Parexel’s Education ServicesWe offer a blended training delivery program including: • Classroom Instructor-Led Sessions • Virtual Instructor-Led Sessions • eLearning • Simulations

© 2019 Parexel International Corporation

Parexel’s Education Services Course Catalog

© 2019 Parexel International Corporation Page 1 of 53

Table of Contents Welcome To Parexel’s Education Services ......................................................................................... 2 Training Services ................................................................................................................................... 2

eLearning Development ....................................................................................................................... 2 Development of Materials for Classroom/Virtual Classroom Delivery ................................................ 2 Job Aid Development ........................................................................................................................... 2 Consultancy ......................................................................................................................................... 3

DataLabs® EDC Courses ......................................................................................................................... 5 EDC Training Map ................................................................................................................................ 5 DataLabs and Designer Roles ............................................................................................................... 6

IMPACT® CTMS Courses ....................................................................................................................... 15 Training for IMPACT® CTMS Express Implementation ...................................................................... 15 IMPACT® Training Map ...................................................................................................................... 15 IMPACT® CTMS Express User Roles ................................................................................................. 16 IMPACT® CTMS Express Online Training Courses ............................................................................ 17 Training for IMPACT® CTMS Full Implementation ............................................................................. 21

Liquent InSight® Training Courses ..................................................................................................... 25 Liquent InSight® Training Map ......................................................................................................... 25

Perceptive My Trials® Courses ........................................................................................................... 44 Perceptive MyTrials® Training Map ................................................................................................... 44 Perceptive MyTrials® Roles ................................................................................................................ 45

Perceptive MyTrials® Data-Driven Monitoring Courses ................................................................... 49 Perceptive MyTrials® Data-Driven Monitoring Training Map ............................................................ 49

Certification Tracks .............................................................................................................................. 51 For more information: .......................................................................................................................... 51


Welcome To Parexel’s Education Services Parexel ’s Education Services training programs provide a comprehensive training service to assist our clients and users in developing their knowledge and skills in:

• Using DataLabs® EDC and DataLabs® Designer • Using IMPACT® CTMS • Using Perceptive MyTrials® Data-Driven Monitoring • Using Perceptive MyTrials® • Using Liquent InSight®

We offer a blended training delivery program including:

• Classroom Instructor-Led Sessions • Virtual Instructor-Led Sessions • eLearning • Simulations

Training Services Parexel’s Education Services has extensive experience in producing training programs to meet the individual requirements of our customers. In addition to our standard courses, we offer a range of training development and consultancy services.

eLearning Development • Parexel’s Education Service’s standard modules are customized to reflect your processes and terminology • New eLearning modules to your specification

Development of Materials for Classroom/Virtual Classroom Delivery • Interactive guides • Hands-on practice exercises • Refreshable training delivery database

Job Aid Development • Interactive task guides accessible from the IMPACT® CTMS menus/your intranet • New Supplemental Training Guides to your specification


Consultancy If you prefer to utilize the resource within your own organization or a 3rd-party vendor, Parexel’s Education Services Instructional Design Specialists and Subject Matter Experts (SMEs) are available to assist you with: • Developing a training strategy • Training needs analysis • Selection of appropriate course content • Production of a suitable training database • Training delivery worldwide • Training support for in-house/external trainers • Evaluation and feedback for in-house/external trainers Our portfolio is modular and flexible. It is designed and delivered with clinical and regulatory roles in mind and is focused on keeping your organization in compliance with an ever-changing and highly regulated world. We can offer fully customized training solutions including role-based training specifically aligned to your processes. In addition to hosting content in our dedicated Learning Management System, we also offer the capability to host your own content, enabling easy management of training and regulatory compliance.


CONFIDENTIAL - © 2019 Parexel International Corporation

DataLabs® EDC Courses


DataLabs® EDC Courses

EDC Training Map

Foundation E

Role-based ILT/E

Administration ILT / E

Reporting E

Designer ILT

Certified trainer

DataLabs and Designer

Orientation (DL001)

DataLabs for Clinical Monitors (DL007)

DataLabs for Administrators

(DL012)

IB Reporting Dashboard

(DL013)

Designer Workshop & Certification

(DL002b)

DataLabs Site Trainer

Workshop & Certification

(DL023)

DataLabs for Paper Data Entry (DL006)

DataLabs for Study Coordinators

(DL008) IB Reporting Standard Reports (DL014)

DataLabs for Principal

Investigators (DL009)

DataLabs Trainer

Certification (DL020a)

DataLabs Version Upgrade

DataLabs for Medical Monitors

(DL011)

DataLabs for Administrators

Certification (DL028)

IB Reporting Custom Reports (DL015) DataLabs for View

Only Roles (DL010)

Designer Trainer Certification

(DL020b)

DataLabs for Data Managers (DL004)

Study Archive Utility

Designer Version Upgrade DataLabs EDC

Workshop (DL002a)

E = eLearning | ILT = Instructor-Led Training


DataLabs and Designer Roles In DataLabs, each user is assigned to a role in the system. Your role in DataLabs will determine the permissions you will have in the system, which in turn drives your training needs. Below is a list of typical roles and the associated permissions in DataLabs:

Study Coordinator Data Manager

The Study Coordinator role is typically responsible for:

• Patient data entry into Case Report Forms (CRFs) • Answering Data Clarification Forms (DCFs)

The Data Manager role is typically responsible for:

• Data review • Raising manual DCFs • Reviewing responses to DCFs • Closing DCFs • Freeze/Thaw of CRFs • Requesting Investigator Signature of CRFs • Lock/Unlock of CRFs

Clinical Research Associate (CRA) Principal Investigator

The CRA role is typically responsible for:

• Source Data Verification (SDV) • Raising manual DCFs • Reviewing responses to DCFs • Closing DCFs • Freeze/Thaw of CRFs

The Principal Investigator role is typically responsible for:

• Reviewing completed CRFs • Signature of CRFs

Medial Monitor Administrators

The Medical Monitor role is typically responsible for:

• Medical review of CRFs • Raising manual DCFs • Reviewing responses to DCFs • Closing DCFs

The Administrator typically responsible for:

• Uploading and managing study XML • Setting user group permissions • Setting study specific parameters and preferences

Study Designers

The Study Designer role is typically responsible for:

• Designing and building studies in DataLabs Designer for use in DataLabs EDC


DataLabs Clinical Monitoring (DL007)

DURATION: 2hrs (Instructor-Led) | 1 hr (eLearning) CLASS SIZE: 12 mas (Instructor-Led Training)

PREREQUISITES PRIMARY AUDIENCE DELIVERY MODES MATERIALS

DataLabs & Designer Orientation Course (DL001) (recommended)

Clinical Research Associates In-house Monitors

Classroom Instructor-led Virtual Instructor-led Self-Paced eLearning

Presentation Participant Guide

COURSE DESCRIPTION

Participants will learn how to manage Source Data Verification of eCRFs, issue and manage Data Clarification Forms (DCFs) to sites, as well as preparing forms for Investigator eSignature.

At the end of this course, the participant will be able to:

• Source Data Verify CRFs • Create, review and close DCF’s • Freeze/Thaw patient data • Use Advanced Patient Search functionality • Prepare forms for eSignature

DataLabs and Designer Orientation (DL001)

DURATION: 15 mins | CLASS SIZE: n/a


None All Roles Self-Paced eLearning n/a

COURSE DESCRIPTION

The DataLabs and Designer Orientation Course will provide an overall introduction to DataLabs Electronic Data Capture (EDC), Designer and their key features and application in the clinical trial. You will be orientated to the background of the products, the study set-up process for DataLabs and view a short demonstration of each system.


• Explain DataLabs EDC and DataLabs Designer background, components and capabilities • Describe key features of DataLabs EDC and Designer


DataLabs Study Coordinators (DL008)

DURATION: 2 hrs (Instructor-Led) | 1 hr (eLearning) | CLASS SIZE: 12 max (ILT)



Study Coordinators Classroom Instructor-led Virtual Instructor-led Self-Paced eLearning


COURSE DESCRIPTION

Participants will learn how to manage Source Data Verification of eCRFs, issue and manage Data Clarification Forms (DCFs) to sites, as well as preparing forms for Investigator eSignature.


• Source Data Verify CRFs • Create, review and close DCF’s • Freeze/Thaw patient data • Use Advanced Patient Search functionality • Prepare forms for eSignature

DataLabs Principal Investigator (DL009)

DURATION: 30 mins | CLASS SIZE: 12 max (Instructor-Led Training)


None

Principal Investigators Study Coordinators Those responsible for reviewing and electronically signing eCRFs

Classroom Instructor-led Virtual Instructor-led Self-Paced eLearning


COURSE DESCRIPTION

Participants will learn to use the DataLabs inbox, review and sign CRFs.


• Log into DataLabs • Use the DataLabs inbox to view signature requests • Accept, reject or skip a CRF • Record an eSignature


IB Reporting Dashboard (DL013)




Any role that uses IB Reporting Dashboard functionality Self-Paced eLearning n/a

COURSE DESCRIPTION

Participants will be given information on Information Builders (IB) Reporting which allows users with the appropriate access the ability to view DataLabs report information. The IB Reports Dashboard is the launch pad to robust reporting.


• Use the IB Reporting Dashboard to view study status including Patient Counts, Data Clarification Form (DCF) query data and completion status of Case Report Forms (CRFs)

DataLabs Administrator (DL012)

DURATION: 2.5 hrs (Instructor–Led) | 1hr (eLearning) | CLASS SIZE: 8


(DL001) DataLabs® EDC and DataLabs Designer Orientation

DataLabs Administrators Self-Paced eLearning n/a

COURSE DESCRIPTION

Participants will be responsible for the set-up and manage an EDC database for training or for live systems. This course will cover a number of Administrator tasks to allow the designated personnel set up and manage a DataLabs EDC database.


• Load and Publish a Study • Perform all administrative functions using DataLabs EDC • Produce a database ready to train other study team members


IB Reporting Custom Reports (DL015)



IB Reporting Standard Reports (DL014)

Any role that is assigned to create custom reports Self-Paced eLearning n/a

COURSE DESCRIPTION

This course will build on the knowledge gained from IB Reporting Dashboard and Standard Reports training and will teach participants how to create custom reports that can be run across sites and across multiple variables.


• Build a simple custom report • Build a complex custom report

IB Reporting Standard Reports (DL014)



IB Reporting Dashboard (DL013)

Any role that uses IB Reporting Standard Reports functionality

Self-Paced eLearning n/a

COURSE DESCRIPTION

Participants will be given information on IB Reporting Standard Reports which are predesigned to provide specific report data based on logical groupings in the report database. This training describes the standard reports and demonstrates how to view them in differing report formats.


• Access the available Standard Reports • Manipulate report filters to view specific data • Export standard reports in a variety of formats


Designer Workshop (DL002)

DURATION: 4.5 days | CLASS SIZE: 8 max (Instructor-Led Training)


DataLabs for Administrators (DL012)

DataLabs EDC for Designer Workshop

Programmers Any role that will build DataLabs studies

Classroom Instructor-led Presentation Participant Guide

COURSE DESCRIPTION

Certification Track Course This workshop is intended to provide a familiarity with the DataLabs product and firm foundation for using the DataLabs Designer tool to build clinical studies. At the end of this course, the participant will be able to: • Build a study xml using the Designer tool with 80% proficiency • Integrate the knowledge obtained from DataLabs exercises to visualize how it will affect the study build process • Explain the functionality of Designer: Domains, Codelists, Dictionaries, Dynamic Forms and Events, Edit Checks and pScripts • Build study using Designer Functionality: Domains, Codelists, Dictionaries, Dynamic Forms and Events, Edit Checks and pScripts • Load, stage and publish study xml in DataLabs EDC • Perform study admin tasks to complete study set-up in DataLabs EDC

* Component of a formal Certification Track EDC Training Map

DataLabs EDC Workshop (DL0002a)

DURATION: 2.5 days | CLASS SIZE: 8 max


DataLabs & Designer Orientation Course

Those who will be responsible for training in DataLabs for any role

Blended Delivery Presentation Participant Guide Training Recording

COURSE DESCRIPTION

The DataLabs EDC Workshop 2.5 Day course is intended to provide a comprehensive training of DataLabs EDC for the end user. An extensive walkthrough of a study from data entry to verification, queries, freeze, signatures and locking will be provided to all users. Users will become familiar with the administrative functions available in DataLabs EDC to prepare a database for a study or training session.


• Load & Manage Study XML • Perform data entry activities • Perform study team activities, including data verification, queries and flagging


DataLabs Certified Trainer (DL020a)

DURATION: 2 days | CLASS SIZE: 8 max (Instructor-Led Training)


DataLabs EDC Workshop (DL002a)

Those who will be responsible for training in DataLabs for any role

Classroom Instructor-led Presentation Participant Guide

COURSE DESCRIPTION

Certification Track Course* Participants will have completed a full DataLabs EDC knowledge-based course prior to participation of the DataLabs EDC Certified Trainer course. The course is designed to train on using DataLabs EDC knowledge and trainer skills to lead delivery of a DataLabs Training session for multiple roles.

At the end of this course, the participant will be taking and acheiving the following :

• DataLabs EDC Train the Trainer Certification Program (2 Days) • Practical assessment • Successful completion of this course leads to Certification * Component of a formal Certification Track EDC Training Map

DataLabs Certified Site Trainer (DL023)

DURATION: 2 days | CLASS SIZE: 8 max (Instructor-Led Training)


DataLabs & Designer Orientation Course (DL001) DataLabs for Clinical Monitors (DL007) DataLabs for Study Coordinators (DL008) DataLabs for Principal Investigators (DL009) DataLabs for Administrators (DL012)

Individuals responsible for providing training to the Principal Investigator, Study Coordinator Clinical Monitor roles

Classroom Instructor-led Virtual Instructor-led


COURSE DESCRIPTION

Certification Track Course*

The Site Train the Trainer course is designed for individuals to deliver DataLabs EDC Study Specific Training for Site personnel. The 2-day course option is suitable for participants that do not have any prior DataLabs EDC experience.


• Deliver a site training for a Principal Investigator, Study Coordinator or Clinical Monitor role in DataLabs Successful completion of this course leads to Certification

* Component of a formal Certification Track EDC Training Map


Study Archive Utility (DL023)



None Those who will be responsible for using the Study Archive Utility


COURSE DESCRIPTION

The Study Archive Utility eLearning module explains the study archive process. Starting with generating the archive XML in DataLabs® EDC and continuing to import that XML into the Study Archive Utility and generating the archive PDF.

At the end of this course, the participant will be able to: • Perform an archive export in DataLabs® EDC • Generate the archive PDF in the Study Archive Utility

Parexel’s Education Services also offers the following DataLabs courses. Please contact [email protected] for more information.

ADDITIONAL COURSES:

• DataLabs EDC Version Upgrade Training

• DataLabs Designer Version Upgrade Training

• DataLabs Data Manager (DL004)

• DataLabs Paper Data Entry (DL006)

• DataLabs Medical Monitors (DL011)

• DataLabs View Only Role (DL010)

mailto:[email protected]



IMPACT® CTMS Courses


IMPACT® CTMS Courses

Training for IMPACT® CTMS Express Implementation Parexel’s Education Services provides online training to enable a streamlined deployment of content to users globally. The role-based curriculum is accessible to learners at any time for initial training, review and reference via a learning portal. Training compliance and completion is tracked, online certificates are available to print and we provide training completion reports to nominated recipients on a regular basis. We recognize that system administrators require contact with an instructor and so we provide virtual instructor-led, self-paced training to meet this need.

IMPACT® Training Map

Foundation Role-based Administration

IMPACT® CTMS Basics

Trial Tracking & Management IMPACT® Administration

Managing Clinical Personnel & Centers

Site Monitoring & Management Using MySites* IMPACT® Investigator

Administration Site Funds & Payments

* For Express Premium Customers

Foundational learning Role-based learning Administration

• Applicable to most users and roles • Pre-requisite knowledge to most of the IMPACT® Express curriculum

Covering core IMPACT® CTMS functionality

Courses to support the personnel administering the system


IMPACT® CTMS Express User Roles In the IMPACT® CTMS system, each user is assigned to a role in the system. This role will determine what permissions each user will have in the system. Below is a list of typical roles and responsibilities.

Project Manager Trial Manager

Manages clinical development programs. Uses the Progress module to view trial data.

Manages global and local trials at trial and country levels. Uses the Investigator module to select Investigators, the Progress module to update trial information and the Clinical Cost Tracking module to manage trial site payments.

Trial Administrator Clinical Research Associate (CRA)

Manages clinical trial administrative tasks. Uses the Investigator module to maintain clinical personnel and center information, the Progress module to maintain trial, trial country and trial site information and the Clinical Cost Tracking module to manage trial site payments.

In-house management of trial sites. Uses the Investigator module to maintain clinical personnel and center information, the Progress module to maintain trial site information and the Clinical Cost Tracking module to manage trial site payments.

Monitor IMPACT Administrators

Manages sites and conducts monitoring visits. Uses IMPACT® MySites for conducting site visits and managing trial site information between visits.

Maintains reference data and configuration and performs administration tasks across all trials (e.g., subject visit design, deleting data). Uses the Investigator module to manage Investigator administration tasks (e.g,data de-duplication). Uses the Progress and Clinical Cost Tracking modules to perform administration tasks.


IMPACT® CTMS Express Online Training Courses

IMPACT® CTMS Basics (PS100)

DURATION: 1.5 hours | CLASS SIZE: n/a


None Any role using IMPACT® CTMS


COURSE DESCRIPTION

The IMPACT Basics eLearning module will provide an overall introduction to the IMPACT Clinical Trial Management System. It can be used as a single course for those who will use IMPACT to access key information on their area of interest, or as a basis for further.


• Describe the IMPACT® modules and functionality of each • Log in and out of the system • Create a new browser set • Customize and Modify browser sets

• Navigate around IMPACT® CTMS (top menu, left menu and between levels) • Search for and select data • Produce an IMPACT report

Trial Tracking and Management (PS120)

DURATION: 3.25 hours | CLASS SIZE: n/a


IMPACT® CTMS Basics

Manager, Trial Manager, Trial Administrator, CRA, IMPACT®

Administrator Self-Paced eLearning n/a

COURSE DESCRIPTION

This training module is designed for users of the IMPACT Progress module. This training course comprises the following modules:

• Recording a New Trial • Trial Level Tasks (Parameters, Design, Vendors and Contacts, New Trial Country, Enrollment Plan, Regulatory References, Protocol Amendments) • Trial Country Level Tasks (Parameters, Regulatory/IRB/IEC Approval, New Trial Sites, Protocol Amendments)

• Trial Site Level Tasks (Parameters, Clinical Personnel, Contacts, IRB/IEC Approval, Recruitment, Visit Report Review, New Subject, Projecting Subject Visit Dates) • Subject Level Tasks (Parameters, Visit Dates, Projecting Subject Visit Dates) • Common IMPACT® Tasks (Company Personnel, Delay/Cancel/Stop, Event Dates)


Site Monitoring and Management Using MySites (MS100)

DURATION: 2 hours | CLASS SIZE: n/a


None CRA, Monitor, IMPACT® Administrator Self-Paced eLearning n/a

COURSE DESCRIPTION

This training module is designed for personnel who are involved in site monitoring using the IMPACT MySites module. This training course comprises the following modules:

• MySites Overview • Planning & Starting Your Visit • Working With Subject Data (Properties, Visit Dates, Issues, Withdrawal, New Subject) • Completing Site Visit Tasks (Clinical Personnel, Issues, Checklists, Recruitment, Event Dates, Current Visit Details)

• Processing Your Visit Report (Narrative, Draft and Formal Report, Visit Report Processing & Finalization) • Completing Your Site Visit (Visit Completion, Resolution of Data Conflicts) • Recording Trial Site Contacts

Managing Clinical Personnel & Centers (IN120)

DURATION: 1 hour | CLASS SIZE: n/a


IMPACT® CTMS Basics (PS100)

Trial Manager, Trial Administrator, CRA, IMPACT® Administrator Self-Paced eLearning n/a

COURSE DESCRIPTION

This training module is designed for users of the IMPACT Investigator module who are responsible for:

• Maintaining up-to-date information on investigators, other site personnel and centers • The selection of suitable investigators for future trials


• Perform simple and advanced searches • Work with lists and create trial sites from a list • Edit clinical personnel records

• Add new clinical personnel • Search for centers and view results • Edit and add new centers


IMPACT® CTMS Administration (IA100)

DURATION: Intro. Webinar 1hr | Self-Paced 3.5 hrs | Follow up Webinar 1hr CLASS SIZE: 4 max


IMPACT® CTMS Basics (PS100) Trial Tracking & Management (PS120) Managing Clinical Personnel and Centers (IN120) Site Monitoring & Management Using MySites (MS100) Site Funds & Payments (CT110)

IMPACT® Administrator Virtual Instructor-led & Self-paced eLearning

Interactive Guide Hands-on Practice Script

COURSE DESCRIPTION

This training module is designed for IMPACT® Administrators who are responsible for maintaining reference data and performing administration tasks across all trials.


• Record a new project • Record that a trial has been archived • Record the MySites set-up requirements • Record the subject visit design • Confirm the investigator file documents • Transfer a subject between sites • Reset a trial site visit • Delete data entered in error • Record and maintain company personnel • Record and maintain vendor details • Record investigational products • Record and maintain payees • Verify new clinical personnel recorded in MySites • Record and maintain visit checklists • Record and maintain currencies • Record fees • Record cost areas


IMPACT® CTMS Investigator Administration (IN11)

DURATION: Intro. Webinar 1 hr | Self-Paced 2-3 hrs | Follow up Webinar 2 hrs CLASS SIZE: 4 max


IMPACT® CTMS Basics (PS100) Trial Tracking & Management (PS120) Managing Clinical Personnel and Centers (IN120) Site Monitoring & Management Using MySites (MS100) Site Funds & Payments (CT110)

IMPACT® Administrator

Virtual Instructor-led & Self-paced eLearning

Word® Documents

COURSE DESCRIPTION

This training module is designed for IMPACT® Administrators who are responsible for managing consent, duplicate records, quality and compliance issues and bulk loading of investigator records.


• Record new clinical personnel and centers • Record quality and compliance events • Revoke and enable consent • Resolve any potential duplicate centers identified by the background processor • Resolve any potential duplicate clinical personnel identified by the background processor • Prepare a suitable data file and use it to import clinical personnel and center records • Check for errors, warnings and the status of background processing. This training module is designed for personnel who are involved in site monitoring using the IMPACT® MySites module.


Training for IMPACT® CTMS Full Implementation In addition to the online eLearning curriculum available for IMPACT® CTMS Express/Express Premium, we provide a range of standard training courses suitable for customers who have implemented the full functionality of IMPACT® CTMS.

Reference Data Set-Up and Maintenance (RD01)

DURATION: 6 hours | CLASS SIZE: 4 max (Instructor-Led Training)


None System Administrator Classroom Instructor-led Presentation Word® Documents

COURSE DESCRIPTION

This training is designed for personnel who are involved in setting up and maintaining IMPACT reference data. This training course includes the following topics:

• Basic reference data • People and places reference data (medical units, company personnel, vendors, centers, clinical personnel, payees) • Checklists used in the Progress and Investigator modules • Investigator Trial File Documents • Monitoring reference data (visit types, visit report review configuration, visit reports, SOPs and checklists used in MySites)

IMPACT® CTMS Configuration (IC01)

DURATION: 4 hours | CLASS SIZE: 4 max (Classroom Instructor-Led Training)


None System Administrator Classroom Instructor-led

Presentation Word® Documents

COURSE DESCRIPTION

This training is designed for personnel who are involved in setting up and maintaining the system configuration. This training course includes the following topics:

• Global settings • Maintaining email notifications • Master events • Setting up pre-defined mail merge templates • Terminology • Occupation security

• Customer mandatory and required fields • Additional fields •” Not Required” functionality and fields • Trial types • Automatic reminders


IMPACT® CTMS Trainer (IN10)

DURATION: 3.5 – 15 hours | CLASS SIZE: 8 max (Classroom Instructor-Led Training)


Completion of appropriate end user training modules Super User, Trainer Classroom Instructor-led Word® Documents

COURSE DESCRIPTION

This training module is designed for personnel who will be delivering the IMPACT training. It may be extended to allow participants to practice their training delivery and receive feedback.


• Describe the training cycle • Write a ‘SMART’ objective • Create a checklist to be used when planning your IMPACT® CTMS training event • Describe two principles of learning theory and how you intend to put each of them into practice during your IMPACT training event

• Draft an evaluation form to enable you to assess the quality and effectiveness of your IMPACT® training • List the trials available on the IMPACT® training database suitable for a training event to be specified by the Trainer • Conduct a short database test

IMPACT® CTMS Investigator Administration (IN11)

DURATION: 3.5 hours | CLASS SIZE: 4 max (Classroom Instructor-Led Training)


None System Administrator Classroom Instructor-led

Presentation Word® Documents

COURSE DESCRIPTION

This training module is designed for IMPACT® Administrators who are responsible for managing consent, duplicate records, quality and compliance issues and bulk loading of investigator records.


• Record new clinical personnel and centers • Record quality and compliance events • Revoke and enable consent • Resolve any potential duplicate centers identified by the background processor

• Resolve any potential duplicate clinical personnel identified by the background processor • Prepare a suitable data file and use it to import clinical personnel and center records • Check for errors, warnings and the status of background processing


IMPACT® CTMS Super User

DURATION: 3.5 – 15 hours | CLASS SIZE: 8 max (Classroom Instructor-Led Training)


End user training for all modules to be supported Super User Classroom Instructor-led Word® Documents

COURSE DESCRIPTION

This training module is designed for personnel who will be providing ongoing support to IMPACT end users. The course materials will be customized based on the IMPACT® CTMS modules implemented and specific training needs, therefore the course duration will vary.


• Extend their knowledge of the system as a whole • Understand the roles and responsibilities for updating the system in their organization • Troubleshoot common problems presented to Super Users • Follow the correct escalation path for problems they are not able to resolve



Liquent InSight® Courses


Liquent InSight® Training Courses

Liquent InSight® Training Map


Liquent InSight® for Registrations (LIRPT)

DURATION: 1.5 days CLASS SIZE: 8 max (Classroom Instructor-Led Training) | eLearning 30 days access $300 60 days $600


None

Clients responsible for tracking data associated with a planned pharmaceutical, medical device or veterinary registrations in a country or countries.

Clients responsible for compliance with agency guidelines for existing product registrations.

Classroom Instructor-led Self Paced eLearning

Presentation Training Manual Exercises

COURSE DESCRIPTION

This course introduces the creation of key entities and data entry necessary to track the registration process for new and existing pharma, veterinary or medical device products.


• Understand the InSight Data Structure • Navigate InSight • Work with Product Families • Create Products, Components and Active Ingredients

• Create Applications, Events and Sequences • Manage Event Status Values • Post Approval updates to Applications • Use Queries InSight

Liquent InSight® Product Detail Management (LIPDM)

DURATION: 1 day | CLASS SIZE: 8 max (Classroom Instructor-Led Training)


InSight®

Registrations

Clients whose responsibilities include tracking CMC and product details for approved, and pending approval, pharmaceutical, veterinary and medical device products

Classroom Instructor-led


COURSE DESCRIPTION

This course is only offered in conjunction with the 1.5-day InSight for Registrations training. It introduces students to the features to create and track the granular, product information associated with Registrations.


• Understand the InSight Data Structure • Understand the Product Detail Set Overview • Create PDS Templates

• Create Component, Product Details • Create Package Set Registration • Manage Changes to PDS • Querying InSight


Liquent InSight® European Union Applications (LIEUAP)

DURATION: 0.5 day | CLASS SIZE: 8 max (Classroom Instructor-Led Training)


InSight®

Registrations

Clients whose responsibilities include planning and tracking multi-country European Applications



COURSE DESCRIPTION

This course introduces the management of European Applications in InSight. Multi-country Applications, country and product tracking, Package Set Registrations, Registrations and the Sunset Clause report.


• Create a Centralized Procedure (CP) Application • Create and maintain a Mutual Recognition Procedure (MRP) / Decentralized Procedure (DCP) • Track country status using Event-Country functionality • Run Package Set Registrations and Sunset Clause querying • Create a European Clinical Trial Authorization Application (CTA)

Liquent InSight® Commitments and Correspondence (LICC)



InSight® Registrations

Clients whose responsibilities include tracking agency commitments and correspondence, managers and employees who will assign/be assigned tasks in InSight, users who will create and maintain Notifications in InSight



COURSE DESCRIPTION

This course introduces References, Tasks and Notifications functionalities which allow users to track and assign commitments and other tasks that support regulatory objectives.


• Create links to external content using References • Create and copy assignments in InSight using Task functionality • Create Task Progression Workflows • Create InSight e-mail alerts using local and global Notifications


Liquent InSight® Advanced Planning and Tracking (LIARPT)

DURATION: 1.5 days | CLASS SIZE: 8 max (Classroom Instructor-Led Training)


Prior training in Liquent InSight® for Registrations, Liquent Insight® for Product Detail Management or Liquent InSight® for Submissions

Clients responsible for regulatory data changes that affect multiple applications and product lines Clients familiar with basic InSight functionality



COURSE DESCRIPTION

This course introduces the management of European Applications in InSight. Multi-country Applications, country and product tracking, Package Set Registrations, Registrations and the Sunset Clause report.


• Create a Centralized Procedure (CP) Application • Create and maintain a Mutual Recognition

Procedure (MRP) / Decentralized Procedure (DCP) • Track country status using Event-Country

functionality

• Run a Package Set Registration and Sunset Clause query • Create a European Clinical Trial Authorization Application (CTA)

What’s New in Registrations in Liquent InSight® (LIWNR)



Attendance in the course Liquent InSight® Registration Planning and Tracking and Product Detail management

Clients responsible for regulatory data changes that affect multiple Applications and product lines Clients familiar with basic InSight functionality.

Clients whose responsibilities include tracking CMC and product details for approved and pending approval, pharmaceutical, veterinary and medical device products.

Classroom Instructor-led Virtual Instructor-Led

Presentation

COURSE DESCRIPTION

This course will introduce users to the new features of Liquent InSight® for Registrations.


Executive Overview for Liquent InSight® for Registrations (LIEOVR)

DURATION: 0.5 day | CLASS SIZE: 8 max (Classroom Instructor Led Training)


None Managers and executives needing a high-level overview to InSight Registration functionality


Presentation Training Manual

COURSE DESCRIPTION

This course introduces executives and managers to the scope of functionality and capabilities available in InSight Registrations.

At the end of this course, the participant will understand how to:

• Create Product Data • Create TimeLine / Event Plans for regulatory objective records (Events) • Create and maintain a Project to track Applications and regulatory objectives

• Create and manage Package Set Registrations • Manage changes to product details • Track commitments and correspondence and create electronic alerts

Publishing with Liquent InSight® for eCTD, Paper and NeeS (LIPEPN)

DURATION: 3 days | CLASS SIZE: 8 max (Classroom Instructor-Led Training)


Working knowledge of the CTD and eCTD Specifications

This course is designed to enable submission planners and publishers with the tools necessary to produce an eCTD, paper and NeeS submission.

Participants are provided with a publishing approach that leverages faster assembly techniques and methods to track the submission lifecycle.



COURSE DESCRIPTION

This course introduces the features of Liquent InSight® to create an eCTD electronic, Non-eCTD (NeeS) and Paper and submissions.


• Understand the Liquent InSight Suite • Navigate in InSight • Create an Application, Event and Sequence • Create Assembly Trees • Assign Documents • Use the In Process Linking and Extracts tool

• Publish and Review the eCTD, Paper and NeeS Output • Manage the eCTD Lifecycle • Apply Overlays and Variables • Create a Tables of Contents • Add Paper Publishing Elements • Create a NeeS submission


Publishing with Liquent InSight® for eCTD and Paper (LIPEP)

DURATION: 3 days CLASS SIZE: 8 max (Classroom Instructor-Led Training) | eLearning 30-day access $300- 60 day $600



This course is designed to enable submission planners and publishers with the tools necessary to produce an eCTD and paper submission.




COURSE DESCRIPTION

This course introduces the features of Liquent InSight® to create an eCTD electronic and paper submissions.



• Publish and Review the eCTD, Paper and NeeS Output • Manage the eCTD Lifecycle • Apply Overlays and Variables • Create a Table of Contents • Add Paper Publishing Elements


Publishing with Liquent InSight® for eCTD and NeeS (LIPEN)

DURATION: 3 days CLASS SIZE: 8 max (Classroom Instructor Led Training)



This course is designed to enable submission planners and publishers with the tools necessary to produce an eCTD and paper submission.




COURSE DESCRIPTION

This course introduces the features of Liquent InSight® to create an eCTD electronic and NeeS submission.



• Publish and Review the eCTD, Paper and NeeS Output • Manage the eCTD Lifecycle • Apply Overlays and Variables • Create a Table of Contents • Create a NeeS Submission


Publishing with Liquent InSight® for Paper (LIPP)



Working knowledge of the CTD

This course is designed to enable submission planners and publishers with the tools necessary to produce an eCTD paper submission.




COURSE DESCRIPTION

This course introduces the features of Liquent InSight® to create a Paper submission.


• Understand the Liquent InSight Suite • Navigate in InSight • Create an Application, Event and Sequence • Create Assembly Trees • Assign Documents

• Use the In Process Linking and Extracts tool • Apply Overlays and Variables • Create a Table of Contents • Add Paper Publishing Elements • Publish and Review the Paper Submission

Publishing with Liquent InSight® for eCTD (LIPE)



Working knowledge of the CTD

This course is designed to enable submission planners and publishers with the tools necessary to produce an eCTD submission.




COURSE DESCRIPTION

This course introduces the features of Liquent InSight® to create an eCTD submission


• Understand the Liquent InSight Suite • Navigate in InSight • Create an Application, Event and Sequence • Create Assembly Trees • Assign Documents

• Use the In Process Linking and Extracts tool • Apply Overlays and Variables • Publish and Review the eCTD Submission • Manage the eCTD Lifecycle


Report Level Publishing with Liquent InSight® (LIRLP)




This course is designed to enable submission planners and report level publishers with the tools necessary to produce reports.




COURSE DESCRIPTION

This course will introduce Publishers to the features of Liquent InSight® to create and modify assembly structures that will contribute content in Modules 4 and 5 and enter and edit metadata used in report level publishing.


• Understand Report Publishing Overview • Navigate through InSight • Manage Standalone Assemblies • Create Assembly Trees • Use the Wizards • Work with Special Data • Apply Overlays and Variables • Create Tables of Content • Publish Clinical Study Reports • Review a Published Output


Advanced Publishing with Liquent InSight® (LIPADV)



Working knowledge of the CTD and eCTD Specifications.

Attendance in Publishing with Liquent InSight® or What’s New with Publishing with Liquent InSight®.

3-6 months prior practical application of the product.

This course approach offers experienced publishers new techniques for faster assembly creation and alternative methods to tracking the lifecycle of a submission.



COURSE DESCRIPTION

This course is designed to present publishers with the knowledge necessary to perform sophisticated publishing tasks for eCTD creation. Participants are provided with an advanced approach to managing concurrently planned sequences, lifecycle applications, and regional submission variances.


• Automate Assemblies • Change Assembly Extensions • Create Study Reports • Create Templates with Variables • Prepare Assemblies in the Lifecycle • Lifecycle Linking


Publishing with Liquent InSight® Certified Professional Exam Preparation (LICPEP)



3-6 months of full-time Liquent InSight® Publisher use, versions 5.1 and above.

Attendance in the course Publishing with Liquent InSight®.

Certified Liquent InSight® Publishers are individuals who have demonstrated mastery in skills necessary to utilize Liquent InSight solutions

Classroom Instructor-Led

Participant Traning Manual

COURSE DESCRIPTION

The purpose of this class is to assist in the preparation for the Publishing with Liquent InSight® Certified Professional Examination. At the beginning of each lesson, students will complete a skills analysis checklist. During the class, questions will be asked to measure students’ knowledge of publishing. In addition, they will have the opportunity to practice their publishing skills with hands-on exercises using Liquent InSight®. Partcipants should bring in their training manuals from the class: Publishing with Liquent InSight®.

Topics

• InSight Entity Relationships • Navigation • Working with Applications • Creating Assembly Trees • Assigning Documents • Creating Special Sheets • Defining Overlays and Variables • Building Tables of Contents • In-Process Linking • Reviewing a Publication • Publishing • Managing the eCTD Lifecycle


Publishing with Liquent InSight® Certified Professional Exam (LICPE)



3-6 months of full-time Liquent InSight® Publisher use, versions 5.1 and above

Attendance in the course Publishing with Liquent InSight®

Certified Liquent InSight® Publishers are individuals who have demonstrated mastery in skills necessary to utilize Liquent solutions


N/A

COURSE DESCRIPTION

Liquent InSight Publisher certification helps companies identify expert publishers who know how use the tool and to distinguish themselves as leaders in their industry. The Certified Publishing with Liquent InSight examination consists of two parts (written and practical) that are taken on the same day.

Part One – 2 Hours – Written • Participants will answer questions about the use of Liquent InSight. Included in this section are Liquent InSight publishing scenarios, matching, true/false, multiple-choice questions and explaining publishing terms.

Part Two – 3 Hours – Practical • Participants will create an eCTD submission. Additonally the following areas will be incorporated: • Creating Applications/Events and Sequences • Creating Assemblies/Assigning Documents • In-Process Linking • Publishing • Managing the eCTD Lifecycle • Building Table of Contents • Creating Special Sheets • Defining Overlays and Variables

Please Note: Unless provided by the instructor, study aids will not be available for use during either part of the examination. Participants will be notified via email on scores approximately one week from completion of the exam. Certificates and a pin will be sent to students passing the exam.


What’s new in Publishing in Liquent InSight® (LIWNP)




Liquent InSight® Submission Publishers

Classroom Instructor-led Virtual Instructor-Led

Presentation

COURSE DESCRIPTION

This course will introduce participantsto the new features of Liquent InSight for Publishing.

Liquent InSight® Administration for Publishers (LIAP)




This course is designed to enable users with Administration responsibilities to manage permissions and data values. Publishing Administrators as well as IT Staff and LAN Administrators will also find this class useful.


Presentation Training Guides Exercises

COURSE DESCRIPTION

This course will introduce administrators to the system features of Liquent InSight® to understand the role of an InSight Publisher Administrator.


• Understand the Architecture Overview • Create new users in Security Administration • Create and update fields in Data Administration • Create and update links and servers in Technical Administration

• Understand Administration Reporting • IRS Rendering and Publishing Services • Administrator Resources • Troubleshooting


Liquent InSight® Submission Planning and Tracking (LISPT)




Individuals who will be planning and tracking submission projects. Individuals may also be responsible for creating tools to aid the submission process.



COURSE DESCRIPTION

This course will introduce participants to the features of InSight to use InSight tools to track the status and guide the production of a publishing project


• Understand InSight for Submissions overview • Navigate through InSight • Create National Applications • Create Events and Sequences • Create Assembly Trees • Use the Wizards • Understand European Applications

• Manipulate Assembly elements • Manage Commitments & Correspondences • Manage Assembilies • AutomateAssembly creation • Create Global Project Plans • Query InSight

Automating the Publishing Process with Liquent Smartdesk for PDF® (LISDPDF)



Working knowledge of the ICH Guidelines Working knowledge of Adobe Acrobat

Individuals who will be planning and tracking submission projects using InSight. Individuals may also be responsible for creating tools to aid the submission process.



COURSE DESCRIPTION

This course will introduce participants to the features of Liquent SmartDesk for PDF to automate the publishing process and help address publishing challenges in a simple and streamlined manner. Topics

• PDF Security • PDF Optimization • PDF Page Verification – Margins, orientation & content • Splitting & Merging PDF Files • Scaling & Redacting PDF Files • PDF Page Stamping – Header/Footers and Link Referencing

• PDF Link Tools • Reversing Bookmark Order & Cloning Bookmarks • Importing/Exporting Links & Bookmarks • Linking the Table of Contents • Modifying magnification settings • Verification & Resolution Tools for Document Information Fields, Navigational Items & Font Information


Liquent InSight® Smartlink for Word (LISLW)



Working knowledge of the ICH Guidelines Working knowledge of Adobe Acrobat

Individuals who will be planning and tracking submission projects using InSight. Individuals may also be responsible for creating tools to aid the submission process.



COURSE DESCRIPTION

This course will introduce students to the features of Liquent SmartDesk for PDF to automate the publishing process and help address publishing challenges in a simple and streamlined manner. Topics

• PDF Security • PDF Optimization • PDF Page Verification – Margins, orientation & content • Splitting & Merging PDF Files • Scaling & Redacting PDF Files • PDF Page Stamping – Header/Footers and Link Referencing • PDF Link Tools • Reversing Bookmark Order & Cloning Bookmarks • Importing/Exporting Links & Bookmarks • Linking the Table of Contents • Modifying magnification settings • Verification & Resolution Tools for Document Information Fields, Navigational Items & Font Information


Reviewing Submissions with Liquent InSight® for Viewing (LIIFV)



None

This course is designed to instruct administrators on how to assign and establish permissions for reviewers of eCTD and Non-eCTD submissions. It will also instructs users on how to access and view the eCTD and Non-CTD submissions.



COURSE DESCRIPTION

This course will introduce participants to the features of Liquent InSight® for Viewing to create and manage user accounts, data repositories and application groups for searching and reviewing CTD and Non-eCTD submissions. Topics Part One – The Administrative Role • Managing Users, Data Repositories and Application Groups • Managing and Registering eCTD & Non-eCTD Applications • Content Indexing • Managing User Groups & Assigning Applications to Groups • Viewing Server Configurations Part Two – The Reviewer Role • Searching for Submissions – Content vs. Metadata • Reviewing the Submission’s Table of Contents, Document Properties and Lifecycle • Creating, Responding to and Closing Comments • User Settings & Preferences • Running and viewing Reports: Comments, Review matrix by User and Auto Registration


Liquent InSight® for Analytics (LIAH)

DURATION: 0.5 day CLASS SIZE: 8 max (Classroom Instructor-Led Training)


Attendance of Liquent InSight® Course

Knowledge base of Relational Databases

This course is designed to provide users with advanced reporting and metrics from Liquent InSight® data



COURSE DESCRIPTION

This course will introduce the features of Liquent InSight® for Analytics in order to provide advanced reporting and metrics from Liquent InSight® data, including the ability to build ad hoc reports.

Topics

• Navigate within Analytics • Understand Security permissions • Run a predefined report • Create Charts from report results

• Use Dashboard reports • Use Guided Ad Hoc reports • Schedule a report • Create a Distribution List

Liquent InSight® for Analytics (LIAF)

DURATION: 1 day | CLASS SIZE: 8 max (Classroom Instructor- Led Training)




This course is designed to provide users with advanced reporting and metrics from Liquent InSight® data, including the ability to build your own ad hoc reports



COURSE DESCRIPTION

This course will introduce the features of Liquent InSight® for Analytics to provide advanced reporting and metrics from Liquent InSight® data, including the ability to build ad hoc reports.

Topics

• Navigate within Analytics • Understand Security permissions • Run a predefined report • Create Charts from report results • Use Dashboard reports

• Use Guided Ad Hoc reports • Schedule a report • Create a Distribution List • Create an adhoc report using InfoAssist • Import and export reports


Liquent InSight® for Workflows (LIWF)

DURATION: 0.5 day CLASS SIZE: 8 max (Classroom Instructor Led Training)




Users who will be assigned activities/ projects

Administrators who will be assigning activities/projects to team members



COURSE DESCRIPTION

This course provides the functionality to utilize client specific workflows to meet process needs within Liquent InSight®. Workflows are configured using XML which is processed by Liquent InSight® at start-up. This functionality allows for workflows to contain multiple activities, with dependencies and defined pre-set fields, which guide processes within the system.

Topics

• Associate a Workflow • Pause/Resume a Workflow • Delete a Workflow • Work with Activities • View Workflows and Activities

• Workflow administration • Create a virtual group • Modify a virtual group • Delete a virtual group

Liquent InSight® for XEVMPD (LIXEV)

DURATION: 0.5 day CLASS SIZE: 8 max (Classroom Instructor Led Training)


Attendance of Liquent Insight® Registration Planning and Tracking Course

Individuals required to submit XEVMPD messages to the EMA, and upload received acknowledgement files



COURSE DESCRIPTION

This course introduces the features of Liquent InSight® for XEVMPD to enter required XEVMPD data in InSight as well as create the message and process acknowledgement files from the EMA.

Topics

• XEVMPD data entry requirements • Creation of the xml message for submission to the EMA • Using the XEVMPD Submission Wizard • Using the XEVMPD Acknowledgement Wizard • Data Administration requirements



Perceptive MyTrials®

Courses


Perceptive My Trials® Courses

Perceptive MyTrials® Training Map

Training Programs E

Reports E

Perceptive MyTrials® Basics (MT001 )

Perceptive MyTrials® Analytics (MT015)

Perceptive MyTrials® Collaboration Toolbox (MT003)

Perceptive MyTrials® User Maintenance Interface (UMI) (MT006)

E = eLearning

Training Programs Reports

• Courses to support different roles • Covers core Perceptive MyTrials® functionality • Basics course applicable to all roles • Includes demonstrations, scenarios and hands-on practice

• Perceptive MyTrials® Analytics for cross-study analysis of clinical data • Includes demonstrations and hands-on practice


Perceptive MyTrials® Roles Each user role below can benefit from our modular courses or pick and choose the relevant modules from the full suite of Parexel’s Education Services Perceptive MyTrials® modules.

Site Users Administrators

Site users are typically responsible for the data entry aspect of clinical studies. Perceptive MyTrials® enables sites to access multiple studies in one place, access associated applications, document libraries and view calendars and announcements.

Designated administrators manage the overall trial and trial access process using the User Maintenance Interface. They are also able to edit the Collaboration Toolbox, filter data, activate and deactivate users and manage the activation keys.

Project Team Users Portfolio Users

Project team users are responsible for overall study management. They may have view/edit rights to certain interfaces, enabling them to upload and edit documents, update calendars and announcements, and view reports. They also may have permission to access the project leader dashboard and Parexel® Master File.

Individuals with oversight responsibility who require at-a-glance, standardized performance metrics across multiple studies to identify individual studies with performance issues and address them accordingly.


Perceptive MyTrials® Collaboration Toolbox (MT003)

DURATION: 25 mins approx. | CLASS SIZE: n/a


Perceptive MyTrials® Basics (MT001) Perceptive MyTrials® System Access Process (MT002)

Any roles with write access in Perceptive MyTrials®


COURSE DESCRIPTION

The Collaboration Toolbox module is designed for users who have edit rights to the Perceptive MyTrials® platform. The participant will receive an overview of the Collaboration Toolbox, features and functionality. Participants will receive complete instruction on the document collaboration process and the benefits of using calendars and announcements.


• Describe the Collaboration Toolbox features and functionality • Be able to load, modify and collaborate on documents using the Collaboration Toolbox • Describe how to insert, modify and use Calendars and Announcements • Describe the benefits of using Quickr Connector to manage documents

Perceptive MyTrials® Basics (MT001)



None All Roles Self-Paced eLearning n/a

COURSE DESCRIPTION

This course will introduce users to the Perceptive MyTrials® portal. Users will learn how to navigate the available dashboards, create a user account, register for trials, and update profiles in User Preferences.


• Explain the purpose of the Perceptive MyTrials® portal • Navigate dashboards, trial applications, and access clinical trial documentation • Create a user account • Register for trial access • Access and edit User Profile


Perceptive MyTrials® User Maintenance Interface (UMI) (MT006)



Perceptive MyTrials® Basics (MT001) Perceptive MyTrials® System Access Process (MT002)

Data Managers Project Managers Any Project Team Member


COURSE DESCRIPTION

Participants will be provided with an overview of the User Maintenance Interface to manage access to a trial.


• Load users into the Perceptive MyTrials® platform tool • Approve users and understand the activation key process • Deactivate and reactivate profiles

Perceptive MyTrials® Study Level Analytics (MT015)



Perceptive MyTrials® Basics (MT001)

Any role that requires access to cross-study analysis of clinical data to identify key trends


COURSE DESCRIPTION

As clinical studies become more complex, there is a growing need for real-time and standardized analytics to leverage the data compiled from the multiple applications being used. Perceptive MyTrials® Study Level Analytics provides a suite of dashboards which translate the data into easy-to-read visualizations to show how the study is performing. This course will introduce users to the Study Level dashboards and how to use the defined milestones, reports, and visualizations to quickly identify and mitigate issues to improve patient safety and data quality.


• Summarize the purpose and benefits of Perceptive MyTrials Analytics for Study Metrics • Navigate Study Level Analytics Dashboards and Visualizations • Practice analyzing Study level data



Perceptive MyTrials® Data-Driven Monitoring (DDM) Courses


Perceptive MyTrials® Data-Driven Monitoring Courses

Perceptive MyTrials® Data-Driven Monitoring Training Map

Foundation E

Role-Based E

Administration E

DDM001 Perceptive MyTrials® Data-Driven Monitoring Orientation

DDM003 Perceptive MyTrials® Data-Driven Monitoring Clinical Monitor

DDM005 Perceptive MyTrials® Data-Driven Monitoring for Study Administrator

DDM002 Perceptive MyTrials® Data-Driven Monitoring Dashboard)

DDM004 Perceptive MyTrials® Data-Driven Monitoring Clinical Oversight

Completion Certificate Completion Certificate

E = eLearning

Orientation Learning • Prerequisite foundation knowledge for role-specific courses

Role-Based Learning • Role-based modules mapped to typical user roles

• Demonstrations and real-world scenarios

Parexel’s Education Services’ Data-Driven Monitoring program is a comprehensive training suite designed to assist our clients and users in developing the knowledge and skills needed to maximize the strength of Perceptive MyTrials® Data-Driven Monitoring application. The Data-Driven Monitoring application captures and organizes clinical metrics in near real-time from multiple sources, such as EDC and IMPACT CTMS. This assists in the prioritization, planning and scheduling of monitoring activities. Users will be able to make timely decisions that effectively allocate monitoring resources and reduce onsite activities leading to improved patient safety, data quality, and productivity. The application also tracks trends and all monitoring activities over time to demonstrate regulatory compliance.

Our courses are applicable for the Clinical Oversight, Clinical Monitor and Administrator roles.



Certification Tracks


Certification Tracks Our Certification programs will enable you to monitor competence in the knowledge and skills acquired. Organizations today with 40-55% of team members who are Certified perform above average among all organizations. In addition, our Train-The-Trainer (TTT) certification courses are designed to equip and empower your organization to scale delivery and cut costs. Our Certification programs offer clear specialist-based Certification paths. Training is delivered using a variety of delivery mechanisms, applying practical and hands-on activities, and incorporating best practices from our experienced trainers. Once passing our skills based and knowledge-based assessments, Certified individuals will receive: • Certified Logo to demonstrate your Certification status • Training guides and where applicable access to Instructor and Student kits for DataLabs • Trainer Certifications Our DataLabs® EDC and DataLabs® Designer Certifications include: • Designer Certified • DataLabs Trainer Certified • DataLabs Site Trainer Certified • Designer Trainer Certified Our IMPACT® CTMS Certifications include: • IMPACT Trainer • IMPACT Administrator Our Liquent Insight® Certifications include: • Train -The -Trainer • Publishing

For more information: • www.parexel.com/solutions/integrated-technologies/parexel-education-services

• [email protected]

http://www.parexel.com/solutions/integrated-technologies/parexel-education-services

http://www.parexel.com/solutions/integrated-technologies/parexel-education-services

mailto:[email protected]



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