Configuring Site Connect

Veeva Site Connect streamlines and automates the sharing of documents and data between Sponsors/CROs and sites through Site Home in Clinical Operations.

Configuration Overview

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 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

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

Enabling the Site Connect User Field

Site users cannot view and exchange study-specific data and documents until they are granted access to Site Connect. To do this, add the Site Connect User field to the Study Person record layout. Enabling the Site Connect User field, sends the user an invitation email with a link to log in to Site Connect.

Once the Site Connect User field is enabled, a system Site Home Access record is created in Business Admin. This record captures the details of the Site Connect user, such as their full name, who requested their access, and their access start and end date. You cannot edit this record.

Ensure the following conditions are met before enabling the Site Connect User field:

  • The Study Person record includes values for Study, Study Country, and Study Site.
  • The Grant Access to Related Records field is set to No on the Study Person.
  • The Email field on the user’s related Person record is not blank.
  • The Person Type on the related Person record is set to Site Staff or Investigator.
  • The Study Person record does not have an inactive VeevaID in this Vault.

If these conditions are not met, Vault displays an error when you save the Study Person record with the Site Connect User field enabled.

Enabling Unblinded Content for Study Person

Clinical Operations utilizes the Blinded (blinded__v) and Unblinded (unblinded__v) values for the Content (blinding__v) field value on documents to enhance security and restrict user access to documents containing sensitive information. Documents with the Unblinded value for the Content field in Clinical Operations documents are also restricted in Site Connect. Only Site Connect users with Manage Unblined Content responsibility can view and access Unblinded documents in Site Connect.

You can allow a site user access to Unblinded documents by adding the Manage Unblinded Content (manage_unblinded__content__v) responsibility to the site user’s Study Person record. A Site Connect user with the Manage Unblinded Content responsibility can view and access Unblinded documents in addition to the standard Blinded, custom, or null Content field value documents. Site Connect only restricts Unblinded content for Document Exchange, End-of-Study Media, and Study Protocol links. Site Connect does not support the restriction of Unblinded content for Safety Distribution, Announcements, or Payment Information. If users send Unblinded documents from Clinical Vaults to sites as Safety Distributions, Payment Letters, or Announcements, the documents will be visible to all site users.

Site Connect users with the Manage Unblinded Content responsibility can use the Restricted checkbox when uploading ad hoc documents to create Blinded or Unblinded documents in Clinical Operations. Users without the Manage Unblinded Content responsibility cannot upload Unblinded documents. Users cannot adjust the Restricted checkbox setting on Revise and Return tasks.

Configuring the Connected Study Type

All Study records in a Clinical Operations Vault have a Connected Study Type field that determines the connections available to a given study. Vault bases the contents of the multi-select picklist for this field on which products you have access to:

  • Document Exchange: Exchange of documents with Site Connect users.
  • Safety Distribution: Exchange of Safety Distributions with SiteVault and via email to sites not yet using Site Connect users.
  • Payment Information: Exchange of Payment Request and Payable Item details with Site Connect users.

Configuring Site Connect User Actions

Send Matched Document

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 sites from the Actions menu of Expected Document records.

Send Site Package

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
Additional Monitoring Activity vdc__310 Correspondence
Advertisements for Subject Recruitment vdc__27 Advertisement for Recruitment
Certificate of Analysis vdc__89 IP & Supply Shipping
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 CRFs
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 Form
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
Import License vdc__36 IP & Supply Shipping
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
IP Recall Documentation vdc__323 IP & Supply Shipping
IP Re-labeling Documentation vdc__85 IP Relabeling
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 Storage Condition Excursion Documentation vdc__309 IP Excursions
IP Supply Plan vdc__79 IP & Supply Shipping
IP Transfer Documentation vdc__84 IP & Supply Shipping
IP Treatment Decoding Documentation vdc__326 Participant Decoding Event
IP Unblinding Plan vdc__90 Decoding Procedures
IP Verification Statements vdc__88 IP & Supply Shipping
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 Progress Report vdc__49 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
Notification to Regulatory Authority of Safety or Trial Information vdc__37 Regulatory Authority Submission
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 Participant 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
Recruitment Plan vdc__1 Recruitment Plan
Regulatory Approval Notification vdc__32 Regulatory Authority Response
Regulatory Progress Report vdc__38 Regulatory Authority Submission
Regulatory Submission vdc__31 Regulatory Authority Submission
Relevant Communications (Site Management) vdc__78 Correspondence
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
Safety Report Supporting Document vdc__327 Expedited Safety 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 Site Contact Details
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 Diary (blank)
Subject Information Sheet vdc__25 Participant Information Sheet
Subject Log vdc_208 Participant Screening Log
Subject Participation Card vdc__26 Study Participation Card
Subject Questionnaire vdc__23 Participant Questionnaire (blank)
System Account Management vdc__110 System User Access
Trial Initiation Monitoring Report vdc__75 Monitoring Visit Follow Up Letter
Visit Log vdc_210 Monitoring Visit Log

Mapping Profile Document Types

When your Vault receives profile documents from SiteVault, 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

If your Vault only has one (1) or two (2) artifacts mapped for the Vault Clinical Docs reference model, Vault automatically checks for other Vault Clinical Docs artifact mappings in a specific, hierarchical order before sending the profile document to the Inbox as an Unclassified document. Vault checks for Vault Clinical Docs artifact configurations in the following order: Principal Investigator, Sub-Investigator, and Other. 

For example, if your Vault receives a Sub-Investigator Medical License document in Site Connect, your Vault first checks for a classification mapped to the Sub-Investigator Medical License Vault Clinical Docs artifact. If no mapping exists for Sub-Investigator Medical License, Vault checks for an Other Site Staff Medical License mapping and then Principal Investigator Medical License mapping. If no mapping is found, the document is uploaded as Unclassified in the Document Inbox.

Designate Documents as Create as Unclassified

Vault automatically classifies the documents sent from your site 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.

You may wish to require authentication for documents exchanged with Site Connect users (such as Protocol or Investigator’s Brochure documents). You can accomplish this by designating Vault Clinical document artifacts as Authenticated Document Links. If enabled, each time a Site Connect user clicks a document link for that artifact from a Site Connect email notification, Vault requires them to authenticate using their VeevaID.

To enable or disable Authenticated Document Links at the Artifact level:

  1. Navigate to Business Admin > Artifacts.
  2. Optional: Select the filter icon () in the Model column to filter by the Vault Clinical Docs model.
  3. Select the Artifact for which you want to enable or disable Authenticated Document Links.
  4. From the All Actions menu, click Toggle Authenticated Document Links. If the field was previously disabled, Vault enables it, and vice versa.

Site users may rely on Sponsors and CROs to share links to systems used on a study, such as EDC or Study Training. You can display study related system information on the System Links section in Site Connect for site users to access at any time.

To create a System Link record:

  1. Navigate to Site Connect > Site System Links.
  2. Click Create.
  3. Select a Study.
  4. Optional: Select a Study Country. If selected, site System Links appear only for sites under this country. 
  5. Optional: Select a Study Site. If selected, site System Links appear only for the selected site.
  6. Enter the System Name.
  7. Select the System Type. Options include EDC, Training, ePRO, eClinRO, RTSM / IRT, and Other.
  8. Enter the System URL Site Connect users need to access. The System URL must include the appropriate “http” or “https” designation and must be a direct link to the study instance when possible.
  9. Optional: Enter a Description.
  10. Click Save.

Once the System Link record is saved, it is shared with site users in Site Connect. To remove a system link from Site Connect, select Make Inactive from the site System Link record’s Actions menu or move the record to the Make Inactive state.

Configuring Field Defaults

Field Defaults allow you to specify a default value for certain fields on incoming documents and object records.

To create a Field Default record:

  1. Create a Field Default record from Business Admin or a custom tab.
  2. Select a Field Default Type and click Continue.
  3. Enter a Name, Field Name, and Default Value to apply. 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.
  4. Depending on the Field Default Type you are creating, select the Connection or Rule Set that this default value will apply to.
  5. The Status defaults to Active on new records. If you want Vault to ignore the Field Default, you can change the Status to Inactive if you want Vault to ignore the Field Default.
  6. 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 Site Notifications

You can adjust the frequency of the notification users receive after their requested documents from a site 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.

Returned Document Notifiction job