Why Your eTMF Needs Role-Based Access

Regulators, investors, and other parties will ask clinical and medical affairs teams questions about their electronic trial master file. These questions can range from inquiries about who has eTMF access to key documents to asking what changes were made to a document (and by whom) and what efforts are being taken to keep unauthorized parties from seeing certain documents.

 Every team needs to know the answers — and they need to be able to provide evidence of the answers on demand, too. Role-based access control, or RBAC, assigns every software user a role. Each role has permission to access certain documents, applications, or other tools on the software platform. When a user logs in, their assigned role controls what they can see and do.

Discover how RBAC can offer a way for clinical teams to answer the tough questions from regulators, investors, and other parties promptly and efficiently.