The Laboratory of Biostatistics and Clinical Epidemiology provides support and methodological advice in the areas of statistics, Computer science and epidemiology for the analysis of data of clinical and epidemiological interest.
The Laboratory's activities are aimed at ensuring the methodological correctness of studies, the quality of statistical analyses and compliance with current regulations, with particular attention to ethical aspects, the protection of personal data and the integrity of research.
The Laboratory is aimed at:
- students in degree, postgraduate and PhD programs;
- staff of the Department of Medicine and Surgery;
- University staff engaged in research in the medical, biomedical and epidemiological fields.
Services offered:
The Laboratory provides methodological and technical support in the following activities:
- analysis and evaluation of study protocols and definition of the research design, with reference to methodological, regulatory and ethical aspects;
- design of data collection instruments and data collection forms (CRFs);
- planning of descriptive and inferential statistical analyses, including estimation of sample size and/or statistical power;
- setting up, management, quality control and cleaning of databases;
- generation and management of randomization sequences;
- statistical analysis and interpretation of results, with evaluation of transferability to clinical settings;
- support for writing research reports and scientific documentation, with emphasis on statistical aspects;
- development and application of mathematical and statistical models for risk assessment;
- methodological support for systematic literature reviews and meta-analyses;
- creation, management and updating of bibliometric databases;
- training activities on the use of major statistical software in clinical settings;
- technical support for the use of software of statistical and clinical interest;
- traineeship opportunities for students and residents and support for doctoral activities.
Strumentations:
The Laboratory uses specialized platforms and software for statistical analysis, data management, and reproducibility of processing, selected according to the methodological needs of individual studies
Support for theses and research projects:
The Laboratory provides data processing support for graduate, postgraduate, and PhD dissertations pertaining to the Department of Medicine and Surgery.
In order to enable proper planning of activities and preliminary evaluation of the request, interested parties are required to provide the following information at the time of initial contact.
Approval of the Ethics Committee:
When the opinion of the Ethics Committee is required:
The opinion of the Ethics Committee is required for application theses with preeminent scientific research purposes, i.e., for work aimed at the development of new scientific knowledge in the medical, biomedical or epidemiological fields.
These types include:
- observational, pharmacological or non-pharmacological studies;
- interventional, pharmacological or non-pharmacological studies;
- studies involving the use of drugs, medical devices, human tissues or other health procedures;
- theses whose results are intended or likely to be intended for scientific publication.
In such cases, the request for Laboratory support must be accompanied by the details of the approval of the relevant Ethics Committee, indicating the title of the project and, if available, the identification code.
When the opinion of the Ethics Committee is not required:
The opinion of the Ethics Committee is not required in the following cases:
- compilative theses based exclusively on scientific literature;
- application theses with a preeminent didactic purpose, carried out for training purposes and not aimed at the development of new scientific knowledge (e.g., case history reviews, clinical audits, analysis of data collected for care purposes), provided that no additional interventions on subjects are involved;
- studies using completely anonymous data, such that subjects cannot be identified in any way;
- systematic literature reviews and meta-analyses;
- analyses of data from studies already approved by an Ethics Committee, if the graduate student is formally authorized and the data provided are anonymous or aggregated.
In such cases, however, it is mandatory:
- to explicitly indicate the type of thesis;
- to provide an attestation from the Rapporteur stating that the opinion of the Ethics Committee is not necessary;
- to comply with the obligations provided for the protection of personal data;
- to transmit to the Laboratory only anonymized data or, when necessary, pseudonymized data, without direct identifying information and without transmission of the rejoining key.
Reference Project:
For application theses, submission of the reference research protocol, approved according to the process provided by the relevant Structure, is required.
Timing:
You must indicate the expected date of delivery of the thesis at the time of the request for support.
For organizational reasons, requests sent less than one month after the expected date of delivery of the thesis cannot be accepted.
Role of the Laboratory in the thesis and publications:
Depending on the complexity of the statistical analyses required, Laboratory staff may be indicated as second rapporteur.
In the case of publication of results, staff involved in methodological and statistical support activities should be included among the co-authors, in accordance with good practice in the attribution of scientific authorship. Participation as a speaker is at the discretion of the Laboratory, in relation to the nature and workload required.
Personal data protection and database preparation:
The Laboratory operates on anonymized or, when necessary, pseudonymized datasets, in compliance with Regulation (EU) 2016/679 (GDPR). The role of data controller remains with the Speaker and the Reference Facility.
Data should be provided in Excel or CSV format.
Any links to identifying data should be stored separately, securely, and should not be transmitted to the Laboratory.
Required structure of the database:
- one row for each subject, identified by a unique code (anonymous or pseudonymous);
- variables arranged in columns;
- no annotations, colors, or additional formatting;
- each piece of information reported in a separate variable;
- short variable names (maximum 12 characters), no spaces or symbols;
- categorical variables coded numerically, with legend provided in a separate sheet.
Databases that allow, even indirectly, identification of subjects will not be accepted.
