Difference
Between Monitoring and Auditing
Monitoring
and auditing are two distinct processes within the context of clinical trials
and research, each serving different purposes in ensuring the quality and
integrity of the trial. Here are the key differences between monitoring and
auditing:
Purpose:
Monitoring:
The primary purpose of monitoring is to oversee and ensure that a clinical
trial is conducted, recorded, and reported in accordance with the protocol,
standard operating procedures (SOPs), Good Clinical Practice (GCP), and
applicable regulatory requirements. Monitoring is an ongoing process throughout
the trial.
Auditing:
Auditing, on the other hand, is a systematic examination of trial-related
activities and documents to verify whether they have been conducted,
documented, and reported in accordance with the trial protocol, GCP, and
relevant regulatory requirements. Auditing is typically performed at specific
intervals, often after the completion of the trial.
Timing:
Monitoring:
Monitoring is a continuous and proactive process that occurs throughout the
duration of the clinical trial. It involves regular site visits by monitors to
assess ongoing trial conduct, data collection, and compliance with regulatory
and ethical standards.
Auditing:
Auditing is a retrospective and periodic process that occurs after the trial
has been completed or at specific intervals. It involves a more comprehensive
review of trial conduct, data, and documentation to ensure overall compliance.
Scope:
Monitoring:
The scope of monitoring is broader and focuses on the day-to-day activities of
the trial, including participant recruitment, data collection, documentation,
and adherence to the protocol. Monitors work closely with investigators and
site staff to address issues in real-time.
Auditing:
Auditing has a narrower and more comprehensive scope. It involves a detailed
examination of trial conduct, documentation, and data management to ensure
overall compliance with regulations and standards.
Responsibility:
Monitoring:
Monitors are typically individuals (clinical research associates or CRAs)
responsible for regularly visiting clinical trial sites, reviewing documents,
and ensuring that the trial is being conducted in compliance with the protocol
and regulatory requirements.
Auditing:
Auditors are often independent individuals or teams external to the trial who
conduct a thorough examination of trial conduct and documentation. They may be
employed by the sponsor, regulatory authorities, or third-party organizations.
Frequency:
Monitoring:
Regular and frequent, occurring throughout the trial's lifecycle with the aim
of identifying and addressing issues promptly.
Auditing:
Intermittent and less frequent, occurring at specific milestones or after trial
completion.
Conclusion
Monitoring
is an ongoing, proactive process that involves continuous oversight during the
course of the trial, while auditing is a retrospective, periodic, and more
comprehensive examination of trial activities conducted after the trial is
completed or at specific intervals. Both processes contribute to the assurance
of data quality, participant safety, and regulatory compliance in clinical
research.
Name: Dr Ummera Banu
Qualification: Doctor of
Pharmacy
Student ID: CLS_226/112023
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