Why you need to have a legal representative in the EU if you want to run a clinical trial in Italy.
In order to guarantee safety and to keep quality standards high, clinical research operations are governed by a certain number of essential regulatory documents and Ministry of Health indications.
One such document is the Italian Ministerial Decree 15.Nov.2011. The more relevant articles are listed and analysed below.
The decree reads as follows:
MINISTRY OF HEALTH
MINISTERIAL DECREE 15 November 2011.
Definition of minimum requirements for Contract Research Organizations (CROs) for pharmaceutical clinical trials.
Article 1.
Scope
This decree establishes the minimum requirements that private organizations, referred to in art. 20, paragraph 3, of the legislative decree of 24 June 2003, n. 211 must possess, or any other body to which the trial sponsor has entrusted some or all of the clinical trial responsibilities, which are defined in the following art. 2 contract research organizations (CROs).
The M.D. 15 November 2011 does not apply to observational studies or studies with medical devices.
For this reason, Monitors operating for these types of studies aren’t required to have the specifications mentioned in the Ministerial Decree.
Furthermore:
Art. 7
Operation and notification of requirements
From the date of entry into force of this decree, only CROs in possession of the requirements, referred to in the previous articles, can operate for experiments conducted on Italian territory unless as provided in the following paragraphs…
CROs which, on the date of entry into force of this decree, have already transmitted their requirements, are not required to submit them again and can continue to operate. CROs who, on the other hand, were formed after the ministerial decree of March 31st, 2008 came into force and have not yet provided for the registration in the National Observatory on Clinical Experimentation of Medicines (OsSC), must notify, within fifteen days from the date of entry into force of this decree, the possession of the aforementioned requirements by self-certification, drawn up in accordance with the provisions in the annexes to this decree, in order to continue to operate. The self-certification must be sent to the GCP Inspectorate and to the AIFA Research and Clinical Trials Office.
Art. 8
Legal representation and liability of promoters
Any CRO established outside Italy wishing to carry out activities in Italy must have legal representation in one of the Member States of the European Union and must meet requirements at least equivalent to those set out in this decree.
This Decree shall not exempt the promoters of trials who entrust CROs with part or all of their competences in the field of clinical trials from the responsibilities assigned to them by the existing rules and regulations on clinical trials.
Therefore, if you are a CRO and you want to run an interventional clinical trial on an IMP in Italy, you need:
A legal representative in EU - please contact info@clinopshub if you need this service!
A quality system which meets the minimum requirements listed in the MD 15 Nov 2011 - Our Quality Management System is compliant to the requirements.
A CRO, operating on the Italian territory must previously prove to have the listed requirements below:
Organizational and structural requirements:
1. A deed of incorporation for the CRO, consistent with the objectives of the CRO.
2. A list of activities that the CRO is able to carry out.
3. A functional and nominative organizational chart.
4. The presence of a medical director or a scientific director with a university degree respectively in medicine, in life sciences or similar degree, with documented experience of at least two years in one or more medical or scientific fields.
5. Presence of suitable personnel sufficient for the planned activities.
6. Operational headquarters must be adequate in order to ensure the correct execution of the CRO's activities and archiving of confidential documents.
For these reasons, a freelance consultant is not compliant with the Italian MD 15 Nov 2011 since a Scientific Director and a QA Manager are both required in the abovementioned MD for managing a clinical trial on an Investigational Medicinal Product in Italy.
Quality requirements:
1. SOPs that describe the activities that the CRO must perform.
2. A QMS set up and defined according to ISO or equivalent standards must be evident and supported by a relative Quality Manual.
3. Evidence of documented quality assurance (QA) activities.
4. A QA manager, with a degree and documented experience of at least 1 year of practical activity in the field and with at least 15 days of theoretical training courses, carried out in the last two years in the quality field.
5. An annual training program for employees and consultants must be prepared and implemented.
6. GCP compliance of all CRO activities.
7. An adequate documentation system to ensure the tracking of all CRO activities.
Only once a CRO can demonstrate to have all the requirements described above and to have received acknowledgment from AIFA, the national competent authority, it can work independently and manage INTERVENTIONAL clinical trials in the Italian Territory without worrying that the data won’t be accepted or that the trial will be interrupted for non-compliance to the regulatory requirements.
Do you need to run an interventional clinical trial on an IMP in Italy?
Contact us for smooth sailing
info@clinopshub
→ We can be your legal representative in EU
→ Our quality system meets the requirements listed in the MD 15 Nov 2011
Ref: Italian Ministerial Decree 15.11.2011