What is an eRegulatory binder?
Every research site keeps a regulatory binder, also called an investigator site file, holding the essential documents for a study. An eRegulatory binder keeps those documents electronically, so staff can find the current version and monitors can review them without a stack of paper.
What is a delegation log?
A delegation log records which study tasks the principal investigator has assigned to each staff member. Keeping it next to staff credentials and training makes gaps easier to spot before a monitoring visit.
Monitor access
Monitors get a read-only portal for reviewing documents, with their source data verification recorded in an SDV trail. Downloads are blocked for monitor roles on the server.