Knowing Your Roles

StudyTRAX is a role-based system. Only those granted a specific role will have access to that functionality / area of the application. With few exceptions, ALL roles granted to a user are specific to a Study (i.e., Project) and Site. The exceptions are the highest-level roles (i.e., System Administration, System Setup, Project Management, and Medication Management) (Learn More).


Video – What Is A Role? More On Roles

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Role With Access Across ALL “Customers”
System Administration    System Admin See Map
Responsibilities: Maintain application, manage global security settings, partition database into customers (within each customer, all system setup entities are shared [see system Setup]).
Typical User: Highest level technical staff, “super-user”. Reserved for IT manager(s) of entire system.
Where Assigned: During installation and afterward from within the System Administration area.
Roles With Access Within One “Customer” And Responsibilities Across Multiple Projects
System Setup    System Setup See Map
  (Optional) – Medication Managment
Responsibilities: Create and maintain entities that can be used across research projects including (1) Users, (2) Sites, (3) Subject Forms [e.g., demographics], (4) Project Forms [e.g., Budget and IRB information].
Typical User: Main technical staff for Customer. Reserved for IT manager(s) of entire Customer.
Where Assigned: Initially from System Administration, subsequently granted to others from with the System Setup area.
Following Roles Are ALL Site Specific, And Within ONE Customer and One Project
Project Management    Project Management See Map
Responsibilities: Create, set up (e.g., create forms, set data collection schedule), and maintain research projects; build automated clinic notes and/or subject reports; program any needed protocol logic (e.g., screening algorithim for pass / fail). This role controls all setup options for a specific Project / study
Typical User: Investigator and other individuals responsible for setting up a project. Technical staff if needed for building clinic notes and subject reports, programming needed protocol logic, etc.
Where Assigned: Initially from System Setup, then that user assigns this role as needed to others from within the Projects area.
Workbench
[**Main Report Builder User(s)]
View Tutorial   Workbench See Map
Responsibilities: Create and maintain Workspaces. Within any given Workspace: (1) build tables, charts and graphs, (2) create data sets within and across Projects / studies [i.e., as permitted by “Data Set Management” role assignment], (3) clean, scrub, transform and export data, (4) archive files, and (5) create, build, maintain, and run reports
Typical User: Investigator and other individuals responsible for setting up a report / manuscript / abstract. Sometimes a technical person if needed.
Where Assigned: Assigned on a Project-by-Project basis by clicking on the “Publish Reports” role for a user in the ‘Projects’ area.
Data Set Management View Tutorial   Datasets See Map
Responsibilities: Create and maintain data sets which include variables from forms, as well as creating calculated variables (e.g., change score from Baseline to Last Follow-up) and recoded variables (e.g., colapsing a ‘Race’ variable from 6 categories to 2).
Typical User: The biostatistician and sometimes a technical person if needed for calculated variables.
Where Assigned: Assigned on a Project-by-Project basis by clicking on the “Data Set Management” role for a user in the ‘Projects’ area.
Reports    Reports See Map
Responsibilities: Run both the canned reports that come with StudyTRAX (e.g., Data Completion Report, Follow-up Status Report), as well as custom reports created in the Workbench area.
Typical User: Study coordinator and / or data entry staff.
Where Assigned: Assigned on a Project-by-Project basis by clicking on the “Reports” role for a user in the ‘Projects’ area.
Note: Remaining Roles all Relate to Data Entry
Subject Management
(Data Entry Role)
View Tutorial   Subject Overview See Map
Responsibilities: Enter subject-related data (e.g., key in data on electronic forms).
Typical User: Study Coordinator and / or data entry staff.
Where Assigned: Assigned on a Project-by-Project basis by clicking on the “Subject Management” role for a user in the ‘Projects’ area.
Subject Management
(Read-Only)
   Subject Overview See Map
Responsibilities: View subject data, but unable to enter or change subject data.
Typical User: Investigator who doesn’t want to be able to change the data by mistake, study coordinator, or study monitor.
Where Assigned: Assigned on a Project-by-Project basis by clicking on the “Subject Management – Read Only” role for a user in the ‘Projects’ area.
Subject Management
(Secondary)
   Subject Overview See Map
Responsibilities: Enter subject data (e.g., key in data on electronic forms) as the secondary person for double data entry. Note that this role is ONLY applicable for Projects with the “Double Data Entry” feature selected.
Typical User: Study Coordinator and / or data entry staff.
Where Assigned: Assigned on a Project-by-Project basis by clicking on the “Subject Management (Secondary)” role for a user in the ‘Projects’ area.
Subject Administration    Subject Overview See Map
Responsibilities: Setup and maintain subject user accounts (e.g., create a subject’s initial User ID, Password, and enter other account information [their email address]). Note that this role is ONLY applicable for Projects with the “Subject Login” feature selected.
Typical User: Study Coordinator and / or data entry staff.
Where Assigned: Assigned on a Project-by-Project basis by clicking on the “Subject Administration” role for a user in the ‘Projects’ area.
View Subject’s Treatment
Responsibilities: View treatment group to which a subject was randomized from the Subject Management page or ability to include the “Subject’s Treatment Group” variable in a data set if Data Set Management role granted for project. Note that this role is ONLY applicable for Projects with the “Randomization” feature selected AND this allows a user to UNBLIND a subject.
Typical User: A pharmacists who is responsible for giving the subject the correct medication. Users on the Study Safety Monitoring Board as needed. The Biostatistician, in combination with the Data Set Management role, so that “Treatment Group” can be included in data sets.
Where Assigned: Assigned on a Project-by-Project basis by clicking on the “View Subject’s Treatment” role for a user in the ‘Projects’ area.
Signing
Responsibilities: Sign (lock) case report forms. Note that this role is ONLY applicable for Projects with the “Electronic Signatures” feature selected.
Typical User: Investigator or Study Coordinator.
Where Assigned: Assigned on a Project-by-Project basis by clicking on the “Signing” role for a user in the ‘Projects’ area.
Unsigning
Responsibilities: Un-Sign (un-lock) case report forms. Note that this role is ONLY applicable for Projects with the “Electronic Signatures” feature selected.
Typical User: Investigator or Study Coordinator.
Where Assigned: Assigned on a Project-by-Project basis by clicking on the “Unsigning” role for a user in the ‘Projects’ area.
Randomize
Responsibilities: Randomize subjects to treatment group. Note that this role is ONLY applicable for Projects with the “Randomization” feature selected.
Typical User: Investigator or main study coordinator.
Where Assigned: Assigned on a Project-by-Project basis by clicking on the “Randomize” role for a user in the ‘Projects’ area.


User Setup Example

Below are the roles that would typically be assigned to the Investigator and Data Entry Staff in a basic study. In this example, a prospective design WITHOUT randomization is used.

  • Principal Investigator –

    Project Management – Set up study (build forms, etc.)

    Publish Reports – give access to Workbench reports

    Data Set Management – Build and export datasets

    Reports – Access to canned StudyTRAX reports

    Subject Management – Data entry

  • Data Entry Staff –

    Reports – Access to canned StudyTRAX reports

    Subject Management – Data entry

StudyTRAX Roles Map [Click image to enlarge]
Roles Map