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Good Documentation Practice & Data Integrity
Integrity Clinical Compliance

A professionally developed, interactive and engaging online course essential for anyone working in Clinical Research.

Summary

Price
£39.99 inc VAT
Study method
Online
Course format
Reading material
Duration
2 hours · Self-paced
Access to content
2 years
Qualification
No formal qualification
Certificates
  • Certificate of completion - Free
2 students purchased this course

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Overview

Ensure regulatory compliance and safeguard the accuracy of clinical data with our in-depth Data Integrity Training course. Designed for professionals working in clinical trials, regulatory affairs, data management, and quality assurance, this course delivers the essential knowledge and practical tools to maintain the accuracy, reliability, and security of data across its entire lifecycle.

Developed by clinical research experts and aligned with the latest regulatory updates, including ICH GCP E6(R3), MHRA guidance, and Good Documentation Practices (GDocP), this interactive course provides a deep dive into global data integrity requirements and best practices.

Participants will explore ALCOA++ principles, data governance, metadata management, and the critical role of quality systems and issue management in preserving trustworthy clinical trial data. The course also integrates real-world case studies and practical assessments to support effective implementation in your day-to-day work environment.

Certificates

Resources

  • GDocP & Data Integrity Leaflet - download

Description

Module One:
Chapter 1 - What is Data Integrity?
• What is data integrity?
• The importance of maintaining data integrity
Chapter 2 - Guidance and Regulations
• Guidance and regulations
• MHRA principles of data integrity
Chapter 3 - Good Documentation Practice and
Essential Records
• Good documentation practice
• Essential records
Chapter 4 - The ALCOA++ Principles
• Data integrity (ALCOA++)
• The history of ALCOA principles
Chapter 5 - Data
• Data
• Data lifecycle
• Data governance
Chapter 6 - Technology and Metadata
• Technology
• Metadata
Chapter 7 - Quality
• Quality
• Data integrity checks
• Issue management

Who is this course for?

This course is ideal for professionals working in:

  • Clinical Research (CRAs, Study Coordinators)

  • Clinical Data Management

  • Quality Assurance & Compliance

  • Regulatory Affairs

  • Clinical Operations

  • Pharmacovigilance

It is especially valuable for individuals seeking to build on their ICH GCP E6 R3 knowledge or integrate ALCOA++ and data governance principles into their routine practices.

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Legal information

This course is advertised on Reed.co.uk by the Course Provider, whose terms and conditions apply. Purchases are made directly from the Course Provider, and as such, content and materials are supplied by the Course Provider directly. Reed is acting as agent and not reseller in relation to this course. Reed's only responsibility is to facilitate your payment for the course. It is your responsibility to review and agree to the Course Provider's terms and conditions and satisfy yourself as to the suitability of the course you intend to purchase. Reed will not have any responsibility for the content of the course and/or associated materials.

FAQs

Study method describes the format in which the course will be delivered. At Reed Courses, courses are delivered in a number of ways, including online courses, where the course content can be accessed online remotely, and classroom courses, where courses are delivered in person at a classroom venue.

CPD stands for Continuing Professional Development. If you work in certain professions or for certain companies, your employer may require you to complete a number of CPD hours or points, per year. You can find a range of CPD courses on Reed Courses, many of which can be completed online.

A regulated qualification is delivered by a learning institution which is regulated by a government body. In England, the government body which regulates courses is Ofqual. Ofqual regulated qualifications sit on the Regulated Qualifications Framework (RQF), which can help students understand how different qualifications in different fields compare to each other. The framework also helps students to understand what qualifications they need to progress towards a higher learning goal, such as a university degree or equivalent higher education award.

An endorsed course is a skills based course which has been checked over and approved by an independent awarding body. Endorsed courses are not regulated so do not result in a qualification - however, the student can usually purchase a certificate showing the awarding body's logo if they wish. Certain awarding bodies - such as Quality Licence Scheme and TQUK - have developed endorsement schemes as a way to help students select the best skills based courses for them.
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