Quality Assurance and Regulatory Affairs for Clinical Studies

The main scope of the Quality Assurance and Regulatory Affairs for Clinical Studies activity of the Mario Negri Institute of Pharmacological Research IRCCS is to ensure that all clinical studies are conducted according to current regulations.

Quality Assurance

In accordance with the Guideline for Good Clinical Practice - GCP, E6 (R2), Step 5; 1 December 2016 EMA / CHMP / ICH / 135/1995 "Committee for Human Medicinal Products") "who promotes clinical studies is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s) (5.1.1) ".

The Quality Assurance for Clinical Studies activity therefore aims to develop and maintain a Quality Assurance System, that ensures adherence to the required standards, during the execution of the Institute's clinical studies, in accordance with current regulations. To achieve this goal, the following activities are carried out:

  • writing and updating of standard working procedures;
  • control of the application of procedures and adherence to standardized working methods;
  • consulting on legislation and requirements for conduct clinical trials.

Regulatory Affairs

The activity of Regulatory Affairs for Clinical Studies aims to support, advise and assist the Laboratories that deal with clinical studies regarding the regulatory aspects during start-up activities and throughout the course of the study. It deals with support/consultancy for the activation of clinical trials and clinical research projects promoted by the institute.

In detail, the activities are:

  • to classify the necessary documentation and the approval process to be followed based on the type of study;
  • to support the study team in defining and drafting the documentation produced from a regulatory point of view, verifying its adequacy;
  • to agree with the study team upon the timing of submission;
  • to act as a contact for communications with the portal of the National Observatory on Clinical Trials of Medicines (OsSC);
  • to support and verify the compilation of the Clinical Trial Application form of clinical studies;
  • to give assistance / advice for all regulatory aspects;
  • to keep update the staff involved in clinical trials with regard to changes in current legislation.
Veronica Giuseppina
Head of the Unit
Marlen Victoria Llerena Mesa

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