This module, called eReg, is a part 11 compliant, online regulatory binder that is available to all faculty.
Because it is separate from OnCore and not part of the OnCore budget we have had to develop a cost associated
with its use. Any clinical trial that is industry initiated and funded that wants to use the eReg module has a one-time fee of $1000 for the life of the study. Investigator-initiated trials and federally funded studies do not have to pay for use of eReg.
Training is required and role-based, even for PIs.
Why use eReg? The advantages include remote monitoring of the regulatory documents by a sponsor for one, they even have their own role.
will be separate access request and separate training.
The eReg Access Request Form will populate required courses at the end of the form, so be sure to note your required training before you click submit!
Complete your training
Receive an email with your assigned training course(s) and instructions for accessing the training. Complete your training and pass your evaluation
Access granted to eReg
Accrual and IRB status must be kept up-to-date in OnCore.