Sponsor monitoring in clinical research refers to the oversight and supervision conducted by the sponsor or sponsor's representative throughout the course of a clinical trial. The purpose of sponsor monitoring is to ensure the rights, safety, and well-being of study participants, as well as the quality and integrity of the trial data. Here are some key aspects and considerations related to sponsor monitoring in clinical research

1. Clinosol Research Pvt.Ltd
Education & Research centre
Presented by:
Dr.Sandhya(BDS) Hema Durgasi(Pharm D) Shahzad Mustaqeem(pharm D)

2. SPONSOR DEFINITION
MONITORING DEFINITION
FREQUENCY OF
MONITORING
TYPES OF MONITORING
MONITORING PURPOSE
SELECTION &
QUALIFICATION OF
MONITORS
EXTENT & NATURE OF
MONITORING
MONITORING PLAN
MONITORING PROCEDURE
MONITORING REPORT
CONTENT

3. Who is a Sponsor
An individual/ institution/ company/
organisation (e.g. Contract Research
Organisation) that takes responsibility to
initiate, manage or finance the clinical trial,
but doesn’t actually conduct the
investigation.

4. What is Monitoring?
The act of overseeing
the progress of a
clinical trial and of
ensuring that is
conducted, recorded
and supported in
accordance with the
protocol, Sop’s, GCP
and any regulatory
requirement.
The Monitor is the main
communication between
the sponsor and the
investigator.
It is a part of Quality
control.

5. Frequency of Monitoring
ICH states that the sponsor
should ensure trial are
adequately monitored
before, during and after the
study.
Frequency of Monitoring depends on:-
Complexity of study
Rate of Enrollment
 GCP compliance issue

6. Types of Monitoring
Coordinating Centre/ Day
to Day Monitoring
Central Monitoring
Onsite Monitoring

7. Coordinating Centre/ Day to Day Monitoring
 Data collected are consistent with protocol.
Case report forms are being completed by authorized staff.
No key data is missing.
Review of recruitment rate, withdrawals and losses.
Data appears to be valid.

8. Central Monitoring
Remote evaluation of accumulating data, performed in timely
manner, supported by appropriate qualified and trained person
(e.g. data manager and Biostatician)
Determination of key eligibility criteria through collection
 Consent Form
 Scans
 Pathology Reports

9. Central MonitoringCont.
Centralized monitoring process provide additional monitoring
capabilities that can compliment and reduce the extent/ frequency
of on site monitoring and help distinguish between reliable data
and potentially unreliable data.
Identify missing data, inconsistent data, data outliers, unexpected
data within and across sites.
Select site / process for targeted on site monitoring.

10. Onsite Monitoring
 Performed at the sites at which the Clinical trial
 Staff Training
 Confirm Pharmacy and Lab resources in places
 Adherence to protocol and GCP
 Check Medical Records

11. Monitoring -Purpose
To verify

12. Selection and Qualification of Monitors

13. Extent and Nature of Monitoring
 objective
 purpose design
 complexity
 blinding
 size
 endpoints of the trial

14. Extent and Nature…

15. MONITORING PLAN
The sponsor should develop a monitoring plan that
is tailored to the specific human subject protection &
data integrity risks of the trial.
The plan should describe the monitoring strategy,
the monitoring responsibilities of all the parties
involved, the various monitoring methods to be
used & the rationale for their use.
 It should also emphasize the monitoring of critical
data & processes.
 Particular attention should be given to those aspects that
are not routine clinical practice & that requires additional
training.
 The plan should reference the applicable policies &
procedures

16. MONITORING
PROCEDURE
The monitor should follow the Sponsor’s
established written SOP’S (standard
operating procedure) as well as those
procedures that are specified by the
sponsor for monitoring a specific trial.

17.  The monitor should submit a written report to the
sponsor after each trial- site visit (or) trial related
communication. According to the sponsor’s SOP’S.
 Reports should include the
i. Date
ii. Site
iii. Name of the Monitor
iv. Name of the investigator / other individual contacted
during study.
 Reports should include a summary of what the monitor
reviewed and the monitor’s statements concerning the
significance findings/ facts, deviations & deficiencies,
conclusions, actions taken or to be taken and actions
recommended to secure compliance.
 The review & follow up of the monitoring report with the
sponsor should be documented by the sponsor’s
designated representative.
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18. REFERENC
E
https://www.ich.org/sites/E6_R2_Integrated
Addendum to ICH_pdf