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Volunteers recruitment

What is a Phase I clinical trial?
Phase I trials are preliminary studies to test a new substance that is used in humans for the first time with the aim of evaluating its safety and mode of action, with particular regard to its absorption, metabolism (transformation) within the body and its elimination.
Phase I studies also include studies concerning substances already in use in humans, however, aimed to evaluate possible interference factors such as nutrition, age, sex, etc..
Phase I studies are usually conducted in healthy adult volunteers, preferably male to avoid interference with the female hormonal cycle.
Experimental drug administration is performed under medical supervision in a specialized facility, and respects the ethical principles of the Declaration of Helsinki and the World Health Organization.  The local Ethics Committee and Regulatory Authorities must also approve the study protocol before study initiation.

Who can become a healthy volunteer?

Healthy volunteers include male or female adults who are in good health, do not suffer from physical or mental illnesses, who are not being treated with any pharmaceuticals and do not assume alcohol or recreational drugs. Subjects must also be able to give their written consent to participate in the study.

How to become a healthy volunteer, and what does participation in a Phase I study entail?

To enroll in the registry of healthy volunteers at the San Matteo Phase I Clinical Trial Unit and Experimental Therapy must you must complete the attached form (in Italian); you must also sign a written consent form for inclusion in the register of volunteers and the processing of your personal data.

Can I withdraw from the study at any time ... ... how? By fax or e-mail?

The volunteer will then be contacted by the staff of the San Matteo’s Phase I Unit and will be informed of the procedures required by the study protocol.

Contact Information for Volunteers:
+39 0382 503 457
+39 0382 502 508


Data ultimo aggiornamento:  21/12/2011

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