Part 11 data management guidance

A Randomized Unblinded Feasibility Study Evaluating the Use of Oral Administration of MB-102 versus Dual Sugar Testing for Gut Permeability in Normal Subjects and Subjects with Active Small Bowel Crohn’s Disease

PI: Dr. Lori Holtz, Department of Pediatrics

This is a single center, industry funded clinical trial involving CFR 21 Part 11 compliant data management. The Trial-CARE Part 11 Services team built the electronic data capture system using the content management system REDCap Cloud and provided the study team with an infrastructure of standard operating procedures (SOPs) and a validation package to achieve compliance to CFR 21 Part 11 and an approved WU FDA Part 11 Security Plan.