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Publication of the Decision of the Italian Personal Data Protection Authority

The general authorization to process the personal data for scientific research goals using data or samples previously collected for treatment or researches has been published in the Official Journal of the Italian Republic n. 72 of the 26th March 2012 (Decision of the Italian Personal Data Protection Authority n. 85 of the 1st March 2012). This authorization is related to the processing of personal data of the subjects involved in the research, without their consent, when they cannot be informed because of particular reasons and the research program obtained the competent Ethics Committee’s favourable opinion.

For consultancy, please find this general authorization at the link: http://www.garanteprivacy.it/garante/doc.jsp?ID=1878276.

(5th April 2012) 

Publication of an explanatory note on art. 16 of the Legislative Decree 200/2007

An explanatory note on article 16 of the Legislative Decree 200/2007 has been published. It was prepared by the AIFA Working Group on the Radiopharmaceutical Medicinal Products.

For consultancy, please see the above-mentioned note in the section Help > Circulars of the Portal of Clinical Research on Medicines.

(20th March 2012)

Publication of the slides related to the Workshop “10 anni di Osservatorio Nazionale sulla Sperimentazione Clinica dei Medicinali: uno sguardo al futuro”

The slides related to the Workshop “10 anni di Osservatorio Nazionale sulla Sperimentazione Clinica dei Medicinali: uno sguardo al futuro”, held on 26th January 2012, are now available in the section Document Area > OsSC Publications.

(28th January 2012)

Request for verification of missing data                    

In view of the publication of the next Report on Clinical trials of drugs in Italy, you are required to bring up to date missing data in OsSC.  Please see section Help>"Circulars" for consultancy.

(16th January 2012)

Publication of the 10th National Report in Italian and English

The 10th National Report on Clinical Trials of Drugs in Italy – 2011 has been published. It is available in Italian and English in the section “AREA DOCUMENTALE (DOCUMENT AREA)” > PUBBLICAZIONI OsSC (OsSC PUBLICATIONS) of the Portal of Clinical Research with Medicines in Italy (PRC).
(13th December, 2011)
 
Guidelines publication 
 
A note has been sent on the publication of the guidelines concerning the declaration of the responsible investigator on a local feasibility of the clinical trial on medicines. For consultancy please see the mentioned note available in the section Help > Circulars and the forms available in the section Investigators on the Portal of Clinical Research
(27th October 2011)