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PROFESSIONAL PROFILE OF THE CLINICAL MONITOR ADHERING TO ASSOMONITOR

1. The Clinical Monitor adhering to Assomonitor has to meet to requirements described at article 4 of the Assomonitor Statute. He/She has to develop his/her professional activity according to Good Clinical Practice (Minister Decree dated July 15th, 1997) and he/she has to protect the privacy of information every time he/she has access to reserved data in carrying-out his/her monitoring activity of clinical trials, according to the guidelines about the protection of personal data (Law Decree # 196 dated June 30th, 2003) and to the Guarantor’s disposal about the protection of personal data (guidelines on handling of personal data in clinical trials with experimental drugs from July 24th, 2008, published on the Gazzetta Ufficiale – Italian official journal of laws - # 190 from August 14th, 2008).
 

2. The Clinical Monitor is aware of the principles and of the procedures applied to the development of the experimental drugs and to the clinical research. The Clinical Monitor must also be aware of the European and Italian legislation and of the guidelines applied to the fulfilment of clinical trials and to the release of authorisations for sale.
 

3. Every Clinical Monitor adhering to Assomonitor undertakes the respect of the Professional Code of Conduct.
 

4. The Clinical Monitor adhering to Assomonitor is identified, within the Association, by a registration code.

 

 

 

 

 

 

 

 

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