Create Folders, and Add and Access Files in the eDrive File System

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Permissions: eDrive Global Read allows users to view global folder content.

eDrive Global Read Write allows users to create, upload, and modify content in global folders.

eDrive Read allows users to view study-level folder content (requires View privilege; access can be granted to all or specific studies).

eDrive Read Write allows users to create, upload, and modify content in study-level folders (requires View privilege; access can be granted to all or specific studies).

Note: Access to both global and study-level content requires assigning both global and study-level permissions in User Management.

eDrive is elluminate's file system for managing data, documents, and unstructured information. It features a global folder structure and separate folders for each study. Documents in global folders should be relevant across multiple studies; study-specific documents belong in study-level folders.

The benefit of eDrive is to share high-level information across multiple studies using global folders, and facilitate document sharing within a specific clinical trial using study folders. Plus, eDrive supports versioning by automatically tracking document versions upon upload. 

Access to eDrive is permission based. Some folders are write-locked, preventing any user from editing, moving, or deleting their contents. The Source folder for each study is an example of a write-locked system folder reserved for imported data.

eDrive Key Features

  • Upload multiple un-versioned files simultaneously (using Google Chrome browser).
  • Create, rename, and delete folders and their contents.
  • Rename and delete files.
  • View file version history.
  • Copy and move files between folders (where authorized).
  • Download files and folders.

eDrive Folder Structure

Global: The Global eDrive folder structure is client-specific and not standardized. However, when PDAP (Protocol Deviation Assessment Plan) files are imported, a PDAP folder displays under Global. PDAP files are read-only, and when files with the same name are imported, they are versioned within eDrive. Additionally, if a Global Data Store named PDAP exists, it is placed in the same folder where PDAP files are downloaded.

Study: Each study contains system folders supporting application mapping, transformation, and importing. These folders are automatically created for every study in elluminate:

  • Data (Legacy Data): Read-only. For most studies, this folder is no longer used for imported data; it now stores system data extracts retained within elluminate but not included in regularly updated data stores.
  • Metadata: Contains information related to 'define.xml' file imports.
  • PDAP: Version controlled and read-only. As new files are imported with the same name, they are versioned within eDrive.
  • Programs: Version controlled. Authorized users can upload data mapping configurations here for use during Excel imports.
  • Protocol: Stores the Study Protocol and related study documents. The Protocol folder is created when Study Advisor or Data Advisor is enabled for the study. While Study Advisor is enabled, the folder is read-only: a message states that the folder is managed by Study Advisor, and upload, delete, and edit actions are disabled.
  • Source: Read-only. Contains imported data organized by study, import date/time, and data store.

    Note: If access to a data store is denied, the data are not accessible in 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 documents are managed in Study Advisor. If Data Advisor was enabled prior to Study Advisor and eDrive was used to upload files, the first time users navigate to Study Advisor, a Sync From eDrive window opens and lists all files in the eDrive Protocol folder. One file can be designated as the Study Protocol, and any remaining files are imported as supporting documents. This sync migrates the documents to Study Advisor so it becomes the single source of document management. For details, refer to the Manage Study Documents and Details in Study Advisor article in the Study Advisor section.

    eDrive Protocol folder with a message that the folder is managed by Study Advisor, the Upload button disabled, and a Study Protocol file listed

Access eDrive

Access Global Level

  1. Click the Platform Menu (9-dot) icon in the master header.
  2. From the Platform Menu, select eDrive under File Management. All folders and files with access permissions display.

    Platform Menu with eDrive under File Management

    Note: The master header may show the name of the last accessed study, regardless of the current folder location.

    Global eDrive with the folder tree and folder contents

Access Study Level

  1. Click the Platform Menu (9-dot) icon in the master header.
  2. From the Platform Menu, select eDrive under Study Management.
  3. Select a study from the list in the Platform Menu. Only folders and files for the selected study display.

    Platform Menu with eDrive under Study Management and the study list

Alternatively, from within a study, click the Study Management drop-down in the master header and select eDrive.

Study Management drop-down in the master header with the eDrive option

The study-level eDrive opens with the study's folders and files.

Study-level eDrive with the study folder tree and file list

Create a Folder

Users with global or study read / write privileges can create folders at the corresponding eDrive level.

  1. Select the folder in the folder tree.
    Global eDrive with the folder tree and folder contents
     
  2. Click the Options icon and select Create.
    Options menu for a folder with the Create option
  3. A create folder window opens. Enter the folder name in the Folder Name field.
    Create folder window with the Folder Name field and the Use Version Control checkbox
  4. Select the Use Version Control checkbox (if needed).
  5. Click Create.

After the folder is created, files can be uploaded. Version control is enabled when the 'Use Version Control' option is selected.

Rename or Delete a Folder

Folder options may also include renaming or deleting a folder, depending on permissions. 

  1. Select the folder in the folder tree.
  2. Click the Options icon and select Rename or Delete.
    Options menu for a folder with the Create, Rename, and Delete options
  3. If Renaming: Enter the new folder name in the Rename Folder window and click Rename, or click Cancel.
  4. If Deleting: Click Yes in the Delete Folder window, or click No to cancel. 

Add a File

  1. Select the folder for the file in the folder tree.
  2. Click Upload.
    eDrive folder with the Upload button
     
  3. In the Upload window, drag the file into the window, or click Choose File and select the file.

    Upload window with the file drop area and the Choose File button

  4. Optionally, add comments about the file.
    If the target folder is version-controlled, the Version and overwrite, if the file exists checkbox is selected by default. Clear the checkbox to prevent versioning of the uploaded file.
    Upload window comments field and the Version and overwrite, if the file exists checkbox
  5. Click Upload. 
  6. Once the file has uploaded, click Close in the Upload window to view it in eDrive.
  7. If version control is enabled, the file version number is 1. Subsequent uploads increment the version number (for example, 2, 3).

By default, files are listed by date modified.

Access Folders / Files and Perform Actions

With multiple file versions, access is available to both the latest and previous versions.

Access File Versions and Details

  1. Click a file name in an eDrive folder to open its File Information window, showing all versions.
    File Information window with the list of file versions
  2. Click the Expand (plus sign) icon for a file to view its details (Action, Comment, User, Date/Time). Click the Collapse (minus sign) icon to hide the details.
  3. Click the Download icon to download the file to the computer.
     

Perform Actions on Folders and Files

Folder and file actions are available from the master header; options depend on user permissions and whether the item is a folder or file. 

  1. Select the checkbox for a file in the eDrive folder to display options in the master header.
    Selected file in an eDrive folder with the Download button and Options icon in the master header
  2. Click the Download button to download the file, or click the Options icon to select an option to copy, move, rename, delete, or download folder files.

View DICOM Images

DICOM (Digital Imaging and Communications in Medicine) (.dcm) images have both a Versions tab and Viewer tab. The image opens in the Viewer tab by default; click the Versions tab to view the version details.

  1. Click a .dcm file name to display its details and the image. The Width/Center view is selected by default.
  2. Click and drag the image to change the view.
  3. Click Measure, then click and drag on the image to make measurements.
  4. Click Probe, then click on the image to place a marker.
  5. Click Clear All to remove measurements, markers, and reset the image.

DICOM image in the Viewer tab with the Measure, Probe, and Clear All options

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