Department for Regulatory, Ethical, Legal Affairs in Clinical Trials

Head
Nadia Rubis
nadia.rubis@marionegri.it

Department for Regulatory, Ethical, Legal Affairs in Clinical Trials

The Department for Regulatory, Ethical, Legal Affairs in Clinical Trials is dedicated to promoting a culture of academic research integrity and excellence through multidisciplinary expertise.

The specific offices that deal with activities related to the organization of clinical trials and their implementation in accordance with standards of Good Clinical Practice and relevant regulations in force on clinical trials are established at the Clinical Research Centr for Rare Diseases “Aldo e Cele Daccò” in Ranica.

In particular, the Department’s staff provides practical and methodological support to researchers in all phases of research, from project planning to its management, up to the generation of the final results

Aims/Objectives

·          To  support researcher in developing study protocols and feasibility assessment.

·          To  plan and organize clinical trials in a methodologically adequate manner by establishing  standard operative procedures (SOPs).

·          To  obtain the required authorizations at National and International levels to  perform the trials.

·          To  foster the implementation of National and International networks of  collaboration.

·          To  train and support study site staff on the study protocol and SOPs.

·          To  assess data collection measures provided by the study protocol.

·          To  ensure maintenance of the structural, information and training requirements  for health accreditation of the Centro Daccò in accordance with local  regulations.

·          To  support the Centro Daccò for the organizational aspects of clinical trials  and the correct management of data and collected samples.

·          To  develop and maintain innovative electronic systems for clinical research in  accordance with the criteria provided in Part 11 of the CFR21.

METHODOLOGICAL APPROACHES

·          Review  and application of national and international regulations regarding clinical  trials and research activities.

·          Review  and application of the GDPR and national regulations for the processing of  personal data in the context of clinical trials and research activities.

·          Implementation  of SOPs and operative manuals for the performance of study activities.

·          Review  and application of national and international regulations regarding the  generation of electronic data collection systems.

·          Compliance  to the SOPs provided by the Institute’s Clinical Trials Quality Management  System.

·          Compliance  to local regulations and guidelines for maintaining the health accreditation  of the Centro Daccò.

Staff
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Head
Nadia Rubis
nadia.rubis@marionegri.it
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