Basic course on clinical research in accordance with the Italian Ministerial Decree dated 15.11.2011

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What is it?

Theoretical basic course on the Clinical Research: 40 hours of theoretical lessons as directed by Italian MD15.11.2011, virtual classrooms meaning meetings with teachers for clarifications and details of what was discussed in class, assessing test.

To whom the course is addressed?

This course is dedicated to those who have been already working in the field of clinical research and want to obtain basic knowledge to improve their skills, as well as who is curious to explore the world of clinical trials and be able to apply for professional roles in CROs, pharmaceutical companies, clinical sites or regulatory structures. Our course allows providing specific skills giving the user flexibility of access, affordability and speed of learning.
There are different actors involved in the management of a clinical trial:

  • Pharmaceutical companies: professional figures of a pharmaceutical company(pharmaceutical representatives, regulatory affairs, ..).
  • CRO: CRO professional figures, Clinical Research Associate.
  • Sites: Principal Investigator, Sub-Investigator, Study Coordinator, Data Manager, Study Nurse, Pharmacist, phlebotomist, and Radiologist Technician Radiologist, Nuclear Physician, Laboratory Technician.
  • Ethics Committees, Hospital CEO, AIFA and Competent Authority.
The professionals involved in Clinical Research are required to have skills and knowledge that is hardly possible to learn in the normal university course. As with many other professions, graduation is just a starting point to build a complete professionalism.

The aim of the course is to provide participants with basic information about the Clinical Research. It is focused on the skills to be able to fit in the different roles of Clinical Research (Data Manager, Research Coordinator , Clinical Trial Assistant, Clinical Research Associate, Auditor and Quality Manager in CRO and / or pharmaceutical companies), and it allows participants who are already working in this area to acquire higher levels of skills to aspire to professional roles of greater responsibility. Thanks to an online way of teaching, the course is an excellent opportunity for the participants (who cannot attend courses 'face to face' for various reason), to receive high-profile course, which allows managing the class attendance and execution of evaluation tests in a completely personalized way.

Program

a) 40-hour course on the following areas:

  • 1. Methodology and regulations related to clinical trials.
  • 2. Good Clinical Practice(GCP).
  • 3. Rules of Good Manufacturing Practice(GMP) with specific reference to investigational medicinal product.
  • 4. Pharmacovigilance.
  • 5. Quality systems and quality assurance.
  • 6. Duties of the monitor referred to in paragraph 5.18 of Anne x1 to Italian Ministerial Decree July 15, 1997.
b) Learning test for each topic (6 tests).

c) Web meetings for deeply discussing each topic, whose participation is mandatory to proceed in the course...

d) Practical exercises on the following topics, to be held always on-line:

  • 1. informed consent;
  • 2. data collection and management;
  • 3. subjects recruitment in a clinical trial;
  • 4. clinical study management in practice;

Why should I register for the course?

  • Direct contact with the teachers during the sessions of virtual classrooms: although 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.
  • Issuing certificate: following the positive test within the established deadlines, you will get the certificate of 40 hours training, as required by Italian MD 15/11/2011. The test can be repeated as often as desired within the specified timelines.
  • Ability to adapt the training program according to the real needs of the participant. If the participant initially considered that only theoretical training is sufficient, but later decides to continue also the practical course in order to obtain a certificate for the profession of Clinical Research Associate, there is the possibility to subscribe at a later time to the 'Qualification as monitor' course. The first theoretical part will be already recognized and only the practical part will be integrated (theoretical training and practical training have to be carried out with in 12 months from the beginning of theoretical training).

How the course is performed?

The course will be activated within 1 working day after your sign up, so the moment when you can access the first module's materials.

Access to study material of the next module is tied to the success of comprehension tests of previous module.

Each module has been programmed a web-meeting (virtual classroom), where the teacher, in charge of the module, is available to deepen or clarify topics. Participation is mandatory.

Lastly, a practical exercise of some fundamental issues is expected to be carried out entirely via web.

The online course (40 hours) must be completed within 6 months from its beginning, including tests at the end of each module. If the user cannot succeed in pass the tests with in the 6 months, it is needed to proceed with a new registration and start the course from the beginning.
In case of negative result of the tests, these can be repeated several times.