Everyone must attend eReg training and pass the eReg training certification program to gain access
The eReg module is a part 11 compliant, online regulatory binder available to all faculty. Training is required and role-based, even for PIs.
Because it is separate from OnCore and not part of the OnCore budget, eReg comes with a cost. Any industry-initiated and funded clinical trial that wants to use the eReg module must pay a $1,000 fee good for the life of the study. (Investigator-initiated trials and federally funded studies do not have to pay for use of eReg.)
Why use eReg? Advantages include remote monitoring of the regulatory documents by a sponsor for one; they even have their own role (requires separate access request and separate training). Note: While CHCO leadership is reviewing the system, CHCO study teams are not permitted to utilize the eReg system.