Monitoring On-going process usually directed by management to ensure processes are working as intended. Auditing A formal, systematic, and disciplined approach designed to evaluate and improve the effectiveness of processes and related controls. Assures quality of trails. Auditing is governed by professional standards, completed by individuals independent of the process being audited, and normally performed by individuals with one of several acknowledged certifications. Objectivity in governance reporting is the benefit of independence

1. Welcome
Difference between Monitoring and Auditing
Dr. Gyansudha Gawali
ClinoSol Reasearch
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2. Definitions
• Monitoring
• On-going process usually directed
by management to ensure
processes are working as intended.
• Controls quality trails.
• Done by sponsor.
• Appointed by monitor who is in
trail.
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• Auditing
• A formal, systematic, and disciplined
approach designed to evaluate and
improve the effectiveness of processes
and related controls.
• Assures quality of trails.
• Auditing is governed by professional
standards, completed by individuals
independent of the process being
audited, and normally performed by
individuals with one of several
acknowledged certifications.
• Objectivity in governance reporting is
the benefit of independence

3. Selection and Qualification
• Monitoring
1. Appointed by sponsors
2. They are trained, scientific and
clinical knowledge
3. Qualification Documented.
4. Familiar with investigational
procedure, protocol, written
informed consent form and any
other written information to be
provided to subjects the sponsors
SOP, GCP and applicable
regulatory requirements.
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• Auditing
1. Sponsors should appoint
individuals who are independent
of clinical trials to conduct audits
2. Qualified by training and
experience to conduct audits.
3. Qualification should be
documented.

4. Who is the clinical trial Monitor?
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In most cases, the monitor is also called a Clinical Research Associate, but in some
cases, the monitor is a physician or doctoral-level scientist at the company.
Doctoral-level staff is more likely to be in charge of writing the protocol and
performing a host of other functions in addition to monitoring activities at the site itself.
An experienced MD or PhD will usually discuss more detailed medical-related issues
with the site investigator than will a Clinical Research Associate, who is generally a
bachelors- or masters-level professional.
What is Monitoring?
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
requirements(ICH GCP.

5. Remote monitoring versus on-site monitoring
• Remote monitoring
1. Although there was a period a
couple of decades ago when some
believed that monitoring could be
almost entirely conducted
remotely by telephone, fax, and
e-mail, this is no longer believed
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• On-site monitoring
1.Treatment INDs have a large
number of investigators, and it may
not be possible to visit each site,
and thus, almost all monitoring
may have to be done by telephone,
fax, and electronic means.
2. This also applies to some Phase 4
active surveillance-type trials. In
each of these cases, only high-
enrolling sites may be monitored,
or only a random selection of sites
may be monitored.
3. Controlled clinical trials (as
opposed to surveillance-type trials)
conducted during Phase 4

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3.Controlled clinical trials (as opposed
to surveillance-type trials) conducted
during Phase 4.
Remote monitoring On-site monitoring
2. It is an important principle that this
approach to monitoring will almost
certainly lead to many surprises
when the site is actually visited.
3.To avoid being misled about a
trial’s true status and to ensure the
trial staff are conducting it according
to the protocol, it is essential to
conduct on-site monitoring visits
on a periodic basis

7. Monitoring activities that are conducted in-house
1. Tracking regulatory document revisions
2. Writing trip reports
3. Writing follow-up letters based on the last monitoring visit
4. Providing the site with a list of queries to be addressed if they
were not provided on-site
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IF M0NITERING IS DONE WELL, WHY AUDIT?
• Objectivity- Auditor is not part of the study team.
• Audit is more process focused.
• Audit -Overview -Looking at the forest versus the tree!
• Audit -Can assess the effectiveness of monitoring.
• Monitoring may trigger an audit – systemic problem.
•Audit can support the monitor in getting compliance from unresponsive sites.
•Audit can support study site in preparing for regulatory inspection.

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WHY IS CLINICAL AUDIT
IMPORTANT?
Clinical Audit provides the
framework to improve the
quality of patient care in a
collaborative and systematic
way.
When clinical audit is conducted
well it enables the quality of
care to be reviewed objectively
within an approach which is
supportive, developmental and
focused on improvement.

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WHAT IS THE AUDIT CYCLE?
The Audit Cycle demonstrates the
steps involved in a complete audit.
When a clinical audit reveals the
need for improvements to a service
it is important that a re-audit takes
place following implementation of
changes. Sometimes it will take
several re-audits to improve a
service and “close the loop”.

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Monitor's Report:
Monitor should submit a written report to sponsor after each trail site visit or trial
related communication.
Report includes date, site name of monitor and name of investigator or individual
contacted.
Include summary of what monitor reviewed and monitors statements concerning the
significant findings, deviation, deficiencies, conclusion, actions taken or to be taken
and actions recommended to secure compliance.
Monitors should follow the sponsors established written SOPs as well as
those procedures that are specified by the sponsors for monitoring a specific
trial
Monitoring procedures:

13. Who should be involved in Clinical Audit?
• Everyone who is involved in the care a patient receives and anyone who might be
affected by the results, such as those who might be asked to change practice.
• If the audit has implications on professionals or disciplines in other areas, these
should be consulted at the planning stages. .
• New Principles of Best Practice in Clinical Audit. Furthermore it is important
that clinical audit is supported by those who have the authority and commitment
to see changes put into practice.
• It is now recognized that services cannot be improved unless patients are
involved.
•
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14. Cont…
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It is a requirement, based in legislation, that the NHS has a duty to involve patients and
that Patient and Public Involvement is embedded in core business.
Some areas of the NHS are better than others in involving patients and their
representatives.
Until recently Clinical Audit has been the sole domain of clinicians and other health
professionals.

15. Thank You!
www.clinosol.com
(India | Canada)
9121151622/623/624
info@clinosol.com
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