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 |