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Oggetto:

How to Write a Clinical Trial

Oggetto:

Academic year 2023/2024

Teacher
Ilaria Stura (Lecturer)
Teaching period
NA
Credits/Recognition
1
Course disciplinary sector (SSD)
FIS/07 - applied physics (a beni culturali, ambientali, biologia e medicina)
Delivery
NA
Language
English
Attendance
Optional
Oggetto:

Sommario del corso

Oggetto:

Course objectives

Knowledge on the conduction of clinical trials on humans. Specifically, the objective
of the course is to acquire expertise in the technique of drafting a clinical protocol to
be submitted to the Ethics Committee of hospitals or research institutions.
At the end of the course, the student will have acquired both technical knowledge and
the ability to apply them. In particular:

  • technical knowledge: how to structure a protocol; what are the main documents
    required for the various types of studies (clinical trial, observational study, profit and
    non-profit); who are the main stakeholders (Principal Investigator, Department
    Director, Secretariat of the Ethics Committee, CRO, Pharmaceutical Company,
    Treasury, Data Protector, ...)
  • applied skills: knowing how to write a clinical protocol, combining the medical-
    biological and statistical knowledge.
Oggetto:

Program

  • Types of studies, how a (general) protocol is formulated, people involved in
    drafting, reviewing, accepting and implementing.
  • Databases and data quality.
  • Randomization of samples.
  • Sample size calculation in different cases (using R).
Oggetto:

Course delivery

  • Lessons: the 5th and the 12th of March, h 14.00-18.00
  • Where: Aula B, Anatomia, Corso Massimo D'Azeglio 50
  • Type: in presence. If you can, bring your laptop for some exercises during the lesson
    (no specific software will be needed)

Suggested readings and bibliography



Oggetto:
Last update: 05/02/2024 09:55
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