pharmacological studies please refer to the list of documents provided in list
1a (for a single opinion) or 1b (request for acceptance o single opinion) in the
DM 21/12/2007 (CTA form).
Since October 2014 all the documents listed hereunder
must be uploaded to the data base of the
Ministry of Health (OsSc ) as per AIFA
home web site.
and detailed information on the documents to be submitted are the following:
- Letter of
intent or invitation to participate signed by Sponsor / CRO, headed as above,
If a CRO is
involved: Promoter's letter delegating the CRO and a detailed list of the
Consent form in Italian according to the latest version approved by the EC
(preferable) or made by the Sponsor. In the latter case, the document must
contain all the points of the oSR template and take into account the privacy
policy and its updates.Letter to the
family doctor (in Italian).Patient’s diary
and / or identification card and / or questionnaire if needed.Study protocol,
signed and dated by the Promoter.Synopsis of the
protocol in Italian.Case Report
participating centres.List of
Competent Authorities (if oSR is the coordinating centre).Curriculum
vitae of the Principal Investigator and Co-Investigator.A copy of the
single opinion of the EC of the coordinating centre.Draft
Convention on oSR model. The draft agreement must be pre-compiled.
- number of patients;
- Flow chart (description of study
activities, start date, end date of enrolment, date of the end of study);
- kind of trial (single or multi-centre);
- study design;
- any use of non-centralized or centralized
- name of the coordinating centre if
- drug delivery;
- insurance policy;
- economic proposal;
- invoice address of the owner for the
invoices (payment of expenses and of the EC; please make a clear distinction);
- referring person’s full name, with email, phone and fax numbers in case
explanations or addition documents are needed;
of all documents.
(Contact the Clinical
Research Office for the template)Copy of the
bank transfer receipt for the payment of the fee for the Protocol submission to
Ethical Committee. From January 2019 the payment of the evaluation fees for C. E. will no longer be required in advance, but will be invoiced only when the study / amendment is evaluated by the Ethics Committee. In the submission letter, the complete information for billing and correct address must be present for invoice receipt.
The transfer must be received within 30 days of the invoice date.
insurance certificate with the following points highlighted:
with the same IMP (if oSR is the coordinating centre).TSE declaration
(if oSR is the coordinating centre).All documents
referred to the study drug characteristics (if oSR is the coordinating centre).EMA Guidelines
reference if present in the protocol, if oSR is the coordinating centre.Copy of the
single opinion released by the coordinating centre."Application for authorization to the competent
authorities (Form CTA) for a clinical trial on a medicinal product for human
use.Cover page containing the number of Eudra-CT, printed
by the Centre;
- the period
- presence or
absence of the unenforceability relief to injured third parties;
- the term of
validity of the extension;
- right of
- list of
Brochure for products not yet on the market;
- full (if oSR
is the coordinating centre) or simplified IMPD for products not yet on the
- benefit /
- Summary of
Product Characteristics (SPC) for products already marketed and used in accordance
with the Marketing Authorisation (MA).
REQUIREMENTS for pharmacogenetic study/substudy:
- specific informed consent for collection of biological
material for genetic studies in the final version approved by the oSR EC;
- "Regulations for the use of biological material
for research and / or experimental" document signed up for acceptance by
the Head of the laboratory where samples will be stored and analyzed.
- Indicate title, first and last name and title
of the signing.
ADDITIONAL REQUIREMENTS FOR STUDIES WITH RADIATION:
Declaration if dose and administration are either
standard or please comment on the IRCP (International Commission on
Radiological Protection) principles and the instructions of the European
Commission (Radiation Protection 99 - Guidance on Medical Exposure in
Biomedical and medical research).
REQUIREMENTS FOF STUDIES WITH A MEDICAL DEVICE:
REQUIREMENTS for observational Studies:
- Commitment to notify the Ministry of Health. Before the start of clinical
trial, the Sponsor shall provide a declaration that no objections have been
received from the Ministry of Health within the 60 days required by law or
alternatively, a copy of the EC certificate of the medical device
- A copy of the Manual of Instructions and of all the documentation regarding the
Investigator's Brochure updated to include all the Guidelines followed for its
- risk analysis
regarding the vigilance of events and adverse conditions.
studies form completed and signed on headed paper (by the investigator if oSR
is the coordinating centre or by the investigator of the coordinating centre)
All documents must be sent
in hard copy (a single copy) and on CD-ROM.
The CD-Rom should also
- The list of all submitted
- A signed declaration
with a list of all submitted documents certifying that the documents on CD-ROM
are the same as the paper documents.
The documentation will be
considered complete and can therefore be submitted to the Ethics Committee only
upon delivery to the Clinical Research Office by the Principal Investigator of
the following documents downloaded from the oSR Intranet:
- “scheda tecnica”;
- 8 points summary of the protocol;
- declaration of conflict of interest signed by the
Principal Investigator and Co-Investigator;
- evaluation form of the study (if oSR is the
- form with specific costs about treatments / procedures
and standard procedures for dealing with additional sources of funding, details
of the supply of drugs, etc ... on the monitoring activities.