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TrialKit Training Outline

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

For a summary of TrialKit Academy, read here

TrialKit 101 - Session 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. 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. System access and the basics

    2. Navigating Subject Records

    3. My Queries

    4. Action Items

Study Administration

    1. Staying Informed: Version updates

    2. Study requests and closure process

    3. Creating and Copying Studies

Monitoring and Record Review

    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. 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. Study Building Guide

    Building Forms

      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. Form libraries

        1. Import from a file

      2. Data Dictionary

      3. Annotating Forms and Blank Casebooks

    Session 2

    Form Building Finish

      1. Auto-Validation (Web Only)

      2. Device and Language Targeting (App Only)

      3. Translated text validation (App Only)

    Study Configuration

      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. Scheduled Visits

        1. Visit Cohorts

      2. Unscheduled Events

      3. Form Sequence

      4. Interval Date Entry

    Session 3


      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. Participant’s experience - App vs Web

      2. Consenting Participants

      3. Timeline report

      4. Joining Virtual Visits

    Testing your builds

      1. Using Data Dictionary for UAT testing.

      2. Removing Test Data

    Go Live and Change Control through Version Management

      1. Going Live
      2. Version Management and Version Override's

    Additional Component Training (Add On's)


      1. Adjudication Setup and Configuration

      2. Performing Adjudication


    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


    Copying Folders and Content

    File Expiration

    Activities Audited By the TMF

    TMF Folder Structure Sample



      1. Defining Randomizations

      2. Allocating and Managing Randomization

      3. Blinding

      4. Using randomization in conditions

    Reporting Objects

      1. Reporting Objects

      2. Graphical Reports

    Medical Coding

      1. Configuring forms for coding

      2. Setting up coding projects

      3. Coding in TKCoder

    Site Payment Tracking

      1. Configuration and management of site payments

    Lab Range Management

    Lab Management Overview

      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. 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