You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
As monitors we spend a significant amount of time reviewing the essential documents at the site during a monitoring visit. The essential documents are usually housed in a Regulatory Binder or sometimes they are referred to as an Investigator Binder.
Topics: Monitor, Regulatory Binder, Essential Documents, Sites
As monitors we spend a significant amount of time reviewing the essential clinical investigation documents at the site during a monitoring visit. These ‘essential documents’ are usually housed in a Regulatory Binder or sometimes they are referred to as an Investigator File.
Topics: Essential Documents, Monitoring Visit, IRB
As monitors we spend a significant amount of time reviewing the Investigator File and the essential documents filed with in it at a site visit. There are many things we look for; here are just a few:
Topics: Wet Ink Version, Investigator File, Essential Documents