Trial Master File
A typical usage of our portal is to share & upload Trial Master File (TMF) documents. Needless to say that having a single source for all TMF documents which is 24/7 available, is of great value. The section below will discuss some of the features in more detail.
Click on a topic for more details:
The built-in feature set of the Portal allows to create detailed TMF access rules for each User or Role. A number of different 'layers' are available to grant or revoke access to TMF content.
Multiple TMFs per trial can be created, like a TMF with internal documents, a general TMF and TMFs containing only Site-related documents.
A first layer is that Menu options allow to control access to each type of TMF as each Menu can be enabled or disabled per Role or even per User.
A second layer of access is controlled by the fact that users working at a Site are linked to that Site and as a result, will only be able to access content of the Site(s) to which they are linked.
For example, if you have Site TMFs , then each Site user will only be able to view/access their own site TMF.
And the last and most detailed level of security is by granting (or revoking) specific access rights to either all Users within a given Role or even to specific Users. This allows to grant 'Upload access' to 'Investigators' for a specific section of the TMF. Or to Revoke 'View access' to Study Nurses for financial topics.
Two options are available for uploading a Document into a TMF. The most commonly used method is by uploading a document into the corresponding (sub)topic of a TMF. Each (sub)topic has its own upload button. When clicked, the document will be uploaded and automatically tagged (linked) to the (sub)topic.
A second method is that documents can be emailed to a dedicated email-address. A Document Adminstrator will be notified upon receipt of a document and then be ablte to tag the document to the corresponing (sub)topic of a TMF.
Events
Certain actions, like sending a Notification to a user, can be programmatically linked to an 'Event'. An Event can be anything, like:
- changing the status of a document from 'draft' to 'active',
- a user downloading a document,
- a document being updated to a newer version.
Each of these event can be programmed to result in one or more Users being notified of the specific event.
Tasks
One of the modules in the Portal is the 'Task Center'. The Task Center provides an overview of the tasks awaiting for user(s). Similar to events, tasks can be programmatically set.
For example, a document workflow could be defined where Investigators are allowed to upload doucment into the Portal. Such documents could be automatically set to status = 'draft'. Uploading a document by an investigator could be defined as an Event, resulting in a Notification being sent to document administrator(s). A Task could be set for document administrator(s) to review any Investigator uploaded documents and set their status to 'Active'. Each document to be reviewed would then be listed in the Task Center.
Timed Triggers
Timed Triggers are a very useful component in handling workflow. Most of the actions in a Portal are 'user-triggered', like a notification being sent when an Investigator uploads a document. Timed Triggers are actions which can be set to be executed at certain points in time (eg each Monday at 9:00 AM). This can be used to check each Site if a reminder has be sent for any missing documents. Or to send a weekly, or daily, reminder to document administrator(s) to review any documents with status 'Draft'.
Example of a weekly 'Timed Trigger' email which notifies users of documents which have been uploaded in a TMF.
A standard policy in the Portal is to track each Document action, like uploading, viewing or downloading a document. As each user is known inside the Portal (as he/she has to login first), each time a document is accessed, a record will be created in an Audit Trail. This Audit Trail allows to check which of your users has actually viewed a certain document (and when).
