Definitions/Acronyms

Term Definition/Description
TP TransPerfect
TI Trial Interactive
eTMF Electronic Trial Master File
CTMS Clinical Trial Management System
CCR CTMS Collaborate Room
mitis Trial Interactive’s mobile application
Collaborate Trial Interactive’s Document Management Solution
21 CFR Part 11 Part 11 of Title 21 of the United States Code of Federal Regulations
ERES Use of Electronic Records and Electronic Signatures in Clinical Investigations
GDPR General Data Protection Regulation
Gape A general reference to good practices, whether they be related to Document, Clinical, Manufacturing, etc.
UI User Interface
EDC Electronic Data Capture
Is Interactive Voice/Web Response System
ICFs Informed Consent Forms
UI User Interface
AP Activity Plan
APT Activity Plan Template
IAM Identity and Access Management