The document outlines the role and responsibilities of monitors in clinical trials, emphasizing the importance of investigational product accountability and adherence to protocols. It details the monitoring process, types of monitoring visits (site selection, initiation, routine, and close-out), and the qualifications required for clinical research associates (CRAs). Additionally, it describes the procedures for ensuring compliance and conducting thorough monitoring throughout the study lifecycle.

1. INVESTIGATIONALPRODUCT
MONITORING VISIT
PRESENTED BY:
LINCY ASHA.S
M.PHARM 1ST YEAR
PHARMACY PRACTICE
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2. INVESTIGATIONAL PRODUCT
An investigational product refers to a preventative (vaccine), a therapeutic (
drug or biologic) or device used in a clinical trial.
The investigator should be thoroughly familiar with the appropriate use of
the investigational products, as described in the protocol, in the current
Investigator’s Brochure, in the product information and in other information
sources provided by the sponsor.
Responsibility for investigational products accountability at the trial site rests
with the investigator.
The investigator should ensure that the investigational products are used only
in accordance with the approved protocol.
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3. MONITORING
The act of overseeing the progress of a clinical trial, and of ensuring that is conducted, recorded and
reported in accordance with the
 Protocol
 Standard Operating Procedures (SOPs)
 Good Clinical Practice (GCP)
 Applicable regulatory requirements
It is an ongoing process conducted before, during and after the trial.
PURPOSE OF MONITORING
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4. MONITOR
A designee of the sponsor who is assigned the task of monitoring the
study.
CLINICAL RESEARCH ASSOCIATE
A monitor in a clinical trial is also called a CRA – Clinical Research
Associate
CRA is a sponsor representative conducts the clinical trial monitoring
by visiting the clinical trial site at frequent intervals.
CRA is responsible for monitoring the clinical trial and making sure
that everything is according to rules, regulations and Good Clinical
Practice.
Acts as main line of communication between sponsor and the
investigator.
The CRA will be involved in all stages of the clinical trial including
identifying an investigation site and setting up, initiating, monitoring
and closing the trial upon completion or termination.
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5. SELECTION AND QUALIFICATION OF MONITORS
Monitors should be appointed by the sponsor.
Monitors should be appropriately trained, and should have the scientific
and/or clinical knowledge needed to monitor the trial adequately.
A monitor’s qualifications should be documented.
Monitors should be thoroughly familiar with the investigational products, the
protocol, written informed consent form and any other written information
to be provided to subjects, the sponsor’s SOPs, GCP and the applicable
regulatory requirements.
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6. ROLES AND RESPONSIBILITIES OF MONITOR(CRA)
To verify
Investigator qualifications
Facilities including laboratories, equipment and
staff are adequate
Investigator follows the approved protocol
Written informed consent was obtained before
each subject's participation in the trial
Investigator is enrolling only eligible subjects
All adverse events are appropriately reported
within the time period
Communicating deviations from the protocol,
SOPs, GCP, and the applicable regulatory
requirements to the investigator.
To verify
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7. TYPES OF MONITORING VISITS
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8. 1.SITE SELECTION VISIT
A site selection visit means that a CRA goes to visit a certain site before it can be awarded a study.
It is a 1-day visit.
When sites look for potential studies, they email or fax the sponsor with their presentation of the site
and their interest in the study.
If the sponsor is interested, he will send a CDA (Confidential disclosure agreement) to sign.
The site that’s interested in conducting a certain study will first fill out a Feasibility survey which the
sponsor will review.
Site feasibility questionnaire
A feasibility questionnaire is the set of questions prepared by a study sponsor to identify the potential
and interest of a site/investigator to run clinical trial feasibility successfully.
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12. If the sponsor considers it to be a good option for their study, they’ll send a CRA to come for a site
selection visit.
On this visit, it is the CRA’s task to confirm that the site actually exists and that everything that they’ve
stated in their feasibility survey matches the real situation.
The CRA will also make sure that the site has enough experience to conduct the study and that they’re
able to enroll the required number of patients.
Other topics of discussion during this visit include:
• Investigator responsibilities
• Qualifications of the investigator or other site personnel
• Study objectives, endpoints, indication challenges, inclusion-exclusion criteria, protocol-required
procedures, eligibility criteria, and patient recruitment
• IRB (e.g., informed consent requirements)
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13. • Adverse event reporting, source documentation, and record retention
• Infrastructure, availability of a storage area to store investigational drug or devices, and availability
of required equipment or instruments
• Reporting of the event, documentation source.
CRA may ask for all the relevant documents from the site to verify the documents.
Upon finalization, CRA will share the follow-up letter along with the site selection letter (whether
selected/rejected) for the clinical trials.
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14. 2.SITE INITIATION VISIT
Site initiation visit happens after the site has been selected, the terms and budget have been negotiated, and
all the documents have been signed.
It takes a 2-day visit.
It focuses on preparation and training the clinical trial site to conduct the study.
It is conducted prior to subject/ patient recruitment.
Contrary to the first type, these visits do require that the CRA has more knowledge and
understands the protocol in-depth.
GOALS:
To train site staff on the protocol and study related processes.
To confirm readiness for study implementation
To identify additional requirements that must be satisfied prior to site activation and subject recruitment.
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15. SIV STEPS AND ACTIVITIES
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16. SIV FOCUSES DISCUSSION AND
TRAINING ON
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18. If questions that needed further follow-up arose during the meeting
the CRA must relay responses to the site as soon as possible.
The report confirms that initiation activities have been completed.
If the study site is new to clinical trials, the CRA should recommend
how the Investigator Site File (ISF) should be maintained.
If the site is experienced, this will be a routine activity.
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19. 3.ROUTINE MONITORING/INTERIM MONITORING VISITS
Routine monitoring visit is a mandatory and frequent visit that occurs every 4 to 6 weeks depending on
the site’s enrollment volume.
The sponsor will have to prepare a monitoring plan for each site conducting the study, which will later
be given to the CRA as a guideline.
In creating this plan, Sponsor can choose between different types of Routine Monitoring Visits:
Traditional monitoring visits - 100% complete Source Data Verification (SDV)
Risk-based monitoring visits - targets the site’s weak points.
Remote monitoring visits - done virtually using digital platforms
Every CRA will have a monitoring plan which will explain what type of monitoring visits are required.
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20. MONITORING VISITS TIMELINE
The Timeline that a CRA will be given will contain information such as:
The frequency of site visits
Which site to visit
When to visit, etc.
Usually in traditional monitoring, CRA will visit sites every 4 to 6 weeks, while in risk-based monitoring the
visits will be on every 6 to 12 weeks.
Timeline also varies from site to site depending on the enrollment numbers and activities.
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21. BEFORE – CONFIRMATION LETTER
Before each Routine monitoring visit, the CRA is supposed to send a
confirmation letter to the site which states the date and time of the visit.
The site should then decide if this date and time are good for them.
Aside from this, the confirmation letter usually contains also bullet points
of which activities the CRA will perform on the following visit and
which documents will be reviewed.
In this way, the site will be able to prepare for the visit and provide all the
necessary details to the CRA
Many confirmation letters will also contain the information of whether or
not the PI will need to be present for the visit, and if so, then for how
long.
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22. DURING THE VISIT
CRA will review/assess the
following
1. Enrollment status of study
subjects
2. Resources
3. Laboratory
4. Study supplies
5. Investigational product
6. Compliance and progress
7. Case report form
8. Source data verification
9. Informed consent form
10. Reporting
11. Regulatory files
12. Adverse events/ serious
adverse events
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23. AFTER – FOLLOW-UP LETTER
The Follow-up letter is an official letter that is sent after the
Routine monitoring visit.
This letter contains a summary or an outline of all the action
items that were reviewed during the latest visit.
Everything that needs to be resolved until the next visit can be
found in the Follow-up letter.
This letter will also note if the PI was available for a
discussion during the visit or not.
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24. MONITORING REPORT
The monitor should submit a written report to the sponsor after each trial-site visit or trial-related
communication.
Reports should include
Date
Site
Name of the monitor
Name of the investigator or other individuals contacted
Summary of what the monitor reviewed
Monitor's statements concerning
Significant findings/facts,
Deviations and deficiencies,
Conclusions,
Actions taken or to be taken and/or actions recommended to secure compliance.
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25. 4.SITE CLOSE-OUT VISIT
The close-out visit takes place when the study has already finished.
A study can end for various reasons, either because it has been successfully completed or the sponsor
dropped the study or even the site because he/she decided that this particular site isn’t a good fit for
their study.
No matter what’s the case, the close-out visit is always the same for the CRA, whose job would be to:
1 2 3 4 5
Ship the IP back to
the sponsor – both
used and unused
IP.
Make sure that the
lab kits are
destroyed.
Make sure that the
site has a plan and
an arrangement
for keeping all the
medical records.
Check if the site
has notified the
IRB that all the
research for that
site and study is
finished.
Check that all the
safety reports are
signed and filed
appropriately, as
well as all the
other
documentation.
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26. REFERENCES
https://ichgcp.net/amp/monitoring
https://clinicalresearchinfo.com/types-of-clinical-trial-site-visits-cra/
Oxford handbook of clinical and healthcare research, 2016, Oxford University Press, ISBN: 9780199608478
https://www.slideshare.net/TrialJoin/monitoring-plan-and-basic-monitoring-visits-everything-that-a-cra-needs-
to-know-77472675
https://globalresearchonline.net/journalcontents/v63-1/07.pdf
https://ichgcp.net/4-investigator
https://youtu.be/AYrtRuABFRA
https://youtu.be/CLFnxlFv6c0
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27. THANK YOU
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