Note Only SiteVault users with the Site Administrator system role can complete the tasks on this page.
Once a connected study is active, sponsor and CRO teams will send you a regulatory document request package for the study, which is displayed as a task for your site’s Site Administrator users and can be viewed in the Documents > Regulatory Document Requests tab. All documents received from a sponsor or CRO are also displayed in your Library in a Received from Sponsor/CRO state.
The Regulatory Document Requests page consists of the sections below. You can sort, search, and paginate the document sections as needed.
- Details: Displays general information about the regulatory document requests such as the study and due date.
- Documents to Return: Displays documents that require you to take action such as revising and returning a document.
- Other Received Documents: Displays sponsor-original documents that should be kept on file at your site.
- Returned Documents: Displays documents that have been sent from your SiteVault to the sponsor or CRO.
To get started, select Accept on the Regulatory Document Request task and complete any open requests.
Each package contains several individual document requests. See the sections below for more information on the types of requests that you might receive. When you complete the last item in the Documents to Return section, SiteVault automatically closes the Regulatory Document Request task for you.
See the Sending Documents to Sponsor/CRO page for more general information on exchanging documents with a sponsor or CRO’s vault. See the Viewing Document Tracking and Comment History page to learn how to view and export the exchange and comment history of Connected Study-related documents.
Revising and Returning a Document
Located in the Documents to Return section, revise and return documents are those sent from the sponsor or CRO for you to update or sign then return, for example, a Protocol Signature Page or Acceptance of IB.
Complete the following steps to complete a revise and return request:
- Initiate the appropriate action on the document, for example, sending the document for PI eSignature or updating the document and moving it to its final state.
- From the document’s All Actions menu, select either Send Document to Sponsor/CRO or Send to Sponsor/CRO as appropriate. The option that’s displayed depends on the document type.
- Enter any comments as needed in the dialog box, then select Continue. The document is removed from the Documents to Return section and, once the transfer is complete, is displayed in the Returned Documents section.
Providing an Original Document
Also located in the Documents to Return section, these requests are for site-original documents (for example, an IRB/IEC Composition document for a local IRB). A provide original request requires you to select an existing steady-state document from your library.
Complete the following steps to provide an original document:
- Ensure that the document exists in your SiteVault and is in a steady state. See the Creating Study Documents help topic to learn more about adding your original documents to SiteVault, and see the Moving Study Documents to the Steady State help topic to learn how to make the document Approved for Use, Current, or Final.
- In the Documents to Return section, select Select Existing Document from the actions menu on the row of the request.
- Select the appropriate document in the dialog box, then select Close.
- Select either Send Document to Sponsor/CRO or Send to Sponsor/CRO as appropriate from the actions menu of the request, enter any comments as needed in the dialog box, then select Continue. The document is removed from the Documents to Return section and, once the transfer is complete, is displayed in the Returned Documents section.
Processing Other Received Documents
Sponsor-original documents for which a copy should be kept on file at the site (for example, a Procedure Manual) are displayed in the Other Received Documents section of the regulatory document request.
With the exception of sponsor-provided templates such as a financial disclosure form, simply process these documents to a steady state (such as Current or Final) as appropriate. See the sections below for more information.
Identifying Sponsor-Provided Templates
When a study document is received from a sponsor or CRO, you can determine whether to approve the document as a sponsor-provided template. If approved as a template, SiteVault prepends [Sponsor Template] to the name of the document, and you can make copies of the document to edit as needed. This ensures that you can easily distinguish documents that are sponsor-provided templates from nontemplate documents.
This option to designate a received document as a sponsor-provided template is available on the following document types:
- Advertisement for Recruitment
- Diary (blank)
- Financial Disclosure Form
- Informed Consent Form (blank)
- IP Accountability
- IP Quality Complaint
- Participant Materials - Other
- Participant Questionnaire (blank)
- Participant Information Sheet
- Study Participation Card
Complete the following steps to specify whether a received document is a sponsor-provided template:
- From the document’s Workflow Actions menu, select Make Approved for Use, Make Current, or Make Final. The option that’s displayed depends on the document type.
- If the document should be designated as a sponsor-provided template from which you can make copies and edit if needed, select Yes. The document is approved and designated as a Sponsor Template and is available to be copied.
- If no site-specific edits or copies are needed, select No. The document is approved and filed to your eBinder but isn’t considered a template.
- Select Start.
Note For any documents designated as a sponsor-provided template, use the Make a Copy action to begin the editing process or each time a copy is needed. Any documents that are copied from the sponsor template are permanently linked to the template document.
If the source template document is ever updated, you can use the Create Draft from Original Document action on the copied document to update the document to the new template version.
See the following help topics to learn more about how to send a study document based on a sponsor-provided template back to the sponsor or CRO:
Completing Financial Disclosure Forms
A financial disclosure form is sent as a template from the sponsor or CRO and is displayed in the Other Received Documents section of the regulatory document request package.
Complete the following steps to complete a financial disclosure form for each site staff member as appropriate:
- From the document’s All Actions menu of the financial disclosure form template, select Make a Copy then select Continue in the dialog box.
- Select the appropriate site staff member in the Person field, then select Save. A draft Financial Disclosure Form document is created. See the Making a Copy of a Document help topic for more information.
- Select Check Out from the All Actions menu of the new draft document. The template is downloaded to your computer.
- Open the downloaded file and complete the form.
- Select Check In from the All Actions menu, upload the completed form using the dialog, then select Check In. See the Checking Out Documents help topic for more information.
- Finalize the document using the most appropriate option. If not already signed, you can send for electronic signature. See the Draft to Final Lifecycle section on the Managing Study Documents page for more information.
- Select Send Document to Sponsor/CRO from the All Actions menu to return the completed form.
Rejecting a Document
Note While rejecting a document removes it from the request, it doesn't remove it from SiteVault. If needed, you can delete the document in the document library to remove it from SiteVault.
You can reject documents or requests that are duplicates, not needed, or incorrect to remove them from the regulatory document request.
Complete the following steps to reject a document or request:
- In the Documents to Return section, select Reject from the actions menu on the row of the document or request.
- Select Yes in the Reject Document Request dialog box.
Finding Documents Sent to SiteVault
Received documents for a connected study are in a Received from Sponsor/CRO state. Creating a shared view for documents in this state helps you to easily identify these documents in the document library. You can also find received documents for a study in the Documents > Regulatory Document Requests tab.