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Providers who provide clinical trial services may experience problems affecting their operations. B such as increasing the cost of equipment or labour or reducing available staff or contractors. In accordance with the directive, the evaluation of clinical trail agreements between the promoter and the examiner by medical research ethics committees is mandatory. This assessment will be included in the evaluation of the ethics committee`s research file. The Ethics Committee cannot approve a proposed clinical trial if the agreement does not comply with the CCMO Directive. The CCMO found that, in many clinical trial agreements, the provisions relating to premature termination and publication of the results of the study were not in the interests of subjects and/or science. A court ruling would require the public publication of a decade of clinical outcomes excluded from the HHS regulation in Italy, and the Italian Medicines Agency (AIFA) has published guidelines containing various requirements and recommendations for further clinical studies, taking into account travel restrictions imposed by COVID-19 in the country. Among other things: study-holders must have hematological analyses performed in public facilities near patients` homes; Clinical trials involving publicly accessible test sites should be suspended or transferred to the nearest experimental facility; Sponsors can reimburse patients for the additional costs directly due to the emergency; and sponsors can provide the test drugs directly to patients and not to the hospital pharmacy. For more information, check out our separate customer alert here.

SOEs working on bids to the U.S. Securities Exchange Commission (SEC) may wish to include a discussion on COVID-19 and the potential for disruption to clinical development programs, clinical and commercial care or other risks that may affect their operations. Study sites may face a variety of obstacles related to the COVID 19 pandemic, including strained resources, reduced study staff and rapid changes in internal policies and procedures to combat the spread of the virus.