Clinical Trial Agreement Italy

contract research organisations, consultants and other professionals who may assist sponsors or healthcare organisations in the technical, clinical or legal aspects related to the conduct of clinical trials). Comments The clinical development of innovative medicines is essentially based on cooperation between pharmaceutical companies and healthcare organisations. The ATVs shall set the conditions for such cooperation in the interest of both parties. Although interbranch organisations may participate in the public consultation, the Italian pharmaceutical landscape includes companies that are not members of these associations, as well as service providers and professionals. It is important that their voices are heard. In such cases, pharmaceutical companies can provide financial assistance. Clinical trial participants should be provided with complete, thorough and clear information about the trial in order to assess the risks and benefits of their participation. The language must be relatively easy for a layman to understand and the subject must be given plenty of time to review the process and seek any necessary clarifications or assurances. As soon as a favourable opinion is available, the sponsor may apply for authorisation from the AIFA, the competent authority for the granting of authorisation for all clinical trials of phase I to IV medicinal products.

If the insurance policy provides for a deductible, it cannot be applied against the object of the test. The guidelines allow clinical trials to be conducted outside control centers if necessary to limit the risk of coronavirus infection. In this case, the sponsors must notify the competent ethics committee of a substantial change in the immediate implementation, which sets out the urgency of the situation. In addition, sponsors and DCS should develop a risk assessment plan and implement an action plan to minimise contact between patients and teaching staff and avoid overloading healthcare facilities. On 12 March 2020, the Italian Medicines Agency (AIFA) provided guidelines for the management of clinical trials in the event of a COVID 19 emergency. The guidelines for NGOs, sponsors and non-profit organisations involved in clinical trials provide for certain exceptions to help them deal with critical aspects. The guidelines are intended to ensure that activities related to clinical trials can continue despite the current situation. . .


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