REQUESTED DOCUMENTS FOR A CLINICAL PHARMACOLOGICAL STUDY
For 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.

Specific and detailed information on the documents to be submitted are the following:
  1. Letter of intent or invitation to participate signed by Sponsor / CRO, headed as above, including:
    • 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);
    • phase;
    • study design;
    • any use of non-centralized or centralized laboratories;
    • monitoring;
    • vigilance;
    • name of the coordinating centre if multi-centre trial;
    • 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;
    • list of all documents.
  2. If a CRO is involved: Promoter's letter delegating the CRO and a detailed list of the delegated activities.
  3. Informed 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.
  4. Letter to the family doctor (in Italian).
  5. Patient’s diary and / or identification card and / or questionnaire if needed.
  6. Study protocol, signed and dated by the Promoter.
  7. Synopsis of the protocol in Italian.
  8. Case Report Forms.
  9. List of participating centres.
  10. List of Competent Authorities (if oSR is the coordinating centre).
  11. Curriculum vitae of the Principal Investigator and Co-Investigator.
  12. A copy of the single opinion of the EC of the coordinating centre.
  13. Draft Convention on oSR model. The draft agreement must be pre-compiled.
    (Contact the Clinical Research Office for the template)
  14. Copy of the bank transfer receipt for the payment of the fee for the Protocol submission to Ethical Committee.
  15. Copy of insurance certificate with the following points highlighted:
    • the period of validity;
    • ceilings;
    • presence or absence of the unenforceability relief to injured third parties;
    • the term of validity of the extension;
    • right of withdrawal;
    • list of exclusions.
  16. Other studies with the same IMP (if oSR is the coordinating centre).
  17. TSE declaration (if oSR is the coordinating centre).
  18. All documents referred to the study drug characteristics (if oSR is the coordinating centre).
  19. EMA Guidelines reference if present in the protocol, if oSR is the coordinating centre.
  20. Copy of the single opinion released by the coordinating centre.
  21. "Application for authorization to the competent authorities (Form CTA) for a clinical trial on a medicinal product for human use.
  22. Cover page containing the number of Eudra-CT, printed by the Centre;
Regarding the investigational product:
  • Investigator's Brochure for products not yet on the market;
  • full (if oSR is the coordinating centre) or simplified IMPD for products not yet on the market;
  • benefit / risk assessment
  • Summary of Product Characteristics (SPC) for products already marketed and used in accordance with the Marketing Authorisation (MA).

ADDITIONAL 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).

ADDITIONAL REQUIREMENTS  FOF STUDIES WITH A MEDICAL DEVICE:

  • 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 device
  • Clinical Investigator's Brochure updated to include all the Guidelines followed for its finalization.
  • risk analysis
  • Statement regarding the vigilance of events and adverse conditions.
ADDITIONAL REQUIREMENTS  for observational Studies:

Observational 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 contain:
  • The list of all submitted documents
  • 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:
  • “frontespizio”;
  • “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 coordinating centre);
  • 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.