Data Management for Clinical Research
Milano
Master 1 Level
Italian
12 months
blended
Vision
Poichè la validità scientifica di uno studio clinico dipende dalla correttezza metodologica del protocollo, dal rispetto delle procedure in esso descritte e dalla qualità dei dati sui quali si basa l'analisi dei risultati, la figura del Data Manager è una figura professionale sempre più richiesta da tutte le aziende, sia pubbliche che private, attive nella pianificazione, conduzione e valutazione della ricerca clinica. Questa figura professionale è esempio indispensabile per svolgere tutte quelle attività inerenti la gestione dei dati clinici e dei documenti che, nel corso di uno studio clinico, gli sperimentatori, i comitati etici, l'azienda sponsor, le eventuali CRO e i centri di elaborazione dati debbono predisporre.
La partecipazione al Master permette di acquisire la certificazione Good Clinical Practice ICH-GCP E6.
Mission
L'obiettivo formativo generale di questo Master è quello di fornire una preparazione qualificata allo svolgimento delle seguenti funzioni:
- Gestire i dati clinici dalla fase della raccolta a quella del loro trattamento ed elaborazione fino al conclusivo trasferimento ai centri statistici;
- Assicurare che lo studio sia condotto in accordo con le linee guida di buona pratica clinica stabilite nelle Good Clinical Practice;
- Garantire un coordinamento di vari aspetti della sperimentazione e rappresentare un punto di riferimento sia per gli sperimentatori (medico, infermiere, farmacologo, biostatistico) sia per le strutture regolatorie locali ed esterne (Direzioni Sanitarie, Comitati Etici, Aziende Farmaceutiche, Contract Research Organization – CRO –, Monitor, Centri di Coordinamento, Gruppi Cooperativi).
Il Master è strutturato in modo da assicurare ai propri studenti:
- Adeguate conoscenze di base della metodologia della ricerca clinica necessarie per valutare criticamente un protocollo di studio e i risultati statistici prodotti;
- Buona padronanza degli strumenti informatici generalmente utilizzati nella ricerca clinica;
- Buona conoscenza dei principi etici, degli aspetti operativi e normativi che regolano le attività della ricerca clinica;
- Buone capacità nella gestione dei dati raccolti negli studi clinici, dalla costituzione della scheda raccolta dati elettronica (eCRF) e del relativo database a tutti gli aspetti di controllo di qualità degli stessi.
The 304 hours of lessons planned in the curriculum are delivered as follows:
The majority of lessons are provided remotely in a blended format, either synchronously (via the Webex platform) or asynchronously (through video lectures and exercises made available to students on the Master’s e-learning portal);
Approximately 30% of the lesson and exercise hours—including 28 hours dedicated to REDCap software training and 28 hours to SAS training—are delivered in person in computer-equipped classrooms at the University.
All synchronous remote lessons are recorded and made available to students through the Master’s e-learning portal. Webex streaming recordings are considered supplementary teaching materials and do not replace participation in live synchronous lessons.
Teaching Organization
304 hours of Lezione
500 hours of Stage/Project Work
The final exam consists of an oral discussion of the internship/project work.
Exams and Attendance
Courses
Drug development phases
Types of clinical studies
Experimental designs, observational designs, adaptive designs
Uncertainty in the diagnostic process
Frequency of clinical events
Random and systematic errors in diagnostic measurements
Bias control
Systematic reviews and meta-analyses
Introduction to relational databases
Conceptual design
Logical design
SQL language
Good Clinical Practice (ICH-GCP R3)
Regulatory framework (observational studies and interventional studies with drugs and medical devices)
Ethical and regulatory evaluation and authorization process of a clinical trial
Clinical trial monitoring
Data governance
Quality requirements in clinical trials
Principles of Computer System Validation (CSV) in the GCP context
Elements of project management and performance indicators
Tools for data collection (CRFs/eCRFs, study database, and other important data)
Cleaning of efficacy and tolerability data
Processes for coding drugs and medical terms
Reconciliation of the study database with the pharmacovigilance database (serious adverse events)
Interaction with the study team for study progress control and data quality monitoring
Importance of clinical data management systems
Introduction to the REDCap system: Piping/Smart Variables/TAGs, Branching Logic, Project HOME/SETUP/Applications (tools), randomization
Introduction to SAS programming language
Procedures for data import
Creation of derived variables
Main procedures for data validation
The importance of biostatistics in clinical research
Elements of descriptive and inferential statistics
Methods for analyzing continuous, categorical, and survival outcomes
Introduction to machine learning
Building machine learning pipelines through visual interaction using the OrangeML suite
- Seminars on specific topics related to clinical research and presentation and discussion of business cases.
Comitato Scientifico
Mauro
Stabile
Faculty
Full Professor at the University of Milano-Bicocca
Tenured Assistant Professor at the University of Milano-Bicocca
Assistant Professor at the University of Milano-Bicocca
What skills do you gain?
Data Management for Clinical Research
Who is it aimed at ?
Bachelor’s and Master’s degree graduates from all disciplines.
in the field of clinical research
The Clinical Research Data Manager is a key figure in the planning and conduct of clinical research studies. Their expertise applies to both commercial (Profit) and non-commercial (Non-Profit) research.
Professional opportunities
Clinical Research Coordinator (CRC)
This professional role is responsible for managing and coordinating clinical studies, usually at the investigative site. The CRC assists researchers and study staff in planning, organizing, and supervising activities related to clinical studies, while ensuring coordination of activities and maintaining communication with Monitors and Sponsors. Responsibilities include managing study documents, recruiting and managing participants, handling data at the clinical investigative site, communicating with various stakeholders, and monitoring study progress to ensure that all procedures are conducted in compliance with protocols and applicable regulations.
Clinical Research Associate (CRA) o Monitor
The Clinical Research Associate (CRA), also known as Monitor, is responsible for overseeing clinical studies to ensure they are conducted in compliance with protocols, Good Clinical Practice (GCP), and applicable regulations. This role includes verifying data collection, monitoring ethical and regulatory compliance, and supporting research sites participating in the study to resolve any operational issues. Typically, the CRA works on behalf of the clinical trial sponsor, whether profit or non-profit (e.g., pharmaceutical companies, CROs, non-profit organizations, etc.).
The Master’s program provides the theoretical training required by the decree of November 15, 2011 (known as the CRO decree), as well as the foundational knowledge necessary for this professional activity. However, the practical monitoring experience—mentored alongside an experienced Monitor at clinical research sites—is essential for CRA certification. This hands-on training depends on the host organization where the student undertakes their internship and is rarely guaranteed.
Clinical Data Manager (CDM)
The Clinical Data Manager (CDM) is responsible for the collection and management of data derived from clinical studies and ensures data quality and integrity. This role involves creating and maintaining clinical databases, verifying data quality and integrity, and managing data cleaning and validation processes. The CDM works closely with other members of the research team to ensure that the collected data are accurate, complete, and suitable for statistical analysis and the presentation of research results.
Clinical Trial Assistant (CTA) e Start Up Specialist
The Clinical Trial Assistant (CTA) is the professional responsible for supporting the Monitor and Project Manager in managing the bureaucratic and documental aspects of a clinical study, in compliance with Good Clinical Practice (GCP), internal Standard Operating Procedures (SOPs), and current regulations.
The role of the Start-Up Specialist, on the other hand, focuses on managing regulatory and authorization processes necessary for the initiation and conduct of a clinical study.
The "Operational Aspects" module of the Master, together with seminars on the practical use of the European Medicines Agency’s (EMA) Clinical Trials Information System (CTIS) platform, enables students to acquire basic regulatory and compliance skills required for entry-level positions in this field.