TrialKit Training Outline

This outline is used for Administrative (TK-101) and Building Certification (TK-201), and serves as a helpful post-training reference

TrialKit 101 - Session 1

Introduction

1. 1. Introductions

   2. How to get Help and Support

   3. Staying Informed: Version updates

   4. Study requests and closure process

   5. Creating and Copying Studies

Session 2

Studies, Users, Roles, and Sites

1. 1. Users Set Up in Host Menu

   2. Role Security (Host)

   3. Role Security (Study)

      1. Role security matrix on application

   4. Site Setup in Host Menu

   5. User Assignments to Studies

   6. Themes and appearance (web only)

Site Users

1. 1. System access and the basics

   2. Navigating Subject Records

   3. My Queries

   4. Action Items

Study Administration

1. 1. Staying Informed: Version updates

   2. Study requests and closure process

   3. Creating and Copying Studies

Monitoring and Record Review

1. 1. Record/CRF Reviewing Overview

   2. Accessing Records Ready for Review

   3. Reviewing a CRF

   4. Monitor Report

   5. Field Level Review and Risk-Based Monitoring (Configuration)

Data Managers

1. 1. Report Builder: Ad-hoc data listings 

   2. Site and Study Documents

   3. Staying Informed: Version updates

   4. Study requests and closure process

   5. Creating and Copying Studies

   6. Data Extraction

      1. Access and blinding

      2. PDF Exports

         1. PDF Batch Exporting Records and Complete Casebooks

TrialKit 201 - Session 1

Study Builders

1. 1. Study Building Guide

Building Forms

1. 1. Form Building

      1. Form Building Tips Video

   2. Copying and pasting

   3. Conditional Actions (Edit checks and form logic)

      1. Field Triggers

      2. Advanced CA's - Blocked conditions and Regular Expressions

1. 1. Form libraries

      1. Import from a file

   2. Data Dictionary

   3. Annotating Forms and Blank Casebooks

Session 2

Form Building Finish

1. 1. Auto-Validation (Web Only)

   2. Device and Language Targeting (App Only)

   3. Translated text validation (App Only)

Study Configuration

1. 1. Functionality

   2. Defining Key Forms 

   3. Record Review Workflow

   4. Metrics

   5. Query Settings

   6. Audit Settings

   7. Study Versioning

   8. Study Status Settings - Process for Moving studies live

Visit Schedule Design

1. 1. Scheduled Visits

      1. Visit Cohorts

   2. Unscheduled Events

   3. Form Sequence

   4. Interval Date Entry

Session 3

ePRO

1. 1. Configuring Studies for Patient Reporting and Diaries

   2. Consent

   3. How to Provide Subjects ePRO Login Information

   4. Patient Access (ePRO)

   5. Participant Notifications

   6. Calendar/Scheduling

   7. Video Meeting

      1. Joining Virtual Visits

Participant Users

1. 1. Participant’s experience - App vs Web

   2. Consenting Participants

   3. Timeline report

   4. Joining Virtual Visits

Testing your builds

1. 1. Using Data Dictionary for UAT testing.

   2. Removing Test Data

Go Live and Change Control through Version Management

1. 1. Going Live

   2. Version Management and Version Override's

Additional Component Training (Add On's)

Adjudication

1. 1. Adjudication Setup and Configuration

   2. Performing Adjudication

eTMF

Trial Master File

TMF Overview and Access

Viewing Files

Downloading and Updating Files

Using Blockchain

Review and Approval of Documents

Folder and File Permissions

Placeholders - Assigning Tasks to Upload Documents

Tasks

Copying Folders and Content

File Expiration

Activities Audited By the TMF

TMF Folder Structure Sample

Randomization

Randomization

1. 1. Defining Randomizations

   2. Allocating and Managing Randomization

   3. Blinding 

   4. Using randomization in conditions

Reporting Objects

1. 1. Reporting Objects

   2. Graphical Reports

Medical Coding

1. 1. Configuring forms for coding or importing datasets

   2. Setting up coding projects

   3. Coding in TKCoder

   4. Synonym management

Site Payment Tracking

1. 1. Configuration and management of site payments

Lab Range Management

Lab Management Overview

1. 1. Creating Lab Forms

   2. Enabling Study For Lab Ranges

   3. Mapping Lab Ranges

   4. Matching Lab Sites With Study Sites

   5. Entering Lab Data

Trial Supply (IP) Tracking

1. 1. Inventory Management and Setup 

   2. Inventory Administration

   3. Site Inventory and Assigning to Subjects

Data Importing

Manual Batch Data Importing

API Integration Basics

Video Conference

Scheduled Virtual Visits

Ad-hoc virtual visits

During the Session

Video Meeting History

1. Calendar/Scheduling

2. Video Meeting

   1. Joining Virtual Visits