Document Actions: Available Tasks

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The tasks below can be completed from the Document Exchange Document Actions tab.

See the Document Exchange in Study Connect training video for more information.

Download Document

Complete the following steps to download a document to open, save, or print locally:

1. Locate the document on the Document Actions table.
2. Select the Download icon related to the Document Action.

Send Document/Respond to Document Action

Complete the following steps to send a document to the connected sponsor or CRO’s vault:

1. Locate the document on the Document Actions table.
2. Select the Send icon related to the Document Action.
3. Select the send method:
   • There are 2 send methods available:
     • Upload: Upload from your computer via folder browse or drag-and-drop.
     • eRegulatory Documents (only visible to eRegulatory users): Select a document from the eRegulatory application.
   • If uploading, then:
     • Select the document by browsing folders or dragging it to the blue shaded area.
     • Once added to the Uploaded section:
       • Select the document name to review the document.
       • If incorrect document, select the X icon to remove.
       • Complete the Description field.
       • Complete the Comments to Sponsor/CRO field.
       • Select Send.
       • Select Continue to confirm your action and complete the process..
     • If sending eRegulatory documents, then:
       • Select the document name to review.
       • Select the updated document.
       • Complete the Comments to Sponsor/CRO field.
       • Select Send.
       • Select Continue to confirm your action and complete the process.

Update and Return Action

Complete the following steps to apply updates and send an updated document to a sponsor or CRO in response to a requested Document Action:

1. Locate the document on the Document Actions table.
2. Access the document:
   • If not using eRegulatory, then select the Download icon related to the Document Action.
   • If using eRegulatory, then access the document in eRegulatory.
3. Update the document:
   • If not using eRegulatory, then:
     • Update the document locally.
     • Save the updated version locally.
   • If using eRegulatory, then update the document in eRegulatory.
4. Select the Send icon related to the Document Action.
   • If uploading, then:
     • Select the document by browsing folders or dragging it to the blue shaded area.
     • Once added to the Uploaded section:
       • Select the document name to review the document.
       • If incorrect document, select the X icon to remove.
       • Complete the Description field.
       • Complete the Comments to Sponsor/CRO field.
       • Select Send.
       • Select Continue to confirm your action and complete the process.
     • If sending eRegulatory documents, then:
       • Select the document name to review.
       • Select the updated document.
       • Complete the Comments to Sponsor/CRO field.
       • Select Send.
       • Select Continue to confirm your action and complete the process.

Reject Document Action

Complete the following steps to reject a Document Action that has been received in error or is a duplicate request:

1. Locate the document on the Document Actions table.
2. Position your pointer over the Document Action row.
3. Select the Reject icon in the last column.
4. Provide a comment to explain the rejection.
5. Select Yes to confirm your action.

Send Additional Documents

Complete the following steps to send documents to a sponsor or CRO’s vault outside the context of a requested Document Action:

1. Select Send Additional Documents.
2. Select the Send icon related to the Document Action.
   • If Uploading, then:
     • Select document by browsing folders or dragging to blue shaded area (100 documents or less).
     • Once added to the Uploaded section:
       • Select the document name to review the document.
       • If incorrect document, select the X icon to remove.
       • Complete the Description field.
       • Complete the Comments to Sponsor/CRO field.
       • Select Send.
       • Select Continue to confirm your action and complete the process.
   • If using eRegulatory Documents
     • Only sendable document types are available.
     • Select the document name to review.
     • Select the appropriate documents (100 documents or less).
     • Complete the Comments to Sponsor/CRO field.
     • Select Send.

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Document Exchange: Overview

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Documents: Available Tasks

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