Certified Data Integrity Professional

Certified Data Integrity Professional

Introduction

According to the industry and regulatory experts the data quality is referred to as “Data Integrity.” It is maintaining and assuring the accuracy and consistency of data over its entire life-cycle. Data integrity means that the data is accurate and reliable. Research and processing Information collected and resulting in an increasing amount and varied types of data being collected. This data is very important, but without integrity, this data not have much value. This course discusses ethics and personal integrity and illustrates how these traits apply to technical staff in a laboratory. This course explains with examples of general workplace ethics. Many of the ways that data integrity can be affected by technical staff are explained, from recognizing when sample integrity has been compromised to documenting errors, handling calibration and quality control issues, and changing or correcting results. This course elaborates on how improper practices and the failure to maintain data integrity can lead to fraud. One major section of the course is dedicated to improper laboratory practices and how they can be avoided. This course also discusses various regulatory guidelines on the data integrity. The GMP requirement for training under the US regulations is 211.25(a), which states, “Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them” (9). The EU GMP requirement in Chapter 2 (11) is similar. This course endeavors to train informed professional who are responsible for the establishment and maintenance of the data integrity procedures in their respective organizations.

Key Outcomes

• Define the terms commonly associated with ethics, data integrity, fraud and Chain of Custody
• Recognize staff’s responsibility to conduct themselves ethically in the workplace
• Describe the role of technical staff in maintaining data integrity
• Describe and list examples of imposter practices
• Explain the relationship of improper practices to fraud
• Recognize the consequences of fraud
• State the responsibilities of management and staff in preventing fraud
• List actions that can affect sample integrity
• Describe the Chain of Custody process for laboratory samples
• Understand the tools for identifying improper laboratory practices during routine assessments

Course Chapters

• Chapter 1 Introduction to Course
• Chapter 2 Ethics and Integrity in Data Use and Management
• Chapter 3 Detecting Improper Lab Technique – Part - I
• Chapter 4 Detecting Improper Lab Technique – Part - II
• Chapter 5 Detecting Improper Lab Technique – Part - III
• Chapter 6 Detecting Improper Lab Technique – Part - IV
• Chapter 7 Detecting Improper Lab Technique – Part - V
• Chapter 8 Detecting Improper Lab Technique – Part - VI
• Chapter 9 Detecting Improper Lab Technique – Part - VII