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

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

- Analysis of UNI EN ISO 9001 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

Module 2 - Data processing in laboratories and research protocols

- Sources of law and applicable standards in the laboratory and protocols

- The right to the protection of personal data and the applicable legislation;

- Personal data and their processing in laboratories and protocols

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

- The processing of health and genetic data;

- Data processing for scientific research purposes;

- The technical and organizational security measures.

Readings/Bibliography

Materials provided by the teachers, and references from the Literature, available on the platform  VIRTUALE

Teaching methods

Frontal teaching, team working

Assessment methods

Verification tests can also be taken on a disjointed date, but for both modules must be taken within the same session. Should this not be done in this way, the student(s) will have to retake the module of the course already taken. Partial marks, one for each module, will contribute to the final grade.

Mode of verification for both modules consists of : 1 - Oral test based on thesis developed on a topic of the student's choice, carried out as an in itinere test (optional) ; 2 - Test with multiple-choice quizzes on topics related to the program carried out (compulsory).

Teaching tools

Video projector, PC, mobile app for interactive teaching.

Office hours

See the website of Piera Versura

See the website of Juri Monducci