Journal of Clinical Trials
Open Access

Department of Independent Quality Assurance Specialist, Italy

Publications

• Short Communication   
  Coronavirus Pandemic (COVID-19) -Clinical Trials Advice
  Author(s): Daniele Novara*
  
  There is currently an outbreak of respiratory disease caused by a novel coronavirus that was first detected in Wuhan City, Hubei Province, China, and that has now been detected in many locations internationally. COVID-19 pandemic may impact the conduct of clinical trials of medical products. Challenges may arise, for example, from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with COVID-19. These challenges may lead to difficulties in meeting protocol-specified procedures, including administering or using the investigational product or adhering to protocol-mandated visits and laboratory/diagnostic testing. Due to the Coronavirus situation most of European Regulatory Authority (Italy, Spain, UK, Finland, Denmark, etc.) and FDA provided some ad.. View More»
  DOI: 10.35248/2167-0870.20.10.407

  Abstract HTML PDF