Y
 


±What preparation is required before

the visit?

- Chetan Patel
11 October 2010
 Y
 
 `

{he act of overseeing
© progress of a clinical trial and
© ensuring that it is conducted, recorded, and
reported in accordance with
Protocol
Standard Operating Procedures (SOPs),
Good Clinical Practice (GCP), and
Applicable regulatory requirement(s).

- ICH GCP Guidelines E6 (1.38)

11 October 2010
 Y
 
` 


© {he rights and well-being of human subjects
are protected.
© {he reported trial data are accurate, complete,
and verifiable from source documents.
© {he conduct of the trial is in compliance with
Currently approved Protocol/Amendment(s),
GCP, and
Applicable regulatory requirement(s).

- ICH GCP Guidelines E6 (5.18.1)

11 October 2010
 
Y
 
 
A. Before the visit

B. During the visit

C. After the visit

11 October 2010
 M
 
© Y
    
Appropriately trained
Have scientific and/or clinical knowledge needed
to monitor the trial adequately.
© Y
     
Investigational Medicinal Product (IMP)
Protocol
Informed Consent Form
Any other written information to be provided to
‡ Subject
‡ Sponsors SOPs
‡ GCP &
‡ Applicable Regulatory Requirement
11 October 2010
 M
 
© Schedule a visit with the Investigator and study
site personnel.

© Send a confirmation letter to the site informing

about the monitoring visit.

© {he letter must specify the details about what

aspects would be monitored e.g. ICFs, Source
Documents, CRFs, IMP storage/accountability,
Subject logs, etc.

11 October 2010
á



© Purpose of the visit (Monitoring Plan)

© {ravel Plan

11 October 2010
 Site SelectionVisit

Study Site
Y Initiation
Close-out
 Visit
Visit

Interim Monitoring Visit

11 October 2010
@
 

Plan, focus and execute the plan.

Do it right, the first time.

11 October 2010
11 October 2010