Contents

List of Tables

Title and Copyright Information

Preface

1 Getting Started: Basic Functions and Common Tools

2 Working with Plans

Roadmap: Creating a Plan
Creating or Editing a Plan
Copying a Plan
Enter Overall Information on the Overview Tab
- Complete the General Information Section
- Specify Plan Descriptions
- Select Currencies and Exchange Rate Options
- Specify Other Factors
  - Select the Study Difficulty
Specify Investigation Sites and Languages on the Locations Tab
- Add a Location to a Plan
- Remove a Location from a Plan
- Add Languages to a Plan
- Deleting Languages from a Plan
Provide Site Approval and Visit Details on the Site Tab
- Global Versus By Location Specifications
- View or Edit the Default Site Approval Schedule for a Location
- Enter Site Information for a Location
Specify the Study Enrollment Details on the Subject Tab
- Define the Treatment Phase Start Date
  - Override the Estimated Date of the First Subject First Visit (FSFV)
  - Manage Location-specific Values
- Enter Screening, Failure Rates, Drops, and Payments Options
  - Specify the Screen Failure Rate
  - Specify the Subject Drop Rate
Specify Subject Treatments on the Treatment Tab
- Specify Study Characteristics
- Define the Treatments
- Copy a Treatment
- Delete a Treatment
Set Study Data Collection and Management Options on the Data Tab
- Specify Data Collection Options
- Specify CRF Design Options
- Enter Biostatistical Study Assumptions
- Specify Project Management Options
- Enter Medical Writing Choices and Timelines
- Specify SAE Management Options
- Select Uses for an Interactive Voice Response System
- Add Protocol Amendments
- Assign Outsourcing Responsibilities for Data Collection
Specify Monitoring Frequency, Approach, and Responsibilities on the Monitoring Tab
- Select the Monitoring Methods
- Establish the On-Site Monitoring Schedule
- Set Up the Monitoring Schedule for Each Location
- Set Up the Phone-based Monitoring Schedule
- Define the Monitoring Approach
- Monitor Data through CRF Pages
- Include Medical Monitoring
- Add Separate Drug Accountability Visits
Add Service Providers on the Provider Tab
- View the Service Providers You Can Select for Your Plan
  - Types of Service Providers
- View or Edit the Default Rates and Responsibilities of a Service Provider
- Add Service Providers to a Plan
  - Specify Provider-specific Information on the Details Tab
  - Editing or Creating an Inflation Profile for a Provider on the Inflation Tab
- Remove a Service Provider
- Designate a Primary Service Provider
- Replace a Service Provider
- Freezing and Unfreezing Rates for a Service Provider
Plan and Track the Cost of Meetings on the Meetings Tab
- Viewing the Planned Meetings
- Adding a Meeting
- Editing a Meeting
- Copying a Meeting
- Excluding a Meeting from the Plan Budget
- Including a Meeting from the Plan Budget
- Deleting a Meeting
Assign Tasks to Service Providers on the Assignment Tab
- Overriding Resources and Rates
Adjust Task Effort and Labor Fees on the Labor Tab
- Viewing Major Tasks
  - Filtering by Service Provider
- Creating a Major Task
- Adjusting Hours and Fees for a Major Task
- Distributing Completed Hours and Fees
- Searching for a Major Task
- Editing a Major Task
- Deleting a Major Task
Specify Pass-through and Indirect Cost Categories on the Cost Tab
- Viewing Costs and Adjustments
  - Filtering by Costs
- Defining a New Cost Category
- Editing a Cost Category
- Excluding a Cost
- Including a Cost
- Deleting a Cost
Specify Service Provider Payment Schedules on the Payments Tab
- Setting Payment Terms
- Working with Recurring Payments
- Adding a Milestone
- Editing a Milestone
- Deleting a Milestone
The Summary Tab Provides a Quick Overview of Study Costs
- Selecting the Included Providers
- Reviewing Fees, Hours, and FTEs
  - FTE Calculation
  - Pass-Through Costs
- Reviewing Dates and Duration
- Reviewing Metrics
Reports for the Current Plan Appear on the Reports Tab
- Report Types
- Generating a Report
Comparing Plans
Other Actions You Can Perform on Plans
- Lock and Unlock Plans
- Freeze and Unfreeze Rates
- Copy as Template
- Change Attributes
- Add to Portfolio
- Create Reforecast
- Reforecast Exchange Rate

3 Creating Requests for Proposals and Reviewing Bids

4 Maintaining Resource Information and Settings

5 Plan and Source Field Descriptions