Table of Contents
- Title and Copyright Information
- Preface
- 1 Before Planning Any Studies
-
2
Plan a Clinical Trial
- Create the Study
- Create a Plan
- Choose the User Edit Mode
-
Add Your Assumptions
- Edit Basic Information on the Overview Tab
- Specify Investigation Sites on the Locations Tab
- Set Up Sites on the Site Tab
- Define Trial Characteristics on the Treatment Tab
-
Select Data Management Options on the Data
Tab
- Specify Data Management Assumptions
- Specify Biostatistics Assumptions
- Specify Project Management Assumptions
- Specify Electronic Master Trial File (eTMF) Assumptions
- Specify Medical Writing Assumptions
- Specify End-of-Study Assumptions
- Specify Safety and Medical Management Assumptions
- Select Interactive Voice Response System Usage
- Anticipate Changes to the Protocol
- Assign Responsibilities
-
Review and Adjust Monitored Data on the
Monitoring Tab
- Specify the Monitoring Methods
- Accept or Modify the On-site Monitoring Schedule
- Review the Remote Monitoring Schedule
- Review the Remote Monitoring Schedule for Centralized Monitoring
- Define the Monitoring Approach
- Specify Total CRF Pages Expected
- Review and Adjust Medical Monitoring Assumptions
- Review and Adjust Separate Drug Accountability Visits
- Add Vendors and Service Providers on the Provider Tab
- Set Up Meeting Details and Attendees on the Meetings Tab
- Define Outsourced Tasks on the Assignment Tab
- View Major Tasks and Adjust Labor Fees on the Labor Tab
- Configure Indirect Costs on the Costs Tab
- Define Provider Payment Schedules on the Payments Tab
- View Expected Study Costs on the Summary Tab
- Run Reports on the Reports Tab
- Build a Portfolio
- Create Templates
- 3 Configure Service Providers, Billing Rates, and Inflation Rates
-
4
Create and Edit Major Tasks with the Task
Manager
- Move a User-defined Task from One Major Task to Another
- Rename or Reorder Major Tasks
- Copy a Major Task
- Reorder Major Tasks from the Labor Tab
- Adjust Hours, Fees, or Units Distribution
- Copy a Task
- Choose Assignment and Summary Groups for Tasks
- Rename or Reorder Tasks
- Delete ClearTrial-defined Major Tasks or Tasks
- 5 Refine a Plan
- 6 Create a Request for Proposal (RFP)