Clinical test-based research center project quality risk assessment method

Abstract

The invention discloses a research center project quality risk assessment method based on a clinical test, and the method comprises the steps: obtaining the information of each research center project and a corresponding risk factor, carrying out the grading severity judgment of each project information and the risk factor, giving a score, judging the probability of affecting the quality of the research center project according to the risk factor, and carrying out the evaluation of the quality of the research center project. Each risk factor is endowed with a weight, the score of the grade severity of each risk factor is multiplied by the corresponding weight, the score of each risk factor is obtained and added, the quality risk score of each research center project is obtained, the quality risk of the research center project is evaluated according to the quality risk score of each research center project, and corresponding measures are taken. According to the method, the project quality risk score of each research center is obtained through calculation, the risk identification of the project quality of each research center is realized, corresponding measures are taken according to the evaluation result, existing problems are found and corrected in time, the quality and efficiency of clinical tests are improved, and the overall project quality is ensured.

Description

Technical Field

[0001] The present invention belongs to the technical field of risk assessment, and in particular relates to a method for project quality risk assessment of a research center based on clinical trials. Background Art

[0002] Predicting and evaluating the quality risks of research centers that may occur in drug clinical trials, establishing a risk management system, formulating corresponding response measures, and reducing the impact of risks on projects are important links in project quality assurance. This includes planning risk management, identifying risk centers, implementing risk (qualitative and quantitative) analysis, planning and implementing risk response, and supervising the various processes of risk to ensure that the project proceeds as planned and that the test process of the research center is standardized and controllable.

[0003] Risks in drug clinical trials are generally divided into two categories: risks caused by objective factors and risks caused by subjective factors. Objective factors are adverse reactions determined by the structure of the drug itself. Clinical trials are scientific research and exploration in nature, which involves risks. Subjective factors refer to risks caused by insufficient or excessive intervention due to insufficient consideration or deviation of the design of the study by relevant personnel in clinical research.

[0004] The quality risks of clinical trials have three characteristics: objectivity, uncertainty, and development. Throughout the entire clinical trial process, quality issues are everywhere, and risks are also everywhere. The risks in the implementation phase are mainly reflected in the supporting hardware and software facilities of professional departments, the management experience and guarantee capabilities of the management department, violations of plans during project implementation, and safety risks.

[0005] The risk of the professionalism of the research team is mainly reflected in the following aspects: (1) The experience of the researchers and the research team in clinical trials, including the ability to participate in protocol design, compliance with the trial protocol, the ability to enroll enough subjects, sufficient clinical trial experience, the ability to manage clinical trials, and the research team's ability to collaborate. (2) The clinical trial experience and mobility of the monitor or clinical trial coordinator are important factors in determining the quality of the project in which they participate.

[0006] A project is often launched by dozens of research centers. There are differences in the number of enrollments in each center, the professional experience of the center's research team, the effectiveness of program execution, and the experience of monitors and clinical trial coordinators, which affects the quality risks of each center. The resources and energy that the project team can mobilize are limited, and it is impossible to conduct internal quality control and on-site audits for all research centers. In this case, a quality risk assessment of the research center is very necessary. The main purpose is to identify risk centers in a timely manner. The project team takes a series of measures based on the assessment results (such as internal quality control, project audits, training researchers, etc.) to promptly discover and correct existing problems and invest limited resources in necessary research centers, thereby improving the quality and efficiency of clinical trials and ensuring the overall project quality.

[0007] In the past, the quality risk assessment of research center projects was mainly based on a rough assessment based on the project manager's project experience, without a systematic and data-based quantitative indicator assessment method. This process requires high experience from the assessors, has low reliability, and is prone to errors in the quality risk assessment of research center projects. In serious cases, it may even affect the quality of the entire clinical trial project. This rough empirical assessment method can no longer meet the needs of clinical trials. It is in this context that there is an urgent need to propose a systematic and data-based quantitative indicator assessment method to identify the quality risk level of research center projects in an efficient, accurate, and human resource-saving manner. Summary of the invention

[0008] The purpose of the present invention is to provide a project quality risk assessment method for a research center based on clinical trials. The technical problem to be solved is that projects in the prior art are often roughly assessed based on the experience of project managers, and there is no systematic, data-based, quantitative indicator assessment method.

[0009] To achieve the above object, the present invention provides the following technical solutions: The present invention provides a method for project quality risk assessment of a research center based on clinical trials, comprising: Obtain project information and corresponding risk factors of each research center; Determine the severity of each project information and the corresponding risk factors and assign scores; Determine the probability of risk factors affecting the quality of research center projects and assign weights to each risk factor; Multiply the severity scores of each risk factor by the corresponding weight to get the score of each risk factor. Add up all the risk factor scores to get the project quality risk score of each research center. Based on the project quality risk scores of each research center, assess the project quality risks of the research center and take corresponding measures.

[0010] By obtaining the project information of the research center and the corresponding risk factors, the project quality risk score of each research center is calculated to identify the risks of the project quality of each research center. The project team takes corresponding measures according to the evaluation results, discovers and corrects existing problems in a timely manner, and invests limited resources in necessary research centers, thereby improving the quality and efficiency of clinical trials and ensuring the overall project quality.

[0011] Optionally, the project information of each research center and the corresponding risk factors are obtained by: Establish communication mechanisms with each research center to obtain, including: regular meetings, report submission; Information gathering through project management software and databases; Interviews and surveys were conducted with project leaders and researchers to collect information.

[0012] By obtaining information data on the center's projects from research centers, databases, and project leaders, and by obtaining data from multiple channels, the comprehensiveness and accuracy of the data can be increased.

[0013] Optionally, the risk factors corresponding to the project information of each research center include the number of enrolled cases, the number of early withdrawal cases, the number of clear violations of inclusion and exclusion, the number of clear violations of banned medication, the number of other protocol deviations, CRC professionalism and turnover rate, the experience level and cooperation degree of professional departments and researchers, monitoring level, monitoring level, CRA turnover rate and project quality control structure. By obtaining the risk factors corresponding to each center's project, a multi-range assessment of the research center's project quality risk is conducted based on multiple risk factors.

[0014] Optionally, a grading standard is formulated based on the risk factors corresponding to each project information, and a severity determination is performed to assign scores. The grading standard grades the severity from A to E according to the degree of impact of the risk factor on the project, and each risk factor is assigned a score of 1 to 5 according to the level of the risk factor and the degree of impact on the project. The severity grades A to E correspond to scores of 1 to 5. After the risk factors are graded, scores are assigned to facilitate subsequent evaluation of the project.

[0015] Optionally, the probability of affecting the quality of the research center project is determined based on the risk factors, and weights are assigned to each risk factor, specifically including: Obtain and analyze the probability data of the impact caused by specific risk factors in the company's previous similar projects, refer to the standards and specifications of the relevant industry, understand the frequency and impact of different risks in similar projects, and invite experts with rich experience to evaluate the probability of different risk factors affecting the quality of the project center based on their professional knowledge and experience. By assigning weights to risk factors, multiple risk factors can be considered comprehensively, resources can be allocated in a targeted manner to deal with risks, and the priority of risk treatment can be determined.

[0016] Optional, high probability: The risk often occurs in similar projects, and once it occurs, it may have a significant impact on the project schedule, quality or cost, requiring high attention and preferential treatment. In this case, it is given a weight of 3; Medium probability: The risk has a certain probability of occurrence and has a moderate impact on the project. It needs to be given proper attention and control in project management. In this case, it is given a weight of 2; Low probability: The possibility of risk occurrence is small, and the impact on the project is small. It needs to be monitored during the project. In this case, it is assigned a weight of 1. The weights of each risk factor are assigned based on the probability of risk occurrence in the project and the impact on the project when it occurs.

[0017] Optionally, the research center project quality risk score is calculated using the following formula:

[0018] Where p is the project quality risk score of the research center, wi represents the graded severity score of the i-th risk factor, and xi represents the weight of the i-th risk factor.

[0019] Optionally, the calculated research center project quality risk score is compared with the score range corresponding to the research center project quality risk level to determine the center project quality risk level.

[0020] Optional, [a1, a2), if p is between [a1, a2), then the quality risk of the center project is low risk; [a2, a3), if p is between [a2, a3), then the quality risk of the center project is general risk; [a3, a4), if p is between [a3, a4), then the quality risk of the center project is a relatively high risk; [a4, +∞], if p is between [a4, +∞], then the quality risk of the center project is a major risk.

[0021] The quality risk level of the research center project can be determined in the form of an interval list.

[0022] Optionally, if the quality risk of the center project is judged to be low risk, the overall quality of the project is relatively stable, and conventional project management and quality control measures can be maintained; If the quality risk of the center project is judged as general risk, the overall quality of the project is general, and regular risk assessment is required to ensure that the risk level remains low; If the quality risk of the center project is determined to be a major risk, then there are certain risk factors in the overall quality of the project, which need to be taken seriously. At the same time, it is necessary to conduct in-depth analysis of various risk factors, ensure key risk points, strengthen project quality monitoring, increase inspection frequency, organize relevant personnel to discuss risks and formulate solutions, and promptly rectify problems in the project implementation process; If the quality risk of the center project is determined to be a major risk, the quality of the project faces a greater risk, which may affect the smooth progress of the project and the quality of the results. A special risk response team can be established, consisting of relevant leaders and professionals, to conduct a comprehensive investigation and in-depth analysis of high-risk factors, formulate a detailed risk response plan, adjust project plans and resource allocation, give priority to solving key risk issues, strengthen communication with relevant parties, promptly report risk situations and response measures, regularly evaluate and adjust the effectiveness of risk response measures, ensure that risks are gradually reduced, and select corresponding response measures based on the calculated quality risk level.

[0023] Compared with the prior art, the present invention has the following beneficial effects: 1. The project quality risk assessment method for research centers based on clinical trials of the present invention obtains research center project information and corresponding risk factors, calculates the project quality risk score of each research center, and realizes risk identification of the project quality of each research center. The project team takes corresponding measures according to the assessment results, discovers and corrects existing problems in a timely manner, and invests limited resources in necessary research centers, thereby improving the quality and efficiency of clinical trials and ensuring the overall project quality.

[0024] 2. The project quality risk assessment method for research centers based on clinical trials of the present invention obtains information data of center projects from research centers, databases, and persons in charge of projects. By acquiring data from multiple channels, the comprehensiveness and accuracy of the data are increased. By assigning weights to risk factors, multiple risk factors can be considered comprehensively, resources can be allocated in a targeted manner to deal with risks, and the priority of risk handling can be determined. Corresponding response measures can be selected based on the calculated quality risk level. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 It is a schematic diagram of the process of the present invention. DETAILED DESCRIPTION

[0026] The present invention will be further described below in conjunction with the accompanying drawings. The following embodiments are only used to more clearly illustrate the technical solution of the present invention, and cannot be used to limit the protection scope of the present invention.

[0027] An embodiment, such as Figure 1 As shown, a method for project quality risk assessment of research centers based on clinical trials is provided, including: obtaining project information and corresponding risk factors of each research center, grading the severity of each project information and the corresponding risk factors and assigning scores, judging the probability of affecting the quality of research center projects based on risk factors, assigning weights to each risk factor, multiplying the score of the severity of each risk factor by the corresponding weight to obtain the score of each risk factor, adding up all risk factor scores to obtain the project quality risk score of each research center, and assessing the project quality risk of the research center based on the project quality risk score of each research center, and taking corresponding measures.

[0028] When in use, by obtaining the project information of the research center and the corresponding risk factors, the project quality risk score of each research center is calculated to identify the risks of the project quality of each research center, and the risk level is determined according to the data comparison table. The project team takes corresponding measures according to the evaluation results, discovers and corrects existing problems in a timely manner, and invests limited resources in necessary research centers, thereby improving the quality and efficiency of clinical trials and ensuring the overall project quality.

[0029] In this embodiment, multiple research centers for the current project are preferably targeted, and the project information of each research center and the corresponding risk factor information can be obtained by establishing a communication mechanism with each research center, including: regular meetings, report submissions; information collection through project management software and databases; interviews and surveys with project leaders and researchers to collect information; and obtaining through professional consulting agencies, social media, and online forums.

[0030] More specifically, in this embodiment, by reviewing project plans, requirement documents, technical specifications, etc., these documents usually contain key information such as the project's goals, scope, schedule, budget, and possible technical challenges, sub-element requirements and other risk factors. Project progress reports, quality reports, etc. can reflect the current status of the project and existing problems, and help identify potential risk factors.

[0031] By communicating with the project manager and project members, you can understand the progress of the project, the difficulties and problems encountered, and the awareness and assessment of risks. You can also collect information through holding project meetings, individual interviews, etc.

[0032] By searching the internal knowledge bases established by various organizations, we can find out the lessons learned, risk cases, etc. from previous projects. By consulting the project knowledge base, we can find out the risk factors that may appear in similar projects and provide reference for the current project.

[0033] Projects may be audited by the organization's internal audit department to evaluate the project's management and execution. Audit reports and evaluation results can reveal risks and problems in the project.

[0034] By paying attention to industry dynamics and trends, reading relevant industry reports, research papers, etc., you can understand the common risk factors and challenges in the industry, such as technology development trends, market competition trends, changes in laws and regulations, etc.

[0035] By communicating with the project's suppliers and partners, you can understand their roles and responsibilities in the project, as well as the risks they may face. Issues with suppliers' supply capabilities, quality control, technical support, etc. may affect the progress of the project.

[0036] By communicating with customers and understanding their expectations and needs for the project, as well as their satisfaction with project quality, progress, etc., customer feedback can help identify possible risk factors in the project, such as changes in requirements and decreased customer satisfaction.

[0037] Learn about other practitioners’ experiences and perspectives on similar projects by focusing on project-related topics and discussions in design media and online forums.

[0038] More specifically, in this embodiment, the graded severity determination of risk factors is achieved by referring to the following Table 1: Table 1: Center Name Severity Number of cases Number of early exits Clearly define the number of violations Number of cases of clear violation of the banned drug regulations Other plan deviations CRC Professional Degree Research Center 1 A 0~5 Not Occurred Not Occurred Not Occurred Not Occurred Overall good evaluation (rich experience, high degree of cooperation) Research Center 2 B 6~10 1 case occurred 1 case occurred 1 case occurred Less than 5 cases Overall evaluation is good (average experience, high degree of cooperation) Research Center 3 C 11~15 2~3 cases 2~3 cases 2~3 cases Less than 6 to 10 cases Overall evaluation is average (average experience, average cooperation) …… D 16~20 4 to 5 cases 4 to 5 cases 4 to 5 cases 11 to 20 cases Poor overall evaluation (poor experience, poor coordination) Research Center E >20 More than 5 cases More than 5 cases More than 5 cases More than 20 cases The overall evaluation is poor (poor experience, poor cooperation, and multiple handovers) CRC flow rate Professional department / researcher level and cooperation Monitoring level CRA Turnover Rate Project quality control results …… Risk Factors No staff changes Overall good evaluation (rich experience, high degree of cooperation) Overall evaluation is good (average monitoring experience, good work attitude) No personnel changes After QA audit / co-mo, the center's quality risk conclusion is low risk …… …… / Overall evaluation is good (average experience, high degree of cooperation) Overall evaluation is good (average monitoring experience, good work attitude) / After QA audit / co-mo, the center's quality risk conclusion is general risk …… …… 1 staff change occurred Overall evaluation is good (average experience, average cooperation) Overall evaluation is good (poor monitoring experience, good work attitude) 1 personnel change occurred After QA audit / co-mo, the center's quality risk conclusion is a high risk …… …… / Overall evaluation is good (average experience, poor cooperation) Overall evaluation is good (poor monitoring experience and poor work attitude) / After QA audit / co-mo, the center's quality risk conclusion is a major risk …… …… 2 or more personnel changes occurred Overall evaluation is good (no clinical trial experience, poor compliance) Overall evaluation is good (poor monitoring experience, poor work attitude, and multiple handovers) 2 or more personnel changes occurred Not QA audited / co-mo …… …… In this embodiment, the graded severity of risk factors is sorted in order from low to high according to the five levels of A, B, C, D, and E, and the risk factor graded severity A is assigned a score of 1, severity B is assigned a score of 2, severity C is assigned a score of 3, severity D is assigned a score of 4, and severity E is assigned a score of 5.

[0039] In this embodiment, the severity of the risk factor classification is determined by formulating a grading standard table based on the risk factors in Table 1 to achieve the determination of severity. More specifically, referring to Table 1, in this embodiment, for the risk factor of the number of cases enrolled, if the number of cases enrolled is 0-5, the severity is determined to be A and a score of 1 is assigned. If the number of cases enrolled is 6-10, the severity is determined to be B and a score of 2 is assigned. If the number of cases enrolled is 11-15, the severity is determined to be C and a score of 3 is assigned. If the number of cases enrolled is 16-20, the severity is determined to be D and a score of 4 is assigned. If the number of cases enrolled is greater than 20, the severity is determined to be E and a score of 5 is assigned. In this embodiment, the severity of the risk factors is determined according to the score standard table in Table 1, so it is not repeated here.

[0040] In this embodiment, the project quality score of each research center is calculated by the following formula:

[0041] Where p is the project quality risk score of the research center, wi represents the graded severity score of the i-th risk factor, and xi represents the weight of the i-th risk factor.

[0042] The weights of risk factors in this embodiment are determined based on the probability of the risk factors of the current research center affecting the quality of the center project. Specifically, the probability data of the impact caused by specific risk factors in the company's previous similar projects are obtained and analyzed, and the standards and specifications of related industries are referred to understand the frequency and impact of different risks in similar projects. Invite experts with rich experience to evaluate the probability of different risk factors affecting the quality of the project center and assign weights based on their professional knowledge and experience.

[0043] In this embodiment, the risk factors in the research center project are specifically divided into high probability, medium probability and low probability, among which high probability means that the risk often occurs in similar projects, and once it occurs, it may have a significant impact on the progress, quality or cost of the project, requiring high attention and preferential treatment, and a weight of 3 is assigned at this time; medium probability means that the risk has a certain possibility of occurrence and a moderate impact on the project, requiring appropriate attention and control in project management, and a weight of 2 is assigned at this time; low probability means that the risk is less likely to occur and has a smaller impact on the project, requiring monitoring during the project, and a weight of 1 is assigned at this time.

[0044] In this embodiment, the weight evaluation is achieved by the following method: S1: Invite experts with rich experience and expertise, preferably 10 to 20 people, who can come from different departments within the company or external industry experts; S2: Provide the experts with a list of risk factors and relevant background information, and ask them to independently assess the importance of each risk factor and give weight recommendations; S3: Collect feedback from experts and calculate the average weight of each risk factor and the dispersion of opinions; S4: Feedback the results of the first round to the experts, asking them to refer to the opinions of other experts and re-evaluate the weights of risk factors. The experts can be asked to explain and clarify their own assessments. S5: Repeat steps S3 and S4 until the experts’ opinions converge to a consensus or a predetermined number of rounds is reached; S6: Determine the weights of risk factors based on the last round of expert opinions, preferably using the average weight or median weight method in the prior art for calculation.

[0045] In this embodiment, the severity score of each risk factor is multiplied by the corresponding weight according to the calculation formula to obtain the score of each risk factor. All risk factor scores are added together to obtain the research center project quality risk score. The calculated research center project quality risk score is compared with the corresponding risk level range to determine the quality risk level of the center project.

[0046] In this embodiment, the corresponding score range is [a1, a2), [a2, a3), [a3, a4), [a4, +∞], where a1, a2, a3 and a4 are all integers. Specifically, if p is between [a1, a2), the quality risk of the center project is low risk; if p is between [a2, a3), the quality risk of the center project is general risk; if p is between [a3, a4), the quality risk of the center project is relatively high risk; if p is between [a4, +∞], the quality risk of the center project is significant risk.

[0047] In this embodiment, whether to take measures is determined based on the quality risk level of the determined central project. If the quality risk of the central project is determined to be low risk, the overall quality of the project is relatively stable, and conventional project management and quality monitoring measures can be maintained.

[0048] If the quality risk of the center's project is judged to be general risk, the overall quality of the project is general, and regular risk assessments are required to ensure that the risk level remains low.

[0049] If the quality risk of the center project is judged to be a major risk, then there are certain risk factors in the overall quality of the project, which need to be taken seriously. At the same time, it is necessary to conduct in-depth analysis of various risk factors, ensure key risk points, strengthen project quality monitoring, increase inspection frequency, organize relevant personnel to discuss risks and formulate solutions, and promptly rectify problems encountered during project implementation.

[0050] If the quality risk of the center's project is determined to be a major risk, the quality of the project faces a greater risk, which may affect the smooth progress of the project and the quality of the results. In this regard, a special risk response team can be established, composed of relevant leaders and professionals, to conduct a comprehensive investigation and in-depth analysis of high-risk factors, formulate a detailed risk response plan, adjust project plans and resource allocation, give priority to solving key risk issues, strengthen communication with relevant parties, promptly report risk situations and response measures, regularly evaluate and adjust the effectiveness of risk response measures, and ensure that risks are gradually reduced.

[0051] The embodiments of the present invention are described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementation methods. The above-mentioned specific implementation methods are merely illustrative and not restrictive. Under the enlightenment of the present invention, ordinary technicians in this field can also make many forms without departing from the scope of protection of the purpose of the present invention and the claims, which all fall within the protection of the present invention.

Claims

1. A method for project quality risk assessment of a research center based on clinical trials, characterized by: include: Obtain project information and corresponding risk factors of each research center; Determine the severity of each project information and the corresponding risk factors and assign scores; Determine the probability of risk factors affecting the quality of research center projects and assign weights to each risk factor; Multiply the severity scores of each risk factor by the corresponding weight to get the score of each risk factor. Add up all the risk factor scores to get the project quality risk score of each research center. Based on the project quality risk scores of each research center, assess the project quality risks of the research center and take corresponding measures.

2. The method for project quality risk assessment of a research center based on clinical trials according to claim 1, characterized in that: The project information and corresponding risk factors of each research center are obtained in the following ways: Establish communication mechanisms with each research center to obtain, including: regular meetings, report submission; Information gathering through project management software and databases; Interviews and surveys were conducted with project leaders and researchers to collect information.

3. The method for project quality risk assessment of a research center based on clinical trials according to claim 1, characterized in that: The risk factors corresponding to the project information of each research center include the number of enrolled cases, the number of premature withdrawal cases, the number of clear violations of inclusion and exclusion, the number of clear violations of banned drugs, the number of other protocol deviations, CRC professionalism, CRC turnover rate, the experience level and cooperation degree of professional departments and researchers, the monitoring level, the CRA turnover rate and the project quality control structure.

4. The method for project quality risk assessment of a research center based on clinical trials according to claim 3, characterized in that: A grading standard is formulated based on the risk factors corresponding to each project information, and a severity determination is performed to assign scores. The grading standard grades the severity from A to E according to the degree of impact of the risk factor on the project, and each risk factor is assigned a score of 1 to 5 based on the level of the risk factor and the degree of impact on the project, and the severity grades A to E correspond to scores of 1 to 5.

5. The method for evaluating the quality trend of research center projects based on clinical trials according to claim 4, characterized in that: The probability of affecting the quality of the research center project is determined based on the risk factors, and each risk factor is assigned a weight, specifically including: Obtain and analyze the probability data of the impact caused by specific risk factors in the company's previous similar projects, refer to the standards and specifications of relevant industries, understand the frequency and impact of different risks in similar projects, and invite experts with rich experience to evaluate the probability of different risk factors affecting the quality of the project center based on their professional knowledge and experience.

6. A method for evaluating the quality of research center projects based on clinical trials according to claim 5, characterized in that: High probability: The risk often occurs in similar projects, and once it occurs, it may have a significant impact on the project schedule, quality or cost, requiring high attention and preferential treatment. In this case, it is given a weight of 3; Medium probability: The risk has a certain probability of occurrence and has a moderate impact on the project. It needs to be given proper attention and control in project management. In this case, it is given a weight of 2; Low probability: The risk is less likely to occur and has less impact on the project. It needs to be monitored during the project and is assigned a weight of 1.

7. The method for evaluating the quality of research center projects based on clinical trials according to claim 1, characterized in that: The research center project quality risk score is calculated using the following formula: ， Where p is the project quality risk score of the research center, wi represents the graded severity score of the i-th risk factor, and xi represents the weight of the i-th risk factor.

8. The method for evaluating the quality trend of research center projects based on clinical trials according to claim 7, characterized in that: The calculated research center project quality risk score will be compared with the score range corresponding to the research center project quality risk level to determine the center project quality risk level.

9. A method for evaluating the quality of research center projects based on clinical trials according to claim 8, characterized in that: [a1, a2), if p is between [a1, a2), then the quality risk of the center project is low risk; [a2, a3), if p is between [a2, a3), then the quality risk of the center project is general risk; [a3, a4), if p is between [a3, a4), then the quality risk of the center project is a relatively high risk; [a4, +∞], if p is between [a4, +∞], then the quality risk of the center project is a major risk.

10. A method for evaluating the quality of research center projects based on clinical trials according to claim 9, characterized in that: If the quality risk of the center project is judged to be low risk, the overall quality of the project is relatively stable, and conventional project management and quality control measures can be maintained; If the quality risk of the center project is judged as general risk, the overall quality of the project is general, and regular risk assessment is required to ensure that the risk level remains low; If the quality risk of the center project is determined to be a major risk, then there are certain risk factors in the overall quality of the project, which need to be taken seriously. At the same time, it is necessary to conduct in-depth analysis of various risk factors, ensure key risk points, strengthen project quality monitoring, increase inspection frequency, organize relevant personnel to discuss risks and formulate solutions, and promptly rectify problems in the project implementation process; If the quality risk of the center's project is determined to be a major risk, the quality of the project faces a greater risk, which may affect the smooth progress of the project and the quality of the results. In this regard, a special risk response team can be established, composed of relevant leaders and professionals, to conduct a comprehensive investigation and in-depth analysis of high-risk factors, formulate a detailed risk response plan, adjust project plans and resource allocation, give priority to solving key risk issues, strengthen communication with relevant parties, promptly report risk situations and response measures, regularly evaluate and adjust the effectiveness of risk response measures, and ensure that risks are gradually reduced.

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