Contents

Title and Copyright Information

Preface

• Audience
• Documentation Accessibility
• Resetting a Forgotten Password
• Accessing ClearTrial Help
• Finding Oracle Documentation
• Related Documents

Part I Working with ClearTrial

1 Products

• Working with Products
  • Roles
  • Creating Products
  • Editing Products
  • Deleting Products
  • Restoring Products

2 Studies

• Working with Studies
  • Study Phases
  • Creating Phase II-IV Studies
  • Creating Phase I Studies
  • Editing Studies
  • Deleting Studies
  • Restoring Studies

3 Plans

• Working with Plans
  • Entering Notes
  • Warnings and Advice
  • Edit Modes
  • Preferred and Maximum Edit Modes
  • Preferred Home Page
  • Preferred Locale
• Creating Plans
• Saving Plans
• Editing Plans
• Deleting Plans
• Copying Plans
• Restoring Plans
• Comparing Plans
• Locking Plans
• Unlocking Plans
• Editing Attributes of a Locked Plan
• View, Print, and Export a Plan
• Freezing Billing Rates for a Plan
• Recalculate a Plan with Service Provider Billing Rates

4 Templates

• Working with Templates
  • Roles
  • Creating Templates
  • Editing Templates
  • Deleting and Restoring Templates
  • Copying Templates
  • Locking and Unlocking Templates

5 Portfolios

• Working with Portfolios
  • Roles
  • Creating Portfolios
  • Editing Portfolios
  • Deleting Portfolios
  • Copying Portfolios

6 Reports

• Working with Reports
• Reports

Part II Entering Plan Assumptions for Studies

7 Overview Tab

• Plan Name
• Plan Status
• Project Activity Start Date
• Start Pre-Study Planning
• Study will be
• Short Description
• Long Description
• Default Modeling Currency
• Default Reporting Currency
• Use Exchange Rates
• Drug Storage
• Radio Labeled
• Portfolio List
• History

8 Locations Tab

• Adding Locations
• Removing Locations

9 Site Tab

• Editing Site Approval Schedule
• Entering Site Information
• Responsibilities

10 Subject Tab

• Define the Enrollment Period
• Define the Enrollment Distribution
• Screening and Drops

11 Treatment Tab

• Trial Design
• Adding Treatments
  • Adding Treatments for Parallel Trial Design Studies - Phase I Healthy Volunteers
  • Adding Treatments for Parallel Trial Design Studies - Late Stage and Phase I Oncology/Vaccine
  • Adding Treatments for Cross-Over Trial Design Studies - Phase I Healthy Volunteers
  • Adding Treatments for Cross-Over Trial Design Studies - Late Stage and Phase I Oncology/Vaccine

12 Data Tab

• Data Collection
  • Data Collection Method
  • EDC Maturity Level
  • Query Rate
  • Percent of database data to audit
  • Minutes for data entry per CRF page
  • Minutes for data coordination per CRF page
  • Total number of data transfers
  • Number of interim analyses to be performed
  • Number of third-party vendors/data sources
  • Total number of data imports from third-party vendors
• CRF Design
  • Number of unique pages
  • CRF page NCR ply
  • Number of screens per CRF Page
  • Cost per page to print CRF
• Biostatistics
  • Number of unique data tables
  • Number of unique data listings
  • Number of unique figures and graphs
• Project Management
  • Number of newsletters per site
  • Will there be an ICF Video/DVD?
  • Number of years to archive data
  • Number of online EDC training sessions
• Medical Writing / Timelines
  • Number of pages in the Investigator brochure
  • Number of manuscripts
  • Days from LSO/LPO until database lock
  • Days from database lock until statistical report is due
  • Days from database lock until draft report is due
  • Days from database lock until final report is due
• SAE Management
  • SAE rate as a percent of randomized subjects
  • Hours medical monitor will spend with each SAE
  • Expected percent of SAE reports to be expedited
  • Provide data to the DSMB
• IVRS (Interactive Voice Response System
• Responsibilities

13 Monitoring Tab

• Monitoring Methods
• On-Site Monitoring Schedule
• Monitoring Approach
• Monitored Data
• Medical Monitoring
• Separate Drug Accountability

14 Provider Tab

• Provider Specific Details
• Working with Providers
  • Adding Providers
  • Removing Providers
  • Primary Providers
  • Replacing Providers
  • Freezing Billing Rates

15 Translations Tab

• Adding Languages
• Removing Languages
• Document Translations

16 Meetings Tab

• Meetings
  • Adding Meetings
  • Editing Meetings
  • Copying Meetings
  • Including and Excluding Meetings
  • Deleting Meetings

17 Assignment Tab

• Task Assignments
  • Assigning Outsourced Tasks
  • Including and Excluding Tasks

18 Labor Tab

• Adjusting Unit Hours and Fees
• Bulk Pinning Labor for Major Tasks
  • Pinning Labor for Major Tasks
  • Unpinning Labor for Major Tasks
• Task Manager
  • Definition of a Major Task
  • Roles
  • Searching for Major Tasks
  • Task Manager Tabs
  • Location-Scoped vs. Study-Scoped Tasks
• Working with User-Defined Major Tasks
  • Creating User-Defined Major Tasks
  • Editing User-Defined Major Tasks
  • Deleting User-Defined Major Tasks
• Working with Tasks
  • Creating Tasks
  • Deleting Tasks
  • Editing Tasks
  • Pinning Service Provider and Billing Rate Location Assignments
• Working with Resources
  • Add a Resource to a Task
    • Resource Tabs
  • Delete a Resource from a Task
  • Edit a Resource for a Task
    • Modify the Billing Rate of a Resource
    • Modify the Billing Rate Location of a Resource
  • Substitute a Resource

19 Costs Tab

• Including and Excluding Costs
• Inflation
• Working with Costs
  • Adding New Costs
  • Editing Costs
  • Deleting Costs

20 Payments Tab

• Creating a Milestone Payment Schedule
• Specifying Recurring Payment Items
• Setting Payment Terms
• Editing Payment Schedules
• Adding Milestones
  • Deleting User-Defined Milestones
  • Editing User-Defined Milestones

21 Summary Tab

• Fee Descriptions
  • Fees, Hours, and FTEs
  • Dates / Duration
  • Metrics

22 Reports Tab

• Clinical Indicator Reports
• Cost Reports
• FTE / Resource Reports

Part III Maintenance Outside of ClearTrial Plans

23 Maintaining Service Providers

• Supported Providers
• Working with Service Providers
  • Roles
  • Adding Service Providers
  • Editing Service Providers
  • Delete and Restore Service Providers
  • Billing Rates Report

24 Maintaining Resources

• Working with Resources
  • Roles
  • Editing ClearTrial Resources
  • Adding User-Defined Resources
  • Editing User-Defined Resources
  • Deleting and Restoring User-Defined Resources

25 Maintaining Billing Rates

• Working with Billing Rates
  • Roles
  • Drafts
  • Revision History
  • Billing Rate Resource Descriptions
  • Adding Billing Rates
  • Editing Billing Rates
  • Copying Billing Rates
  • Publishing Billing Rates
  • Deleting and Restoring Billing Rates

26 Maintaining Departments

• Working with Departments
  • Roles
  • Creating User-Defined Departments
  • Editing Departments
  • Deleting and Restoring Departments
• Mapping Departments
  • Mapping by Resource
  • Mapping by Location
  • Mapping by Task
  • Mapping by Rule (Advanced Mode)

27 Maintaining GL Codes

• Working with GL Codes
  • Roles
  • Creating User-Defined GL Codes
  • Editing GL Codes
  • Deleting and Restoring GL Codes
• Mapping GL Codes
  • Mapping by Resource
  • Mapping by Location
  • Mapping by Task
  • Mapping by Rule (Advanced Mode)

28 Maintaining Exchange Rates

• Working with Exchange Rates
  • Roles
  • State
  • Creating Exchange Rate Tables
  • Editing Exchange Rate Tables
  • Deleting Exchange Rate Tables
  • Restoring Exchange Rate Tables
  • Publishing Exchange Rate Tables
  • Setting Default Exchange Rate Tables

29 Maintaining Reporting Regions

• Working with Reporting Regions
  • Roles
  • Adding and Mapping Reporting Regions
  • Editing Reporting Regions
  • Deleting Reporting Regions

30 Resource Descriptions

• Resource Descriptions
  • CR01 - Clinical Research Associate (CRA)
  • CR02 - Senior Clinical Research Associate (SCRA)
  • CR03 - Regional Clinical Research Associate (Regional CRA)
  • CR04/CR05 - Senior Vice President Clinical or Senior Director Clinical/Therapeutic
  • CR06 - Project Manager
  • CR07/CR08 - Project Admin Assistant or Secretarial Support
  • DM01 - Data Coordinator
  • DM02 - Data Entry Clerk
  • DM03 - Data Manager
  • DM04/ST03 - Senior Programmer or Statistical Programmer
  • DM05 - Program Analyst
  • DM06 - Senior Program Analyst
  • DM07 - Help Desk Support Specialist
  • DM08 - Help Desk Manager
  • DM09 - EDC Trainer
  • DS01 - Medical Monitor
  • GA01 - Records Clerk
  • GA02 - Records Manager
  • Medical Writer
  • PK01 - Clinical Pharmacokineticist
  • PK02 - Senior Pharmacokineticist
  • QA01 - Compliance/QA Manager
  • QA02 - Compliance/QA Auditor
  • RG01 - Regulatory Submissions Specialist
  • RG02 - Regulatory Submissions Manager
  • RG03 - Director Regulatory Affairs
  • ST01 - Junior Biostatistician
  • ST02 - Senior Biostatistician
  • ST04 - Director Biostatistics/Data Management