This scenario is professionally challenging because it requires a clinical research professional to balance the need for efficient data collection with the ethical imperative to protect participant privacy and ensure the integrity of the study design. The decision involves understanding the nuances of different observational study designs and their implications for risk assessment and regulatory compliance. Careful judgment is required to select the most appropriate approach that minimizes bias and adheres to ethical principles. The best professional practice involves proactively identifying potential risks associated with the chosen observational study design and implementing robust mitigation strategies before the study commences. This includes a thorough assessment of how the study design might inadvertently lead to selection bias or confounding factors that could compromise the validity of the findings. By anticipating these challenges and developing a plan to address them, the research team can ensure the study’s integrity and the protection of participants. This approach aligns with Good Clinical Practice (GCP) guidelines, which emphasize the importance of scientific validity and ethical conduct throughout the research process, including the design phase. Specifically, ICH E6(R2) section 2.10 highlights the need for study design to be scientifically sound and appropriate for the research question. An unacceptable approach would be to proceed with a case-control study without first considering the potential for recall bias. Case-control studies are retrospective and rely on participants’ memories of past exposures, which can be inaccurate or influenced by their current health status. Failing to acknowledge and plan for this inherent risk could lead to biased results and misinterpretations. This violates the principle of scientific rigor and could mislead future clinical decisions. Another professionally unacceptable approach would be to select a cross-sectional study design solely for its speed and cost-effectiveness, without adequately assessing its limitations in establishing temporal relationships between exposures and outcomes. Cross-sectional studies capture data at a single point in time, making it difficult to determine whether an exposure preceded an outcome, thus limiting their ability to infer causality. This oversight neglects the fundamental requirement for a study design to be capable of answering the research question effectively and ethically. A further professionally unacceptable approach would be to choose a cohort study without a clear plan for managing potential loss to follow-up. While cohort studies are strong for establishing temporal relationships, significant participant attrition can introduce bias and weaken the study’s conclusions. Failing to proactively plan for retention strategies and statistical methods to handle missing data demonstrates a lack of due diligence and compromises the study’s scientific validity. The professional decision-making process should involve a systematic evaluation of the research question, the feasibility of different observational study designs, and the inherent risks and benefits associated with each. This includes consulting relevant ethical guidelines and regulatory requirements, engaging with subject matter experts, and conducting a comprehensive risk assessment to identify potential biases and challenges. The chosen design should be the one that best balances scientific rigor, ethical considerations, and the ability to answer the research question with minimal bias.

Scenario Analysis: This scenario is professionally challenging because it requires the clinical research coordinator to balance the ethical imperative of ensuring genuine understanding with the practical need to obtain informed consent efficiently. The pressure to meet enrollment targets can inadvertently lead to a rushed or superficial consent process, jeopardizing participant autonomy and regulatory compliance. Careful judgment is required to identify subtle signs of participant confusion or coercion, which may not be immediately apparent. Correct Approach Analysis: The best professional practice involves actively seeking clarification and confirming comprehension through open-ended questions and by observing non-verbal cues. This approach directly addresses the core ethical principle of respect for autonomy, ensuring participants can make a voluntary and informed decision. Regulatory frameworks, such as those outlined by the FDA (e.g., 21 CFR Part 50), mandate that consent be obtained from a person legally authorized to give consent, and that the information provided be understandable. This approach ensures that the participant not only receives the information but truly comprehends its implications, including risks, benefits, and alternatives, thereby fulfilling the spirit and letter of these regulations. Incorrect Approaches Analysis: One incorrect approach involves proceeding with the consent process after the participant expresses a general understanding without probing for specific comprehension. This fails to adequately assess whether the participant grasps the critical details of the study, such as potential side effects or the voluntary nature of their participation. Ethically, this undermines autonomy by assuming understanding rather than verifying it. Legally, it could be seen as a failure to meet the regulatory requirement of providing sufficient information for an informed decision. Another incorrect approach is to rely solely on the participant’s verbal confirmation of understanding after a lengthy explanation, especially if they appear hesitant or distracted. This approach overlooks the possibility of social desirability bias, where participants may agree to consent to please the researcher or avoid appearing unintelligent. It also neglects the importance of non-verbal communication and the opportunity for the participant to ask questions freely. This falls short of the regulatory expectation that consent be truly informed and voluntary. A further incorrect approach is to delegate the responsibility of ensuring comprehension solely to the participant, assuming they will ask questions if they are confused. While participants are encouraged to ask questions, the responsibility for ensuring understanding rests with the investigator and their team. This passive approach can lead to participants feeling uncomfortable or unable to voice their concerns, thereby failing to uphold the ethical duty of care and potentially violating regulatory requirements for a robust informed consent process. Professional Reasoning: Professionals should adopt a proactive and interactive approach to informed consent. This involves not just presenting information but actively engaging the participant in a dialogue. Key steps include: assessing the participant’s baseline understanding of medical research, using clear and simple language, breaking down complex information into manageable parts, encouraging questions throughout the process, and using teach-back methods or asking participants to explain key aspects of the study in their own words. When in doubt about a participant’s comprehension, it is always best to err on the side of caution, provide further explanation, or involve a neutral third party if necessary, rather than proceeding with consent.

This scenario is professionally challenging because it requires a clinical research professional to balance the immediate needs of a study with the overarching ethical and regulatory obligations to protect human subjects. The pressure to maintain study timelines and achieve recruitment goals can create a conflict with the IRB’s mandate to ensure participant safety and data integrity. Careful judgment is required to navigate these competing interests while upholding the highest ethical standards. The best professional approach involves proactively engaging the IRB with a clear, comprehensive plan that addresses potential risks and outlines robust mitigation strategies. This includes providing detailed information about the proposed screening process, the rationale for the expanded criteria, and a thorough risk-benefit analysis specifically for the vulnerable population being considered. Demonstrating a commitment to participant welfare through well-defined safety monitoring protocols and a clear plan for obtaining informed consent that fully discloses the risks associated with the expanded criteria is paramount. This approach aligns with the core principles of the Common Rule (45 CFR Part 46), which emphasizes the IRB’s responsibility to review research involving human subjects to ensure their rights and welfare are protected. Specifically, the IRB must consider the risks and potential benefits to subjects, the selection of subjects, and the adequacy of informed consent. By presenting a well-thought-out plan that anticipates and addresses these concerns, the research professional facilitates the IRB’s deliberative process and demonstrates a commitment to ethical research conduct. An approach that involves proceeding with the expanded screening criteria without prior IRB notification and approval is ethically and regulatorily unacceptable. This bypasses the IRB’s essential oversight function, violating the principles of independent ethical review and potentially exposing participants to unforeseen risks without adequate safeguards. It undermines the trust placed in researchers and the regulatory framework designed to protect vulnerable populations. Another unacceptable approach is to present the expanded criteria to the IRB as a fait accompli, implying that the decision has already been made and seeking only perfunctory approval. This demonstrates a lack of respect for the IRB’s role and a failure to engage in genuine collaborative ethical review. It suggests a prioritization of study objectives over participant protection and can lead to a perception of non-compliance. Finally, an approach that focuses solely on the potential benefits of increased recruitment without adequately addressing the associated risks to participants or the ethical implications of potentially altering the study population’s risk profile is also professionally unsound. While recruitment is important, it cannot come at the expense of participant safety or the integrity of the ethical review process. The professional decision-making process for similar situations should involve a proactive, transparent, and collaborative engagement with the IRB. Before implementing any significant changes to study protocols, especially those that could impact participant safety or the selection of subjects, researchers should consult the IRB. This involves preparing a detailed amendment request that clearly articulates the proposed changes, provides a strong scientific and ethical rationale, and includes a comprehensive assessment of risks and benefits, along with proposed mitigation strategies. Maintaining open communication and being prepared to address the IRB’s questions and concerns are crucial for ensuring ethical and compliant research.

Scenario Analysis: This scenario presents a common challenge in clinical research where a sponsor’s internal process appears to deviate from established regulatory expectations for data integrity and quality oversight. The tension lies between the sponsor’s desire for efficiency and the critical need for independent, documented quality control to ensure the reliability and validity of research data, which directly impacts patient safety and the interpretability of study results. Navigating this requires a deep understanding of regulatory frameworks and the ethical imperative to uphold research integrity. Correct Approach Analysis: The best professional practice involves ensuring that the sponsor’s internal quality control (QC) procedures are distinct from the quality assurance (QA) function responsible for independent oversight. This means that the team performing the initial data entry and review should not be the same team responsible for auditing or verifying the accuracy and completeness of that data against source documents. This separation of duties is fundamental to robust quality management systems, as mandated by regulatory bodies like the FDA (e.g., 21 CFR Part 11, GCP guidelines) and the EMA, and emphasized in ICH E6(R2) Good Clinical Practice (GCP) guidelines. This separation provides an independent check, minimizing the risk of systemic errors or biases being overlooked and ensuring that data submitted to regulatory authorities is reliable and accurate. Incorrect Approaches Analysis: One incorrect approach is to consider the sponsor’s internal data review process as sufficient quality control without independent verification. This fails to meet the spirit and letter of GCP, which requires independent monitoring and auditing to ensure data integrity. Relying solely on the data entry team’s own review introduces a significant risk of confirmation bias and the perpetuation of errors, as the same individuals are reviewing their own work. This approach lacks the necessary checks and balances expected by regulatory agencies. Another incorrect approach is to assume that the investigator site’s own internal quality checks are sufficient to satisfy sponsor-level quality control requirements. While investigator sites have their own responsibilities for data accuracy and completeness, the sponsor bears the ultimate responsibility for the overall quality of the data generated in their trial. The sponsor must implement its own independent QC/QA processes to oversee the data collected from all sites, ensuring consistency and adherence to the protocol and GCP across the entire study. A further incorrect approach is to delegate all quality control responsibilities to a third-party vendor without establishing clear oversight and verification mechanisms. While vendors can be valuable partners, the sponsor cannot abdicate its regulatory responsibility. The sponsor must ensure that the vendor’s processes are adequate, that they adhere to the agreed-upon quality standards, and that the sponsor retains the ability to audit and verify the vendor’s quality control activities. Without this oversight, the sponsor risks non-compliance and compromised data integrity. Professional Reasoning: Professionals should employ a decision-making framework that prioritizes regulatory compliance and ethical conduct. This involves: 1) Identifying the core regulatory requirements related to data integrity and quality management (e.g., ICH E6(R2) GCP, FDA regulations). 2) Assessing the proposed internal process against these requirements, specifically looking for independence in quality control functions. 3) Evaluating potential risks to data integrity and patient safety associated with any proposed deviation. 4) Consulting with internal quality assurance departments or regulatory experts when uncertainties arise. 5) Advocating for processes that uphold the highest standards of research integrity, even if it requires additional resources or time.

Scenario Analysis: This scenario is professionally challenging because it requires a clinical research professional to navigate the nuanced definition of clinical research, particularly when activities might blur the lines between standard medical practice and investigational activities. Misinterpreting this distinction can lead to non-compliance with regulatory requirements, ethical breaches, and potential harm to participants. Careful judgment is required to ensure that all activities falling under the definition of clinical research are conducted according to established ethical principles and regulatory standards, such as those outlined by the US Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP). Correct Approach Analysis: The best professional practice involves a comprehensive review of the proposed activity against the established definitions of clinical research. This includes considering whether the activity involves the prospective assignment of human subjects to one or more interventions (which may include placebo) to evaluate the cause-and-effect relationship between a medical, behavioral, or educational intervention and a health-related biomedical or behavioral outcome. It also requires assessing if the activity is intended to add to generalizable knowledge. If the activity meets these criteria, it is considered clinical research and must adhere to all applicable regulations, including Institutional Review Board (IRB) review, informed consent processes, and Good Clinical Practice (GCP) guidelines. This approach ensures that participant safety and data integrity are prioritized and that regulatory obligations are met. Incorrect Approaches Analysis: One incorrect approach is to assume that any activity performed within a healthcare setting by a healthcare professional is automatically standard medical practice and therefore exempt from clinical research regulations. This fails to recognize that even interventions delivered by clinicians can be investigational if they are not part of routine care or are being evaluated for efficacy or safety. This oversight can lead to conducting research without proper IRB approval, informed consent, or adherence to GCP, thereby violating ethical principles and FDA regulations (e.g., 21 CFR Part 50, 21 CFR Part 56). Another incorrect approach is to focus solely on whether a new drug or device is involved. While the use of investigational products is a strong indicator of clinical research, the definition extends to behavioral interventions, educational programs, and diagnostic procedures when they are prospectively assigned and evaluated for their impact on health outcomes. Ignoring non-drug/device interventions that fit the definition can result in research being conducted outside the regulatory framework, compromising participant protections and the validity of findings. A third incorrect approach is to rely on the absence of a formal research protocol as a determinant of whether an activity is clinical research. While a formal protocol is a hallmark of well-designed clinical research, the regulatory definition is based on the nature of the activity itself, not solely on the documentation. An activity that meets the definition of clinical research requires regulatory oversight regardless of whether a formal protocol has been developed, though the lack of one is a significant red flag for potential non-compliance. Professional Reasoning: Professionals should adopt a proactive and inquisitive mindset. When faced with an activity that might be clinical research, the decision-making framework should involve: 1) Clearly understanding the definitions of clinical research as per relevant regulatory bodies (e.g., FDA, OHRP). 2) Systematically evaluating the proposed activity against each component of these definitions. 3) Consulting with institutional resources, such as the IRB or research compliance office, when there is any ambiguity. 4) Prioritizing participant safety and ethical conduct above all else, ensuring that all activities are appropriately reviewed and overseen if they fall under the purview of clinical research.

The investigation demonstrates a common challenge in clinical research: balancing the scientific rigor required for a statistically sound study with the ethical imperative to minimize participant exposure and resource utilization. Determining an appropriate sample size is critical for ensuring a study can detect a meaningful treatment effect (power) while avoiding unnecessary risks and costs associated with overly large or small participant groups. This scenario is professionally challenging because a flawed sample size calculation can lead to a study that is either underpowered, failing to identify a potentially beneficial treatment, or overpowered, exposing more participants than necessary to risks and burdens without a commensurate increase in scientific value. Careful judgment is required to align statistical needs with ethical considerations and regulatory expectations. The approach that represents best professional practice involves a comprehensive power analysis conducted by a qualified statistician, considering the primary endpoint, expected effect size, desired statistical power (typically 80% or 90%), and a pre-defined significance level (alpha, usually 0.05). This analysis should also account for anticipated dropout rates and potential variability in the data. This method is correct because it directly addresses the core principles of statistical validity and ethical participant protection. Regulatory bodies like the FDA (in the US context, assuming this is the relevant jurisdiction based on the SoCRA exam focus) expect study protocols to include a well-justified sample size calculation that demonstrates the study is designed to answer the research question effectively and efficiently. This approach ensures that the study has a reasonable chance of detecting a true effect if one exists, thereby maximizing the scientific return on investment and minimizing participant burden. An incorrect approach would be to select a sample size based on convenience or the number of participants available at a single site without a formal statistical justification. This fails to meet regulatory expectations for a robust study design and can lead to an underpowered study that cannot reliably answer the research question. Ethically, it exposes participants to the risks and burdens of research without a strong likelihood of generating meaningful scientific data. Another incorrect approach would be to simply double the sample size of a previous, similar study without re-evaluating the specific parameters of the current investigation. While historical data can inform sample size calculations, each study has unique characteristics, including different inclusion/exclusion criteria, treatment protocols, and outcome measures, which can significantly impact the required sample size. Failing to perform a new, specific power analysis for the current study is a regulatory and ethical oversight. A further incorrect approach would be to choose a sample size solely based on the budget available for the study. While financial constraints are a practical consideration, they should not be the primary determinant of sample size. The sample size must first be scientifically and ethically justified. If the budget is insufficient to support a statistically sound study, the research question may need to be revised, the study design modified, or the study deferred until adequate funding is secured. Prioritizing budget over scientific validity and participant protection is professionally unacceptable. The professional reasoning framework for such situations involves a systematic approach: 1. Clearly define the primary research question and the primary endpoint. 2. Consult with a qualified statistician to perform a formal power analysis, specifying the desired power, alpha level, and estimating the effect size and variability based on prior research or pilot data. 3. Incorporate anticipated attrition rates into the calculation. 4. Document the rationale for the chosen sample size in the study protocol, referencing the statistical methods used. 5. Consider ethical implications, ensuring the sample size is not unnecessarily large. 6. Review the proposed sample size against available resources and feasibility, and if necessary, engage in discussions about study design modifications or funding.

Scenario Analysis: This scenario presents a common challenge in clinical research: selecting the most appropriate data collection method to answer a specific research question while adhering to ethical and regulatory standards. The principal investigator (PI) must balance the need for robust, generalizable data with the practicalities of participant burden and resource allocation. A misstep in choosing the data collection method can lead to compromised data integrity, ethical breaches, and regulatory non-compliance, potentially jeopardizing the study’s validity and patient safety. Careful judgment is required to ensure the chosen method aligns with the study’s objectives and respects participant rights and well-being. Correct Approach Analysis: The best approach involves prioritizing the collection of objective, measurable data that can be statistically analyzed to determine the efficacy and safety of the investigational product. This aligns with the core principles of clinical research, which aim to generate reliable evidence. Specifically, utilizing structured questionnaires with pre-defined response options (e.g., Likert scales, multiple-choice) and objective physiological measurements (e.g., blood pressure readings, laboratory test results) allows for quantitative analysis. This method directly addresses the study’s primary endpoints by providing quantifiable outcomes that can be compared between treatment groups. Regulatory bodies like the FDA (under 21 CFR Part 312) and ICH GCP guidelines (specifically sections related to data quality and integrity) emphasize the importance of collecting data that is accurate, verifiable, and suitable for statistical analysis to support claims about the investigational product. This approach ensures that the data collected is robust enough to support regulatory decision-making. Incorrect Approaches Analysis: Relying solely on open-ended interview questions to gather all data would be an inappropriate approach. While qualitative data can provide rich insights into participant experiences and perceptions, it is inherently subjective and difficult to quantify or generalize across a larger population. This would make it challenging to statistically demonstrate the efficacy or safety of the investigational product, which is the primary goal of most clinical trials. Furthermore, the lack of standardized responses could lead to significant variability in data interpretation, potentially compromising the study’s validity and making it difficult to meet regulatory requirements for evidence of efficacy. Focusing exclusively on participant diaries without structured prompts or objective measurements would also be an inadequate approach. Participant diaries, while valuable for capturing real-world experiences, are prone to recall bias and inconsistencies in reporting. Without structured questions or objective verification, the data may lack the rigor required for regulatory submission. This method might capture subjective experiences but would fail to provide the objective, measurable data needed to confirm or refute hypotheses about the investigational product’s performance. Collecting only anecdotal feedback from participants during informal conversations would be the least appropriate approach. This method is highly subjective, lacks standardization, and is not verifiable. Anecdotal evidence is not considered scientifically valid for regulatory purposes and carries a high risk of bias. Such an approach would fail to meet the fundamental requirements for data collection in a clinical trial, as it would not provide reliable or reproducible information about the investigational product’s effects. Professional Reasoning: Professionals should employ a decision-making framework that begins with a clear understanding of the study’s objectives and primary endpoints. This involves identifying what specific questions the research aims to answer. Next, consider the nature of the data required to answer these questions – is it measurable and objective, or experiential and subjective? Evaluate potential data collection methods against these requirements, considering their suitability for quantitative or qualitative analysis. Crucially, assess each method’s alignment with regulatory expectations (e.g., FDA regulations, ICH GCP) and ethical principles, particularly regarding participant burden and data integrity. Prioritize methods that yield objective, verifiable, and statistically analyzable data for efficacy and safety endpoints, while acknowledging the potential complementary role of qualitative methods for specific exploratory objectives, provided they are appropriately designed and integrated.

Scenario Analysis: This scenario presents a common challenge in randomized controlled trials (RCTs) where a participant’s perceived benefit from an investigational product might lead them to question the integrity of the randomization process. Maintaining participant trust and adherence to the protocol is paramount for the validity of RCT data. The challenge lies in addressing the participant’s concern without compromising the blinding or the integrity of the trial’s design, while also ensuring the participant’s well-being and continued involvement. Correct Approach Analysis: The best professional practice involves acknowledging the participant’s observation, reassuring them about the rigorous nature of RCTs and the importance of maintaining the blind, and gently redirecting their focus back to the study protocol and their role as a participant. This approach involves active listening, empathy, and a clear, concise explanation of why the blind is critical for unbiased results. It reinforces the scientific integrity of the study and educates the participant on the principles of RCTs, thereby fostering continued trust and adherence. This aligns with ethical principles of respect for persons and beneficence, ensuring the participant is informed and their participation is valued within the study’s scientific framework. Incorrect Approaches Analysis: One incorrect approach involves directly confirming or denying the participant’s suspicion about their treatment assignment. This action would immediately break the blind for that participant, compromising the integrity of their data and potentially all data collected from them. It violates the core principle of blinding in RCTs, which is designed to prevent bias in assessment and reporting of outcomes. Another incorrect approach is to dismiss the participant’s concern outright without proper acknowledgment or explanation. This can lead to the participant feeling unheard, undervalued, and may erode their trust in the research team and the study itself. It fails to uphold the ethical obligation to treat participants with respect and to ensure they understand their role and the study’s purpose. Such dismissal could also lead to increased anxiety or non-compliance. A further incorrect approach is to offer the participant a change in their treatment assignment or to suggest they might be receiving the placebo. This directly undermines the randomization process and the study’s scientific validity. It introduces bias and deviates from the established protocol, rendering the participant’s data unreliable for analysis. This action is ethically unsound as it manipulates the study design based on a participant’s subjective experience. Professional Reasoning: When faced with a participant questioning their treatment assignment in an RCT, a clinical research professional should employ a decision-making framework that prioritizes participant trust, protocol adherence, and scientific integrity. The framework involves: 1. Active Listening and Empathy: Acknowledge and validate the participant’s feelings and observations. 2. Education and Reassurance: Explain the importance of blinding in RCTs in simple terms and reassure them that their concerns are noted but the protocol must be maintained. 3. Protocol Reinforcement: Gently guide the conversation back to the study procedures and the participant’s role. 4. Documentation: Record the participant’s concern and the interaction in the study records. 5. Consultation (if necessary): If the participant remains distressed or if there are safety concerns, consult with the principal investigator or study sponsor.

Scenario Analysis: This scenario presents a common challenge in clinical research where a deviation from the protocol is identified post-hoc. The professional challenge lies in balancing the need for data integrity and patient safety with the practical realities of research conduct. It requires a thorough understanding of regulatory requirements for reporting and addressing deviations, as well as ethical considerations regarding transparency and scientific validity. The urgency of the situation, coupled with the potential impact on the study’s integrity and regulatory standing, necessitates careful and informed decision-making. Correct Approach Analysis: The best professional practice involves immediately documenting the deviation in the source documents, assessing its potential impact on patient safety and data integrity, and promptly notifying the Principal Investigator (PI) and the Institutional Review Board (IRB)/Ethics Committee (EC). This approach aligns with Good Clinical Practice (GCP) guidelines, specifically ICH E6(R2) Section 4.5.1, which mandates that all deviations from the protocol must be documented and reported. Prompt notification ensures that the IRB/EC can assess the situation and provide guidance, and it upholds the ethical principle of transparency with regulatory bodies and study participants. The PI, as the ultimate responsible party for the conduct of the trial, must be fully informed to make critical decisions regarding the study. Incorrect Approaches Analysis: One incorrect approach involves attempting to correct the source documentation without reporting the deviation. This is a serious regulatory and ethical failure as it constitutes data falsification and undermines the integrity of the research record. It violates GCP principles regarding accurate and complete documentation and the ethical obligation of honesty in research. Another incorrect approach is to ignore the deviation, assuming it has no significant impact. This is professionally unacceptable because it bypasses the required assessment of potential risks to patient safety and data validity. It fails to comply with regulatory requirements for deviation management and reporting, potentially leading to the use of unreliable data and compromising the safety of future participants if the issue is systemic. A third incorrect approach is to only report the deviation to the sponsor without informing the PI or the IRB/EC. While sponsor notification is important, it is insufficient. The PI has direct oversight responsibility for the study at the site, and the IRB/EC has the mandate to protect the rights and welfare of human subjects. Failing to inform these parties leaves critical decision-making authority unaddressed and violates the established lines of communication and oversight required by regulatory frameworks. Professional Reasoning: Professionals should employ a systematic approach to deviation management. First, identify and document the deviation thoroughly. Second, assess the immediate and potential impact on patient safety and data integrity. Third, consult relevant study documents, including the protocol and investigator’s brochure, for guidance. Fourth, follow the established reporting lines as per the clinical trial agreement and institutional policies, which typically involve notifying the PI, IRB/EC, and sponsor. Finally, implement corrective and preventive actions (CAPA) to mitigate the impact of the deviation and prevent recurrence. This structured process ensures compliance, protects participants, and maintains the scientific rigor of the research.