84939 - Quality systems in the laboratory and management of experimental protocols

Learning outcomes

At the end of the course, students will have acquired knowledge of quality assurance and certification systems applied to biological laboratories. They will be able to: 1. apply standard methods and procedures within a certified laboratory Quality System; 2. oversee data control and validation in laboratory workflows; 3. manage clinical research protocols, including the drafting of informed consent documents and compliance with data protection regulations.

Course contents

The course provides students with both theoretical and practical tools to understand quality systems in biological laboratories operating in the healthcare, forensic, and nutritional sectors. Particular attention is given to the regulatory, ethical, and methodological implications of managing experimental protocols and handling personal, health-related, and research data.

Module 1 – Quality Systems in the Laboratory and Management of Experimental Protocols

• Quality Systems: history, development, and models. The ISO system and its fundamental principles

• Overview and updates on UNI EN ISO 9001 and 14001 standards

• Certification and accreditation processes

• Application of ISO standards in healthcare, nutritional, and agri-food laboratories

• The HACCP system

• ISO-based audit: guidelines and case studies

• Clinical audit: definition, methodology, and practical examples

• Ethics in clinical research

• Guided case study for submission to Ethics Committees

• Conduct and monitoring of clinical trials: practical examples

• Risk management in biomedical laboratories: basic principles, risk assessment, tools and standards (e.g., ISO 31000, ISO 14971); applications in healthcare, nutrition, and forensic contexts

• Introduction to Project Management in clinical and laboratory research: fundamentals of planning, resource management, project timelines (WBS, Gantt charts), and protocol implementation

• Big data analysis and privacy issues

Module 2 – Data Management in Laboratories and Research Protocols

• Legal frameworks and normative sources in laboratory and experimental research settings

• Protection of personal data: general principles and applicable regulations

• Principles of lawfulness, transparency, and informed consent

• Accountability and technical/organizational security measures

• Processing of health-related and genetic data for scientific research purposes

Readings/Bibliography

Materials provided by the Teachers  and references from the scientific literature will be made available on the course’s Virtual Learning Platform.

Teaching methods

Module 1 – In-person lectures, practical exercises, group work, use of multimedia resources and interactive tools.

Module 2 – In-person lectures. Remote sessions with group-based practical exercises conducted via the Microsoft Teams platform.

This course aligns with several UN Sustainable Development Goals by promoting quality, ethics, and innovation in biomedical laboratory practice.

• It supports SDG 3 – Good Health and Well-being, by enhancing the safety, reliability, and transparency of diagnostic and research processes through the application of quality systems (e.g., ISO standards, HACCP, audit procedures).

• It contributes to SDG 4 – Quality Education, by offering specialized and practice-oriented training in quality assurance, protocol design, and regulatory compliance.

• It promotes SDG 9 – Industry, Innovation and Infrastructure, by introducing students to tools such as risk management, project planning, and big data analysis for the continuous improvement of laboratory systems.

• It addresses SDG 16 – Peace, Justice and Strong Institutions, through its focus on ethical research conduct, informed consent, data protection, and regulatory accountability.

Assessment methods

he course is structured into two modules, for a total of 6 ECTS credits.

Assessment consists of:

1. An optional oral exam based on a written paper developed by the student on a topic of their choice (valid as a formative assessment during the course);

2. A mandatory written test with multiple-choice questions covering the course content.

Both modules must be completed within the same examination session. If this condition is not met, even the module already passed must be retaken.
The final grade is the average of the grades obtained in the two modules. Any rounding of the final mark will take into account the difference in performance between the two modules.

Teaching tools

Teaching tools:
Video projector, computer, interactive apps and software.

Students with Specific Learning Disabilities (SLD) or temporary/permanent disabilities
Students are advised to contact the University's dedicated support office in advance:
https://site.unibo.it/studenti-con-disabilita-e-dsa/en
The office will be responsible for proposing any necessary accommodations. These must be submitted for approval to the course instructor at least 15 days in advance, who will evaluate their appropriateness in relation to the learning objectives of the course.

Office hours

See the website of Piera Versura

See the website of Juri Monducci