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Trial Master File (eTMF)

Setting up and Managing the Electronic File Control System

TMF Overview and Access

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 by each study to house corresponding documents, and permissions can be granted to specific folders based on users in each study if needed.

Study Administrators: In addition to the storage and management of these files, site and study forms can be collected electronically as well. Files can also be directly uploaded on those forms, but are not 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
  • The applicable permissions are granted at the host level by an Administrator

The TMF is located under the Host menu in the Web Browser:

TMFwebmenu

Or on the main home screen of the Mobile App:

TMFmobmenu

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.

 

 


Viewing Files

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

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:
TMFfilepreview


Downloading and Updating Files

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

TMFdownloadweb

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 other users from changing the file while it is being edited.

Mobile App:

TMFdownloadapp

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

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:

TMFlocked

Uploading 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 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.

image-20220414-202149

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 on the new version.

 

Mobile App:

image-20220414-202656

 

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 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 of a file that already exists in the blockchain, the TrialKit TMF will prompt you to rename the file so it can be unique.

 

 

 


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:

image-20220414-200123

Assign applicable users:
image-20220414-200355

Once users are assigned, they will receive an email notification and see the task in their task lists:
image-20220414-195216

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.

image-20220414-200653

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.

Mobile App:

image-20220414-201217

 

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.

Web Browser:

TMFpropweb1

Mobile App:


TMFpropmob1

Selecting the “Properties” option for the current selected folder/file will open a screen containing various file properties, node history, and list of Users for managing the file access permissions.

TMFpropmob2

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.


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 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:

image-20220414-195642

image-20220414-195720

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.

 

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.

Web Browser:

tmftasksweb

Mobile App:

taskmob

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.

Copying Folders and Content

 Copying requires permission being granted and the user having view access to the folder being copied. 

Folder 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. 

This 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:

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:

image-20220414-201657

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 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.
image-20220414-201336


Folder Structure Sample

Here are common folder and/or file examples applicable in a trial master file. Keep in mind that folders can be easily copied. If you create a structure for one study like you see below, it could easily be copied for subsequent studies.

  • Study Materials

    • Recruitment

    • Surveys

    • Instructions for Use (IFUs)

    • Product Labeling

  • Protocols

    • Final Signed Copies

    • Amendments

    • Change Summaries

  • Training documents

    • Site Training Materials

    • Sponsor Training Material

    • HSR Training Certs

  • Monitoring

    • Monitoring Plan

    • Site Initiation Letters/Reports

    • Site Activation Letters

    • Visit Reports

    • Site Close-out Letters

  • Data Management

    • DM Plans

    • CRFs

    • Completion Guidelines

    • Master randomization list

  • Protocol Deviations

    • PD Reports

    • IRB application submitted for PD

  • Safety Management

    • Safety Management Plan

    • AE reports

    • IRB application submitted for AE

  • Regulatory Authority Authorizations

  • Project Management

    • Timelines

    • Invoices

    • Meeting minutes

  • Notes to File

    • NTFs

    • Letters and emails

    • Meeting notes

    • Telephone calls

  • Vendor Management

    • CRO contracts

    • Project Plans

    • Correspondence

    • Meeting minutes

  • IRB

    • Submissions

    • Approvals

    • Roster

    • Correspondence

  • Study Agreements

    • CTA and SOWs

    • Investigator Agreement

    • Study Insurance

  • Site Management

    • Contact List

    • Delegation of Authority (DOA)

    • Site Documents

    • Study staff qualifications

  • Informed Consent Documents

    • IRB Approved Copies

    • ICF Checklists

    • Amendments

  • Inventory Management

    • Shipping Records

    • Device Accountability Logs

  • Country Master Files