As part of the overall mission to improve the efficiency and quality of the clinical trials conducted at RBHS, the RBHS Chancellor’s Office and NJACTS have invested in eReg, an electronic regulatory filing system.
What is eReg and what are its key benefits?
Advarra’s eReg is a web-based, 21CFR Part compliant and validated electronic regulatory filing system that is capable of fully replacing paper and wet-ink regulatory files.
What can eReg do for me and my studies?
- eFiling: View and manage all your studies’ regulatory files in one convenient location with customizable folders.
- Convenient file sharing: Documents you receive via email can easily be uploaded to eReg by forwarding the email to the study’s eReg email address, or by uploading the document directly into the system. Additionally, documents already in eReg can be pushed directly into OnCore to eliminate uploading documents multiple times.
- Institutional Documents: Easy access to University-wide, department-specific, and local partner hospital documents, such as SOPs, CLIA/CAP certifications, laboratory reference ranges, study staff licenses/certifications/CVs, etc.
- eSignatures: Effortlessly and quickly obtain 21CFR Part11 compliant staff/investigator e-signatures on essential documents such as training and delegation logs, protocol signature pages, investigator brochure acknowledgments, etc.
- Subject eBinders: Securely store subject source documentation with PHI (such as electronically signed consent forms or scanned consents) in subject-specific e-binders
- Monitor Access: Easily provide access to study documents for remote monitoring visits or for monitors to review independently while on site.
Should my study use eReg?
eReg is a very useful tool to file essential documents for any kind of clinical research, but eReg is most useful when used in combination with the OnCore Clinical Trial Management System. If your study exists in OnCore, we recommend also using eReg for your regulatory file management.
Should I have an eReg account?
If you are responsible for managing your study’s regulatory, IRB, or other essential documents, you should have an eReg account. Additionally, any investigator or study staff person who uses the electronic signature functionality within eReg must have an eReg account.
How do I get access to eReg?
A brief training module is required in order to access your account. To request training and an account, you can click this link.
Does eReg interface with any other systems?
Yes, eReg currently interfaces with OnCore and Advarra IRB, but Advarra and the CTO are in the process of exploring interfaces with Rutgers’ eIRB. If your study already exists in OnCore, the study record and the study staff list can be easily transferred over to eReg. Additionally, if your study uses Advarra IRB, all of the approved regulatory documents flow into eReg for filing without any additional work.
Can eReg help me if Rutgers is serving as a coordinating center for a for a multisite trial?
Yes! eReg has functionality designed to help a coordinating center file and track regulatory documentation for each site participating in the trial. Affiliate sites can be granted direct access to eReg for the purpose of uploading documents, though they cannot electronically sign their documents unless their institution has eReg as well.