Course Summary:

This program will explore the evolution of Clinical Data Management from a paper case report form (CRF) process to the “real time” data review capable world of electronic data capture (EDC). We will review the specific regulations that govern the electronic data capture and electronic signature requirements, and examine the changing role of the Data Manager in an environment where the technology drives the process. Although the basic data management principles remain the same, for example good CRF design and ensuring the integrity of the data, the timelines and tasks surrounding today’s EDC are not interpreted exactly as the paper CRF process has previously dictated.

The understanding of how the technology has changed the process will enable today’s Data Managers to move forward in the discipline and ensure their place as viable members of the clinical study team. As electronic data capture utilized as patient e-source or eCRF becomes more the routine, it is important that the CDM be fully aware of the capabilities of the EDC application in order to ensure a comprehensive data management component in the clinical trial conduct.

Course Objectives:

• Assess the impact of the regulations on Data Management 
• Discuss the rationale and enhancements regarding the utilization of EDC
• Discuss in-depth the changing role of the Clinical Data Manager
• Outline the CDM focus on protocol review and CRF design
• Employ “best practices” for eCRF design
• Describe the Data Management documentation required in clinical trial conduct
• Identify EDC system enhancements for the industry

Course Outline

Develop and implement data collection strategies.

• Create data collection guidelines
• Develop and implement guidelines for data review
• Review data for accuracy and clarity
• Discuss methods for data capture including data entry, fax based data capture and electronic data capture (remote data entry)

Understand the validation program.

• Describe the data validation process.
• Develop edit specifications.
• Describe self-evident changes.
• Conduct a review of validation output.

Advanced Word Processing

• Starting Word Program
• Word Screen Layout
• Typing Screen Objects
• Managing Documents
• Protecting and Finding Documents
• Printing Documents

Formatting Documents

• Working with text
• Formatting Text
• Formatting Paragraphs
• Bulleted and Numbered Lists
• Copying and Moving Text
• Spelling and Grammar
• Page Formatting
• Creating Tables

Mail Merge

• Types of document in Mail merge
• Creating data Source
• Creating Mailing Labels
• Merging Data into Main Document

Spreadsheets

• Selecting, Adding and Renaming Worksheets
• Modifying a Worksheet
• Resizing Rows and Columns
• Workbook Protection 

Formatting Worksheets

• Formatting Toolbar
• Formatting Cells
• Formatting Rows and Columns
• Formatting Worksheets Using Styles
• Protect and Unprotect Worksheets

Assist in the review, resolution and tracking of data errors

• Describe the process for query handling
• Generate and resolve manual and electronic queries
• Discuss query tracking and database update
• Describe components of an audit trail

Develop a Quality Assurance Plan for a clinical research study

• Describe quality control and quality assurance activities.
• Describe types of quality assurance audits, data points audited and required error rates.
• Define timelines for audits.
• Develop an audit report.

Formulas, Functions and Charts

• Formulas and Functions
• Copying a Formula
• Types of Functions
• Types of Charts
• Auto Shapes and Smart art

Creating Presentation

• Creating Slides
• Slide Sorter View
• Changing Slide Layouts
• Moving Between Slides

Introduction to Internet

• Getting Connected to Internet
• Types of Internet Connections
• Internet Terminology
• Understanding Internet Address
• Web Browser and Internet Services