Add Document Versions | CSV input | unlimited; CSV must be under 1GB |
| Add Document Renditions | CSV input | unlimited; CSV must be under 1GB |
| Update & Delete Document Roles | CSV input | unlimited; CSV must be under 1GB |
| Create, Update & Delete Object Records | CSV input | unlimited; CSV must be under 1GB |
| Create Object Record Attachments | CSV input | unlimited; CSV must be under 1GB |
| Create & Update Users | CSV input | unlimited; CSV must be under 1GB |
| Create & Update Groups | CSV input | unlimited; CSV must be under 1GB |
| Update & Delete Object Record Roles | CSV Input | up to 500; CSV must be under 1GB |
Notifications & Output Files
Vault shows the status of loader jobs in Admin > Operations > Job Status and also sends notifications for both successes and failures.
Success & Failure Log Files
After each load, Vault creates separate success and failure logs as CSV files. You can download these files from the in-Vault notification or email notification. Vault deletes these files after 16 days. Both files contain the system-managed id values of each record.
If you select the Include fields in output log checkbox when loading, Vault queries the fields and validates that the fields were successfully created.
Failure Logs
Failure logs include:
- Error messages for each record that failed to load
- Original data alongside corresponding errors
- Row IDs from the original CSV file for the corresponding row
- Lines that Vault Loader skipped due to a mismatch in column counts
You can review and fix errors from within the error log. Once you correct any errors, you can re-import the failure log.
About the Vault Loader Command Line Tool
With the Vault Loader command line tool, you can manage files and folders on your Vault’s file staging, load data to your Vault, or extract data from your Vault directly from the command line.
Migration Mode
To add document versions or renditions, or to set document numbering during import, you must select the Document Migration Mode checkbox.
To create or update object records in any lifecycle state or state type, you must select the Record Migration Mode checkbox. Vault bypasses entry criteria, entry actions, validation rules, event actions, and reference constraints when creating or updating records in migration mode.
Auditing
Vault tracks all Vault Loader actions in the System Audit History, including data export. Each loader action will appear as a single row. Note that only actions which occurred after your Vault upgraded to 18R3 will appear in the System Audit History.
Vault Loader actions on documents also appear in the Document Audit History, and actions on object records appear in the Object Record Audit History.
About the User Object
You can use Vault Loader to create and update User records with the user__sys object. This allows you to update custom fields on User records, as well as standard fields such as Manager. Because Vault synchronizes User records with Legacy User accounts, Vault automatically updates Legacy User accounts when you create or update User records.
Using Vault Loader in Clinical Basics
- Test your data load in Sandbox first before loading data into Production
- Download the provided templates to create your actual loaders from
- Delete the provided example data in the templates when replacing with your own data
Persons Loader
This template should only be used for creating Personnel who will not have access to the system (will not have a User account). For example, Principal Investigators, Sub-Investigators, Site Staff.
- When a User is added to the system, their associated Person record is automatically created
- All Users have associated Person records
- Not all Persons have associated User accounts (i.e. site staff who will not have access to the system, but will be tracked on their associated sites)
- Load Persons prior to Study Personnel (the Person record must exist in order to assign them to a Study/Site)
Template Fields/Column Headers
Refer to this table as you’re filling out your template.
| Field/Column Header | Description | Required |
|---|---|---|
| object_type__v.name__v | Person Type, synonymous with the initial dropdown dialog in the system when creating a Person (Investigator, Site Staff, etc.). You will almost always be using Investigator and Site Staff. | |
| first_name__sys | First Name | |
| middle_name__v | Middle Name | |
| last_name__sys | Last Name | |
| suffix__v | Suffix | |
| email__sys | ||
| mobile_phone__sys | Mobile phone number |
Study Personnel Loader
Template Fields/Column Headers
Refer to this table as you’re filling out your template.
| Field/Column Header | Description | Required |
|---|---|---|
| person__clin.name__v | Person Name | |
| team_role__v.name__v | Vault Users: Study Contributor, Study Viewer, TMF Manager, Study Manager (if your Vault has CTMS), or Monitor (if your Vault has CTMS) Inspector Users: External Inspector Site Personnel (non-Users): Budgest & Contracts, Clinical Research Coordinator, Data Coordinator, Other Non-Investigator, Pharmacist, Principal Investigator, Regulatory Coordinator, Research Nurse, Site Staff, Subinvestigator Note
The Person Type must be Investigator in order for the Study Person role to be Principal Investigator. | |
| start_date__clin | Start Date, YYYY-MM-DD format | |
| study__clin.name__v | Study Name | |
| study_country__clin.name__v | Only populate for site-level personnel (PI, Sub-I, Site Staff, etc.) Leave blank for Vault personnel | |
| site__clin.name__v | Only populated for site-level personnel (PI, Sub-I, Site Staff, etc.) Leave blank for Vault personnel | |
| create_urs__v | FALSE for site-level personnel, TRUE or FALSE for Vault personnel, as appropriate |
Organization Loader
Template Fields/Column Headers
Refer to this table as you’re filling out your template.
| Field/Column Header | Description | Required |
|---|---|---|
| name__v | Organization Name | |
| object_type__v.name__v | Organization Type (choose from Institution, Sponsor, Vendor, IRB/IEC) |
Location Loader
Template Fields/Column Headers
Refer to this table as you’re filling out your template.
| Field/Column Header | Description | Required |
|---|---|---|
| name__v | Location Name | |
| organization__clin.name__v | Must match associated Organization record name exactly | |
| address_line_1__clin | Address Line 1 | |
| town_city__clin | Town / City | |
| state_province_region__clin | State / Province / Region | |
| country__v.name__v | Country | |
| postal_zip_code__clin | Postal / Zip Code |
Subjects Loader
Template Fields/Column Headers
Refer to this table as you’re filling out your template.
| Field/Column Header | Description | Required |
|---|---|---|
| name__v | Subject ID | |
| subject_status__clin | Subject Status (choose from Pre Screening, Started Treatment, Started Follow Up, Lost to Follow Up, Consented, In Screening, Screen Failure, Enrolled, Randomized, Withdrawn, End of Treatment, Complete, Deleted in CDMS) | |
| study__clin.name__v | Study Number | |
| study_country__clin.name__v | Study Country Name | |
| site__clin.name__v | Study Site Number | |
| screened_date__v | Screened Date, YYYY-MM-DD format | |
| enrolled_date__v | Enrolled Date, YYYY-MM-DD format | |
| initial_consent_date__v | Initial Consent Date, YYYY-MM-DD format | |
| randomized_date__v | Randomized Date, YYYY-MM-DD format | |
| started_treatment_date__v | Started Treatment Date, YYYY-MM-DD format | |
| started_follow_up_date__v | Started Follow Up Date, YYYY-MM-DD format | |
| end_of_treatment_date__v | End of Treatment Date, YYYY-MM-DD format | |
| end_of_study_date__v | End of Study Date, YYYY-MM-DD format | |
| screen_failed_date__v | Screen Failed Date, YYYY-MM-DD format | |
| lost_to_follow_up_date__v | Lost to Follow Up Date, YYYY-MM-DD format | |
| withdrawn_date__v | Withdrawn Date, YYYY-MM-DD format |
Subject Visits Loader
Template Fields/Column Headers
Refer to this table as you’re filling out your template.
| Field/Column Header | Description | Required |
|---|---|---|
| subject__v.name__v | Subject | |
| visit_def__v.name__v | Visit (the name of the related Visit Definition created on the Study) | |
| visit_status__v | Visit Status (choose from Planned, Blank, In Progress, Submitted, Did Not Occur) | |
| planned_date__v | Planned Date, YYYY-MM-DD format | |
| visit_date__v | Visit Date, YYYY-MM-DD format | |
| rev_sdv__v | SDV Complete? (TRUE or FALSE) Defaults to No if left blank. | |
| sdv_date__v | SDV Complete Date, YYYY-MM-DD format | |
| sdv_mode__v | SDV Requiredness. Use the api name: | |
| required__v | ||
| optional__v | ||
| not_applicable__v | ||
| sdr_requiredness__v | SDR Requiredness. Use the api name: | |
| required__v | ||
| not_required__v | ||
| rev_sdr__v | SDR Complete? (TRUE or FALSE) Defaults to No if left blank. | |
| study__v.name__v | Study Number | |
| study_country__v.name__v | Study Country Name | |
| site__v.name__v | Study Site Number |
Issues Loader
Template Fields/Column Headers
Refer to this table as you’re filling out your template.
| Field/Column Header | Description | Required |
|---|---|---|
| object_type__v.name__v | Protocol Deviation or Observation | |
| date_identified__ctms | Date Identified, YYYY-MM-DD format | |
| date_of_violation_deviation__ctms | Date of Issue, YYYY-MM-DD format | |
| protocol_version__c | Number field with one decimal place optional | |
| summary__ctms | Text field, 500 character limit | |
| description__ctms | Text field, 1500 character limit | |
| category_pdv__ctms | See Issue Category/Sub Category for picklist values, use the api name | |
| sub_category__ctms.name__v | See Issue Category/Sub Category for picklist values, dependent on Category selection | |
| severity_pdv__ctms | Use the api name: | |
| major__ctms (Important) | ||
| minor__ctms (Non-Important) | ||
| include_in_site_letters__c | TRUE (issue will be included on confirmation/follow up letters) | |
| FALSE (issue will not be included on confirmation/follow up letters) | ||
| study__ctms.name__v | Study Number | |
| study_country__ctms.name__v | Study Country Name | |
| site__ctms.name__v | Study Site Number | |
| monitoring_event__ctms.name__v | Monitoring Visit Name | |
| subject__ctms.name__v | Subject ID |
Issue Category/Sub Category
This table lists the available Issue Categories and Sub Categories.
| Issue Category | Issue Sub Category |
|---|---|
| eligibility_criteria__ctms | Participant enrolled did not meet all inclusion criteria |
| eligibility_criteria__ctms | Participant enrolled met one or more exclusion criteria |
| informed_consent__ctms | Consent form signed by participant was not current approved version |
| informed_consent__ctms | Consent form or process has insufficient documentation |
| informed_consent__ctms | Failure to obtain informed consent prior to study-specific procedures |
| informed_consent__ctms | Failure to obtain reconsent |
| investigational_product__c | Participant received incorrect IP / dose |
| investigational_product__c | Dosing compliance issue noted |
| investigational_product__c | Improper storage, handling, or dispensing of IP |
| investigational_product__c | Failure to return IP by participant |
| investigational_product__c | Use / dispensing of damaged or expired IP |
| investigational_product__c | IP documentation insufficiency |
| protocol_implementation__ctms | Missed assessment |
| protocol_implementation__ctms | Missed visit |
| protocol_implementation__ctms | Participant seen outside of visit window |
| protocol_implementation__ctms | Enrollment prior to IRB approval of protocol |
| protocol_implementation__ctms | Use of prohibited medication or interventions |
| protocol_implementation__ctms | Regulatory or training documentation missing |
| protocol_implementation__ctms | Visit / Procedure / Assessment not performed as defined in the protocol or supporting study documents |
| protocol_implementation__ctms | Incorrect or incomplete IRT / enrollment process |
| protocol_implementation__ctms | GCP violation |
| safety__ctms | Safety event not reported to IRB per policy |
| safety__ctms | Safety event not reported within protocol-defined timelines |
| safety__ctms | Failure to withdraw participant meeting discontinuation criteria |