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Clinical trials of human medicinal products

A Clinical Trial is a study on humans designed to discover or verify the clinical, pharmacological and pharmacodynamic effects and safety of one or more medicinal products, in order to identify the benefits and any possible adverse reactions.

The authorization procedure to start a clinical trial on medicinal products involves the assessment – by the Competent Authority and Ethics Committees involved – of all documentation relating to clinical trials that are to be conducted.

In particular, the Clinical Protocol, the Investigational Medicinal Product Dossier (IMPD), the informed consent and documentation intended for patients, the insurance policy, manufacturing site authorisations and any agreements with clinical sites are all carefully assessed, in order to provide public assurance regarding the feasibility and the scientific and ethical aspects of the clinical trial.

Regulation (EU) no. 536/2014 on clinical trials, as amended, has provided for the introduction of a centralised European information system on clinical trials (CTIS) as well as a EU database, that is a more transparent system on the availability of clinical trials information, new regulations on the acquisition of the informed consent, and possible co-sponsorships. The CTIS will become operative on 31 January 2022.

In Italy, a particularly important role in the management of domestic processes is held by the National Observatory on Clinical Trials (OsSC), a monitoring body whose activities are required for all authorisation procedures of interventional trials.

Di Renzo Regulatory Affairs has a special unit dedicated to clinical trials of human medicinal products, and can assist companies in all regulatory activities carrying out the following:

  • regulatory consultancy and assistance for the authorisation of interventional and observational clinical trials
  • review of documentation to be submitted to the competent authority and the Ethics Committees
  • contacts with Ethics Committees
  • data entry into the OsSC and the National Register for Observational Studies
  • translation of the dossier, clinical protocols, informed consent and other documents to be included in the Clinical Trial Application (CTA).