Building Quality into Clinical Trials_ A Plan-Do-Check-Act Approach (1)
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Building Quality into Clinical Trials: A Plan-Do-Check-Act Approach
Arizona State University
HCR 563: Regulatory Affairs
Dr. Pfeiffer
November 7th, 2023
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Introduction:
Quality is paramount in clinical research, ensuring the reliability of data and the
protection of participants. One effective approach to achieving quality is to follow the Plan-Do-
Check-Act (PDCA) cycle or the principles of "Say What You Do; Do What You Say; Prove it;
Improve it." as proposed in Bhatt's article. These principles emphasize a systematic, continuous
improvement process to build quality into clinical trials. In this essay, we will explore how these
principles apply at a site level, emphasizing the importance of quality from the beginning to the
end of a clinical trial.
Plan: Building the Foundation for Quality
The first step in building quality into clinical trials is to plan meticulously. Planning
involves defining clear objectives, roles, and responsibilities. At the site level, it means
establishing a comprehensive quality management plan that outlines how quality will be assured
throughout the trial (Ball & Meeker O'Connell, n.d). This plan should specify the procedures,
protocols, and standards that all team members must adhere to.
Moreover, planning includes risk assessment to identify potential issues that may
compromise data integrity or participant safety. It's crucial to anticipate and address challenges in
advance. The site should also plan for adequate training of all staff involved in the trial, from
investigators to data managers (Bhatt, 2011).
Do: Executing the Plan with Precision
The "Do" phase entails executing the plan with precision. At the site level, this means
implementing the procedures and standards outlined in the quality management plan(Ball &
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Meeker O'Connell, n.d). All staff members should be aware of their responsibilities and execute
them diligently. For clinical investigators, this involves ensuring that protocols are followed
meticulously and data is collected accurately. Monitors play a pivotal role in this phase,
conducting site visits, verifying data, and ensuring that the trial runs according to the plan.
It's essential to emphasize the importance of documentation during the "Do" phase.
Detailed and accurate records must be maintained, covering all aspects of the trial, from
informed consent to adverse event reporting (Bhatt, 2011). The site should also prioritize subject
protection by adhering to ethical guidelines and safety measures.
Check: Continuous Monitoring and Evaluation
The "Check" phase focuses on continuous monitoring and evaluation. At the site level,
this means regular assessments of the trial's progress and data quality. Monitoring is not limited
to post hoc inspections but should be an ongoing process.
Central to the "Check" phase is data verification. Data should be checked for accuracy
and consistency. Any discrepancies or deviations from the protocol should be identified and
addressed promptly. If errors are detected, root cause analysis should be conducted to prevent
their recurrence (Bhatt, 2011).
Monitoring also extends to the assessment of the trial's performance against predefined
quality objectives. Are the recruitment targets being met? Is the site complying with protocols
and regulations?(Ball & Meeker O'Connell, n.d) These questions must be answered through
regular checks.
Act: Continuous Improvement and Corrective Actions
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The "Act" phase involves taking corrective actions based on the findings in the "Check"
phase. At the site level, this means addressing issues promptly, implementing necessary changes,
and preventing their recurrence. If any deviations from quality standards or protocol are
identified, corrective and preventive actions (CAPA) should be initiated (Bhatt, 2011).
The emphasis in the "Act" phase is not only on rectifying mistakes but on identifying
opportunities for improvement. The site should continuously seek ways to enhance its processes,
minimize risks, and increase the efficiency of the trial.
Conclusion: Culminating in Quality Outcomes
The Plan-Do-Check-Act cycle, along with the principles of "Say What You Do; Do What
You Say; Prove it; Improve it," culminates in quality outcomes in clinical trials. By planning
meticulously, executing with precision, continuously monitoring, and taking corrective actions,
sites ensure that the data generated is reliable and the rights and safety of participants are
safeguarded.
Quality is not an endpoint but a journey. It is an ongoing commitment to excellence in
clinical research. When sites embrace these principles, they contribute to the overall success of
clinical trials and, most importantly, to the advancement of safe and effective medical products.
In conclusion, building quality into clinical trials is a shared responsibility among all
stakeholders, from investigators to monitors and sponsors. The principles of Plan-Do-Check-Act
guide this process, ensuring that every aspect of the trial aligns with the highest standards of
quality. Through this approach, clinical research continues to evolve, emphasizing the vital
importance of quality throughout the entire trial lifecycle.
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References
Ball , L., & Meeker O’Connell, A. (n.d.).
Building Quality into Clinical Trials by Leslie Ball Ann
Meeker O’Connell
.
Bhatt, A. (2011). Quality of clinical trials: A moving target.
Perspectives in Clinical
Research
,
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(4), 124.
https://doi.org/10.4103/2229-3485.86880