Transcript Overview of Research Ethics & Compliance

Elements of Clinical
Trial Quality
Assurance
Stephanie Gentilin, CCRA
Regulatory Coordinator –SCTR SUCCESS Center
QA Monitor – NIDA Clinical Trials Network
Monitor’s Responsibilities – ICH E6
Section 5.18
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Overall Purpose of Monitoring
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Verify the rights and well-being of human
subjects are protected
Verify that reported trial data are accurate,
complete and verifiable from source documents
Verify the study is conducted in compliance
with the study protocol, GCP guidelines and
applicable regulations
Clinical Trials Network
Selection and Qualifications of
Monitors
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Should be appointed by the sponsor
Should be appropriately trained, and should
have the scientific and/or clinical knowledge
needed to monitor the trial adequately
Should be thoroughly familiar with the
investigational product(s), the protocol,
consent and any other written information
Clinical Trials Network
Monitor Responsibilities
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Act as main line of communication between the
sponsor and investigator
Follow sponsor SOPs for monitoring and
protocol specific requirements
Site-selection / Pre-study visit
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Study-Mandated Criteria
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Investigator qualifications
Facilities and Equipment
Basic Investigator Criteria
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Reputation / Access to Subjects / Concurrent studies
Clinical Trials Network
Study Initiation Visit
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Detailed explanation of protocol
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CRF review
AEs
Schedule of Events
Verify regulatory approvals in place
Assess supply inventory
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Confirm labeling / organization of investigational
product
Clinical Trials Network
Routine / Interim Monitoring visits
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Investigator compliance
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With protocol, regulations and GCP guidelines
Check accuracy and completeness of CRFs and
source against one another
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Data are reported accurately
Modifications to the IP are well documented
AEs and concomitant medications reviewed
Withdrawals and dropouts reported
Consent obtained
Clinical Trials Network
Routine / Interim Monitoring visits
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Evaluate study conduct
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Review for protocol deviations and reporting
Review recruitment
Check supplies
Factory influencing the rate of visits
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Type of disease
Level of complicated medical condition
Complexity of study design
Previous performance
Clinical Trials Network
Study Closeout Visit
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Collect CRFs
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Outstanding corrections are made
Ship and/or pick up all remaining clinical
supplies
Confirms regulatory files are complete
Review record retention policies
Clarify remaining sponsor commitments
Clinical Trials Network
Monitoring Report
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Written report to sponsor after each site visit or
trial-related communication. Should include:
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Date of visit
Site
Name of monitor
Name of investigator and personnel contacted
Summary of information reviewed
Significant findings and corrective action plans
Review and follow up on corrective actions
should be documented
Clinical Trials Network
Audits
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Independent of the clinical trials/systems
Independent of and separate from routine
monitoring or QC functions
To evaluate trial conduct and compliance
with protocol, SOPs, GCP and applicable
regulatory requirements
Clinical Trials Network
Auditing Procedures
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Should be conducted in accordance with
Sponsor SOPs
Based on:
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Type and complexity of trial
Level of risk to the subject
Regulatory reporting requirements
Identified problems
Audit findings should be documented
When required by law, sponsor should
provide an audit certificate
Clinical Trials Network
Noncompliance
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Prompt action by sponsor should be taken to
secure compliance
If serious and/or persistent noncompliance on
the part of an investigator/institution, the
sponsor may terminate participation in the
trial
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Sponsor should promptly notify regulatory
authority(ies).
Clinical Trials Network