Contents

Title and Copyright Information

Preface

• Audience
• Documentation Accessibility
• Related Documents

1 Getting Started

• 1.1 Forgotten Password
• 1.2 How to Get Help

2 Products

• 2.1 Working with Products
  • 2.1.1 Roles
  • 2.1.2 Creating Products
  • 2.1.3 Editing Products
  • 2.1.4 Deleting Products
  • 2.1.5 Restoring Products

3 Studies

• 3.1 Working with Studies
  • 3.1.1 Study Phases
  • 3.1.2 Creating Phase II-IV Studies
  • 3.1.3 Creating Phase I Studies
  • 3.1.4 Editing Studies
  • 3.1.5 Deleting Studies
  • 3.1.6 Restoring Studies

4 Plans

• 4.1 Working with Plans
  • 4.1.1 Creating Plans
  • 4.1.2 Saving Plans
  • 4.1.3 Editing Plans
  • 4.1.4 Deleting Plans
  • 4.1.5 Restoring Plans
  • 4.1.6 Copying Plans
  • 4.1.7 Comparing Plans
  • 4.1.8 Locking Plans
  • 4.1.9 Unlocking Plans
  • 4.1.10 Editing Attributes of a Locked Plan
  • 4.1.11 View, Print, and Export a Plan
  • 4.1.12 Freezing Billing Rates for a Plan
  • 4.1.13 Recalculate a Plan with Service Provider Billing Rates

5 Templates

• 5.1 Working with Templates
  • 5.1.1 Roles
  • 5.1.2 Creating Templates
  • 5.1.3 Editing Templates
  • 5.1.4 Deleting and Restoring Templates
  • 5.1.5 Copying Templates
  • 5.1.6 Locking and Unlocking Templates

6 Portfolios

• 6.1 Working with Portfolios
  • 6.1.1 Roles
  • 6.1.2 Creating Portfolios
  • 6.1.3 Editing Portfolios
  • 6.1.4 Deleting Portfolios
  • 6.1.5 Copying Portfolios

7 Entering Plan Specifications for Studies

• 7.1 Plan Tabs
• 7.2 Entering Notes
• 7.3 Warnings and Advice
• 7.4 Edit Modes
• 7.5 Preferred and Maximum Edit Modes
• 7.6 Preferred Home Page
• 7.7 Preferred Locale

8 Overview Tab

• 8.1 Plan Name
• 8.2 Plan Status
• 8.3 Project Activity Start Date
• 8.4 Start Pre-Study Planning
• 8.5 Study will be
• 8.6 Short Description
• 8.7 Long Description
• 8.8 Default Modeling Currency
• 8.9 Default Reporting Currency
• 8.10 Use Exchange Rates
• 8.11 Drug Storage
• 8.12 Radio Labeled
• 8.13 Portfolio List
• 8.14 History

9 Locations Tab

• 9.1 Adding Locations
• 9.2 Removing Locations

10 Site Tab

• 10.1 Editing Site Approval Schedule
• 10.2 Entering Site Information
• 10.3 Responsibilities

11 Subject Tab

• 11.1 Define the Enrollment Period
• 11.2 Define the Enrollment Distribution
• 11.3 Screening and Drops

12 Treatment Tab

• 12.1 Trial Design
• 12.2 Adding Treatments
  • 12.2.1 Adding Treatments for Parallel Trial Design Studies - Phase I Healthy Volunteers
  • 12.2.2 Adding Treatments for Parallel Trial Design Studies - Late Stage and Phase I Oncology/Vaccine
  • 12.2.3 Adding Treatments for Cross-Over Trial Design Studies - Phase I Healthy Volunteers
  • 12.2.4 Adding Treatments for Cross-Over Trial Design Studies - Late Stage and Phase I Oncology/Vaccine

13 Data Tab

• 13.1 Data Collection
  • 13.1.1 Data Collection Method
  • 13.1.2 EDC Maturity Level
  • 13.1.3 Query Rate
  • 13.1.4 Percent of database data to audit
  • 13.1.5 Minutes for data entry per CRF page
  • 13.1.6 Minutes for data coordination per CRF page
  • 13.1.7 Total number of data transfers
  • 13.1.8 Number of interim analyses to be performed
  • 13.1.9 Number of third-party vendors/data sources
  • 13.1.10 Total number of data imports from third-party vendors
• 13.2 CRF Design
  • 13.2.1 Number of unique pages
  • 13.2.2 CRF page NCR ply
  • 13.2.3 Number of screens per CRF Page
  • 13.2.4 Cost per page to print CRF
• 13.3 Biostatistics
  • 13.3.1 Number of unique data tables
  • 13.3.2 Number of unique data listings
  • 13.3.3 Number of unique figures and graphs
• 13.4 Project Management
  • 13.4.1 Number of newsletters per site
  • 13.4.2 Will there be an ICF Video/DVD?
  • 13.4.3 Number of years to archive data
  • 13.4.4 Number of online EDC training sessions
• 13.5 Medical Writing / Timelines
  • 13.5.1 Number of pages in the Investigator brochure
  • 13.5.2 Number of manuscripts
  • 13.5.3 Days from LSO/LPO until database lock
  • 13.5.4 Days from database lock until statistical report is due
  • 13.5.5 Days from database lock until draft report is due
  • 13.5.6 Days from database lock until final report is due
• 13.6 SAE Management
  • 13.6.1 SAE rate as a percent of randomized subjects
  • 13.6.2 Hours medical monitor will spend with each SAE
  • 13.6.3 Expected percent of SAE reports to be expedited
  • 13.6.4 Provide data to the DSMB
• 13.7 IVRS (Interactive Voice Response System
• 13.8 Responsibilities

14 Monitoring Tab

• 14.1 Monitoring Methods
• 14.2 On-Site Monitoring Schedule
• 14.3 Monitoring Approach
• 14.4 Monitored Data
• 14.5 Medical Monitoring
• 14.6 Separate Drug Accountability

15 Provider Tab

• 15.1 Provider Specific Details
• 15.2 Working with Providers
  • 15.2.1 Adding Providers
  • 15.2.2 Removing Providers
  • 15.2.3 Primary Providers
  • 15.2.4 Replacing Providers
  • 15.2.5 Freezing Billing Rates

16 Translations Tab

• 16.1 Adding Languages
• 16.2 Removing Languages
• 16.3 Document Translations

17 Meetings Tab

• 17.1 Meetings
  • 17.1.1 Adding Meetings
  • 17.1.2 Editing Meetings
  • 17.1.3 Copying Meetings
  • 17.1.4 Including and Excluding Meetings
  • 17.1.5 Deleting Meetings

18 Assignment Tab

• 18.1 Task Assignments
  • 18.1.1 Assigning Outsourced Tasks
  • 18.1.2 Including and Excluding Tasks

19 Labor Tab

• 19.1 Adjusting Unit Hours and Fees
• 19.2 Bulk Pinning Labor for Major Tasks
  • 19.2.1 Pinning Labor for Major Tasks
  • 19.2.2 Unpinning Labor for Major Tasks
• 19.3 Task Manager
  • 19.3.1 Definition of a Major Task
  • 19.3.2 Roles
  • 19.3.3 Searching for Major Tasks
  • 19.3.4 Task Manager Tabs
  • 19.3.5 Location-Scoped vs. Study-Scoped Tasks
• 19.4 Working with User-Defined Major Tasks
  • 19.4.1 Creating User-Defined Major Tasks
  • 19.4.2 Editing User-Defined Major Tasks
  • 19.4.3 Deleting User-Defined Major Tasks
• 19.5 Working with Tasks
  • 19.5.1 Creating Tasks
  • 19.5.2 Deleting Tasks
  • 19.5.3 Editing Tasks
  • 19.5.4 Pinning Service Provider and Billing Rate Location Assignments
• 19.6 Working with Resources
  • 19.6.1 Add a Resource to a Task
    • 19.6.1.1 Resource Tabs
  • 19.6.2 Delete a Resource from a Task
  • 19.6.3 Edit a Resource for a Task
    • 19.6.3.1 Modify the Billing Rate of a Resource
    • 19.6.3.2 Modify the Billing Rate Location of a Resource
  • 19.6.4 Substitute a Resource

20 Costs Tab

• 20.1 Including and Excluding Costs
• 20.2 Inflation
• 20.3 Working with Costs
  • 20.3.1 Adding New Costs
  • 20.3.2 Editing Costs
  • 20.3.3 Deleting Costs

21 Payments Tab

• 21.1 Creating a Milestone Payment Schedule
• 21.2 Specifying Recurring Payment Items
• 21.3 Setting Payment Terms
• 21.4 Editing Payment Schedules
• 21.5 Adding Milestones
  • 21.5.1 Deleting User-Defined Milestones
  • 21.5.2 Editing User-Defined Milestones

22 Summary Tab

• 22.1 Fee Descriptions
  • 22.1.1 Fees, Hours, and FTEs
  • 22.1.2 Dates / Duration
  • 22.1.3 Metrics

23 Reports Tab

• 23.1 Clinical Indicator Reports
• 23.2 Cost Reports
• 23.3 FTE / Resource Reports

24 Maintaining Service Providers

• 24.1 Supported Providers
• 24.2 Working with Service Providers
  • 24.2.1 Roles
  • 24.2.2 Adding Service Providers
  • 24.2.3 Editing Service Providers
  • 24.2.4 Delete and Restore Service Providers
  • 24.2.5 Billing Rates Report

25 Maintaining Resources

• 25.1 Working with Resources
  • 25.1.1 Roles
  • 25.1.2 Editing ClearTrial Resources
  • 25.1.3 Adding User-Defined Resources
  • 25.1.4 Editing User-Defined Resources
  • 25.1.5 Deleting and Restoring User-Defined Resources

26 Maintaining Billing Rates

• 26.1 Working with Billing Rates
  • 26.1.1 Roles
  • 26.1.2 Drafts
  • 26.1.3 Revision History
  • 26.1.4 Billing Rate Resource Descriptions
  • 26.1.5 Adding Billing Rates
  • 26.1.6 Editing Billing Rates
  • 26.1.7 Copying Billing Rates
  • 26.1.8 Publishing Billing Rates
  • 26.1.9 Deleting and Restoring Billing Rates

27 Maintaining Departments

• 27.1 Working with Departments
  • 27.1.1 Roles
  • 27.1.2 Creating User-Defined Departments
  • 27.1.3 Editing Departments
  • 27.1.4 Deleting and Restoring Departments
• 27.2 Mapping Departments
  • 27.2.1 Mapping by Resource
  • 27.2.2 Mapping by Location
  • 27.2.3 Mapping by Task
  • 27.2.4 Mapping by Rule (Advanced Mode)

28 Maintaining GL Codes

• 28.1 Working with GL Codes
  • 28.1.1 Roles
  • 28.1.2 Creating User-Defined GL Codes
  • 28.1.3 Editing GL Codes
  • 28.1.4 Deleting and Restoring GL Codes
• 28.2 Mapping GL Codes
  • 28.2.1 Mapping by Resource
  • 28.2.2 Mapping by Location
  • 28.2.3 Mapping by Task
  • 28.2.4 Mapping by Rule (Advanced Mode)

29 Maintaining Exchange Rates

• 29.1 Working with Exchange Rates
  • 29.1.1 Roles
  • 29.1.2 State
  • 29.1.3 Creating Exchange Rate Tables
  • 29.1.4 Editing Exchange Rate Tables
  • 29.1.5 Deleting Exchange Rate Tables
  • 29.1.6 Restoring Exchange Rate Tables
  • 29.1.7 Publishing Exchange Rate Tables
  • 29.1.8 Setting Default Exchange Rate Tables

30 Maintaining Reporting Regions

• 30.1 Working with Reporting Regions
  • 30.1.1 Roles
  • 30.1.2 Adding and Mapping Reporting Regions
  • 30.1.3 Editing Reporting Regions
  • 30.1.4 Deleting Reporting Regions

31 Resource Descriptions

• 31.1 Resource Descriptions
  • 31.1.1 CR01 - Clinical Research Associate (CRA)
  • 31.1.2 CR02 - Senior Clinical Research Associate (SCRA)
  • 31.1.3 CR03 - Regional Clinical Research Associate (Regional CRA)
  • 31.1.4 CR04/CR05 - Senior Vice President Clinical or Senior Director Clinical/Therapeutic
  • 31.1.5 CR06 - Project Manager
  • 31.1.6 CR07/CR08 - Project Admin Assistant or Secretarial Support
  • 31.1.7 DM01 - Data Coordinator
  • 31.1.8 DM02 - Data Entry Clerk
  • 31.1.9 DM03 - Data Manager
  • 31.1.10 DM04/ST03 - Senior Programmer or Statistical Programmer
  • 31.1.11 DM05 - Program Analyst
  • 31.1.12 DM06 - Senior Program Analyst
  • 31.1.13 DM07 - Help Desk Support Specialist
  • 31.1.14 DM08 - Help Desk Manager
  • 31.1.15 DM09 - EDC Trainer
  • 31.1.16 DS01 - Medical Monitor
  • 31.1.17 GA01 - Records Clerk
  • 31.1.18 GA02 - Records Manager
  • 31.1.19 Medical Writer
  • 31.1.20 PK01 - Clinical Pharmacokineticist
  • 31.1.21 PK02 - Senior Pharmacokineticist
  • 31.1.22 QA01 - Compliance/QA Manager
  • 31.1.23 QA02 - Compliance/QA Auditor
  • 31.1.24 RG01 - Regulatory Submissions Specialist
  • 31.1.25 RG02 - Regulatory Submissions Manager
  • 31.1.26 RG03 - Director Regulatory Affairs
  • 31.1.27 ST01 - Junior Biostatistician
  • 31.1.28 ST02 - Senior Biostatistician
  • 31.1.29 ST04 - Director Biostatistics/Data Management