An assignment on Monitoring Of Clinical Trial on the topic " "Write down the factors that determine the strategy of monitoring ".

1. “MONITORING OF
CLINICAL TRIALS
ASSIGNMENT”
TOPIC- “ Write About The Factors That Determine The strategy Of
Monitoring “

2. “FIRST, WHAT IS
MONITORING
EXACTLY”?? :)
Clinical monitoring is the oversight and administrative efforts that monitor a participant's health
and efficacy of the treatment during a clinical trial.

3. EXTENT AND NATURE OF
MONITORING:-
The sponsor should ensure that the trials are adequately
monitored. The sponsor should determine the appropriate
extent and nature of monitoring. The determination of the
extent and nature of monitoring should be based on
considerations such as the objective, purpose, design,
complexity, blinding, size, an endpoints of the trial.

5. DURATION,CONDUCT
MONITORING:-
In general there is a need for on-site monitoring, before,
during, and after the trial; however in exceptional
circumstances the sponsor determine that central monitoring
in conjunction with investigators’ training and meetings, and
extensive written guidance can assure appropriate conduct of
the trial in accordance with GCP.

8. Identify Critical Data and
Processes to be Monitored
Sponsors should prospectively identify critical data and processes
that if inaccurate, not performed, or performed incorrectly, would
threaten the protection of human subjects or the integrity of the study
results.
As examples, the following types of data and processes should
ordinarily be identified as critical:
• Verification that informed consent was obtained appropriately

9. Adherence to protocol eligibility criteria designed to exclude
individuals for whom the investigational product may be less safe than
the protocol intended and to include only subjects from the targeted
study population for whom the test article is most appropriate •
Procedures for documenting appropriate accountability and
administration of the investigational product (e.g., ensuring the
integrity of randomization at the site level, where appropriate) •

11. FACTORS TO CONSIDER WHEN DEVELOPING A MONITORING PLAN :-
A monitoring plan ordinarily should focus on
preventing or mitigating important and likely risks,
identified by the risk assessment, to critical data and
processes.
The types (e.g., on-site, centralized), frequency (e.g., early, for
initial assessment and training versus throughout the
study), and extent (comprehensive (100% data verification)
versus targeted or random review of certain data (less than
100% data verification) of monitoring activities will depend to
some degree on a range of factors, considered during the

13. 1) Complexity of the study design :-
More intensive monitoring (e.g., increased frequency and
extent of review) may be necessary as study design
complexity increases. Examples may include studies with
adaptive designs, stratified designs or complex dose
titrations
2) Types of study endpoints -
Endpoints that are more interpretative or subjective
may require on-site visits to assess the totality of
subject records and to review application of protocol

14. More objective endpoints (e.g., death, hospitalization, or clinical
laboratory values and standard measurements) may be more
suitable for remote verification.
Endpoints for which inappropriate subject withdrawal or lack
of follow-up may impede study evaluation are likely to need
more intensive monitoring to identify the reason(s) subjects
are withdrawing and to determine whether follow-up can be
improved.
3) Clinical complexity of the study population - A study that involves a
population that is seriously ill or vulnerable may require more
intensive monitoring and consideration of on-site monitoring
visits to be sure appropriate protection is being provided.

15. Relative experience of the CI and of the sponsor with
the CI
CIs who lack significant experience in conducting and overseeing
investigations, using a novel or innovative medical device, or with the
surgical procedure associated with medical device use may benefit
from more intensive monitoring and frequent communication to
ensure CI understanding of responsibilities.
In addition, the relative experience of a sponsor with the CI may be a
factor in determining an appropriate monitoring plan.

16. Aspects of monitoring:-
1) Failure to follow investigation protocol (the procedures and
treatment subjects must undergo,
as well as the schedule of assessments)
1) Failure to keep adequate and accurate records
2) Problems with the informed consent form
3) Failure to report adverse events
4) Failure to account for the disposition of study drugs

17. Factors that determine the strategy of
monitoring:-
1)BACKGROUND :-it is a critical element of the planning process which enables
stakeholders to get feedback about performance and monitors strategy
implementation.
2) Research Methodology :-The study involves the case study research design
because it develops analytic and problem solving skills allows for exploration of
solutions for complex issues and allows the researcher to apply new knowledge and
skills

18. Monitoring plan :-
For each clinical trial, the sponsor should develop a monitoring plan that
describes the monitoring methods, responsibilities, and requirements for
the trial.
The monitoring plan should include a brief description of the study, its
objectives, and the critical data and study procedures, with particular
attention to data and procedures that are unusual in relation to
clinical routine and require training of study site staff.
The plan should also communicate the specific risks to be addressed
by monitoring and should provide those involved in monitoring with
adequate information to effectively carry out their duties.

20. The components of a monitoring plan might
include the following :-
1. Description of Monitoring Approaches - A description of each
monitoring method to be employed during the study and how it will
be used to address important risks and ensure the validity of critical
data.
2. Communication of Monitoring Results • Format, content, timing, and
archiving requirements for reports and other documentation of
monitoring activities
3. Management of Noncompliance
4. Ensuring Quality Monitoring
5. Monitoring Plan Amendments

21. DOCUMENTING MONITORING ACTIVITIES:-
Documentation of monitoring activities should generally include the
following :
• The date of the activity and the individual(s) conducting and
participating in it
• A summary of the data or activities reviewed
• A description of any noncompliance, potential noncompliance, data
irregularities, or other deficiencies identified
• A description of any actions taken, to be taken, or recommended,
including the person responsible for completing actions and the
anticipated date of completion

22. A fundamental component of ensuring quality
monitoring is a sponsor’s compliance with
monitoring plans and any accompanying
procedures.
1) Protocol and Case Report Form Design
2).Clinical Investigator Training and Communication
3). Delegation of Monitoring Responsibilities to a CRO
4). Clinical Investigator and Site Selection and
Initiation

23. MONITORING REPORT :-)
(a) The monitor should submit a written report to the sponsor
after each trial-site visit or trial-related communication.
(b) Reports should include the date, site, name of the monitor, and
name of the investigator or other individual(s) contacted.
(c) Reports should include a summary of what the monitor reviewed
and the monitor’s statements concerning the significant
findings/facts, deviations and conclusions, actions taken or to be
taken and/or actions recommended to secure compliance.
(d) The review and follow-up of the monitoring report with the
sponsor should be documented by the sponsor’s designated

24. MONITORING REPORT :-
(a) The monitor should submit a written report to the sponsor
after each trial-site visit or trial-related communication.
(b) Reports should include the date, site, name of the monitor, and
name of the investigator or other individual(s) contacted.
(c) Reports should include a summary of what the monitor reviewed
and the monitor’s statements concerning the significant
findings/facts, deviations and conclusions, actions taken or to be
taken and/or actions recommended to secure compliance.
(d) The review and follow-up of the monitoring report with the
sponsor should be documented by the sponsor’s designated
representative.

26. REFERENCES:-)https://en.wikipedia.org/wiki/Monitoring_in_clinical_trialshttps://pdfs.semanticscholar.org/c901/00ee816e07c1ede4c78ac6f284e01d9094
9d.pdf
https://www.google.com/search?q=Factors+that+affect+the+strategy+of+clinical+trial+monitoring&tbm=isch&ved=2ahUKEwiKn5b509_
oA
https://www.fda.gov/media/116754/download
https://www.google.com/search?q=Clinical+Trial+Monitoring+cartoons&rlz=1C1SQJL_enIN877IN877&sxsrf=ALeKk03VxGootc_U8qwU
M84pc5Mv9YsVPg:1586583536905&source=lnms&tbm=isch&sa=X&ved=2ahUKEwi-
p_6g1N_oAhWe8HMBHUfUBTAQ_AUoAXoECAsQAw&biw=1455&bih=688#imgrc=Sbq1EhQ09z0eoM

27. SUBMITTED TO :- DR. NILANJAN SAHA
MADE BY:-) RISHABH SHARMA B.Sc 2nd
Year