The course is open to candidates who have a (Bachelor's or Master's) science degree and a good working knowledge of written and spoken English, as outlined in the application guidelines on this site.
Clinical Monitor is a person employed who performs clinical trial monitoring activities. Clinical trial monitoring is the act of overseeing the progress of a clinical trial, and ensuring that it is conducted, recorded and reported in accordance with the Study Protocol, Standard Operating Procedures (SOPs), Declaration of Helsinki, principles of International Conference of Harmonization (ICH)- Good Clinical Practice (GCP) and all applicable legal and regulatory requirements.
The course, which lasts 22 months, is divided into different areas: theory and practical work - some of which is conducted while shadowing a certified Clinical Monitor and some of which is carried out independently - research group activities, institute or departmental seminars, laboratory meetings, and single-subject courses.
Each student is integrated into a research group and actively involved in ongoing projects, enabling students to participate in the planning, execution, and evaluation of work.
Admission to the course is through an exam following a call for applications. Candidates must pass a written exam and an interview at the headquarters of Milan, where its activities will be carried out.
Admission is selective because applications outnumber available places. The number of places is limited in order to guarantee that instructors will be able to support students as needed, and to ensure all scientific equipment is used correctly.
Applications must be submitted to the administrative offices in Milan (email@example.com) following the instructions in the call for applications, and by the date indicated.
At the end of the initial theoretical part of the course, which will last 3 months, candidates will be evaluated through a written exam composed of multiple choice questions that refer to all subject matter covered during training.
In addition, candidates' performance will be assessed by reviewing their work, and by evaluating their commitment to the course as well as attendance at and participation in the institute's training activities and events (seminars, clubs and courses).
A second evaluation step will be carried out approximately 11 months after the beginning of the course, with the evaluation criteria indicated previously. For the final 11 months of the course, the monitor nominees will continue to carry out autonomous monitoring activities.
At the end of the course there is a final exam conducted by an internal commission. Admission to the exam is contingent on the instructor's recommendation.
Students who were absent for extended periods or left the institute before the end of the course cannot be admitted to the final exam.
The exam consists of a written test that evaluates the candidate's knowledge of the subject matter covered, the correct application of work procedures, and the correct execution of a Clinical Monitor's tasks.