Study center field check risk assessment method

Abstract

The invention discloses a research center field check risk assessment method. The method comprises the steps of obtaining project information of each research center and performing risk factor identification; performing grading severity judgment according to the identified risk factors and giving scores; according to the probability that the identified risk factors can influence the on-site checking possibility, each risk is endowed with a weight; multiplying the grading severity score of each risk factor by the corresponding weight, calculating to obtain the score of each risk factor, and adding the scores of all the risk factors to obtain the check risk score of the current research center; according to the risk checking score of the research center, the risk on-site checking possibility of the research center is evaluated, and corresponding measures are taken. Risk factor identification is carried out on acquired project information, risk score calculation is carried out on severity level judgment, the research center is identified in time according to a result to check risk possibility on site, manpower and resources are inclined to carry out preparatory work, and thus on-site check is successfully passed.

Description

Technical Field

[0001] The invention belongs to the technical field of risk assessment methods, and in particular relates to a research center on-site verification risk assessment method. Background Art

[0002] Registration verification is initiated by the Drug Review Center of the State Drug Administration (hereinafter referred to as the Drug Review Center) to verify the authenticity and consistency of drug registration application materials and the commercial production conditions of drugs, check the compliance of drug development and data reliability, and conduct verification activities on the development and production sites around the development and production conditions involved in the application materials for relevant registration applications.

[0003] The on-site inspection of drug clinical trials mainly verifies the registration application materials with the original records and documents of the clinical trials, evaluates whether the trial implementation, data recording and result reporting comply with the trial plan and relevant regulations on drug clinical trials, and pays attention to the protection of subjects. If necessary, random inspections can be conducted on drugs used in clinical trials. The Drug Review Center will notify the verification center and the applicant to conduct registration inspection within a certain period of time after accepting the drug registration application.

[0004] A project often involves dozens of research centers. The verification center will generally conduct on-site verification of 2-4 research centers. The completion status of each center's experiments is different, and the research centers and participating professional departments may have different experiences of on-site verification in recent years, which leads to different risks for each research center to be verified on-site.

[0005] After receiving the registration verification notice from the Drug Review Center and before the on-site verification, during this period of time, the applicant shall promptly assess the risk possibility of each research center being subject to on-site verification, allocate personnel and resources to research centers with a high risk of being inspected, and carry out relevant preparatory work to better pass the on-site verification of the research center and complete the drug registration application.

[0006] In this case, it is very necessary to evaluate the risk possibility of on-site inspection of each research center. The main purpose is to timely identify the risk possibility of on-site inspection of research centers and invest limited resources in research centers with high risk possibility, so as to successfully pass the on-site inspection. The existing technology often makes judgments based on the past experience of personnel, which has certain errors and untimeliness. Summary of the invention

[0007] The purpose of the present invention is to provide a method for risk assessment of on-site inspection of research centers. The technical problem to be solved is that in the prior art, it is necessary to timely identify the possibility of on-site inspection risks of research centers and invest limited resources in research centers with high risk possibilities so as to successfully pass the on-site inspection.

[0008] To achieve the above object, the present invention provides the following technical solutions: The present invention provides a research center on-site verification risk assessment method, comprising: Obtain project information from each research center and identify risk factors; Grading severity and assigning scores based on identified risk factors; Assign weights to each risk based on the probability that the identified risk factor will affect the likelihood of an on-site verification; Multiply the severity score of each risk factor by the corresponding weight to calculate the score of each risk factor, and add up all the risk factor scores to get the current research center verification risk score; Assess the possibility of on-site verification risk for the research center based on the research center's verification risk score and take corresponding measures.

[0009] By identifying risk factors based on the acquired project information, determining their severity levels and assigning scores and weights for score calculation, the possibility of on-site verification risks for research centers can be identified in a timely manner based on their verification risk scores. Limited resources can be invested in research centers with high risk potentials, and manpower and resources can be allocated to preparatory work to successfully pass on-site verifications.

[0010] Optionally, the project information includes: Research content: the subject, objectives, research methods and technical routes of the project; Participants: professional background, technical level, work experience and personnel stability of project team members; Time schedule: project start and end time, key nodes and schedule; Budget: The project's budget amount, funding sources, and spending plan.

[0011] By collecting project information from multiple aspects, we ensure the diversity and completeness of the information, thereby adding rigor to the subsequent evaluation methods.

[0012] Optionally, the risk factors are identified by selecting at least two groups of experts, with at least ten experts in each group, and statistically analyzing their opinions on project risks multiple times through questionnaire surveys until they reach a consensus. By using the Delphi method to identify risk factors, it is possible to fully utilize the experience and knowledge of experts and improve the accuracy and reliability of risk factor identification.

[0013] Optionally, the step of determining the severity of the identified risk factors and assigning scores specifically includes: The risk factors are graded according to the five levels of A, B, C, D, and E from low to high. According to the impact of the risk factors on the project, the risk level of each risk factor is determined and a score is assigned. A is assigned a score of 1 for a low level, B is assigned a score of 2 for a medium-low level, C is assigned a score of 3 for a medium level, D is assigned a score of 4 for a medium-high level, and E is assigned a score of 5 for a high level. By determining the severity of the risk factors, the size of the risk can be presented intuitively, and it is also convenient to compare risks, provide a basis for decision-making, promote the normalization and standardization of risk management, and facilitate the continuous improvement of risk management.

[0014] Optionally, the weighting of each risk is assigned based on the probability that the identified risk factors will affect the possibility of on-site verification, specifically including: Determine the probability assessment standards that affect the possibility of on-site verification, clarify the main aspects of risk factors that affect the possibility of on-site verification, formulate five-level assessment standards: high probability, medium-high probability, medium probability, medium-low probability, and low probability, analyze the characteristics and impact of risk factors, refer to historical data, review risk assessment records and on-site verification situations of similar projects, communicate and evaluate with experienced project managers and experts, and assign weights according to the probability level of risk factors affecting the possibility of on-site verification.

[0015] Optionally, weights are assigned to the probability of the possibility of on-site verification, specifically: High probability: Risk factors involve major changes in relevant core personnel, changes in the external environment have a significant adverse impact on the project, and this impact shows a clear trend. In this case, the weight is given as 5; Medium-high probability: Once the risk factor occurs, it will have a serious impact on the project. There will be certain conflicts and communication barriers among team members, which will affect the collaboration and efficiency of the project, triggering on-site inspections, and the supply of key resources required for the project will show signs of instability. In this case, the weight is given as 4; Medium probability: Some team members are inefficient, but the project progress is not seriously affected. Market demand changes, but the project has room for adjustment. In this case, the weight is 3. Medium-low probability: some team members are absent and the external environment changes, which has an impact on the project. In this case, the weight is 2; Low probability: very accidental behavior between team members and changes in the external environment have no impact on the project, and a weight of 1 is assigned in this case.

[0016] By assigning weights to risk factors, managers can more accurately assess risks, reflect the actual impact of risks, distinguish the importance of risks, optimize resource allocation, develop higher-priority risk response strategies, enhance the transparency and traceability of risk management, promote continuous improvement, and provide reference for future projects.

[0017] Optionally, the verification risk score of the research center is calculated by the following formula:

[0018] In the formula, p is the verification 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. The verification risk score of the research center is calculated directly through the formula.

[0019] Optionally, the calculated verification risk score of the research center is compared with a preset research center verification risk score range to determine the verification risk score level of the research center and take corresponding measures.

[0020] Optionally, the research center verification risk score range is expressed in the form of a mathematical set, specifically: [a1, a2), if p is between [a1, a2), then the verification risk of the research center is low risk; [a2, a3), if p is between [a2, a3), then the verification risk of the research center is general risk; [a3, a4), if p is between [a3, a4), then the verification risk of the research center is relatively high risk; [a4, +∞], if p is between [a4, +∞], the risk verified by the research center is a significant risk.

[0021] Optionally, if the risk determined by the research center is low risk, measures such as continuous monitoring, timely communication and feedback, documentation, training and education will be taken; if the risk determined by the research center is general risk, measures such as strengthened supervision, adjustment of plans, risk communication and formulation of emergency plans will be taken; if the risk determined by the research center is relatively high risk, measures such as special governance, resource allocation, high-level involvement and regular evaluation will be taken; if the risk determined by the research center is major risk, measures such as project suspension, comprehensive evaluation, multi-party cooperation and risk transfer will be taken. By comparing the risk score verified by the research center with the preset range, the final score will be obtained, so as to formulate a detailed risk response guide, clarify the specific response methods under different risk levels, and improve the pertinence and effectiveness of the response measures.

[0022] Compared with the prior art, the present invention has the following beneficial effects: 1. The research center on-site verification risk assessment method of the present invention identifies risk factors of the acquired project information, assigns scores and weights to calculate scores after determining the severity level, and timely identifies the possibility of on-site verification risks of the research center according to the research center verification risk score, invests limited resources in research centers with high risk possibilities, and allocates manpower and resources to preparatory work, so as to successfully pass the on-site verification.

[0023] 2. The research center on-site verification risk assessment method of the present invention can intuitively present the size of the risk by determining the severity of the risk factors, and is convenient for comparing risks, providing a basis for decision-making, promoting the normalization and standardization of risk management, and facilitating continuous improvement of risk management. By assigning weights to risk factors, it is convenient for managers to assess risks more accurately, reflect the actual impact of risks, distinguish the importance of risks, optimize resource allocation, formulate more prioritized risk response strategies, enhance the transparency and traceability of risk management, promote continuous improvement, and provide a reference for future projects. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 It is a schematic diagram of the process of the present invention. DETAILED DESCRIPTION

[0025] 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.

[0026] An embodiment, such as Figure 1 As shown, a method for assessing the risk of on-site verification of research centers is provided, including: obtaining project information of each research center and identifying risk factors; making graded severity determinations based on the identified risk factors and assigning scores to them; assigning weights to each risk factor based on the probability that the identified risk factors affect the possibility of on-site verification; substituting the new graded severity score of each risk factor and the corresponding weight into the formula to calculate the score of each risk factor, adding up all the risk factor scores to obtain the verification risk score of the current research center; assessing the possibility of on-site verification risk of the research center based on the research center verification risk score, and taking corresponding measures; and establishing a dynamic monitoring mechanism for risk factors to continuously pay attention to changes in risk factors during project implementation and adjust response measures accordingly.

[0027] When used, this method identifies risk factors based on the acquired project information, determines the severity level, assigns points and weights to calculate the scores, and promptly identifies the possibility of on-site verification risks for research centers based on their verification risk scores. Limited resources are invested in research centers with high risk possibilities, and manpower and resources are allocated to preparatory work, thereby successfully passing the on-site verification.

[0028] In this embodiment, when obtaining project information, it is preferred to determine the source of information, that is, communicate with the responsible persons of each research center to obtain detailed information of the project, consult the project files, reports and documents of the research center line, including project plans, progress reports, budget statements, and interview the researchers, technicians and other relevant personnel involved in the project to understand the actual situation of the project; At the same time, in this embodiment, the collected project information includes: Research content: the subject, objectives, research methods and technical routes of the project; Participants: professional background, technical level, work experience and personnel stability of project team members; Time schedule: project start and end time, key nodes and schedule; Budget: The project's budget amount, funding sources, and spending plan.

[0029] More specifically, referring to Table 1, the research center project information in this embodiment includes: the number of informed cases, the number of enrolled cases, the number of completed cases, the number of early withdrawal cases, the number of excluded cases, the AE incidence rate, the number of SAEs, the number of protocol deviations, whether the research center has undergone on-site verification in the past year, whether the research center has undergone on-site verification in the past three years, whether the professional department has undergone on-site verification in the past year, whether the professional department has undergone on-site verification in the past three years, and on-site verification structure interview (whether passed, if not, it is recommended to collect the reasons).

[0030] Table 1: Number of cases informed Number of cases Number of completed cases Number of early exits Number of cases eliminated AE incidence SAE quantity examples Number of deviations from the plan Research Center 1 Research Center 2 Research Center 3 Research Center 4 …… Research Center Continued from the table: Has the research center been subject to on-site inspection in the past year? Has the research center been subject to on-site inspection in the past three years? Has the professional department received on-site inspection in the past year? Have the professional departments been subject to on-site inspections in the past three years? Description of on-site inspection results (whether it passed, and if not, suggest reasons for collection) …… Information The risk factor identification in this embodiment is carried out by selecting at least two groups of experts, each group of experts has at least ten experts, and adopting the Delphi method in the prior art to statistically analyze their opinions on project risks for multiple times until they reach a consensus, which specifically includes determining the purpose and questions of the survey, involving questionnaires, selecting appropriate experts, sending survey documents, experts answering questions in the questionnaire based on their own experience and knowledge, collecting experts' answers, conducting statistical analysis, adjusting and modifying the questionnaire based on the analysis results, and sending it to experts for answers again, and repeating the above steps multiple times until the experts' opinions reach a consensus.

[0031] The risk factors in this embodiment involve: Technical risks: Assess whether the technology involved in the project is complex and advanced, whether there are any unresolved technical problems, whether the technology used in the project is mature and reliable, whether it has been fully verified and tested, whether the technical field involved in the project is developing rapidly, and whether there is a risk of technological upgrading.

[0032] Personnel risks: Analyze the stability of project team members, whether there is a risk of staff loss, evaluate whether the professional skills and experience of project team members meet the needs of the project, observe whether the communication and collaboration between project team members are smooth, and whether there are any team collaboration problems.

[0033] Time schedule risk: Check whether the project schedule is reasonable and whether there is a risk of project delay. Pay attention to whether the key nodes of the project can be completed on time and whether there is a risk of delay in key nodes.

[0034] Budget risk: Analyze whether the project budget is reasonable and whether there is a risk of budget overruns; consider whether the project's funding source is stable and whether there is a risk of funding shortages.

[0035] External environmental risks: Pay attention to whether national and local policies and regulations have changed and whether they have an impact on the project; analyze whether market demand has changed and whether it affects the feasibility and commercial value of the project; understand the dynamics of competitors and whether there is a risk that competitors' actions will threaten the project.

[0036] Reference Table 2 is a table of risk factors identified based on project information and their corresponding severity ratings: Severity Number of cases Number of early exits Number of cases eliminated AE incidence SAE number Number of deviations from the plan A 0-5 Not Occurred Not Occurred [55-75%) Not Occurred Not Occurred B 6-10 1 case occurred 1 case occurred [75-90%) Less than 5 cases Less than 5 cases C 11-15 2~3 cases 2~3 cases [25-55%) 6 to 10 cases 6 to 10 cases D 16-20 4 to 5 cases 4 to 5 cases [90-150%) 11 to 20 cases 11 to 20 cases E >20 More than 5 cases More than 5 cases [0%-25%) More than 20 cases More than 20 cases Continued from the table: The last time the study center was checked PI filing time Routine supervision and inspection results Registration Verification Results …… Risk Factors In the past year 2019 pass pass 2020 In the past three years 2021 After rectification, Passed after due inspection / rectification 2022 none none none 2023 Order rectification / issue warning letter Order rectification / issue warning letter In this embodiment, the risk factors are graded into five levels of severity from low to high, namely A, B, C, D, and E. According to the impact of the risk factors on the project, the risk level of each risk factor is determined and a score is assigned, where A is a low level with a score of 1, B is a medium-low level with a score of 2, C is a medium level with a score of 3, D is a medium-high level with a score of 4, and E is a high level with a score of 5.

[0037] More specifically, referring to Table 2, for the number of cases included in the risk factor, if the number of cases included is 0-5, it is determined to be Class A and is assigned a score of 1; if the number of cases included is 6-10, it is determined to be Class B and is assigned a score of 2; if the number of cases included is 11-15, it is determined to be Class C and is assigned a score of 3; if the number of cases included is 16-20, it is determined to be Class D and is assigned a score of 4; if the number of cases included is more than 20, it is determined to be Class E and is assigned a score of 5. In this embodiment, other risk factors are determined according to the standards given in Table 2 above, and the principles are the same, so they will not be repeated here.

[0038] More specifically, in this embodiment, according to the probability that the identified risk factors will affect the possibility of on-site verification, each risk is weighted, including: Determine the probability assessment standards that affect the possibility of on-site verification: clarify the main aspects of risk factors that affect the possibility of on-site verification. For example, the occurrence of risk factors may lead to project delays, quality decline, cost overruns, etc., all of which may increase the necessity and urgency of on-site verification; formulate five level standards for evaluation: high probability, medium-high probability, medium probability, medium-low probability and low probability, or use specific probability intervals to express them.

[0039] Analyze the characteristics and impact of each risk factor: For each identified risk factor, conduct in-depth research on its nature, possibility of occurrence, and potential impact on the project. Risk factors with high technical difficulty: Consider the complexity and innovation of the technology, as well as the required expertise and skill level. If the technical difficulty is very high, it may take more time and resources to solve the problem, thereby increasing the possibility of on-site verification. Risk factors with possible high staff turnover: Analyze the stability of the project team, the importance of personnel, and the impact of personnel turnover on project progress and quality. If key personnel are lost, it may seriously affect the progress of the project and increase the probability of on-site verification. Based on the characteristics of the risk factors, preliminarily determine the probability level of their impact on the possibility of verification.

[0040] Refer to historical data and lessons learned: Review risk assessment records and on-site verification of similar projects to understand how different risk factors manifest themselves in time projects and their impact on on-site verification. Communicate with experienced project managers and experts to listen to their views and suggestions on the impact of different risk factors on the possibility of on-site verification, and assign weights based on the probability level of the risk factors’ impact on the possibility of on-site verification.

[0041] In this embodiment, weights are assigned to the probability of the possibility of on-site verification, specifically: High probability: After the risk factor occurs, there is a probability of more than 80% that it will affect the on-site inspection. The risk factor has extremely high certainty and urgency. For example, key technical problems are almost certain to occur and seriously affect the project progress, resulting in a high possibility of on-site inspection; major changes involving relevant core personnel, such as the confirmed resignation of the project leader or major technical backbone, will seriously hinder the advancement of the project, which is very likely to trigger an on-site inspection; changes in the external environment have a significant adverse impact on the project, and this impact has shown an obvious trend, such as major adjustments to policies and regulations directly affect the legality and feasibility of the project, and the weight is given 5 at this time.

[0042] Medium-high probability: After the risk factor occurs, there is a 60%-80% probability that it will affect the on-site inspection. The risk factor has a high probability of occurring, and once it occurs, it will have a more serious impact on the project. For example, the probability of failure of important equipment is high, which may cause delays in the project schedule and increase the possibility of on-site inspections. There are certain conflicts and communication barriers between team members, which may affect the collaboration and efficiency of the project, and there is a high probability of attracting on-site inspection attention. There are signs of instability in the supply of key resources required for the project, such as tight supply of raw materials or large price fluctuations, which may affect the normal progress of the project, and thus have a medium-to-high probability of triggering on-site inspections. In this case, the weight is given as 4.

[0043] Medium probability: After the risk factor occurs, there is a 40%-60% probability of affecting the on-site inspection. The possibility of the risk factor occurring and the degree of impact on the project are at a medium level. For example, general technical problems may occur, but there are certain solutions. There is a certain impact on the project progress, which may cause an on-site inspection. The work efficiency of some team members is low, but it will not seriously affect the project progress. There is a certain probability of causing an on-site inspection. There are certain changes in market demand, but the project has a certain adjustment space. The probability of triggering an on-site inspection is medium, and the weight is given at this time 3.

[0044] Medium-low probability: After the risk factor occurs, there is a 20% - 40% probability of affecting the on-site inspection. The probability of the risk factor occurring is relatively low, and the impact on the project is relatively limited. For example, some minor technical flaws may occur, but they do not affect the overall progress and quality of the project, and the possibility of triggering an on-site inspection is small. Occasional absences of team members or minor miscommunication have little impact on the project, and there is a medium-to-low probability of triggering an on-site inspection. Slight changes in the external environment have no obvious impact on the project, and there is a medium-to-low probability of leading to an on-site inspection. In this case, the weight is given as 2.

[0045] Low probability: After the risk factor occurs, there is a probability of less than 20% that it will affect the on-site inspection. The probability of the risk factor occurring is extremely small, and even if it does occur, the impact on the project is minimal. For example, very rare equipment failures or extreme weather conditions have little impact on the project and are almost impossible to trigger an on-site inspection. Very accidental behaviors of team members, such as sudden illness, have little impact on the project and are unlikely to trigger an on-site inspection. Extremely small probability changes in the external environment have basically no impact on the project and are very unlikely to trigger an on-site inspection. In this case, a weight of 1 is assigned.

[0046] This embodiment also provides a calculation formula for the verification risk score of the research center:

[0047] Where p is the verification risk score of the research center, wi represents the graded severity score of the ith risk factor, and xi represents the weight of the ith risk factor.

[0048] In this embodiment, the verification risk score of the research center calculated by the above calculation formula is compared with the preset research center verification risk score range to determine the verification risk score level of the research center and take corresponding measures. The preset research center verification risk score range is as follows: [a1, a2), if p is between [a1, a2), then the verification risk of the research center is low risk; [a2, a3), if p is between [a2, a3), then the verification risk of the research center is general risk; [a3, a4), if p is between [a3, a4), then the verification risk of the research center is relatively high risk; [a4, +∞], if p is between [a4, +∞], the risk verified by the research center is a significant risk.

[0049] In this embodiment, corresponding measures are taken according to the level of risk score verification, specifically: Low risk: Maintain daily monitoring of risk factors to ensure that the risk situation does not deteriorate. This can be done by regularly collecting project information and observing changes in monitoring indicators. Maintain good communication with project team members to keep abreast of potential problems in the project progress. Encourage team members to proactively report possible risk signs. Record the risk assessment process and results, as well as the monitoring measures taken, in detail. This will provide a reference for future projects and also facilitate review and analysis when necessary. Provide risk awareness training to project team members to improve their ability to identify and respond to potential risks. This can be done by organizing internal training courses and sharing cases.

[0050] General risks: Increase supervision of the project to ensure that the project proceeds as planned. You can designate someone to oversee the project progress, quality, and cost. According to the results of the risk assessment, make appropriate adjustments to the project plan. For example, arrange resources reasonably, optimize work processes, adjust project progress, etc. to reduce the impact of risks. Communicate risks with relevant stakeholders in a timely manner, including project team members, superiors, partners, etc. Inform them of the risk status and measures taken to gain their support and cooperation. Develop emergency plans to deal with possible risk events. Emergency plans should include emergency response processes, division of responsibilities, resource allocation, etc.

[0051] Major risks: For major risk factors, a special governance team is established to develop a detailed governance plan. The special governance team is responsible for coordinating resources from all parties and taking effective measures to reduce risks. According to the needs of risk governance, human, material and financial resources are reasonably allocated. Resources can be transferred from other projects, or additional resource support can be applied for. Risk status should be reported to superiors in a timely manner to gain support and decision-making from senior leaders. Senior leaders can coordinate resources from all parties to promote the smooth progress of risk governance. Regular assessment of risks should be strengthened and governance measures should be adjusted in a timely manner. According to changes in risks, governance plans should be continuously optimized to ensure that risks are effectively controlled.

[0052] Major risks: When the risk situation seriously affects the progress of the project, consider suspending the project. Suspending the project can avoid further expansion of risks and buy time for formulating effective response measures. Conduct a comprehensive assessment of the project, including risk status, project goals, resource requirements, etc., and re-formulate the project plan and risk response strategy based on the assessment results. Seek support from external professional institutions or experts to jointly formulate risk governance plans. You can cooperate with experts and consulting companies in related fields to solve risk problems with their expertise and experience. If necessary, consider transferring risks to other parties. For example, purchase insurance, sign contracts, etc. to transfer part of the risks to insurance companies or partners.

[0053] More specifically, in this embodiment, a dynamic monitoring mechanism for risk factors is established to continuously monitor changes in risk factors during project implementation, including: Establish monitoring indicators: determine a series of monitoring indicators that can reflect changes in risk factors, such as project schedule deviation rate, staff turnover rate, speed of technological change, etc. For each risk factor, clearly define the relevant monitoring indicators and set a reasonable threshold range.

[0054] Regular monitoring and evaluation: During the implementation of the project, monitoring indicators are collected and analyzed according to a predetermined time period (such as weekly or monthly). The actual monitoring values ​​are compared with the set thresholds to determine whether the severity of the risk factors has changed and whether the probability of affecting the possibility of on-site verification has changed.

[0055] Adjustment trigger mechanism: When the monitoring indicator exceeds the threshold range, the risk factor adjustment mechanism is triggered. For example, if the staff turnover rate exceeds a certain proportion, the classification severity and weight of the staff turnover risk factor need to be re-evaluated.

[0056] Adjustment process: Once the adjustment mechanism is triggered, a dedicated risk assessment team will reassess the risk factors. Based on the latest project conditions and monitoring data, the risk factors’ severity classification, weight assignment, and risk score calculation will be adjusted. At the same time, other risk factors that may be affected will also be reviewed and assessed.

[0057] Update of response measures: Re-evaluate the risk possibility based on the adjusted risk score and update the response measures accordingly. If the risk is reduced, the intensity of risk control can be appropriately reduced; if the risk is increased, it is necessary to strengthen risk control measures, such as increasing resource investment, adjusting project plans, strengthening communication and coordination, etc. 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 research center on-site verification risk assessment method, characterized by: include: Obtain project information from each research center and identify risk factors; Grading severity and assigning scores based on identified risk factors; Assign weights to each risk based on the probability that the identified risk factor will affect the likelihood of an on-site verification; Multiply the severity score of each risk factor by the corresponding weight to calculate the score of each risk factor, and add up all the risk factor scores to get the current research center verification risk score; Assess the possibility of on-site verification risk for the research center based on the research center's verification risk score and take corresponding measures.

2. A research center on-site verification risk assessment method according to claim 1, characterized in that: The project information includes: Research content: the subject, objectives, research methods and technical routes of the project; Participants: professional background, technical level, work experience and personnel stability of project team members; Time schedule: project start and end time, key nodes and schedule; Budget: The project's budget amount, funding sources, and spending plan.

3. A research center on-site verification risk assessment method according to claim 2, characterized in that: The risk factors are identified by selecting at least two groups of experts, each group of experts having at least ten people, and statistically analyzing their opinions on project risks multiple times through questionnaire surveys until they reach a consensus.

4. A research center on-site verification risk assessment method according to claim 3, characterized in that: The severity of the identified risk factors is graded and scored, specifically including: The risk factors are graded into severity levels from low to high according to five levels: A, B, C, D, and E. According to the impact of the risk factors on the project, the risk level of each risk factor is determined and a score is assigned. A is a low level with a score of 1, B is a medium-low level with a score of 2, C is a medium level with a score of 3, D is a medium-high level with a score of 4, and E is a high level with a score of 5.

5. A research center on-site verification risk assessment method according to claim 4, characterized in that: The identified risk factors are weighted according to their probability of affecting the possibility of on-site verification, including: Determine the probability assessment standards that affect the possibility of on-site verification, clarify the main aspects of risk factors that affect the possibility of on-site verification, formulate five-level assessment standards: high probability, medium-high probability, medium probability, medium-low probability, and low probability, analyze the characteristics and impact of risk factors, refer to historical data, review risk assessment records and on-site verification situations of similar projects, communicate and evaluate with experienced project managers and experts, and assign weights according to the probability level of risk factors affecting the possibility of on-site verification.

6. A research center on-site verification risk assessment method according to claim 5, characterized in that: Weights are assigned to the probability of the possibility of on-site verification, specifically: High probability: Risk factors involve major changes in relevant core personnel, changes in the external environment have a significant adverse impact on the project, and this impact shows a clear trend. In this case, the weight is given as 5; Medium-high probability: Once the risk factor occurs, it will have a serious impact on the project. There will be certain conflicts and communication barriers among team members, which will affect the collaboration and efficiency of the project, triggering on-site inspections, and the supply of key resources required for the project will show signs of instability. In this case, the weight is given as 4; Medium probability: Some team members are inefficient, but the project progress is not seriously affected. Market demand changes, but the project has room for adjustment. In this case, the weight is 3. Medium-low probability: some team members are absent and the external environment changes, which has an impact on the project. In this case, the weight is 2; Low probability: very accidental behavior between team members and changes in the external environment have no impact on the project, and a weight of 1 is assigned in this case.

7. A research center on-site verification risk assessment method according to claim 6, characterized in that: The verification risk score for the study center was calculated using the following formula: ， Where p is the verification risk score of the research center, wi represents the graded severity score of the ith risk factor, and xi represents the weight of the ith risk factor.

8. A research center on-site verification risk assessment method according to claim 7, characterized in that: The calculated verification risk score of the research center will be compared with the preset verification risk score range of the research center to determine the verification risk score level of the research center and take corresponding measures.

9. A research center on-site verification risk assessment method according to claim 8, characterized in that: The research center verification risk score range is expressed in the form of a mathematical set, specifically: [a1, a2), if p is between [a1, a2), then the verification risk of the research center is low risk; [a2, a3), if p is between [a2, a3), then the verification risk of the research center is general risk; [a3, a4), if p is between [a3, a4), then the verification risk of the research center is relatively high risk; [a4, +∞], if p is between [a4, +∞], the risk verified by the research center is a significant risk.

10. A research center on-site verification risk assessment method according to claim 8, characterized in that: If the research center verifies that the risk is low, measures such as continuous monitoring, timely communication and feedback, documentation, and training and education will be taken; if the research center verifies that the risk is general, measures such as strengthening supervision, adjusting plans, risk communication, and formulation of emergency plans will be taken; If the research center verifies that the risk is a major risk, it will take measures such as special governance, resource allocation, high-level involvement, and regular evaluation; If the research center verifies that the risk is a major risk, it will take measures such as suspending the project, comprehensive assessment, multi-party cooperation and risk transfer.

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