Although the concept of Data Integrity (DI) is not new, there are uncertainties in the pharmaceutical industry as to how to implement these requirements into daily business, and more specifically, integrating data governance into GxP Quality Systems.
Inspection results commonly show inadequate controls on the integrity, authenticity, and reliability of data, therefore embedding DI across the company culture is becoming essential.
This course is designed to provide guidance on regulatory requirements, DI risk-based approach, concepts and components ensuring Data Integrity across its lifecycle, from initial generation, recording, through processing, use, retention, archiving and retrieval.
Understanding Data Integrity is the basis for implementing systems and processes that fulfil the expectations of the health authorities.
Several guidance documents have been published within the last few years detailing Health Authorities’ expectations on implementing data governance, establishing control measures, and how procedures should cover the lifecycle of data and documents.The first day will cover these regulatory requirements and Data Integrity expectations for data and documents, related key concepts, and expands on the practicalities of assessing Data Integrity Risks and Compliance Controls.
The second day is built as a workshop focusing on real-life examples. Split into small groups we will analyse real cases, investigate the root cause, define priorities, and end with potential corrective and preventive actions. Results are shared and discussed with all participants during the day. This workshop will lead course participants to be able to develop activities that will help achieve DI compliance in their own business and to better understand the importance of DI across the GxPs. Attendees will gain best practices to ensure their data is managed reliably and to be able to minimize the threats of poor Data Integrity to clinical trials.
The course provides a mixture of presentations, discussions and practical workshops.
Course time2-day classroom / from 09h00 to 17h00
Who should attend
This 2-day course is for all who want to expand their understanding of Data Integrity requirements through interactive lessons, practical exercises and discussions.
The knowledge gained will help people from Sponsors, CROs, Laboratories, and Investigational Sites who are directly involved in data collection and documentation handling, ensure compliance with the applicable regulations on DI.
This training is an excellent opportunity for people external training opportunity for people external training opportunity for people working in DI-related areas such as clinical trial management, clinical data collection, bio sample analytics, clinical monitoring, data processing, Quality Assurance, and Quality Control.
- Introduction and Basics of Data Integrity
- Guidelines and definitions
- The Data Lifecycle
- Data Considerations, Sources, Workflows & Interactions
- Data Governance and Principles in Practice
- Mistakes or Falsification
- Factors impacting data quality
- Data Integrity Risk Management
- ALCOA+ principles
- Components ensuring Data Integrity
- Building DI into Quality System
- Practical Approach Data Integrity Controls
- Workshop with real-life examples
- Become familiar with the current regulatory requirements on data integrity
- Get a deeper understanding on what authorities expects regarding Data Integrity
- Understand the importance of data integrity and how it could impact your activities
- Know how to integrate data governance into your quality systems
- Understand the difference between mistakes and falsification or fraud
- Learn how to investigate Data Integrity issues in your company
- Be able to identify the data lifecycle elements for both manual (paper) and electronic data
- Recognize challenges and be able to identify areas where DI issues could occur
- Managing DI cases and define improvement strategies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (0)
- Investigational Product Development and Regulation (3)
- Clinical Studies Operations (GCPs or ISO 14155) (4)
- Study and Site Management (0)
- Data Management and Informatics (5)
- Leadership and Professionalism (2)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained