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
Recently, a clinical site received a call from an inspector on a Thursday notifying the site of a not-for-cause inspection the following Monday. This was a short gap of time between the notification and actual audit conduct. How can sites make sure they are ready if an inspector calls today?
Topics: BIMO, Auditing, Inspection Ready, Sites