ICH GCP E6(R1) Flashcards


Set Details Share
created 9 years ago by felicia_l_frank_7
1,102 views
Guideline for Good Clinical Practice E6 (R1)
Subjects:
research
show moreless
Page to share:
Embed this setcancel
COPY
code changes based on your size selection
Size:
X
Show:

1

Audit

A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activites were conducted, and the data recorded, analyzed, and accuratedly reported according to ther procol, sponsor's standard operating procedures, GCP, and the applicable regulator requirement(s).

2

Audit certificate

A declaration of confirmation by the auditor that an audit has taken place.

3

Audit Report

A written evaluation by the sponsor's auditor of the results of the audit.

4

Audit Trail

Documentation that allows reconstruction of the course of events.

5

Blinding/Masking

A procedure in which one or more parties to the trial are kept unaware of the treatment assignments.

6

Single blinding

Usually refers to the subjects being unaware of their treatment assignment.

7

Double blinding

Usually refers to the subject's investigators, monitors, and in some cases data analysts being unaware of the treatment assignment.

8

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.