Table of Contents
- Title and Copyright Information
- Preface
-
1
Getting Started with
Remote Data Capture Onsite
- About Electronic Data Capture
- Terminology to Know and Understand
- About RDC Onsite User Roles
- Starting the RDC Onsite Application
- Starting at the Home Page
- Changing Your RDC Onsite Login Password
- Setting Your Preferences for Lists and Dates
- Getting Help and Assistance
- Logging Out
- 2 Learning the Common Tools
-
3
Entering and Updating Patient Data
- Starting Data Entry for Patients in a Clinical Study
- Using the Patient Casebooks Page
- Using the Data Entry Window
-
Entering Data in a CRF
- Standard Text Fields versus Extended Text Fields
- Entering Data in a Standard Text Field
- Entering Data in an Extended Text Field
- Selecting Data from a List of Acceptable Values
- Entering Dates
- Processing Validation Errors During Initial Data Entry
- Adding and Updating an Investigator Comment
- Changing Your Preferences for Data Entry
- Viewing CRF and Field Help Customized by Your Sponsor
- Updating Existing Data in a CRF
- Saving a CRF
- Removing Data from a CRF
- Generating a CRF Report or a CRF History Report
- Viewing the Audit History of a CRF Field
- Using the Navigator Pane for Discrepancies and Investigator Comments
- Adding Pages
- Validating Patient Data
-
4
Managing Discrepancies
- Understanding Discrepancies and the Management Process
- Types of Discrepancies
- Discrepancy Status
- Finding CRFs with Discrepancies
- Reviewing Discrepancies
-
Resolving and Routing Discrepancies
- Highlighting the Discrepancies in a CRF
-
Reviewing Discrepancies in the Navigator
Pane
- Opening, Closing, and Resizing the Navigator Pane
- Showing and Selecting Discrepancies in the Navigator Pane
- Reviewing Discrepancy Information in the Details Pane
- Viewing the History of a Discrepancy
- Viewing Related Values for Multivariate Discrepancies
- Reviewing the Audit History for a Discrepancy
- Updating Discrepancy Comments
- Taking Action on Discrepancies
- Creating and Routing Manual Discrepancies
- 5 Reviewing Investigator Comments
- 6 Reviewing Special Listings
- 7 Performing Custom Reviews
- 8 Verifying CRFs
- 9 Approving CRFs
-
10
Using Search
- Selecting the Study and Site Context for a Search
- Using the Search Pane
- Using Patient Search Criteria
- Using CRF Status Search Criteria
- Using CRF Source Search Criteria
- Using Search Criteria During a Drill-down
- Clearing Your Search Criteria
- 11 Viewing Summary Reports
-
12
Generating CRF Reports
- Working with the Reports Page
- CRF Report Content
- Generating a Patient Data Report
- Generating a Blank Casebook Report
- Generating a Standalone Deleted CRFs Report
- Searching for Report Jobs
- Monitoring the Status and Progress of Your Report Jobs
- Printing a Report
- 13 Using Source Data Verification
- A Description of the CRF Icons
-
B
Patient Auto-Selection in Partial Source Data Verification
- SDV Patient Pools
- Auto-select Processing
- Patient Eligibility is Reversed
- All Data for a Patient is Deleted
- Patient SDV Plan is Updated
- Patient Transferred from One Site to Another
- Data Transferred from One Patient to Another
- Patient ID Is Updated in a CRF (Key Changes or Mass Key Changes)
- DCI or Other Date Is Updated in a CRF