Veeva Site Connect streamlines and automates the sharing of documents and data between CROs and sponsors on Clinical Operations Vaults and study sites on SiteVault Vaults.
Note: Veeva Site Connect is an add-on product available for any Clinical Operations Vault.
Configuration Overview
- Enable Veeva Site Connect in your Clinical Operations Vault.
- Ensure users have access to related objects.
- Optional: Add the Site Document Exchange section to the Study Site page layout.
- Optional: Configure the Send Agreement Invitation entry action to automate the transfer of Agreements to study sites.
- Optional: Configure the Create Agreement Invitation and Send Agreement Invitation user actions.
- Configure Site Package Definitions that users can select when defining Site Packages.
- Configure user actions to allow users to trigger the exchange of documents and document requests.
- Optional: Configure the Site Connect Details user action.
- Optional: Configure single-study documents.
- Map document types to Vault Clinical Docs reference model artifacts.
- Optional: Configure Field Defaults to specify default values for fields on incoming documents and records.
- Optional: Configure Safety Distributions to allow users to send safety documents to study sites, including sites that aren’t on SiteVault.
- Optional: Configure document reconciliation so that users can verify that a site’s eISF contains the appropriate study documents in their SiteVault.
- Optional: Configure Create as Unclassified documents.
- Optional: Adjust the frequency of the Received from SiteVault notification.
Enabling Veeva Site Connect
Veeva Site Connect is an add-on product available for Vaults in the Clinical Operations family. Contact Veeva Support to add Veeva Site Connect to your Clinical Operations Vault.
Site Document Exchange Page Layout Section
Adding this section to the Study Site object page layout allows users to see and search all document transfers in a given context at a glance. When configured, all Study Site records with Site Connect Agreements will display a grid view of transfer details.
Once a context is selected, Vault displays the associated columns:
Open At Site
- Name
- Document Type
- Document Number
- Sent Date
- Expected Action
- Sent Comments
Received From Site
- Name
- Document Type
- Document Number
- Received Date
- Expected Action
- Sent Comments
- Received Comments
Rejected By Site
- Name
- Document Type
- Document Number
- Expected Action
- Sent Comments
- Received Comments
All Sent To Site
- Name
- Document Type
- Document Number
- Sent Date
- Expected Action
- Sent Comments
Creating connections to SiteVault
Vault automatically establishes connections between your production Vault and any SiteVaults you have. Simply create an Organization record and enter a valid Universal Study Number (USN) value. If a connection to that SiteVault doesn’t already exist, Vault creates it.
The corresponding record in SiteVault will use the Display Name set in the Admin > Settings > Application Settings > Site Connect > Sponsor/CRO Connection Naming field. When enabling Veeva Site Connect for the first time, connections to all SiteVaults with matching USN values in existing Organization records will be automatically created once this field is populated.
Configuring the Send Agreement Invitation Entry Action
You can add the Send Agreement Invitation entry action to any Active lifecycle state on the Study Site Lifecycle. For example, you can configure your Vault to send an Agreement invitation when a Study Site moves to Initiating state.
Note: Contact your managed services or customer success manager for information about configuring the Send Agreement Invitation entry action.
Configuring the Create & Send Agreement Invitation User Actions
Add the Create Agreement Invitation and Send Agreement Invitation user actions to a lifecycle state to allow users to manually rebuild and send Agreement invitations. This is useful if the entry action above fails, or if the target SiteVault fails to process the invitation correctly.
Configuring Site Package Definitions
Site Package Definitions are templates of document types that users can exchange with Study Sites. These packages are used by Vault to automatically retrieve relevant study documents and add them to site-specific packages. Every Site Package Definition parent record contains a set of Site Package Document records. These document records represent the document types that Vault will include in a Site Package.
To create a Site Package Definition record:
- Navigate to the Site Package Definition object record list page from Business Admin or a custom tab.
- Click Create.
- Enter a Site Package Definition.
- Click Save.
Site Package Documents
To add Site Package Documents to a Site Package Definition:
- Open a Site Package Definition record.
- In the Site Package Document section, click Create.
- Select a Document Type, Level, and Expected Site Action.
- Optional: Enter Default Comments. Vault displays default values will be to users on the Preview Site Packages page.
- Click Save.
Below is a simple set of Site Package Documents that you could include in a Site Package Definition:
Document Type |
Level |
Expected Site Action |
Protocol |
Study |
None |
Protocol Signature Page |
Site |
Revise & Return |
Investigator’s Brochure |
Study |
None |
Acceptance of Investigator Brochure |
Site |
Revise & Return |
IRB or IEC Submission |
Site |
Provide Original |
Configuring Clinical Network User Actions
Send Document Via Clinical Network
You can add the Send Document Via Clinical Network user action to any active document lifecycle state. When configured, this action allows users to select the Send Documents to Sites option from a document’s Actions menu to send documents to SiteVault sites from their Library.
Select a State Change for the user action to specify which lifecycle state the document enters in the source Vault once Vault successfully transfers it to the target SiteVault.
Note: If you utilize the State Change option, you are limited to just one Send Document Via Clinical Network user action per lifecycle.
This user action only appears to users if there are active Agreements associated with the Study or Study Sites related to the document.
Send Matched Document Via Clinical Network
You can add the Send Matched Document Via Clinical Network user action to any Active state of the Expected Documents lifecycle. When configured, this action allows users to send documents and document requests to SiteVault sites from the Actions menu of Expected Document records. This action will only be available to users if there are active Agreements associated with the Study or Study Sites related to the Expected Document.
Send Site Package Via Clinical Network
You can add the Send Site Package Via Clinical Network user action to any Active state of the Study Country or Study Site Lifecycle. When configured, this action allows users to send Site Packages to SiteVault sites from the Actions menu of Study Country or Study Site records.
Configuring the Site Connect Details User Action
You can add the Site Connect Details user action to any document lifecycle state. The action will display when the Study referenced on the document has an active Site Connect agreement. When taken, the action:
- Initially displays the Comment History page if the document was sent to a single Study Site; or
- Initially displays the Track Document Distribution page if the document was sent to multiple Study Sites.
Users can toggle between both displays, and export the contents to either Excel or CSV.
Comment History
This displays all comments related to the document as it is exchanged between Sponsor/CRO and the Site. Each comment shows the Study Site name and associated document version, the latter of which can be clicked to launch in a new browser tab.
Track Document Distribution
This displays which Sites a document was sent to, along with the Sent Date, Due Date, and Expected Site Action for each exchange.
Configuring the Single-Study Documents Setting
The Enable Single-Study Documents setting tells Vault what to do when your Clinical Operations Vault receives a document from your Site Vault that references multiple Study records. If you set Enable Single-Study Documents to True, Vault creates a new document for each of the studies referenced. If set to False, Vault creates a single new document that references all the studies.
You can change the Enable Single-Study Documents setting by navigating to Admin > Settings > Application Settings > Connected Studies.
Mapping Vault Clinical Docs Artifacts
Ensure that document types in your Vault are mapped to the Vault Clinical Docs model so that transferred documents are classified correctly.
Users can utilize the Send Documents to Sites user action for document types mapped to the following artifacts:
Vault Clinical Docs Artifact | Vault Clinical Docs External ID | SiteVault Document Type |
---|---|---|
Acceptance of Investigator Brochure | vdc__57 | Acceptance of IB |
Advertisements for Subject Recruitment | vdc__27 | Advertisement for Subject Recruitment |
Certification or Accreditation | vdc__95 | Lab Certification |
Clinical Study Report | vdc__29 | Clinical Study Report |
Clinical Trial Agreement | vdc__68 | Contract |
Close-Out Visit Confirmation Letter | vdc_166 | Monitoring Visit Confirmation Letter |
Close-Out Visit Follow Up Letter | vdc_167 | Monitoring Visit Follow Up Letter |
Completed CRF | vdc_204 | Completed CRF |
Confidentiality Agreement | vdc__53 | Confidentiality Agreement |
Contractual Agreement | vdc__106 | Contract |
CRF Completion Requirements | vdc__108 | Procedure Manual |
Data Privacy Agreement | vdc__67 | Data Privacy |
Expedited Safety Report | vdc_151 | Expedited Safety Report |
Feasibility Documentation | vdc__54 | Feasibility Questionnaire |
Form FDA 1572 | vdc__64 | 1572 or Equivalent |
Head of Facility Curriculum Vitae | vdc__101 | Lab Director Qualifications |
Indemnity | vdc__69 | Contract |
Informed Consent Form | vdc__24 | Informed Consent Form (blank) |
Insurance | vdc__18 | Insurance |
Interim Monitoring Visit Confirmation Letter | vdc_164 | Monitoring Visit Confirmation Letter |
Interim Monitoring Visit Follow Up Letter | vdc_165 | Monitoring Visit Follow Up Letter |
Investigator Newsletter | vdc_209 | Correspondence |
Investigator Brochure Summary of Changes | vdc__317 | Investigator Brochure |
Investigator Regulatory Agreement | vdc__65 | 1572 or Equivalent |
Investigator’s Brochure | vdc__13 | Investigator Brochure |
Investigators Agreement (Device) | vdc__73 | 1572 or Equivalent |
Investigators Meeting Material | vdc__308 | Training Material |
IP Accountability Documentation | vdc__83 | IP Accountability |
IP Certificate of Destruction | vdc__305 | IP Destruction |
IP Instructions for Handling | vdc__80 | IP Instructions for Handling |
IP Quality Complaint Form | vdc__306 | IP Quality Complaint Form |
IP Sample Label | vdc__81 | IP Sample Label |
IP Supply Plan | vdc__79 | IP & Supply Shipping |
IP Unblinding Plan | vdc__90 | Decoding Procedures |
IRB or IEC Approval | vdc__42 | IRB/IEC Response |
IRB or IEC Compliance Documentation | vdc__45 | IRB/IEC Compliance |
IRB or IEC Composition | vdc__43 | IRB/IEC Composition |
IRB or IEC Notification of Trial Termination | vdc__50 | IRB/IEC Submission |
IRB or IEC Submission | vdc__41 | IRB/IEC Submission |
Marketed Product Material | vdc__21 | Marketed Product Material |
Normal Ranges | vdc__98 | Lab Normal Ranges |
Note to File | vdc_207 | Note to File |
Operational Procedure Manual | vdc_150 | Procedure Manual |
Other Approvals | vdc__47 | Ancillary Committee Response |
Other Curriculum Vitae | vdc__62 | CV |
Other Financial Agreement | vdc__70 | Contract |
Other Information Given to Subjects | vdc__28 | Subject Materials – Other |
Other Site Staff Medical License | vdc_211 | Medical License |
Other Site Staff Qualification Supporting Information | vdc__63 | Training Evidence (non study-specific) |
Other Submissions | vdc__46 | Ancillary Committee Submission |
Participant Adverse Event Log | vdc__315 | Participant Adverse Event Log |
Payment Letter | vdc_201 | Correspondence |
Pregnancy Report Form Template | vdc__313 | Adverse Event Report |
Pre-Study Visit Confirmation Letter | vdc_160 | Monitoring Visit Confirmation Letter |
Pre-Study Visit Follow Up Letter | vdc_161 | Monitoring Visit Follow Up Letter |
Principal Investigator Curriculum Vitae | vdc__60 | CV |
Principal Investigator Financial Disclosure Form | vdc__66 | Financial Disclosure Form |
Principal Investigator Medical License | vdc__175 | Medical License |
Principal Investigator Qualification Supporting Information | vdc__196 | Training Evidence (non study-specific) |
Protocol | vdc__14 | Protocol |
Protocol Clarification | vdc__212 | Protocol Clarification |
Protocol Deviations | vdc__316 | Protocol Deviations |
Protocol Signature Page | vdc__58 | Protocol Signature Page |
Protocol Summary of Changes | vdc__213 | Protocol Summary of Changes |
Protocol Synopsis | vdc__15 | Protocol Synopsis |
Regulatory Approval Notification | vdc__32 | Regulatory Authority Response |
Regulatory Submission | vdc__31 | Regulatory Submission |
Remote Monitoring Visit Confirmation Letter | vdc_168 | Monitoring Visit Confirmation Letter |
Remote Monitoring Visit Follow Up Letter | vdc_169 | Monitoring Visit Follow Up Letter |
SAE Report Form Template | vdc__318 | Adverse Event Report |
Sample Case Report Form | vdc__19 | Sample Case Report Form |
Sample Storage Condition Log | vdc__307 | Specimen Tracking |
Site Budget | vdc__302 | Budget |
Site Contact Details | vdc__52 | Study Contact Info Form |
Site Evidence of Training | vdc__77 | Training Evidence (study-specific) |
Site Initiation Visit Confirmation Letter | vdc_162 | Monitoring Visit Confirmation Letter |
Site Initiation Visit Follow Up Letter | vdc_163 | Monitoring Visit Follow Up Letter |
Site Invoice | vdc_206 | Invoice |
Site Selection Letter | vdc__303 | Correspondence |
Site Signature & Initials | vdc__301 | Signature & Initials |
Site Signature Sheet | vdc__72 | Delegation of Authority |
Site Training Material | vdc__76 | Training Material |
Source Data Agreement | vdc__311 | Source Data Agreement |
Special Events of Interest Form Template | vdc__314 | Adverse Event Report |
Study Team Member Contact List | vdc__304 | Sponsor/CRO Contact Information |
Sub-Investigator Curriculum Vitae | vdc__61 | CV |
Sub-Investigator Medical License | vdc__176 | Medical License |
Sub-Investigator Qualification Supporting Information | vdc__197 | Training Evidence (non study-specific) |
Subject Diary | vdc__22 | Subject Diary (blank) |
Subject Information Sheet | vdc__25 | Subject Information Sheet |
Subject Log | vdc_208 | Subject Screening Log |
Subject Participation Card | vdc__26 | Study Participation Card |
Subject Questionnaire | vdc__23 | Subject Questionnaire (blank) |
Visit Log | vdc_210 | Monitoring Visit Log |
Mapping Profile Document Types
When your Vault receives profile documents from a SiteVault Vault, Vault automatically classifies the document based on the document’s attributes in SiteVault and the configuration of artifacts for the Vault Clinical Docs reference model in your Vault.
Vault Clinical Docs Artifact Applied to Document |
SiteVault Document Attributes |
Other Site Staff Medical License |
Document type is Other Site Staff Medical License and the Study Team Role is not Principal Investigator or Sub-Investigator |
Other Curriculum Vitae |
Document type is CV and the Study Team Role is not Principal Investigator or Subinvestigator |
Other Site Staff Qualification Supporting Information |
Document type is Training Evidence (non study-specific) and the Study Team Role is not Principal Investigator or Subinvestigator |
Principal Investigator Curriculum Vitae |
Document type is CV and the Study Team Role is Principal Investigator |
Principal Investigator Medical License |
Document type is Medical License and the Study Team Role is Principal Investigator |
Principal Investigator Qualification Supporting Information |
Document type is Training Evidence (non study-specific) and the Study Team Role is Principal Investigator |
Sub-Investigator Curriculum Vitae |
Document type is CV and the Study Team Role is Subinvestigator |
Sub-Investigator Medical License |
Document type is Medical License and the Study Team Role is Subinvestigator |
Sub-Investigator Qualification Supporting Information |
Document type is Training Evidence (non study-specific) and the Study Team Role is Subinvestigator |
Designate Documents as Create as Unclassified
Vault automatically classifies the documents sent from your Site Vault to your Clinical Operations Vault based on the document type. In some cases, however, you may wish for certain documents to be created as Unclassified so that you can classify them later, either manually or using the TMF Bot.
Note: Any documents received from SiteVault are created as Unclassified documents when the Clinical Operations Vault is missing a mapping to the corresponding Vault Clinical Docs artifact, regardless of the Create as Unclassified setting.
To enable or disable the Create as Unclassified field at the Artifact level:
- Navigate to Admin > Vault Clinical Docs > Hierarchy Items.
- Select the Artifact for which you want to enable or disable Create as Unclassified.
- From the All Actions menu, click Toggle Create as Unclassified. If the field was previously disabled, Vault enables it, and vice versa.
Configuring Field Defaults
Field Defaults allow you to specify a default value to apply to certain fields on incoming documents and object records. You can apply Field Defaults to all Agreements associated with a specific Connection or a specific Rule Set.
To create a Field Default record:
- Create a Field Default record from Business Admin or a custom tab.
- Select a Field Default Type and click Continue.
- Enter a Name, Field Name, and Default Value to apply. Note that you must enter Default Values in a specific format depending on the data type. For Object Field and Object Field Default (Rule Set) types of defaults, enter an Object Name.
- Depending on the Field Default Type you are creating, select the Connection or Rule Set that this default value will apply to.
- The Status defaults to Active on new records. You can change the status to Inactive if you want Vault to ignore the Field Default.
- Click Save.
If you create both Rule Set-level and Connection-level Field Defaults for a field, Vault applies the Default Value specified in the Connection-level Field Default Type.
Note: Vault prioritizes Field Defaults over default document and object configurations.
Default Value Formatting
You must enter values in the Default Value field in the correct format:
Data Type |
Format |
Text |
Text |
Yes/No |
true/false |
Object |
Object ID |
Date Time |
YYYY:MM:DDTHH:MM:SS.MMMZ |
Date |
YYYY:MM:DD |
Picklist Value for Object |
Picklist Value Name |
Picklist Value for Document |
Picklist Value Label |
Number |
123 |
Received from SiteVault Notifications
You can adjust the frequency of the notification users receive after their requested documents from SiteVault are created in the Clinical Operations Vault by navigating to Admin > Operations > Job Definitions and clicking on the Notify Senders of Returned Documents job. You can configure the notification to send Hourly, Daily, Weekly, or Monthly in the Schedule field, or set the Status to Inactive to prevent Vault from sending the notification.