TrialKit Help

Getting Started FAQs 8

• Signing Up For TrialKit
• Where To Start?
• The Basics - Data Entry and Queries
• Why do I not see my study when I login?
• How Do I Create A Study?

View all 8

User Guides 1

• Site Users

Version Release Notes 39

• Android v3.5 - December 6, 2020
• iOS v8.7 - December 6, 2020
• Web v5.4 - Nov 21, 2020
• Web v5.3 - October 24, 2020
• Android v3.4 - October 24, 2020

View all 39

Other Links 6

• Overview to Building a Study - Progress
• User Preferences
• Locking Your Workstation
• Signing Out
• Renew Session Timer

View all 6

Data, User Privacy and Terms of Use 3

• European Court of Justice’s Decision and Impact to the EU-US Privacy Shield Framework
• Privacy and GDPR
• Compliance, Data Storage, and Security

Site Coordinator/End User FAQs 11

• Where Do I Start?
• How do I log in to the Android or IOS Application?
• What if I get an error using the Android or IOS device application(s)?
• Forgot Password
• What if I have protocol question on study?

View all 11

Enrolling & Record Entry 7

• Enrolling Subjects
• Entering Records
• Patient Handoff Mode
• Bundled Handoff Mode
• Moving A Subject To A Different Cohort

View all 7

Navigating Subject Records 10

• Subject Manager
• Subject Records
• Scheduled Visits
• Unscheduled Visits
• Log Forms

View all 10

Queries 3

• Query Types and Overview
• Posting Messages to Queries
• Managing Your Queries

Helpful Reports 4

• My Queries Report
• Action Item Report
• Dashboard Report
• Record Status Report

Inventory Management 1

• Managing Site Inventory

Patient Reporting (ePRO) and Patient Messaging 4

• Providing Patients with ePRO Login Credentials
• Can ePRO subjects enter their data on a web browser?
• What Mobile Devices do you support for ePRO?
• Manual Patient Notifications

Monitoring and Record Review 6

• Record/CRF Reviewing Overview
• Accessing Records Ready for Review
• Reviewing a CRF
• Field Lock Report
• Monitor Report

View all 6

Risk Based Monitoring 8

• Overview
• Implementation – Two Methods
• Defining Risk Based Monitoring Rules
• Grant Rights to Configure RBM
• Setup a Field Level Source Verification Study/CRF

View all 8

Setting Up Medical Coding (For studies running in TrialKit) 1

• Setting Up a Study For Medical Coding

TrialKit Coder Website 4

• TrialKit Coder Overview
• Setting Up Coding Projects
• Coding In TrialKit Coder For the Web
• Medical Coding Algorithm

Data Management FAQ's 3

• Can I extract all versions of my Case Report Forms (CRF's) in one Extract (SAS XML, Excel ETC)?
• Why can't one of my user roles extract (export) all data even if they have the permission to export?
• What is the difference between Study Archival and Form Freeze?

Built-In Reports 14

• My Queries Report
• Action Items Report
• Dashboard Report
• Record Status Report
• Study Progress Report

View all 14

Custom Reporting 6

• J-Review
• Report Builder
• Graphical Chart Building
• PDF Upload
• Database Merge Reports

View all 6

Adjudication 6

• Overview
• Adjudication Roles
• Configuring Forms for Adjudication
• Adjudicating Forms In Your Study
• Assigning Adjudication

View all 6

Query Management 3

• Query Overview
• Creating Manual Queries
• Closing Queries

Adding and Managing Users 1

• Adding and Managing Users

File and Document Management 4

• Site Documents
• File Management
• Study Forms
• File Repository Manager (Old Study Document Manager)

Product Tracking, Inventory Control, IWRS, RTSM 6

• Inventory Management Overview
• Defining Inventories and CRF Attributes
• Importing, Configuring, and Overseeing Inventory
• Accessing and Managing Existing Inventories
• Inventory Roles and Permissions

View all 6

Data Extraction 3

• Extract Study Data By Form
• Extract All Study Data
• Form Status (Record Status) and Record Type Definitions

Manage Mobile Devices 2

• Manage User Mobile Devices
• Manage ePRO Devices

Send ePRO Notifications 1

• Send ePRO Notifications

Data Manager Tools 2

• Re-Run Edit Checks for a New Version of Live Study
• Data Import

Payment Tracking 3

• Payment Tracking Overview
• Configuring Payments
• Managing Payments

Risk Based Monitoring Rules 3

• Risk-Based Monitoring Overview
• Enable Risk-Based Monitoring Function
• Defining RBM

Regulatory Audit Reports 2

• Subject Audit Report
• Role Rights Audit Report

Study Building Guide 2

• Study Building Guide
• Process for Moving a Study Live

Methods of Data Collection 1

• Collecting Data Not Directly Related to a Subject/Patient

Customizing the Logo/Theme and Page Content 3

• Site Theme/Appearance Customization Overview
• How to Customize the Site Theme
• Build Web Page

Study Builder FAQs 18

• Can I bulk import a list of choices to a Choice Type field?
• How do I populate and hide visit/Transaction Date to users on the data entry screen?
• Is there a built-in version control system?
• How do I remove all versions BUT keep the latest versioned forms in a new study build?
• How come I added a site or sites and I cannot toggle to them in data entry mode?

View all 18

Customizing the Study Theme 1

• Customizing the Study Theme and Page Content

Randomization and ID Allocations 8

• Randomization Overview
• Defining a Randomization
• Setting up a Randomization Scheme
• Randomization - Confirmation Email Distribution List
• Define User Permissions for Randomization

View all 8

Study Versioning (Mid-Study Changes) 3

• Study Versioning
• Version Manager
• Migrating Subjects To a New Study Version

Importing Data 7

• Data Import Overview
• Preparing Imports - Form Building
• Preparing the Import Source File
• Create Import Configuration
• Mapping a Configuration

View all 7

Automated Health and Activity Data Collection 1

• Health and Activity Data Overview

Form Building Overview and Guide 6

• Common Form Building FAQs
• Form Builder Overview
• Form Building Guide
• Conditional Action/Field Triggers Building Guide
• Field Triggers

View all 6

Form Types 2

• Website Host Level Form Types
• Study Level Form Types

Form Properties 4

• Design Tools - Toolbox
• Data Field Types
• Form Properties
• Defining Log Forms

Field Types and Properties 18

• Field Labels
• Date and Time
• Normalized Tables
• Text Fields
• Barcode Scanning

View all 18

Form Logic & Edit Checks 14

• Conditional Actions Overview
• Building Conditions
• Advanced Edit Checks (Operators, Time Calculations, Computed Field Functions and Hiding Form/Intervals)
• Disable Fields
• Hide or Hidden Fields

View all 14

Copying, Moving & Reusing Forms 4

• Form Libraries
• Importing & Exporting Forms
• Moving Fields to Another Tab on Form
• Replicate Form

Other Form Builder Tools 13

• Form Editing Tools
• Data Dictionaries
• Annotated Forms
• Previewing Forms
• Auto-Validating Forms

View all 13

Making Mid-Study Changes 1

• Making Form Changes

Labs and Lab Ranges 6

• Labs Overview
• Creating Lab Forms
• Enabling Study For Lab Ranges
• Mapping Lab Ranges
• Matching Lab Sites With Study Sites

View all 6

Functionality Options 2

• Study Configuration Overview
• Functionality Overview

Role Security 2

• Role Security (User Permissions)
• Blind Form Fields by Role

Role Permissions Guide 2

• Study Role Permissions Guide
• Role Permissions Template

Sites and Users 1

• Adding Sites and Users to a Study

Record Review Workflow 2

• Setting up Study Workflow and Form Definitions
• Configuring Study for Partial Monitoring

Metrics 1

• Metrics

Query Settings 1

• Query Settings

Audit Settings 6

• Study Audit Settings
• Audit Changes to Subject CRF Data
• Require Reason for Any Change to Subject CRF Data
• Use Coded Instead of Free Text field for Reason
• Allow First Reason to be Inserted to All Other Reasons

View all 6

Study Versioning 6

• Study Versioning Overview
• Adding a Study Version
• Publishing a Study Version
• Viewing Study Version Changes
• Deleting a Study Version

View all 6

Double Data Entry 3

• Double Data Entry - Introduction
• Configuring Double Data Entry
• Using Double Data Entry

Hooks and Integrations 1

• Integrations and Web Service Hooks

Study Status Settings 2

• Changing the Study Status
• Resetting the Study Status

Removing All Data 1

• Clearing (Deleting) All Study Data

Scheduled Visits 3

• Scheduled Visits Overview
• Setting Up the Scheduled Visits and Visit Cohorts
• Cohorts Defined and Setting Up Multiple Visit Schedules

Unscheduled Visits 1

• Setting Up Unscheduled Events

Form Sequence 1

• Setting the Order of Forms In a Visit Schedule

Interval Date Entry (IDE) 2

• Configuring Interval Date Entry
• Using Interval Date Entry

Configuring Study for Patient Reporting (ePRO) 3

• Setting Up A Study With ePRO
• ePRO Email and In-App Notifications
• Setting Up Patient Consent

How to Provide Patients ePRO functionality 3

• Providing Patients With Login Credentials
• What Mobile Devices do you support for patient reporting (ePRO)
• Patient Single Form or Bundled Forms Handoff Mode

eDiary Configuration 1

• How to Configure eDiary Functionality

ePro Building FAQ's 4

• Why can I see the ePRO patient's email address I am typing?
• When subject withdraws, does subject continue to have access to ePRO forms?
• Why can't subject level user see the form on their device? I set up the form correctly.
• How Do I Send Surveys to Patients?

Account Manager 5

• Creating/Updating Account Profile
• Updating Payment Information
• Change Password
• Version Information
• Contact Us

Account Roles and Permissions 4

• Host Level Roles and Rights
• Role Manager
• Rights Manager
• Grant Rights to all Forms for all Users

Account FAQs 4

• How Do I Change My Subscription/Invoicing?
• How To Close A Study
• How do I change the name of my website host?
• How does study licensing work?

Creating and Copying Studies 5

• Creating Administrative/Validation Copies of Live Studies in your host
• Making Copies of Studies
• What Gets Copied When Creating New Studies
• Re-Using Multi-Versioned Studies
• Host Copy Study

Users 6

• User Overview
• Adding Users to the Account
• User Management
• Site/User Audit Report
• User Management FAQ

View all 6

Sites 2

• Site Overview
• Adding Sites to the Account

Host Level Role Security 1

• Host/Account Level Role Security

Steps to become Certified 1

• Steps to Become Certified

TrialKit Certification Training Wizard 3

• Training Plan Wizard
• ePro and eConsent Training
• Study Building Guide

Medical Coding Self Training Wizard 1

• Medical Coding

SF-12 Interface 1

• Quality Metric

Logging In 1

• How To Sign In

TrialKit Mobile App 2

• How to sign in as a Subject on the TrialKit App
• Completing Forms On the TrialKit App

Patient Website Portal 1

• ePRO Subject or Patient Web Site Log In

Training Agenda 1

• Agenda

ePRO Set up 3

• Installing the TrialKit Application on Mobile Device
• ePRO Set Up
• What devices does TrialKit Support?

Subject Workflow 5

• Providing Patients with ePRO Login Credentials
• Subject View
• Completing Forms On the TrialKit App
• Manual Patient Notifications
• Subject Portal Via Web Browser

Building ePRO Forms to Use in Study 2

• Form Builder Overview
• Building New ePRO Forms