Summary

This article describes how to add, edit, and delete prerequisites and how to set exemptions and create a status report.

Table of Contents

• Prerequisites in Action
• Setting Prerequisites
  • Add Prerequisites
  • Edit Prerequisites
  • Delete Prerequisites
  • Prerequisites Status Report
• Setting Exemptions
  • Add Exemption to a Single Prerequisite
  • Add Exemption to Multiple Prerequisites
  • Delete Exemptions

The user administration related Prerequisite and User Request Invitation functions have been created to facilitate and partially automate the process of providing users with access to the Fountayn system. These features can be used in conjunction with each other to request user participation in your studies/CTMS and enforce training requirements before providing the requested users with access to the system.

Note: It is often critical that the Prerequisite function is used in combination with the User Request Invitation function. If role related prerequisites for study or CTMS access are not created prior to user access invitations being sent, a user may gain access to a study’s application or CTMS without having been properly trained.

Prerequisites in Action

When a user is invited to participate in a study or added to a CTMS, they will be required to complete prerequisites related to their role before they can gain access to the study or CTMS. The required prerequisites are presented to the user in the form of a Prerequisite panel on the user’s Desktop.

The panel identifies all courses and files that must be reviewed before access to the study or CTMS can be granted. The user may access either the courses or the documents via the links within the Prerequisite panel. Completion of the prerequisites will result in the user automatically gaining access to the study or CTMS.

Setting Prerequisites

The Prerequisite feature allows Enterprise Manager Administrators and Client Trainers to create and enforce user access related requirements. Prerequisites can be associated with eTrain courses or documents that must be reviewed, training or otherwise.

Add Prerequisites

1. Navigate to the study, site, or CTMS for which the prerequisites should be added.
2. In the Prerequisite column, click ‘View’ beside the appropriate study, site or CTMS.

Note: Sites categorized for use in “Training” will automatically be exempt from any prerequisites created for the applicable study.

3. On the ‘Manage Prerequisite’ screen, click the ‘New’ button to create a new prerequisite.

The ‘Create Prerequisite’ screen will be displayed.

4. Name: Enter a brief yet descriptive name for the prerequisite.
5. Severity: Select either ‘Required’ or ‘Optional’ to specify how the prerequisite will be enforced.

Note: If there are no required prerequisites for a role, anyone invited to participate in the study or CTMS with said role will immediately be granted access to the study upon accepting the invitation. It is critical that all training requirements are defined and the necessary required prerequisites are created to prevent users with specific roles from gaining immediate access to the study or CTMS.

6. Type:
   • Select ‘Document’ if the user should review a file stored in the workgroup or study’s File Manager prior to accessing the study for the first time.
   • Select ‘Training’ if the user should complete a pre-defined eTrain course prior to accessing the study or CTMS for the first time.
   • After a ‘Type’ is selected, an additional dropdown menu appears.
7. In the additional dropdown menu, select the appropriate document or eTrain course.
8. Apply to All Roles: If the prerequisite should be applied to all roles, select ‘Yes.’ Otherwise, select ‘No.’
9. Select Roles: If you selected ‘No’ in step 8, select the roles to which the prerequisite should be applied.
   • To select more than one role at a time, hold the “Ctrl” key and select all necessary roles.
10. After selecting the roles, click the ‘Add Selected’ button.
    • The roles will be added to the ‘Selected Roles’ category. To remove roles from the ‘Selected Roles’ category, select the roles and click the ‘Remove Selected’ button.
11. Once all the roles have been added, click the ‘Save’ button to create the prerequisite.

Edit Prerequisites

Prerequisites can also be edited and updated.

1. Navigate to the study, site, or CTMS for which the prerequisites should be added.
2. In the Prerequisite column, click ‘View’ beside the appropriate study, site, or CTMS.
3. On the ‘Manage Prerequisite’ screen click the ‘Edit’ button beside the prerequisite that you want to edit.
4. Reconfigure the prerequisite.

Delete Prerequisites

Prerequisites can be deleted individually or all at once.

1. Navigate to the study, site, or CTMS for which the prerequisites should be added.
2. In the Prerequisite column, click ‘View’ beside the appropriate study, site, or CTMS.
3. To delete a prerequisite, click the ‘Delete’ icon beside the prerequisite that you want to delete on the ‘Manage Prerequisites’ screen.

Note: Deleting a required prerequisite could immediately grant access to unauthorized users. Exercise caution.

4. To delete multiple prerequisites, check the checkboxes beside all the prerequisites that should be deleted and click the ‘Delete’ button.

Prerequisites Status Report

On the Prerequisites screen at the trial and enterprise level, you can generate a report in Excel format to track the status of any user’s pre-requisite level of training. Select an active prerequisites option for a given tool in the Prerequisites column:

On the Prerequisites screen, you have an Export User Status tab:

Note: The Export User Status report provides you a User Status report of prerequisites for active users and their status of the prerequisites.

1. Click a checkbox next to the desired entry from the Manage Prerequisites table
2. Hover over the Export User Status tab, to display the dropdown menu options
3. Select either All, In Progress, Not Started, or Completed from the menu

A dialog prompts you to save or open a zip file containing your Excel worksheet with the training information. The Excel worksheet inside the zip file is labeled export.xlsx.

The worksheet contains basic user information, completion status and site information. Also, whether or not the user fulfilled the prerequisite by completing the prerequisite course or an equivalent course. The .zip file default naming convention is a time stamp detailing [year >> milliseconds]: yyyyMMddHHmmssSSS.zip

The Date Applied in the Prerequisite Report shall display the Date the course assigned in the prerequisite was first assigned to the user.  If the same course is assigned across multiple Trials/prerequisite the date will be the first date the course was assigned to that user, not when the prerequisite was assigned.  As well, if a user is assigned a prerequisite and then the prerequisite is deleted, and another prerequisite is added for that same course, the date applied would be the original date the user was assigned to that course.

Note: If a user is assigned a prerequisite and then the prerequisite is deleted, and another prerequisite is added for that same course, the date applied would be the original date the user was assigned to that course. 

Setting Exemptions

Exemptions can be created in relation to prerequisites which will allow specified users to gain access to the study or CTMS without having completed the prerequisite as it is defined. This is useful, for example, when a user has been trained via some external means and needs to be exempted from redundant training within the system.

Add Exemption to a Single Prerequisite

Exemptions are added on the ‘Manage Prerequisites’ screen.

1. In the ‘Exemptions’ column, select ‘View’ beside the appropriate prerequisite.
2. On the ‘Exemptions’ screen, click the ‘New Exemption’ button.
3. The ‘Create Exemption’ screen will be displayed.
4. Username: Enter the username of the user who should be issued an exemption.
5. Reason: Enter a reason why the exemption is being issued.
6. Click the ‘Save’ button to create the exemption.

Add Exemption to Multiple Prerequisites

1. On the ‘Manage Prerequisites’ screen, check the checkbox beside each prerequisite for which the exemption should be added.
2. Click the ‘Add Exemptions’ tab.
3. Username: Enter the username of the user who should be issued an exemption.
4. Reason: Enter a reason why the exemption is being issued.
5. Click the ‘Save’ button to create the exemption.

Delete Exemptions

Exemptions can be deleted individually or all at once on the ‘Exemptions’ screen.

1. To delete an exemption, click the ‘Delete’ icon beside the exemption that you want to delete.
2. To delete multiple exemptions, check the checkboxes beside all the exemptions that should be deleted and click the ‘Delete’ button.

Note: Be aware that deleting an exemption from a required prerequisite will cause that user to lose access to the study or CTMS.

Need more help?

Please visit the Fountayn Contact Information page.