Monitoring, Close-out visits and

Archiving
• According to the Guidelines for GCP,
monitoring is “the act of overseeing the
progress of a clinical trial, and of ensuring that
it is conducted, recorded, and reported in
accordance with the protocol, Standard
Operating Procedures (SOPs), Good Clinical
Practice (GCP), and the applicable regulatory
requirement(s)” (in the country where the
trial will be conducted).
• It is the Sponsor’s responsibility to ensure that
all trials are monitored according to ICH-GCP
• Onsite monitoring vs centralized monitoring
• Depends upon design, objective, complexity,
size, blinding, risk, and endpoints of the trial.
• Purpose of the monitor
• Responsibility of the monitor
• Preparing for the visits: Site initiation visit,
visit before first dose, subsequent visits.
 Close out meeting
• Ensure that the Site delegation log is completed
and signed off by the Principal Investigator.
• Arrange the return of all study-related equipment,
wherever necessary.
• Confirm or arrange for the destruction or return of
investigative medicinal product.
• Ensure that all biological samples have been
shipped to the analytical laboratories or destroyed.
• Advise about archiving.
 Archiving
• According to ICH-GCP, research records must
be kept for a minimum of 2 years following the
approval of the last marketing application.
• Ensure adequate space and safety.
• Keeping documents at trial sites is required in
some instances.
• Sponsor shall notify about when to destroy
the documents.
 Audits and Inspection
• Audit is a “systematic and independent
examination of trial related activities and
documents to determine whether the
evaluated trial related activities were
conducted, and the data were recorded,
analysed and accurately reported according to
the protocol, sponsor’s SOPs, GCP, and the
applicable regulatory requirements.”
• Inspection as “An act by a Competent Authority
of conducting an official review of documents,
facilities, records and other resources that are
deemed by the competent authority to be
related to the clinical trial and that may be
located at the trial site, at the sponsor and/or
contract research organization's facilities or at
other establishments deemed appropriate by
the Regulatory Authority.”
• The format of findings is different depending
on the Regulatory Body/ Auditor and which
country they are from.