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The Importance of Having GCP Auditors and Quality Assurance Personnel Certified by the Italian Law

Aggiornamento: 20 lug 2022

Clinical Research in Italy

The Clinical Research sector is considered an excellence of the scientific, economic and social Italian system.

Given the high quality standards required, Italy has a strict regulation concerning all aspects of clinical trials and key persons operating in this field and, in a wider panorama, Italian procedures are considered as an international benchmark of quality.


In order to operate legally as an official Contract Research Organization in Italy, it is mandatory to demonstrate certain “minimum” requirements, which are thoroughly described in the Decree emitted by the Italian Ministry of Health of November 2011: “Minimum CRO requirements”, Article 3. Furthermore, the decree describes the necessary requirements an auditor and a quality assurance manager must demonstrate.

The requirements are organized in two main paragraphs:

  • Organizational and structural requirements;

  • Quality requirements.

Following is a brief summary:

Organizational and structural requirements

The CRO must describe the objectives and the activities it will carry out; it must have a clear organizational chart in which names and job titles are listed; there must be an experienced and qualified medical director or scientific director head of operations; the resources must be adequate (presence of a sufficient number of personnel and adequate infrastructures).

Quality requirements

A clear Quality Management System with adequate Standard Operating Procedures, a quality manual and evidence of documented quality assurance activities must be set up. There must be a qualified Quality Assurance manager and a pondered training program for employees and consultants must be prepared and implemented. Furthermore, the CRO must demonstrate to be GCP compliant with an adequate documentation system to ensure the tracking of all CRO activities.


ClinOpsHub S.r.l., founded in 2014 and registered as a CRO on the AIFA website since 2019, is a privately owned recognized Clinical Research Organization in compliance with the requirements of the Italian Ministry of Health Decree DM 15.11.2011.

Our company provides management solutions for pharmaceutical and medical device clinical trials from phases I-IV. In particular, our organization’s expertise is supplying services for the correct conduct of Phase 1 Clinical Trials and is 100% GCP compliant.

ClinOpsHub delivers clinical trial services which are flexible to the client while remaining competitively cost effective. Our expert technology and remote service options adapt to the needs of today.

If your Company is planning on working on multinational clinical trials involving trial centers in Italy, please get in touch with us; we can provide the necessary Quality Assurance and Auditing services. Furthermore, we also provide Clinical Trial Management, Patient Recruitment and Retention services and Clinical Research Training Programs for all needs.

Did you know that in order to operate legally as GCP auditor in Italy, it is mandatory to demonstrate certain “minimum” requirements?


Audits may concern all organizations involved in conducting a clinical trial, both experimental centers (including ethics committees, hospital pharmacies and analysis laboratories, other technical structures) and Sponsor or CROs.

Audits can take place before, during or after the conduct of a clinical trial. In general, they are of two main types:

1) a system-audit: aimed at acquiring information in general on the compliance of the audited facility to GCP standards;

2) a study-specific audit: which focuses on the procedures and documentation relating to a particular clinical study.

In many countries, it is possible to become a GCP auditor thanks to experience. Of course, there are some “highly recommended” requirements. First of all, an auditor should be educated at university level with a degree in a scientific/medical discipline or in a quality-related field, or equivalent combination of education, training and experience. In Italy, auditors must also comply with national regulations stated in the abovementioned Ministry of Health Decree DM 15.11.2011. This ensures a higher level of quality for the specific qualifications are regularly checked at each audit session. In other words, if an audit is to be considered valid, it is necessary that the auditor provides proof of qualification as per national standards.

The requirements are thoroughly described in the Ministry of Health Decree DM 15.11.2011 Article 3. The decree furthermore reports the necessary requirements an auditor (Art. 5) and a quality assurance manager (Art. 3) must demonstrate.


Only qualified auditors in compliance with the DM 15.11.2011 may conduct audits on Clinical Trials in Italy.

Some of the main requirements are stated in Paragraph 1: in order to operate as an auditor, one must possess:

  • a bachelor's degree in health or in scientific disciplines;

  • at least 60 hours of theoretical training (carried out during the 12 months prior to the start of the auditing activities),

  • at least 20 days of auditing activities in support of an expert auditor (carried out in the 12 months prior to the start of the autonomous auditing activity, with at least 50% of activities having taken place on-site, at clinical trial sites);

  • at least 4 months of activity (in the 12 months prior to the start of the autonomous auditing activity) in the QA and/or QC or vigilance of medicinal products or clinical trial fields.

To maintain the status of auditor, he/she must further his/her education and be updated yearly with no less than 30 hours on specific clinical research topics and must provide proof of at least 12 days of auditing activities per year.

If your organization does not have auditors with the abovementioned requirements, ClinOpsHub can help you by outsourcing our GCP Auditors. For further information or for a non-binding quote, book a free introductory call by filling out the form here: contact us. Thank you!

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