18. Appendix

Terms	Explaination
Clinical trial/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 an Visit
Schedule Visit	Schedule when subject come to visit
Enter Data	Entry data to CRF
Sign data	you provide your approval for data which entered
Verify data	When you review the conformity of data in CRFs, you can use "verify" function to track your evaluations, helping to ensure the Study is complete, accurate, and verifiable.
Lock data	After signing, user have to lock data to prevent from editing, signing, verifying ,etc...to data. Only view data when locking
Freeze	After completing to enter data, user freeze data to prevent editing data.
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	Check entered data is correct or incorrect with rule
Rule	You can create Rules to perform advanced validation for Study data. For example, "Tem" filed has value from 35.5-42
DN (Discrepancy Note)	provides a means for users to document, communicate, and manage issues about data in a clinical trial