Terms | Explaination |
---|---|
Study/Clinical trial | 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 |
Manage space
Manage content
Integrations