Transcript SCCA Monitors

Tips to a
Successful
Monitoring Visit
Ngoc Tran, CCRA
NT Research, Inc.
Study
Monitor
Person delegated
by the Sponsor to
oversee the
conduct of a clinical
trial by ensuring
that study activities
are in accordance
to the protocol and
regulatory
requirements.
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Roles and
Responsibilities
Act as a liaison between
Site and Sponsor
Assure rights, safety
and well-being of
subjects are protected
Review trial data for
accuracy, completeness
and verifiable
Oversee study activities
for protocol, GCP and
regulatory compliance
Different but
Same
Changing mindsets
All for One and
One for All
Monitor-Site Encounters
Site Visits
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Evaluation/Pre-Study
Initiation
Monitoring
Close-out
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Assess Investigator’s
interest and
qualification
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Evaluate Site’s
capability to
properly and safely
conduct clinical trial
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Request Investigator
and Study
Coordinator
attendance
Evaluation/
Pre-Study Visit
Purpose
Setting the stage.
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Obtain Signed
Confidentiality
Agreement
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Provide protocol
synopsis for
review
Evaluation/
Pre-Study Visit
Expectations
Meet & Greet
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Evaluate by
phone or in
person
Preparing for an
Evaluation/Pre-Study Visit
 Review
protocol synopsis
 Obtain copies of the Investigator’s CV
and credentials
 Verify that there is sufficient personnel,
resources and necessary equipment to
conduct the clinical trial
 Assess ability to meet enrollment goals
and timelines
 Schedule tour of facilities (i.e. pharmacy,
lab, etc).
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Provide Protocol
and Investigational
Product/Device
Training
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Outline expectations
of Investigator and
research personnel
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Confirm study
supplies received
Initiation Visit
Purpose
Why Initiations are so critical for
the Sponsor and the Site to
engage in open dialogue.
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Collect remaining
essential documents
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Occurs prior to
enrollment
commencing
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Attendance
expected of
Investigator and Key
Research Personnel
Initiation Visit
Purpose
Why Initiations are so critical for
the Sponsor and the Site to
engage in open dialogue.
Sample of Initiation Agenda
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Detailed discussion of the protocol, including:
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Overall study design and objective
Study primary and secondary endpoints
Inclusion/Exclusion Criteria
Study Procedures
Drug/Device Administration, Storage, and Handling
Consent and enrollment procedures
Adverse event reporting
Investigator and research personnel
roles/responsibilities
Case report forms (Electronic or Paper)
Monitoring frequency & expectations
Sponsor specific forms/logs
Identify potential problems and concerns
Preparing for Initiation Visit
 Review
protocol and identify potential
challenges and/or concerns for
discussion
 Become familiar with Sponsor provided
documents/forms
 Begin maintenance of regulatory files
 Obtain remaining essential documents
 Confirm and audit supplies received
Preparing for Initiation Visit
 Schedule
tour of the site, pharmacy & lab
 Notify appropriate research personnel
 Arrange meeting room logistics
 Start Delegation of Authority Log & Site
Signature Log and Training Log
 Compare Sponsor forms and Institutional
Forms for similarities/differences
Monitoring Visit Purpose
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Review progress of clinical trial and ensure
protocol adherence and regulatory
compliance while maintaining the rights,
safety and well-being of subjects
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Frequency is dictated by complexity of the
study and Sponsor requirements
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Investigator and key research personnel
should be available for questions
Monitoring Visit Preparation
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Reserve monitoring space which provides
access to phone, internet, and copy/fax
Schedule visits with the Investigator,
Pharmacy, Laboratory and Regulatory office,
if applicable
Request access to medical records/source
documents
Complete CRFs
Prepare regulatory files
Allot time to meet with Monitor to discuss visit
findings
Preparing Source Documents
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Provide list of subjects
with corresponding
medical record number
Orient monitor to medical
record layout
Verify all consented
subjects have properly
completed Informed
Consent Forms and
process is well
documented
Review drug compliance
records and reconcile
discrepancies
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Assure lab, diagnostic
and radiology reports are
available for review
Flag sections of the chart
to ease search of
information
Have Investigator or
designee document
review of laboratory
results especially if out-ofrange
Ensure deviations or
missing information is well
documented
Preparing CRFs
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Complete CRFs up to visit date
Answer queries appropriately
Ensure data is accurate and verifiable by
making source documents available
Review Adverse Events(AE) being sure that
grade, severity and attribution are assessed
and documented
Review concomitant medications for
start/stop dates and corresponding AE entry
Preparing Regulatory Files
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Make sure files are complete and current
Retain all versions of the protocol, Investigator
Brochures, laboratory certification, lab
normals, FDA Form 1572, CVs, licenses,
financial disclosure
File IRB acknowledgement of receipt, if
applicable, approval and correspondences
Update signature and enrollment logs
Retain Sponsor correspondences
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Occurs when study
is complete and
database is locked
Final review of
regulatory files
Reconciliation of
IP/Device
Review record
retention
requirements
Collect IRB
notification of study
closure
Close-Out Visit
Purpose
Close-Out Visit Preparation
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Secure monitor space/room
Provide regulatory files and case books
Ensure Investigator and site staff are
available
Schedule final pharmacy visit for drug
return
Gather unused supplies for
return/destruction
Are You
Ready?