Electronic Trial Master File (eTMF)

Electronic Trial Master File (eTMF) The Trial Master File is a structured set of files used by sponsors and CROs to demonstrate proof of regulatory and ethical requirements for conducting clinical trials. It includes documentation of the following items:* Regulatory...

Electronic Submissions Gateway (ESG)

Electronic Submissions Gateway (ESG) The Food and Drug Administra­tion’s Electronic Submissions Gateway (the ESG) is an agency-wide solution for accepting regulatory submissions from regulated entities. It allows companies to securely submit their premarket and...