Configuring Veeva Site Connect (Clinical Operations)

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.

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.

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:

1. Navigate to the Site Package Definition object record list page from Business Admin or a custom tab.
2. Click Create.
3. Enter a Site Package Definition.
4. Click Save.

Site Package Documents

To add Site Package Documents to a Site Package Definition:

1. Open a Site Package Definition record.
2. In the Site Package Document section, click Create.
3. Select a Document Type, Level, and Expected Site Action.
4. Optional: Enter Default Comments. Vault displays default values will be to users on the Preview Site Packages page.
5. 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.

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
Acceptance of Marketed Product Material	vdc__325	Acceptance of Marketed Product Material
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 Recall Documentation	vdc__323	IP & Supply Shipping
IP Return Documentation	vdc__324	IP & Supply Shipping
IP Sample Label	vdc__81	IP Sample Label
IP Storage Condition Documentation	vdc__320	Equipment Log
IP Supply Plan	vdc__79	IP & Supply Shipping
IP Transfer Documentation	vdc__84	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
Maintenance Logs	vdc__321	Equipment Log
Marketed Product Material	vdc__21	Marketed Product Material
Non-IP Return Documentation	vdc__93	IP & Supply Shipping
Non-IP Shipment Documentation	vdc__92	IP & Supply Shipping
Non-IP Storage Documentation	vdc__322	Equipment Log
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
Relevant External Communications	vdc__319	Correspondence
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.

To enable or disable the Create as Unclassified field at the Artifact level:

1. Navigate to Admin > Vault Clinical Docs > Hierarchy Items.
2. Select the Artifact for which you want to enable or disable Create as Unclassified.
3. 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.

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.