Versions Compared

Old Version 4

changes.mady.by.user Thao Ngo Thi

Saved on

compared with

New Version Current

changes.mady.by.user Viet Anh Mai Thach

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.


TermsExplaination
Clinical trial/
Study
Clinical studyAny 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.
SiteThe location(s) where trial-related activities are actually conducted.
SubjectAn individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.
Visit
a Study Visit
A study visit has a type, date(s), status, and a package of Case Report Forms (CRFs) associated with it. A
Study Visit
study visit is also referred to as
an
a Visit
Schedule VisitSchedule a date when the subject
come
comes to visit
Enter Data
Entry data to CRF
Data entry onto CRFs
Sign
data
Data
you provide your approval for data which entered
Provide approval of entered data
Verify
data
DataWhen you review the conformity of data in CRFs, you can use
"verify"
the Verify function to track your evaluations, helping to ensure the Study is complete, accurate, and verifiable.
Lock
data
DataAfter signing,
user have to
can lock data to prevent
from
editing, signing, verifying,
etc
... to data.
Only view data when locking
Data can only be viewed after locking.
FreezeAfter completing
to enter
entering data,
user
you can freeze data to prevent data 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
To check whether the entered data is correct or incorrect
with rule
compared to Rules
RuleYou can create Rules to perform advanced validation for Study data.
For example, "Tem" filed has value from 35.5-42
 
DN (Discrepancy Note)
provides
Provides a means for users to document, communicate, and manage data issues
about data
in a clinical trial