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

Learning outcomes

The student acquires the knowledge regarding quality control and certification procedures in the biological laboratory. In particular, the student is able to: - use the methods, techniques and procedures to operate in a Quality System within a biological laboratory; - manage the control of the data obtained in the biological laboratory. The management of clinical protocols, preparing information on informed consent and data processing are also discussed.

Course contents

The topics of the program are hereby summarized:

Module 1 - Laboratory quality systems and experimental protocol management:

- Quality System: history, evolution and models. The ISO system and its basic principles

- Analysis of UNI EN ISO 9001 and 14001 standards, rationale and novelty.

- Certifications and Accreditation

- ISO standards, specific techniques for laboratories in the Healthcare and Agri-food sectors

- The HACCP system

- Audit according to the ISO model: Guidelines for conducting the Audit and explanatory cases

- The Clinical Assistance Audit: definition, management method and explanatory cases

- Ethics in conducting clinical research studies

- Guided case study to be submitted to the requests of the Ethics Committees

- Conducting and Monitoring the clinical studies - explanatory cases

- Big data analytics and privacy issues

Module 2 - Data processing in laboratories and research protocols.

- The sources of law and applicable regulations in the laboratory and protocols

- The right to protection of personal data and applicable regulations;

- Personal data and their processing in the context of laboratories and protocols; 

- The principles of lawfulness of data processing, information and consent;

- The processing of health and genetic data;

- The processing of data for scientific research purposes;

- The technical and organizational security measures.

 

 

 

 

Readings/Bibliography

Materials provided by the teacher, and references from the Literature, available on the Virtuale platform

Teaching methods

Frontal teaching, team working

Assessment methods

The course consists of two modules for a total of 6 CFUs. The examination for both modules must be taken in the same session. In case it is not taken in this way, the student(s) will have to repeat the modules already taken.

The examination mode consists of: 1. an oral test based on a paper developed on a topic of the student's choice (optional); 2. tests with multiple-choice quizzes with topics related to the program taken. The grade of each module contributes to the final grade.

Teaching tools

Video projector, PC, mobile app for interactive teaching.

Office hours

See the website of Piera Versura

See the website of Juri Monducci