19. Appendix

Terms	Explaination
Clinical trial/ Clinical study	Any investigation using human subjects that is intended to discover or verify the clinical, pharmacological, and/or other pharmacodynamic effects of an investigational product(s); and/or to identify any adverse reactions to an investigational product(s); and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) for the purpose of ascertaining its safety and/or efficacy. The terms “clinical trial” and “clinical study” are synonymous.
Site	The location(s) where trial-related activities are actually conducted.
Subject	An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.
Visit	A study visit has a type, date(s), status, and a package of Case Report Forms (CRFs) associated with it. A study visit is also referred to as a Visit
Schedule Visit	Schedule a date when the subject comes to visit
Enter Data	Data entry onto CRFs
Sign Data	Provide approval of entered data
Verify Data	When you review the conformity of data in CRFs, you can use the Verify function to track your evaluations, helping to ensure the Study is complete, accurate, and verifiable.
Lock Data	After signing, can lock data to prevent editing, signing, verifying,... to data. Data can only be viewed after locking.
Freeze	After completing entering data, you can freeze data to prevent data editing.
CRF (Case Report Form)	A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject.
Edit Check	To check whether the entered data is correct or incorrect compared to Rules
Rule	You can create Rules to perform advanced validation for Study data.
DN (Discrepancy Note)	Provides a means for users to document, communicate, and manage data issues in a clinical trial