Manage Personnel Training Assignment

User Guide

Date: March 2020

Version: 1.6

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Contents

Introduction ........................................................................................................................ 4

Manage Personnel Training Assignment (MPTA) Overview ......................................................... 4

Implementation ............................................................................................................................ 4

Configuring Training Assignments .................................................................................. 5

Accessing MPTA .......................................................................................................................... 5

Navigating the MPTA Dialog ........................................................................................................ 6

Configuring Country Criteria ......................................................................................................... 7

Setting the Countries criteria ........................................................................................................ 7

Configuring Site and Site Roles Criteria ....................................................................................... 8

Setting the Sites and Site Roles Criteria ....................................................................................... 9

Configuring Monitor and Study Roles Criteria............................................................................. 10

Setting the Monitor and Study Roles Criteria .............................................................................. 11

Configuring User Notifications for Training Assignments ........................................... 12

User Notifications Overview ....................................................................................................... 12

Configuring User Notifications .................................................................................................... 12

Setting the Criteria ..................................................................................................................... 13

User-Level Overrides ................................................................................................................. 13

Activating the MPTA Configuration ................................................................................ 14

Confirming the Changes Made ................................................................................................... 14

Reporting on Training Assignments ........................................................................................... 15

Requesting the Training Assignment Report .............................................................................. 15

The Training Assignment Report ................................................................................................ 17

Appendix I ........................................................................................................................ 18

Assignment Notification Emails .................................................................................................. 18

Appendix II ....................................................................................................................... 19

Reminder Notification Emails ..................................................................................................... 19

Appendix III ...................................................................................................................... 20

Change Notification Emails ........................................................................................................ 20

Appendix IV ...................................................................................................................... 21

FIRECREST Customer Support ................................................................................................. 21

ICON Confidential and Proprietary Information

This document represents valuable, confidential, and proprietary information of ICON Clinical Research and its corporate affiliates (ICON plc). By accepting this document, the sponsor acknowledges that such material is valuable, confidential, and proprietary to ICON

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plc and agrees not to disclose it to any third party without the prior written consent of ICON plc. The sponsor shall not use this document, nor any information contained within it, for any purpose other than its intended purpose.

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Introduction

Manage Personnel Training Assignment (MPTA) Overview

This document is intended to provide study managers with guidance on how to use the Manage

Personnel Training Assignment (MPTA) feature on the FIRECREST Site Portal. Screenshots with

sample data are included throughout.

The MPTA feature provides enhanced flexibility when setting up the rules, or criteria, for the

automatic assignment of users to training lessons that are available on the Site Portal.

Once the criteria are set up within MPTA for a specific training lesson, that training lesson will be

assigned to all the user accounts that meet those criteria. Each training lesson can have different

MPTA criteria.

Implementation

MPTA is enhanced functionality that is enabled at the sponsor level.

Once enabled, training assignments for new training lessons can be managed using MPTA.

Existing training assignments rules can be migrated to MPTA and subsequently managed within

MPTA.

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Configuring Training Assignments

In MPTA, a training lesson can be configured to be automatically assigned to active users in

specific countries, specific sites, and with specific site or study roles on the Site Portal.

New users in active status will automatically be assigned a training lesson if they meet the

configured MPTA criteria for that training lesson.

When an active user’s country or site/study role assignment is changed on the Site Portal, their

training assignments will automatically be updated in accordance with the MPTA criteria for the

training lessons available on the portal. Training assignment records for users who no longer meet

the MPTA criteria for a training lesson will be retained only if the training has been completed.

Users who are unassigned from the study will lose the training assignments for training lessons on

the portal.

If users are unassigned from the study and subsequently reassigned to the same study as active

users, their completed training assignment records will be reactivated. As “new” users in active

status, they will automatically be assigned a training lesson if they meet the configured MPTA

criteria for the training lesson.

Accessing MPTA

The MPTA configuration module is available to study managers on the Site Portal.

To gain access to the MPTA configuration module:

1. Log in to the Site Portal.

Note: Due to recent updates, you may notice some visual changes to the FIRECREST Site

Portal as you navigate through the different sections.

2. Click on the Navigation tab and select the Study Console option:

Alternatively, you may need to click the More tab to select Study Console from the updated Navigation bar.

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3. In the Training Records tab, select the relevant training lesson from the Select a Training

dropdown.

Note: Only training lessons in a Deployed status on the Site Portal will be presented for

selection.

4. Click on the Actions button in the top right of the Training Records page and select

Manage Personnel Training Assignment from the dropdown menu:

If Manage Personnel Training Assignment is not one of the options available to you in the

Actions dropdown, the MPTA feature has not been activated for your training lesson.

Navigating the MPTA Dialog

The MPTA dialog window is made up of three core sections: the first for country selection (Select

Countries), the second for site and site role selection (Select Sites and Site Roles), and the third

for monitor and study role selections (Select Monitor and Study Roles):

If the training lesson has been configured so that users assigned to the training can receive user

notifications, a fourth section will appear in the MPTA dialog window to allow the configuration of

the criteria for user notifications:

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For more information on the configuration of user notifications, please consult the Configuring

User Notifications for Training Assignments section of this document.

To view and edit the detailed criteria within each section, click on the icons to expand, and the

icons to collapse the section when complete.

Configuring Country Criteria

All countries on the Site Portal for the study that have assigned sites in Planned or Ongoing

status or that have active assigned non-site users will be available for selection in the Select

Countries section.

Setting the Countries criteria

Select the countries for which the training is applicable in the Country panel:

1. Select the Global checkbox to assign training to all existing and future countries added to a

study, or

2. Unselect the Global checkbox and select the individual countries as required.

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Note: Use the scrollbar to view the full list of countries.

If a country is added to the study in the Site Portal after these criteria have been set and Global is

selected, users assigned to that country will automatically be assigned training.

When you have selected all the countries relevant for the training, continue to the Select Sites and

Site Roles section by clicking on the section header.

Configuring Site and Site Roles Criteria

The Select Sites and Site Roles section has two panels:

All active sites that are assigned to the study are in Planned or Ongoing status, and are assigned

to the countries selected in the Select Countries section will be available for selection in the Site

panel.

Note: The country for each site will be indicated by a country header and a two-letter code in

parentheses after the each site ID.

All site roles that have been specified in the training lesson setup parameters as in scope for

MPTA will be available for selection in the Site Role panel. Note: CRA or monitors who are

assigned to sites can be assigned training in this dialog if the CRA or monitor role has been added

to the site roles specification in the training lesson setup parameters.

At least one country must have been selected in the Select Countries section before site and site

roles criteria can be entered. An error message will display if at least one country has not been

selected:

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Setting the Sites and Site Roles Criteria

Select the sites for which the training is applicable from the list of sites in the Site panel:

1. Select the Global checkbox to assign training to all existing and future sites added to a

study, or

2. Unselect the Global checkbox and select the individual sites as required.

Note: Use the scrollbar to view the full list of sites.

At least one site must be selected for site roles to be displayed.

Indicate the training assignment requirement for each of the site roles in the Site Role panel:

1. Select Mandatory to denote the training as mandatory for users assigned to the site with

that site role.

2. Select Optional to denote the training as optional for users assigned to the site with that site

role.

3. Select Unassigned to exclude users assigned to the site with that site role from the training

assignment. Unassigned is the default assignment.

Note: Use the scrollbar to view the full list of site roles.

When a site is selected, then at least one site role must have the training assigned to them. If not,

an error message will be displayed when an attempt is made to save the MPTA training

assignment configuration:

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If a site is added to the study in the Site Portal after these criteria have been set, and Global has

been selected, users assigned to that site will automatically be assigned training.

Configuring Monitor and Study Roles Criteria

All study roles that have been specified in the training lesson setup parameters as in scope for

MPTA will be available for selection in the Select Monitor and Study Roles section.

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At least one country must have been selected in the Select Countries section before monitor and

study team criteria can be entered. An error message will display if at least one country has not

been selected:

Setting the Monitor and Study Roles Criteria

Indicate the training assignment requirement for each of the monitor and study roles in the Study

Role panel:

1. Select Mandatory to denote the training as mandatory for users in the selected countries

with that study role.

2. Select Optional to denote the training as optional for users in the selected countries with

that study role.

3. Select Unassigned to exclude users in the selected countries with that study role from the

training assignment. Unassigned is the default assignment.

Note: Use the scrollbar to view the full list of study roles.

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Configuring User Notifications for Training Assignments

User Notifications Overview

Training lessons on the Site Portal can be configured to send automatic notifications to users

assigned to the training lesson. A parameter set at the training lesson administration level indicates

whether users assigned to training can receive user notifications or not.

The set of notifications for training assignments are as follows:

1. Notification of training assignment

The email notification of training assignment (“assignment notification”) occurs once, when the user

is assigned to the training lesson. There is no user notification when a user is unassigned from

training.

2. Reminders to complete assigned training

The scheduling of email notifications to remind users to complete assigned training (“reminder

notifications”) is governed by parameters set at the training lesson administration level. These

parameters define when the reminder notifications should start and how frequently the reminder

notifications should be sent.

3. Notification of a change to an assignment requirement

An email notification can also be sent to alert the user that their training assignment has changed

from mandatory to optional, or vice versa (“change notification”). This notification is only available

for training lessons where the training assignments are managed using MPTA.

Please consult the Appendices to view the templates for these email notifications.

Configuring User Notifications

If a training lesson has been configured so that users assigned to the training can receive user

notifications, MPTA can be used to specify whether the user notifications (assignment, reminders,

and change notifications) should be sent for mandatory training, for optional training, or for both:

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Setting the Criteria

To configure user notifications in MPTA:

1. Select the checkbox for Notifications for Mandatory Training to switch the user

notifications on for mandatory training assignments.

2. Select the checkbox for Notifications for Optional Training to switch the user notifications

on for optional training assignments.

3. Select All or both checkboxes to turn user notifications on for both mandatory and optional

training assignments.

Note: By default, user notifications will be deactivated unless they are activated within MPTA.

Any assignment and reminder notifications sent will indicate in the email content whether the

training is mandatory or optional.

Any reminder notifications sent will follow the scheduling policy specified in the training lesson

setup parameters.

If a user’s training assignment is changed from mandatory to optional, the user will receive an

email notification for the change if the Notifications for Optional Training has been selected in

MPTA.

If a user’s training assignment is changed from optional to mandatory, the user will receive an

email notification for the change if the Notifications for Mandatory Training has been selected in

MPTA.

User-Level Overrides

User notifications activated in MPTA can be deactivated at the individual user training assignment

level in the Training Records tab in the Study Console on the Site Portal.

If the MPTA configuration specifies that users should not get user notifications (e.g., users with

optional training assignments), user notifications should not be activated at the individual user

training assignment level in the Training Records tab in the Study Console on the Site Portal.

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Activating the MPTA Configuration

Confirming the Changes Made

To review and confirm the updated training assignment rules:

1. Enter an explanatory comment in Comment field. This is for audit purposes only.

2. Click on the Save button to continue to the confirmation dialog. Clicking Cancel will bring

you out of the MPTA dialog and all your changes will be discarded.

Note: The Save button will only become active if at least one site role is selected.

3. In the Summary of Actions confirmation dialog presented to you, review the training

assignment changes listed in each of the Countries, Sites, and Roles panels:

Note: If no changes have been made to any of the criteria, the following message will be displayed

at the top of the dialog: “No Changes have been made to the Training Assignment during this

session”.

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Click Go Back to edit the changes made to the training assignments or click Confirm to accept the

changes made.

Once you click on the Confirm button, the changes will be saved and the Training Records page

will be refreshed to show the updated training assignments.

Reporting on Training Assignments

In MPTA, study managers can request a Training Assignment Report to view the changes made

to the training assignment records so they can track when training was assigned, the current status

of training and who it was assigned or amended by.

The Training Assignment Report is generated in the background and a link to the generated

report is sent to the report requestor. You will need to log in to the Site Portal to download and view

the report.

Requesting the Training Assignment Report

To request the Training Assignment Report:

1. Log in to the Site Portal.

Note: Due to recent updates, you may notice some visual changes to the FIRECREST Site

Portal as you navigate through the different sections.

2. Click on the Navigation tab and select the Study Console option. Alternatively, you may

need to click the More tab to select Study Console from the updated Navigation bar.

3. In the Training Records tab, select the relevant training lesson from the Select a Training

dropdown.

4. Click on the Actions button in the top right of the Training Records page and select

Request Personnel Training Assignment from the dropdown menu.

5. Select whether you would like to filter the report by Sites or Study Team And Monitor

Roles.

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6. If you have selected the Sites filter, select the country for the site to be reported on from

the Countries dropdown, and when prompted, select the site from the Sites dropdown:

7. If you have selected the Study Team And Monitor Roles filter, select the Countries to

include in the report:

8. Click on Submit Request to request the report.

9. Click OK on the Email Confirmation notification displayed:

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You will receive an email containing a link from which to download the report in Excel format.

When you click on the link, you will be prompted to log in to the Site Portal in order to retrieve the

report.

The Training Assignment Report

The report includes information on who performed the training assignments and when, to whom

the training was assigned, the completion status of the training assigned, and whether the training

was assigned as mandatory or optional:

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Appendix I

Assignment Notification Emails

The email notifications for training assignments indicate whether the training assignment is

mandatory or optional. Both versions of the assignment notification emails are reproduced below.

Subject Line:

FIRECREST [Mandatory/Optional] Training Assigned - [Training Name] for [Study Name XXX]

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Appendix II

Reminder Notification Emails

The email notifications for reminders indicate whether the training assignment is mandatory or

optional. Both versions of the reminder notification emails are reproduced below.

Subject Line:

Reminder: [Mandatory/Optional] Training for [Study Name] Available on FIRECREST

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Appendix III

Change Notification Emails

The email notifications for change notifications indicate whether the training assignment has

changed from mandatory to optional, or vice versa. Both versions of the change notification emails

are reproduced below.

Subject Line:

Training Now [Mandatory/Optional] – [Training Name] for [Study Name XXX]

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Appendix IV

FIRECREST Customer Support

We are always happy to receive feedback, queries, or comments from users of the FIRECREST

Site Portal and will always respond as quickly as possible. Our Customer Support team manages,

coordinates, and resolves issues for study personnel located all over the world.

If you cannot access the FIRECREST Site Portal, contact FIRECREST Customer Support, as

follows:

1. On the Home page, go to the upper-right corner and select Support. The FIRECREST

Customer Support page will display.

2. In the Contact Us tab, you can access contact information specific to your country.