All of the following are examples of what monitors review EXCEPT:
A.
Regulatory binder which includes copies of current certifications for all laboratories.
B.
The signed ICF retained in the participant's study file.
C.
Potential patient medical records for eligibility prior to the informed consent process.
D.
Documentation in the participant's medical record of study drug administration.
The Answer Is:
C
This question includes an explanation.
Explanation:
Monitors are responsible for reviewing documents that pertain to study conduct and data integrity,including regulatory binders, informed consent forms (ICFs), and documentation of study drug administration. However, reviewing potential patient medical records for eligibility prior to the informed consent process is not part of a monitor's responsibilities, as this would violate patient confidentiality and GCP standards.
According to GCP guidelines, monitors should ensure compliance with the protocol and data integrity but should not access non-consented patient records.
"Monitors should verify that only enrolled and consented subjects' data are reviewed, ensuring compliance with privacy regulations."
Objectives:
Understand the scope of monitoring responsibilities.
Protect patient confidentiality during the monitoring process.
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