Managing Protocols Documents

Vestigo’s document management module enables a paperless pharmacy binder, organizing files into clear sections. Features like drag-and-drop, filters, and pagination streamline navigation within the application.

Protocol documents is designed to store information related to the protocol. Files like Protocols, Amendments, Pharmacy Manuals, and IBs can be added here. The files can be uploaded and sorted into one of the designated sections below:

• Protocol Information
• Dispensing Guidelines
• Communications/Memos
• Documents Visible on Patients/Subjects Tab
• Order Documents Visible on Dispense
• Other
• Master Protocol Forms

Unlike Transaction Documents, these documents can be managed directly on the Protocol Documents tab, with one exception, Order Documents Visible on Dispense.

Vestigo supports up to a max of 50 MB per file, and a variety of file types that include: .doc, .docx, .pdf, .jpg, .jpeg, .png, .gif, .txt, .xlsx, .xls, .ppt, .msg, .ttv, .tiff, .pptx.

Historical Shipments

For studies that were active prior to Vestigo Version 5.1 (July 2020), there is also a section for shipment receipts previously associated with a receive completed prior to Vestigo Version 5.0 (February 2020).

The Protocol and Transaction Documents tabs each contain a section for Historical Shipment Receipts. Documents grouped under Historical Shipment Receipts, whether within Protocol Documents or Transaction Documents, relate to received items and were added to Vestigo before February 2020. If the document source was “Protocol” (uploaded via Edit Protocol > Documents), the document is now housed in Protocol Documents > Historical Shipment Receipts.

Permissions Needed

ProtocolSnapshot - Ability to view the Summary page of a Protocol (Protocol Snapshot). Required for all other protocol view permissions.

ProtocolDocuments - Ability to view and manage protocol documents in a protocol

 EditProtocolDocuments - Ability to edit Protocol Documents tab 

Contents

1. Visibility Options
2. Filters and Pagination
3. Uploading a Document
4. Creating a Document
5. Editing a Document
6. Deleting a Document
7. Managing Documents in the Order Documents Visible on Dispense section
8. Certifying a Document

Visibility Options

When a file is added to Vestigo, it will have the client level default visibility options automatically set. These options are "Visible on Protocol" and "Visible to Monitor". When a File has the "Visible on Protocol" checked, the file is visible on the Protocol Documents or Transaction Documents tabs at Protocol Snapshot. When a File has the "Visible to Monitor" flag checked, the file will be visible to monitors when they are reviewing the protocol during a routine Visit.

Some files may have both flags checked, some may only have one, and some may have none. If a file has no visibility flags checked, the file will always be visible when the user is in Protocol Management mode, or commonly referred to as Edit Protocol.

Visibility options can be modified directly on the Protocol Documents Tab. If you want to bulk update visibility for transaction documents, please reference this KB article.

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Filters and Pagination

The link for “Hide/Show Filters” allows users to search and organize the documents that appear on the grid based on the filters applied.  

For categories containing numerous documents, the pagination feature located at the bottom of the section facilitates efficient navigation. Users may adjust the number of rows displayed per page by utilizing the dropdown menu positioned in the bottom left corner of the section.

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Uploading a Document

Adding a document to most sections of Protocol Documents can be done directly on the Protocol Documents tab.

1. Navigate to the Protocol
2. Click on Protocol Documents tab
3. Click on Manage
4. Locate the section you wish to upload the file to and click on Add New
5. Select Upload File
   
   
6. (Optional) Modify the visibility options. Client settings are defaulted here but can be adjusted.
7. Users can drag and drop to the area on the screen, or they can click to use the explorer to locate the file.
8. Once uploaded, the screen will refresh and users will see the newly uploaded file with the selected visibility options.

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Creating a Document

In some instances, uploading a document isn't an option and instead, users can choose to create a file that can also be easily modified directly in Vestigo.

1. Navigate to the Protocol
2. Click on Protocol Documents tab
3. Click on Manage
4. Locate the section you wish to upload the file to and click on Add New
5. Select Create File
   
6. Enter a File Name
7. (Optional) Modify the visibility options. Client settings are defaulted here but can be adjusted.
8. (Optional) Users can select a template that was built prior to creating the protocol document from the Template Drop Down. Only one template can be used at a time.
9. Enter the note into the note section
10. Click Save

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Editing a Document

The types of modifications users can do to Protocol Documents are dependent on the type of file to be edited is.

• If the file was uploaded, users can edit the file name, visibility, and file certification.

• If the file was created, users can edit the file name, visibility, and the content of the created document.

To edit the document:

1. Navigate to the Protocol
2. Click on Protocol Documents tab
3. Click on Manage
4. Locate the file to edit and click on Edit
5. Modify the options as needed
6. Click Submit

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Deleting a Document

In certain instances, like uploading to the wrong protocol, a document may need to be deleted out of Vestigo. 

1. Navigate to the Protocol
2. Click on Protocol Documents tab
3. Click on Manage
4. Locate the file to edit and click on Delete
5. Users will need to confirm the deletion of the document by clicking Confirm

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Managing Documents in the Order Documents Visible on Dispense section

This is a special section of Protocol Documents. This section shows all files that are uploaded to Vestigo Order builds. From Protocol Documents, these files can be downloaded, modified or deleted. However, to Add Files, to this section, you have to add them to the Protocol Order. If you click Add New in this section of Edit Protocol Documents, Vestigo will take you to the Protocol Orders section to manage files.

1. Navigate to the Protocol
2. Click On Edit Protocol
3. Click on Drugs/Orders tab
4. Scroll down to the Orders Section
5. Locate the order you want to add a file to and click Manage Files
6. Click Add New
7. If the user is Uploading a file
   1. Select Upload File
      
      
      
   2. (Optional) Modify the visibility options. Client settings are defaulted here but can be adjusted.
   3. Users can drag and drop to the area on the screen, or they can click to use the explorer to locate the file.
   4. Once uploaded, the screen will refresh and users will see the newly uploaded file with the selected visibility options.
8. If the user is Creating a File
   1. Select Create File
      
   2. Enter a File Name
   3. (Optional) Modify the visibility options. Client settings are defaulted here but can be adjusted.
   4. (Optional) Users can select a template that was built prior to creating the protocol document from the Template Drop Down. Only one template can be used at a time.
   5. Enter the note into the note section
   6. Click Save

To modify these documents, you would follow the same steps from this section of this article.

Certifying a Document

Certifying documents allows users to document that the document added is an exact copy of the physical document. Only files that were uploaded can be certified. Files that are created in Vestigo cannot be certified. For instructions on how to certify a document, please reference our Certifying a Document KB.

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