Many sponsors in the medical device research industry are challenged with the decision between having a remote or on-site initiation visit. An initiation visit is imperative to the overall success of a study as many tasks are accomplished during these visits.
Topics: 21 CFR 812.110, Site Initiation Visits, 21 CRF 50
According to 21 CFR 812.110 an Investigator is responsible for conducting an investigation in accordance with the signed agreement with the sponsor, the investigational plan, this part and other applicable FDA regulations, and any conditions of approval imposed by an IRB or FDA.
Topics: 21 CFR 812.110, Electronic Regulatory Compliance, Clinical Monitoring
