Permissions: Users with the Administer, Study Configure, or eDrive Read Write privileges can upload documents in Study Advisor.

Study Advisor centralizes study documents, AI-extracted study details, AI-suggested Review Objectives, and protocol-driven study setup in a single location.

Study Advisor is enabled per study on the Settings tab of the Add / Edit Study window and must also be enabled at the URL level. For details, refer to the Configure and Manage Studies article in the Administration section.

Access Study Advisor

Study Advisor is accessed from the Study Management drop-down within a study. 
 

Study Advisor is also available from the Study Management section of the Platform Menu.

Study Advisor opens with the Documents, Details, and Review Objectives sections in the left navigation.

Manage Documents

The Documents section supports uploading, downloading, versioning, and managing the Study Protocol and other study documents. Each document card displays the file name, a version badge, the Uploaded Date, Uploaded By, and File Size, and the Upload New Version and Download buttons. Click Upload New in the masthead to upload a new document as a new card.

• Study Protocol: Uploaded to the dedicated Study Protocol card, which is always the first card. Supported in PDF and DOCX formats up to 50 MB. Files cannot be deleted from the Study Protocol card.
• Other study documents: No file type constraints, with a 1 GB file size limit. Documents can be downloaded or deleted, including deleting the current version or all versions.

Upload the Study Protocol

1. In the Documents section, locate the Study Protocol card (the first card).
2. Upload the Study Protocol in PDF or DOCX format (up to 50 MB). To upload a new version, click Upload New Version on the Study Protocol card.

Note: Uploading a Study Protocol to the Study Protocol card automatically triggers AI extraction of study details and generation of Review Objective suggestions.

Important: Files cannot be deleted from the Study Protocol card, so verify the correct file is uploaded before proceeding.

Manage Document Versions

Documents are versioned upon upload using the Upload New Version button on each card. The version badge on the card image displays the current version, for example, v1.1. To view a document's version history, click the Version History (clock) icon next to the Download button. The Version History panel opens and lists the previous versions, with the number of previous versions at the top. Each row displays the version number, upload date and time, uploader, and file size, and a Download icon for downloading that version.

Note: The Version History icon displays after a new version is uploaded to a card. Supporting document cards also display the Delete icon.

View Details

The Details section displays the AI-extracted study details from the latest Study Protocol version. The section is read-only and remains synchronized with the latest Study Protocol version.

Push to Study Configuration

The Push to Study Configuration button updates the existing study configuration to align with the latest Study Protocol.

1. In the Details section, click Push to Study Configuration. The Study Configuration window opens with suggested values populated for fields that differ from the study's current configuration.
2. Review the suggested values. Fields with suggested values are marked with a sparkle icon; hover over the icon to display the previous value for comparison. Fields that already match remain unchanged.
3. Click Add to Configuration to add the suggested values to the study configuration. 

Note: If all AI-extracted details already match the study's configuration, the Push to Study Configuration action is disabled.

Review Objectives

The Review Objectives section provides a centralized location for reviewing and managing AI-generated Review Objective suggestions based on the uploaded Study Protocol. For details, refer to the Manage AI-Powered Review Objective Suggestions in Study Advisor article in the Study Advisor section. 

Sync Files From eDrive

Important: Study Advisor's Documents section is integrated with the eDrive Protocol folder. While Study Advisor is enabled, the eDrive Protocol folder is read-only, and users are redirected to Study Advisor, where documents are managed. Documents uploaded in Study Advisor are also stored in the eDrive Protocol folder. For studies with Data Advisor enabled prior to Study Advisor, the first time users navigate to Study Advisor, a Sync From eDrive is required to migrate documents to Study Advisor, making Study Advisor the single source of document management.

1. Navigate to Study Advisor for the first time. The Sync From eDrive window opens and lists all files in the eDrive Protocol folder.
2. Designate one file as the Study Protocol. 
3. Complete the sync. Any remaining files are imported as supporting documents.