Setting up and Managing the Electronic File System
Table of Contents:
Downloading and Uploading Files
Review and Approval of Documents
TMF Overview and Access
Study Administrators: In addition to the storage and management of these files, site and study forms can be collected electronically as well. Files can be directly uploaded on-site and study forms, but note that they will not be related to files stored in the TMF. Keep this in mind when choosing which tool best fits your requirements.
There are three requirements for accessing the TMF:
- Must be enabled by CDS based on licensing
- User has been identified as “TMF users” in the host User Manager by an Administrator
TMF User
Users who will use the Trial Master File (TMF) in any capacity should be given access by an Administrator as shown below. This will display the user as an option when assigning TMF tasks.
Web Browser:
The TMF attribute is accessed in the user details as shown below.
- The applicable permissions are granted at the host level by an Administrator
The TMF is located under the Host menu in the Web Browser:
Or on the main home screen of the Mobile App:
This will open the table of folders that are available based on the view permissions granted to the current user’s host-level role. Tap any folder to expand its contents.
If the TMF has not yet been set up by a Host Administrator, by default there is only one “Root” folder which other folders can be created under. Note, the folders and files shown here are examples. Every TMF will have different content.
Viewing Files
With View permissions, files can be previewed within both the web and mobile app without downloading.
NOTE: Files and Folders are referred to as "Nodes" within TrialKit and throughout this help document.
Web Browser:
On the web, tap on the file name to open the preview window. Most common file types are supported natively in the browser. If support cannot be detected, an option to download will be provided.
Mobile App:
On the app, tap the file row and then the Preview button at the top of the screen as shown below.
Active Files
By default, only active files will be displayed. To see files or folders that have been deactivated, use the filter option at the top (Web Browser only) as shown below.
Tasks
The Tasks report will display any assigned tasks. Tapping on a task will open the node where the task can be performed. Tasks can include uploading files or performing a review of an existing file.
Web Browser:
Mobile App:
Acting On Tasks
There are three types of tasks:
- Upload a new file (placeholders)
- Review a file
- Set an expired file as inactive
On the web, use the icon within the tasks window to perform the corresponding action.
Viewing All Open Tasks
To see all tasks across the TMF, the corresponding permission must be granted. Tasks can be exported for the purpose of producing reports of open tasks at a given time point.
File and Folder Properties
Adding, Renaming, and Moving Folders
To add a new folder within another folder, tap the add folder option:
The user who adds a folder becomes the folder "owner", which can be changed at any time by anyone with access to folder properties. Email notifications sent for files uploaded into that folder will be sent to the folder owner.
Renaming or Copying Folders and Contents
Renaming and copying require the user to have edit property and copy permissions granted.
Folders can be renamed and structures can easily be copied for rapid recreation. For example, a study folder might contain a large number of sub-folders that need to be copied for another study or project. This prevents the user from needing to recreate all the folders manually.
NOTE: Copying will only copy the folder structures and will not include the file content.
To copy a folder and its subfolders, open the folder properties and tap the copy option as shown below.
Moving Folders
On the Web Browser, open the folder properties on the folder that needs to be moved. Tap the move option to enter a destination. Note, you must have view permissions for both the source and destination folders, along with access to view folder properties:
File properties
Prerequisite: User has access to Add/Change Properties
If a user has access to file properties, they will see several options to set various parameters about a file, including:
- File name
- Display name (name shown in the TMF table)
- Description of the file
- Expiration
- Active vs archive
- Filed at site
- List of users/permissions
Downloading and Uploading Files
Any user who has access to view files within folders will be able to download the file. Folders can also be downloaded, which will download all the files in that folder into a single zip file.
When downloading a file, and the user has permission to change the file, the user will have the option to lock the file in the process. This can be helpful to prevent other users from changing the file while it is being edited. If the user only has view permissions, there will not be an option to lock the file.
Mobile App:
On iOS devices, downloading a file will download it to the Files app > TrialKit app folder > eTMF Downloads
Locked Files
Locking a file is not required as part of normal workflow, but is a helpful tool to prevent accidental changes by users who have access to modify the file.
When a file is locked, other users can download it or view it, but cannot upload a new one to replace it until it has been unlocked.
Note, a user who has Modify permissions on an individual file will be able to lock/unlock that specific file - even if they don’t have the master permission to lock folders/files in general.
Mobile App:
When a file is locked, other users can download it or view it, but cannot upload a new one to replace it until it has been unlocked.
Uploading Files
Use the upload icon to upload a new file in a folder, or to upload over an existing file. If uploading a file to a folder, it will create a new file entity.
The user who initially creates a file is the file's "owner", but this can be changed later on.
The user who owns the folder where the file is uploaded will receive an email notification about the new file.
Batch file uploading is supported on the Web Browser. From the file explorer on your computer, use the CNTL or CMD key to select multiple files. Note, the more files selected, the longer it will take to process.
There is a max size limit of 250Mb per file
If adding a new file to a folder, there is an opportunity to rename the file during the upload process, so it does not need to be renamed later on. The user who owns the file will always be able to edit the name, but not any other properties unless they have permission to access properties.
Uploading new file versions:
- Will replace and archive the prior version.
- Will remove any reviewers if they existed on the prior version. Reviewers must be re-assigned to the new version.
Mobile App:
File Upload Notifications
When a new file is uploaded, the system will send a notification to the user who owns the folder where that file is uploaded. Folder ownership can be seen within the folder properties or in the folder structure export.
Review and Approval of Documents
Any node in the TMF can be assigned to individual users for review. Electronic Signature can also be required as an approval step.
To assign reviewers, a user’s role must have the associated permission. The icon shown below will display in the Web Browser next to all files and folders.
Assign applicable users:
Once users are assigned, they will receive an email notification and see the task in their task lists as shown below.
Tapping on the task will open the window to Accept or Reject the file.
Once all assigned reviewers have accepted the file, its status will be updated to Approved.
Uploading a new file will remove that status. Optionally, the file can be locked to prevent accidentally uploading a new version. File locking requires permission.
Review History
Versioned documents that get reviewed are stamped into a Review Audit report. This will display a current and historical listing of documents that are awaiting or underwent review/approval and what version it was performed on.
Web Browser:
Found in the list of links on the right side of the screen.
Mobile App:
File and Folder Properties
Access Permissions
The TMF is highly configurable when it comes to who can view or change specific files and folders within the directory. If the user has permission to change folder/file properties, they will see the ‘info’ icon next to the folders/files.
Web Browser:
Mobile App:
Selecting the “Properties” option for the currently selected folder/file will open a screen containing various file properties, node history, and a list of Users for managing the file access permissions.
How Permissions Work
If a user’s host-level role has access to the TMF but has not been given access to any folders or files within it, they will see a blank screen. To give someone access to everything, use the master permission ‘grant access to all files and folders’ within the host permissions. This is a simple shortcut to giving full access instead of checking the permissions on every folder.
For other users who only need view or modify access on specific folders/files (Nodes), open the properties for the applicable node and include that user as a view-only user, or a view-and-modify user.
Permissions are inherited on sub-nodes - meaning a child folder underneath a parent folder will get the same user permissions as its parent. If needed, the inherited permissions could be removed so the user only has access to the parent.
With that said, inherited permissions only work the first time they are granted to a user. If that user is later updated on a parent folder, by default the sub-folders will not inherit that change.
To force the same user permission down all sub-nodes, confirm the option that is presented:
Exporting File Permissions
To export and view all file permissions rather than opening each folder and file to see who has access, use the export link on the right. Note, this function is enforced based on access to the TMF audit report.
Placeholders - Assigning Tasks to Upload Documents
Sometimes files need to be collected from other parties who don’t necessarily have full access to the TMF. This is where the creation of “Placeholders” comes in.
To create a placeholder, the current user’s role must have both permission to do so, and the ability to modify the folder where the placeholder is getting created.
In this example, we need a specific user to upload IRB Approval. Tapping the ‘Add’ icon will present options as shown below.
Type in the Name of the placeholder and assign it to a user. All TMF users on the account will be listed.
The Description will be used by the system in the email notification that goes out to the assigned user as soon as the placeholder is saved. At this point, the user is notified and a task is assigned in the Tasks Report. That user can then access their tasks.
File Expiration
The file properties allow for defining an expiration. There are two ways to define expiration:
- By date
- Based on the number of days from the final review. Once a file has been fully reviewed, date of expiration is stamped (Day of Review + Number of days until expiration)
The expiration date can be seen in the main table:
Once that day is reached, the file will be made into a task for the file owner.
Expired files will remain as tasks until they are inactivated. This will remove them from both the task list and the default TMF view.
Exporting the TMF
There are five elements of the TMF that can be exported, some of which are covered in other applicable sections in this article:
- The folder structure in Excel format
- The files in zip format
- Audited activities
- Review History
- Folder/File Permissions
Normally, the best approach when the TMF is needed externally is to download the files from a specific folder (bullet 2 above). This will produce a zip file with the same folder structure of the folder that was downloaded. For example, if the entire TMF is needed for a given study and there are multiple study folders housed in the TMF, use the download button on just the one study folder. This can be done by anyone with view access to the folder.
Activities Audited By the TMF
The following transactions are tracked by the TMF:
- Created folder
- Deleted
- Locked
- Unlocked
- Added View right
- Added change right
- Removed view right
- Removed change right
- Downloaded
- General Access - user opening the TMF directory
- Uploaded file
- Changed right
- Removed all rights
- Node renamed
For each transaction, the following is tracked:
- Date and time
- Node name (file path)
- Node type
- Transaction
- User
- Version ID and number
- Blockchain hash
- User
Access to the full Audit Report is based on permissions. On the Mobile App, it can be found via the Reports button at the top. On the Web Browser, there is a button to access at the right side of the table.
Files In the Blockchain
A unique feature of TrialKit's TMF solution is its ability to store files in an independent blockchain for unparalleled audit trails and document security.
If the TMF account is enabled for blockchain storage - determined by the account Administrator - files will be automatically stored in the blockchain when they are uploaded.
If this is being done on your TMF, a button to "Verify" will display as part of the file properties when a file is selected.
Tapping the Verify button will run a real-time verification against the blockchain to ensure the file is still unchanged and display the date the file was registered in the blockchain.
What is the Blockchain and How Does it Work?
The blockchain is an open and independent entity for storing transactions and encrypted content. In other words, the content of files is secure from other users seeing, but the existence of a file's content is public. If a file has the same name and content as a file that already exists in the blockchain, the TrialKit TMF will prompt you to rename the file so it can be unique.
DIA Folder Structure Sample and Importing
Below is a common folder structure used which is based on the DIA model. Keep in mind that folders can be easily copied. If you create a structure for one study by importing this template ZIP file, it can be copied as a whole or in parts in the future.
Importing a zip file in the TMF gives users the option of unzipping the file to create the folder structure contained in the zip file
DIA Trial Master File Template Zip File
Closing Out a Study/Folder
If a folder is no longer needed for any reason, but it still needs to be retained, the folder can be deactivated. This will remove it from the default view of all users, but will not remove access. To also remove access, before deactivating the folder, update it's user permissions by de-selecting all users. When doing so, be sure to also apply those updated permissions to all sub-folders.
Now the folder is ready to be deactivated:
