Data Integrity and Reporting Course

Register for this course

We are committed to delivering this course in multiple training formats to accommodate your needs. Our state-of-the-art learning facilities ensure a comfortable and engaging experience. With our flexible face-to-face training calendar, you can select any classroom course and have it delivered at a venue of your choice, offering you unparalleled convenience and exceptional value.

Course Overview

This course equips participants with a deep understanding of data integrity principles and how to apply them across the data lifecycle, from creation through reporting. With regulatory scrutiny increasing (FDA, MHRA, EMA) and advances in technology, maintaining trustworthy, accurate, and traceable data is more important than ever. Participants will learn to put in place strong governance, documentation practices, and controls, while also leveraging modern tools to ensure data is “fit for purpose.”

Course Duration

5 Days

Target Audience

Quality Assurance / Quality Control Professionals
Clinical Data Managers and Trial Coordinators
MEAL (Monitoring, Evaluation, Accountability & Learning) / Reporting Officers
Regulatory, Compliance & Audit Teams
Laboratory, Research, and Manufacturing Personnel in Regulated Industries

Personal Impact

Gain confidence in applying data integrity principles across different systems and processes.
Develop expert level documentation and reporting skills that reduce compliance risk.
Enhance your ability to design and manage data governance frameworks that support reliable decision making.
Build forward looking skills in using predictive tools to detect data anomalies and improve data quality.

Organizational Impact

Strengthen the reliability and trustworthiness of organizational data, reducing regulatory risk.
Build a culture of data accountability and compliance across teams and departments.
Improve audit readiness and reduce inspection findings related to poor data practices.
Increase efficiency by implementing proactive data validation, monitoring, and reporting mechanisms.

Course Level: Foundation

Course Objectives

By the end of this course, participants will be able to:

Define and apply key data integrity principles (such as ALCOA+) in both paper and electronic systems.
Build a data governance framework that supports data quality, traceability, and security throughout the data life cycle.
Implement good documentation practices (GDocP) for hybrid and computerized systems and control risk from record keeping.
Use risk based approaches to ensure data integrity in systems per regulatory guidance (FDA, EMA, MHRA).
Establish robust reporting structures and audit trails that align with data integrity controls.
Leverage modern approaches, including AI assisted data quality checks and governance automation, to ensure long term integrity.

Course Outline

Module 1: Foundations of Data Integrity

What is data integrity? Definitions, context, and importance.
Key regulatory expectations: ALCOA, ALCOA+ principles.
The data life cycle: from creation to retirement, and where risks can lie.
Data governance roles: governance structure, responsibilities, policies.
Exercise: Map out your organization’s current data lifecycle and identify potential integrity risk points.

Module 2: Good Documentation Practice (GDocP)

Principles of good documentation (GDocP) for paper, hybrid, and electronic records.
Controlling forms, templates, change control, and versioning.
Audit trails, review processes, and ensuring traceability.
Training staff in documentation and data integrity best practices.
Case Study: Review a flawed record keeping scenario; identify documentation failures and redesign a compliant process.

Module 3: Risk-Based Integrity Controls

Implementing a risk based approach to data integrity, per FDA guidance.
System validation and controls for computerized systems: access controls, audit trails.
Data backup, recovery, and contingency planning.
Monitoring and periodic review for data integrity controls.
Group Project: Develop a data integrity risk management plan that includes system controls, risk mitigation, and monitoring strategy.

Module 4: Reporting, Audit Trails & Review

Building reliable and transparent reporting processes aligned with data integrity frameworks.
Designing audit trail review workflows and data quality checks.
Incident investigation: handling data deviations, anomalies, and suspected falsification.
Continuous improvement: integrating lessons learned from reviews into data governance.
Exercise: Draft a standard operating procedure (SOP) for audit trail review and reporting for your team or organization.

Module 5: Emerging Practices & Technology in Data Integrity

AI and machine learning for automated data cleaning and anomaly detection.
Blockchain and cryptographic methods for immutable data records.
Ensuring data integrity in decentralized and real world data environments (real world evidence).
Preparing systems for ICH E6(R3) and risk based data management in clinical research.
Capstone Project: Create a data integrity roadmap for your organization: define policies, controls, governance, reporting, and technology interventions for 5 years.

Course Administration Details:

METHODOLOGY

The instructor-led trainings are delivered using a blended learning approach and comprise presentations, guided sessions of practical exercise, web-based tutorials, and group work. Our facilitators are seasoned industry experts with years of experience, working as professionals and trainers in these fields. All facilitation and course materials will be offered in English. The participants should be reasonably proficient in English.

ACCREDITATION

Upon successful completion of this training, participants will be issued a Skillstate Institute certificate.

TRAINING VENUE

The training will be held at a Skillstate Institute Training Centre. The course fee covers the course tuition, training materials, two break refreshments, and lunch. All participants will additionally cater to their travel expenses, visa application, insurance, and other personal expenses.

ACCOMMODATION AND AIRPORT PICKUP

Accommodation and airport pickup are arranged upon request. For reservations contact the Training Officer.

Email: info@skillstateinstitute.org
Phone: +254100920301

TAILOR-MADE

This training can also be customized to suit the needs of your institution upon request. You can have it delivered in our Training Centre or at a convenient location. For further inquiries, please contact us on:

Email: info@skillstateinstitute.org
Phone: +254100920301

PAYMENT

Payment should be transferred to our Skillstate Institute account through a bank on or before the start of the course. Send proof of payment to info@skillstateinstitute.org