Trial Master File (eTMF)

TMF Overview and Access

There are FOUR requirements for accessing the TMF:

• Licensing is enabled on the account

• User has been identified as “TMF user” in the host User Manager by an Administrator

• The user’s host level role has permissions to access the TMF and specific permissions required for that role.

• The user has view access to at least one folder

Continue reading about how the 2nd two of those are controlled.

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.

TMF Permissions

Permissions in the TMF have two factors:

• Which functions the user’s host level role has rights to. The permissions for each user role are granted at the host level by an Administrator.

• The user’s access to specific folders in the TMF, discussed next.

Folder and File User Permissions

If a user’s host-level role has access to the TMF but the user has not been given access to any folders or files within it, they will see a blank screen.

User permissions are granted within the node properties. Read about properties further below.

When granting someone access, a prompt will ask if you want to give them access to the current folder only, or also give them access to sub-folders that might exist. This level of control ensures users can only access very specific folders regardless of how the folders are organized.

Tip

To give someone access to the entire TMF, 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.

Accessing the TMF

The TMF is located under the Host menu

This will open the table of folders (“nodes”) that are available based on the view permissions granted to the current user’s host-level role. Tap any folder to expand the contents of only that folder, or the expand/collapse all icon to perform the same action on that folder plus all of its sub folders:

What are Nodes?

Files and Folders are referred to as "Nodes" within TrialKit and throughout this help document. This is because TrialKit has the advantage of being connected to a blockchain where each entity (folder or file) exists as a node in the blockchain.

Viewing Files

If a user has View permissions for a file, it will be listed in the TMF. Those 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, an option to download will be provided.

Tasks

The Tasks report will display any assigned tasks.

Viewing All Open Tasks

Administrators may need to see all tasks for all users across the TMF. This is possible with the corresponding permission granted. This list can also be exported from the Tasks window, or searched for specific users or action items.

Adding Folders or Files

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.

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. The folders and files shown in this article are examples. Every TMF will have different content.

Access folder or file properties

Prerequisite

User must have access to folder properties to modify any properties. Basic properties can be seen by the node owner.

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 - Optional name to display in the TMF table instead of the original file name

• Description of the file - For internal notes/comments

• Effective date - The date the file was uploaded, unless manually changed

• Expiration date

• Expiration duration - This is a number of days since the last user reviewed the document

• Active status

• Filed at site

• List of users and permissions

• List of Reviewers

Renaming or Copying Folders and Contents

Prerequisuites

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.

What gets copied?

Copying folders will only copy the folder structure by default (no files included). However, there is an option to also include placeholder files when the copy is being done. Any placeholders that exist in the source folder(s) will be copied as well. This is useful for templates to be re-used and already have the expected placeholders ready in the new location.

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:

Downloading Files

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

Where Do Files Get Downloaded On iOS?

On iOS devices, downloading a file will download it to the device’s 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.

Web browser:

Mobile App:

Uploading Files

Prerequisite

A user must have the role permission to Upload 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 will be the file's "owner" (as seen in the file properties), 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 that was added.

The effective date of the file will be set based on date of upload, but this can be modified in the file’s properties panel after upload.

Uploading multiple files at once

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.

Here’s an example where 3 files are selected in the file explorer prior to uploading.

If adding a new single 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 version over an existing one

• 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.

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 list. The exception to this is if the reviewer was assigned on a placeholder file. In that case they will get notified later when the file is uploaded.

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 the user’s role to have permission.

Here the .docx file can be seen as being fully reviewed by all assigned users:

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.

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.

TIP

Reviewers can also be assigned ahead of time on a placeholder. Reviewer users will not get notified of their review task until the file has been uploaded.

Once the user uploads a document in place of the placeholder, the effective date will get set for the date of upload, but can be modified if needed in the properties

Study Filter (Parent folder filter)

Since the TMF is user-defined, it can be organized with parent level folders being based on anything. Most commonly, parent folders are configured as studies. For this reason, to make the TMF easier to manage across multiple studies or projects, there is a parent level filter at the top of the TMF table on the web, which helps a user focus on specific projects at once.

Search For Files

The search function can be used to quickly type part of a folder or file name and jump to that node’s position in the TMF.

As search results are displayed, hovering over each item will display its full path.

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

• Node archived - When a folder or file is archived manually by a user

• Node restored - A file that was previously archived that has been restored to active status

• File archived - A new file was uploaded over an existing file, which caused the previous version to get archived

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

Prerequisite

Access to the TMF Audit Report is based on the corresponding permission granted by a host Administrator

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.

This report is intended only for Administrators as it gives audit details about all TMF content.

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 on both web and app:

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.

If the file has not yet been anchored in the blockchain, there is a button to Register the file.

What is the Blockchain and How Does it Work?

The blockchain is an open and independent location for storing transactions and encrypted content. The content of files is secure from other users seeing, but the existence of a file's content is public. The blockchain is host specific, so the content of a given file is unique with a host and cannot exist multiple times. In other words, as an example, Jane Doe’s CV from 2023 can only be uploaded once on ACME Pharma’s host. It then gets anchored in the blockchain and cannot be disputed. If that same exact file (regardless of the file name) is uploaded again, it will be blocked.

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.

CDISC (DIA) Trial Master File Template Zip File

Creating a Zip file on Mac OS

Mac computers running Mac OS create zip files with .DS_store system files included. This is unfavorable when using that zip file to import to a TMF. Please create zip files using a PC or Chrome OS to avoid that behavior.

Deactivate vs Archive vs Delete

If a folder is no longer needed, but it still needs to be retained, the folder can be either deactivated or archived. This section covers the difference.

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Archiving and deleting can be done by any user with the permission to delete files and folders.

Deactivating files can be done by any user with the permission to access file properties.

Archiving

Use this when a folder or file is no longer needed, but still needs to be retained long term for record keeping. The option is found in the right column of the table on the web, and will prompt for confirmation.

Archived nodes get moved to an archiving location which is only accessible to users who have the host level permission to View all files and folders. Any other users who had view access on the archived content, but do not have that permission, will no longer be able to access it.

Note

The action of archiving a node is reversible.

Deactivate

For retaining a file in a still-active folder, but where the file is not needed in immediate view at all times.

For example, an older version of the study protocol is still needed in the active study folder, but the Administrator only wants the current version of the file displayed.

To deactivate a file, open the properties window (web only):

Deactivating a file or folder will remove it from the default view of all users who have view access, but will not remove their access (i.e Those users can still see the files when using their own filters).  Based on the situation, it’s worth considering if user access needs to be removed before deactivating the file.

To view inactive files, simply toggle the filter at the top of the TMF table. All users have access to this filter.

Deleting Folders or Files

Deleting will completely remove the content from the TMF and is not recoverable. A file can only be deleted within the archives after it has already been archived. To permanently delete a file, open the Archives and tap the delete button.

Closing A Study or Folder

Archiving a study folder is normally the recommended approach. This way all users maintain the access they had for the purpose of easily seeing who had access to the nodes in the past. However, since the folder is archived, the users will not actually have access.