Trial Master File (eTMF)

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TrialKit’s Trial Master File (TMF) application allows users to create a customized folder structure for the purpose of controlling, and storing important documents related, but not limited, to sponsor, sites, users, or studies. Built-in review and approval is coming soon.

TMF Overview

The TMF exists at the host level, so is not tied to any specific study within the host. This allows folders to be created for different applications and workflows. For example, folders can be created for each study to house corresponding documents, and permissions can be granted to specific folders based on users in each study if needed.

Access and Navigation

There are three requirements for accessing the TMF:

• Must be enabled by CDS based on licensing

• Users have been identified as “TMF users” in the host User Manager

• Permissions are granted and managed at the host level by an account Administrator

A user who has access can find it under the Host menu of the website, or on the main home screen of the mobile app.

Web:

Open

Mobile App:

Open

This will open to 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 setup 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.

Mobile App View:

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 review on an existing file.

On the mobile app, tap Reports, then Task List

Viewing all open tasks

To see all tasks across the TMF, the corresponding permission must be granted. This can be exported for the purpose of producing any reports to see open tasks at a given time point.

Folder and File 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 on the web:

or, on the mobile app, the “Properties” option for the current selected folder/file:

This will open a screen containing various file properties, node history, and 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.

Viewing Files

With View permissions, files can be previewed within both the web and mobile app without downloading.

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, TrialKit’s file viewer may open the document. As a last resort, the file may need to be downloaded to view it locally.

On the app, tap the file row and then the Preview button at the top of the screen:

Downloading and Updating Files

Downloading

Any user who has access to view files within folders will be able to download the file.

When doing so, if the user also has permissions to change the file, they will have the option to lock the file in the process. This can be helpful to prevent others from changing the file while its being worked on.

If the user only has view permissions, there will not be an option to lock the file.

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 its been unlocked again.

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.

Uploading Files

When the file is unlocked, the user (or any other user with change permission), will be able to upload a new version.

If upload is performed on a folder, it will create an entirely new node.

On the web, to upload a new version of an existing document, use the upload icon for that file:

On the app, tap the file, followed by the upload button at the top:

Copying Folders and Content

Folder structures and content 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. Optionally, files can also be included. This will create copies of the original files from the source folder.

Copying requires permission being granted and the user having view access to the folder being copied. When a folder is selected, the “copy” option will appear at the top of the screen (on the mobile app).

Placeholders - Assigning Tasks to Upload Documents

Its common that files need to be collected from other parties who don’t necessarily have full access to the TMF. This is where creation of “Placeholders” comes in.

To create a placeholder, the current user’s role must have both permission to do so, and 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:

Type in the Name of the placeholder and assign it to a user. The list of available users is based on users in the account that are TMF users.

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 Tasks as described above.

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. This icon will display on the web next to all files and folders:

Tap the icon to open a list of users to assign:

Once users are assigned, they will receive an email notification and see the task in their task lists:

Tapping the task row or icon 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 historical listing of documents that underwent review/approval and what version it was performed on.

On the mobile app:

File Expiration

The file properties allow for defining an expiration in number of days. Once a file has been fully reviewed, a 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/creator.

Activities Audited By the TMF

The following transactions are tracked by 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 app it can be found via the Reports button at the top. On the web, there is a button to access at the right side of the table.

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