Theoretical and practical training to obtain CRA license in accordance with the Ministerial Decree dated 15.11.2011

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What is it?

Theoretical and practical course to obtain Monitor's qualification: 40 hours of lectures, virtual classrooms or meetings with teachers for clarifications and details of what was studied during classes, tests, at least 20 days of monitoring activities along side a certified clinical Monitor (of which at least 50% at experimental site), at least * 4 months of activity in the areas of control and / or surveillance of medicinal products and / or clinical trials.

* NOTE(4 months of activity):
4 months of activities are not intended for users who have completed post-graduate master's degree or graduate school or equivalent post graduate university degree in clinical trials or regulatory science or equivalent disciplines.

To whom the course is addressed?

The course is addressed to aspiring clinical monitors.

Who is the clinical monitor?

Definition according to the Italian DM 15/11/2011: the person who oversees the progress of the study at the experimental sites, to ensure that research is carried out in accordance with the protocol, standard operating procedures (SOP), the applicable regulatory requirements, and the GCP. He/she is responsible for trials' monitoring according to the rules provided in Annex 1 to the Italian Decree of 15/07/1997 (transposition of GCP).

The monitor is a professional figure that is involved in the phases of drugs testing. It is the person to who the sponsor has given the task to organize, track and monitor the progress of the clinical trial at the experimental site. The monitor then follows the trial on behalf of the company, visiting the hospital sand working with the physicians involved in the study.

The Monitor must:

  • ensure that the study is performed according to the clinical protocol;
  • control the activities of the study staff by visiting the site in order to verify the database;
  • interact with the investigators (physicians), the Sponsor and the Ethics Committees;
Minimum requirements to access the course:
  • According to Italian MD 15/11/2011, to become a clinical monitor you must be in possession of bachelor's degree in health / science.
  • Knowledge of English.
Step 1:Theoretical phase-web-based
a) 40-hour course on the following areas:
  • Methodology and regulations related to clinical trials;
  • Good ClinicalPractice(GCP);
  • Rules of Good Manufacturing Practice(GMP) with specific reference to the investigational medicinal product;
  • Pharmacovigilance;
  • Quality systems and quality assurance;
  • Monitor tasks referred in paragraph 5.18 of Annex 1 to Ministerial Decree of July 15, 1997
b) Test for each area (6tests). c) Web meetings for deeply discussing each topic, whose participation is mandatory to proceed in the course(the schedule will be provided at the beginning of the course). d) Practical exercises on the following topics (to be carried outonline):
  • informed consent;
  • collection and data management;
  • subjects recruited for a clinical trial;
  • practical management of a clinical study;
Step 2: Practical phase
a) Monitoring activities (20 days, of which at least 50% at the experimental sites) alongside with an expert monitor.
b) At least four months of mandatory attendance at the CRO to conduct practical activities in the areas of control and / or surveillance of medicinal products and / or clinical trial, for participants who have not achieved university master degree or post graduate school or equivalent postgraduate degree in clinical trials or regulatory science or equivalent disciplines.

Step 3: Mentor evaluation
Following the positive outcome of mentor after the first phase, the certification of monitor according to the Italian MD 15/11/2011 will be issued.

Why should I register for the course?

Uniqueness of the knowledge provided:
- Uniqueness of the course.
- University education is not enough to enter into the profession of the monitor. That is why special training is required by MD 15/11/2011.
In recent years, some university masters have laid the foundation for this profession, but only from the theoretical point of view. Other facilities and training companies offer the theoretical courses which covers 40 hours training required by MD.
This training provides theoretical and practical complete package, so at the end you obtain a license to practice the profession of clinical monitor in compliance with MD 15.11.2011 and consequently to such certification, you can be nominated as a monitor at pharmaceutical companies and CROs.

Direct contact with the teachers during the virtual classrooms:
despite this course is available as an online course for the theoretical part, a direct contact with teachers, programmed in the web-sessions of each macro-area, is guaranteed.

Mentor assignment for the practical part:
- During the second phase (practical one) a mentor will be assigned to each participant. This figure will follow you during the period of permanence in the company.
- Certificate issuing: Following the successful completion of tests and practical part within the established deadline, you will get a license of Monitor:
- The test can be repeated as often as desired with in the specified time. During the practical part, there is possibility to discuss and deepen more difficult issues comparing to the theoretical part, together with the mentor assigned to each participant; the process will end up once the mentor gives positive opinion regarding the practical part. These two assumptions (to pass the tests and to obtain the positive opinion of the mentor) are required for the certification.

How the course is performed?

According to Italian MD 15/11/2011, the course includes three distinct phases, with release of certification stating that all activities and trainings were performed:
  • Online training(40 hours) with tests, accessible 24/7 with virtual classrooms(web-meeting, whose participation is mandatory) with the teachers in charge of each module and practical exercises.
  • Monitoring activities (20 days, of which at least 50% at the experimental sites) along side with an expert monitor.
  • 4 months activity in the field of clinical trials at the CRO, carrying out various activities related to the clinical trials' management. Monitoring visits at the experimental sites will be carried out in accordance with the schedule of experienced monitors who work in the company. The 4-month practical training is carried out at the premises of Medical Trials Analysis Italy (Via Ariosto 28, 44121 Ferrara, Italy and/or Via W. Tobagi 6, 20143 Milan, Italy)
  • The training course lasts maximum 12 months starting from the first access to didactic material. In case of overruns of deadlines established, it is needed to start all the way with a new registration.