Monday, July 18, 2016
The Pulse on Study Conduct by Elizabeth Weeks-Rowe
The monitoring visit report serves a spectrum of integral purposes specific to each monitoring visit type. It is the medium by which all findings identified at monitoring visits, and the status of findings from previous monitoring visits, are documented. It provides conceptual proof of training delivery for initiation visit conduct, and a logistical, clinical and developmental summary recommendation of the investigational site following the pre-study assessment. The closeout visit report signifies closure of investigational sites with submission and signature. The monitoring visit report is the full confirmation of monitoring processes at investigational sites.