A method and system for electronic payment of clinical trial participants

Abstract

The present application provides a kind of clinical trial participant electronic payment method and system, it is related to medical informatization electronic payment field, including: the establishment condition of each compensation subject, aggregation mode and amount parameter are configured, obtain subject configuration information;Obtain the information and state data of claim corresponding to payment application;The performance determination of each to be accounted unit is carried out, and the performance state is obtained;According to subject configuration information and performance state, the expected payable amount of each to be accounted unit is accounted;The claim amount of each to be accounted unit is compared with the corresponding expected payable amount, and each to be accounted unit is classified in combination with performance state;According to the classification result of each to be accounted unit, determine the to be accounted unit that meets the payment condition and initiate electronic payment to it, obtain payment result.The present application realizes that to be accounted unit of different completion state, different confirmation progress can be distinguished and processed and respectively promoted subsequent payment.

Description

Technical Field

[0001] This invention relates to the field of electronic payment technology in medical information, and in particular to an electronic payment method and system for clinical trial participants. Background Technology

[0002] Compensation for participants typically includes compensation for participation in visits, transportation allowances, and reimbursement for food and lodging or individual procedure allowances as specified in the ethics approval document. In domestic practice, the examination and testing fees stipulated in the protocol are generally settled between the hospital and the sponsor, and are not distributed to participants according to the completion rate; trial-related injuries are handled through safety reports and insurance or sponsor claims, and are not accounted for in the same way as visit compensation.

[0003] There are roughly three existing methods for disbursing compensation to test subjects. The first is manual offline settlement. The second is using a general payment channel, but this often requires manual adjustment of the merged amount or suspending the entire application for processing. The third is relying on the visit completion status and merged visit markers in the clinical trial management system, supplemented by manual confirmation, to determine the attribution of attendance to planned visits. However, after the attribution is determined, the entire visit is often priced uniformly. If there is even one unresolved issue in the same payment application, the entire application will be pending.

[0004] Chinese invention patent CN106471506A discloses an immersive software-as-a-service patient licensing platform for clinical trial participants. This platform provides patients, researchers, and sponsors with multiple core modules, including personal health records, messaging, calendars, and payment services. The payment service module is used to initiate and process payment requests within the platform and supports multiple payment channels such as credit cards, bank transfers, and online payments. It also provides the necessary payment services for disbursing participant compensation. However, it only describes the initiation and processing of payment requests and the access methods for multiple payment channels. It does not provide specific processing methods for classifying and calculating multiple outstanding expenses incurred by participants during clinical trials based on their respective completion status and advancing payment progress accordingly. Summary of the Invention

[0005] In view of this, the present invention provides an electronic payment method and system for clinical trial participants, which addresses the technical problem in the prior art that it is impossible to classify and calculate multiple outstanding payments based on the completion status of the participant's participation and process them independently. This enables the calculation units with different completion statuses and different confirmation progresses to be distinguished, processed, and subsequently paid separately.

[0006] The technical solution of this invention is implemented as follows: On one hand, the present invention provides an electronic payment method for clinical trial participants, comprising: S1. Based on the subject compensation standards confirmed through ethical review, configure the establishment conditions, aggregation methods, and amount parameters of each compensation item to obtain the item configuration information; S2. Receive payment requests for subjects, obtain the corresponding claim information and status data for payment requests. The claim information includes the claim amount for one or more units to be accounted for, and the status data is used to characterize the completion progress of each unit to be accounted for. S3. Based on the status data, determine the performance of each unit to be accounted for, and obtain the performance status of each unit to be accounted for, where the performance status is performed, not occurred, or pending; where pending status is used to indicate that the status data is insufficient to determine whether the corresponding unit to be accounted for has performed. S4. Based on the account configuration information and performance status, calculate the expected amount payable for each accounting unit, compare the claimed amount of each accounting unit with the corresponding expected amount payable, and in combination with the performance status, classify each accounting unit into one of the following categories: pending certification, rejected, payable, or pending confirmation. The accounting unit classified into the pending certification category has a performance status of pending status. S5. Based on the classification results of each accounting unit, determine the accounting units that meet the payment conditions and initiate electronic payments to them to obtain payment results.

[0007] Based on the above technical solutions, preferably, the subject configuration information includes the establishment conditions, aggregation method, and base amount / reimbursement limit, and step S1 specifically includes: Load the compensation items that have been confirmed through ethical review, and configure the establishment conditions, aggregation methods, and amount parameters for each compensation item to obtain the item parameters for each compensation item; wherein the establishment conditions are taken from the condition type set, which includes node completion type, on-site event type, operation completion type, supplementary event confirmation type, and voucher verification type; the aggregation method includes counting once for each bound plan node, counting once for each trigger event, and counting once for each calendar day; the amount parameter is the base amount or the reimbursement limit; The planned nodes specified in the clinical trial protocol are numbered in sequence, and a time reference point and time tolerance range are configured for each planned node to obtain the node parameters of each planned node. For compensation items whose establishment condition is node completion type, a benchmark amount is configured for each planned node to obtain the benchmark amount of the node completion type compensation item under each planned node. For compensation items whose establishment conditions are on-site event type, operation completion type, or supplementary event confirmation type, corresponding benchmark amounts shall be configured respectively; For compensation accounts whose establishment condition is voucher verification type, configure the corresponding reimbursement limit; the account parameters and node parameters together constitute the account configuration information.

[0008] Based on the above technical solutions, preferably, step S2 specifically includes: Upon receiving a payment application, the claim amount for each accounting unit is determined according to the planned node or unassigned trigger event and the corresponding compensation item. The claim amount for an unassigned accounting unit is recorded as zero. The unassigned trigger event is a trigger event that is not bound to any planned node. Acquire status data, including trigger event details, plan node status, subject recording start and end status, evidence closure status, operation completion status, and voucher verification results. Trigger event details include the occurrence time of each trigger event, the method of participation (on-site or off-site), and the attribution markers assigned to each trigger event by the processing end. Attribution markers include binding markers, missing markers, invalid markers, and supplementary markers. Plan node status includes the completion status markers for each plan node, with values ​​including missing, no longer incomplete, or default. Subject recording start and end status includes the subject's start recording time, end recording time, and exit recording time. Evidence closure status includes event record submission status, objection closed status, record locked status, and consistency between on-site records and event completion status when on-site participation is required by plan nodes. Event completion status values ​​include completed and incomplete, and on-site records indicate whether the subject attended the event and whether the corresponding event was completed on-site. Operation completion status includes operation completed, confirmed but not completed, or completion status unknown. Voucher verification results include verification passed, verification incomplete, or verification failed. For each triggering event, if a binding marker exists, the planned node to which the triggering event is bound is determined based on the binding marker; if a missing marker exists, the corresponding relationship is determined to be a missing planned node; if an invalid marker exists, the corresponding relationship is determined to be invalid; if a supplementary marker exists, the corresponding relationship is determined to be a supplementary event; if no attribution marker exists, the time range of each planned node is first determined, and then the occurrence time of the triggering event is compared with the time range of each planned node; the time range of each planned node is the time tolerance interval of that planned node, which extends to both sides of the time reference point of the planned node by a preset half-width to form a closed interval; if the occurrence time falls within the time range of only one planned node, the triggering event is bound to that planned node; if the occurrence time falls within the time range of two or more planned nodes simultaneously, or if the occurrence time does not fall within the time range of any planned node, the corresponding relationship of the triggering event is determined to be pending confirmation.

[0009] Based on the above technical solutions, preferably, step S3 specifically includes: The performance status of the unit to be accounted for is taken from the performance status of its corresponding planned node or the corresponding triggering event; If the correspondence between the triggering event and the planned node is pending confirmation, then the accounting unit corresponding to the planned node will be classified as pending confirmation and placed in the pending state; triggering events with a correspondence that do not produce performance effect will not participate in the performance determination. For planned nodes whose corresponding relationships are not yet confirmed, determine whether the planned node meets the termination conditions. The termination conditions include the following four items. If any one of them is met, the performance status of the unit to be calculated corresponding to the planned node is determined to be "not occurred": The subject's exit record was earlier than the time reference point of the program node; The corresponding relationship between this triggering event and the planned node is that the planned node is missing; The completion status of this plan node is marked as missing; The time tolerance period for this planned node has expired, and the completion status of this planned node has been marked as no longer incomplete; For planned nodes that do not meet the termination conditions, the performance status is determined based on the closure of evidence: if the closure conditions are met, it is determined to be performed; if the closure conditions are not met, it is considered as insufficient evidence and is classified as pending.

[0010] Based on the above technical solutions, preferably, the closure condition must simultaneously satisfy the following: The event log submission status is "Submitted", the objection closure status is "No unclosed objections", and the log lock status is "Locked". When a planned node requires on-site participation, the on-site record must be consistent with the event completion status, or the planned node must have been confirmed as being completed off-site. If the above conditions are met, the performance status is determined to be "performed"; if any condition is not met, it is considered insufficient evidence and the status is classified as "pending".

[0011] Based on the above technical solutions, preferably, step S4 specifically includes: S41. Based on the establishment conditions in the subject configuration information, determine the condition type to which the establishment conditions of each accounting unit belong; the condition type includes node completion type, on-site event type, operation completion type, supplementary event confirmation type, and voucher verification type; S42. Based on the condition type, and according to the performance status of the corresponding plan node, the evidence closure of the corresponding triggering event, the completion status of the corresponding operation, the confirmation status of the corresponding relationship, or the voucher verification result, determine the expected amount payable for each accounting unit. The expected amount payable for accounting units with a performance status of pending status is marked as pending amount. S43. Compare the claimed amount with the expected payable amount, and determine the category to which each accounting unit belongs based on the comparison results.

[0012] Based on the above technical solutions, preferably, step S42 specifically includes: For conditions of node completion type, the expected amount payable is determined based on the performance status of the corresponding planned node. For nodes that have been performed, the amount is determined according to the corresponding benchmark amount. For nodes that have not occurred, the amount is determined to be zero. Nodes with pending status are marked as having pending amount. Aggregation is only performed on planned nodes. For conditions classified as on-site events, the evidence closure status is determined according to the corresponding benchmark amount if it is closed and involves on-site participation, and zero if it involves non-on-site participation. If the evidence closure status is not closed, the amount is marked as pending. For conditions of type "operation completion", the amount is determined according to the corresponding benchmark if the operation has been completed, zero if it has been confirmed but not completed, and the amount is marked as pending if the completion status is unknown. If the condition type is a supplementary event confirmation type, and the corresponding relationship is a supplementary event, or if the corresponding relationship was originally pending confirmation but was confirmed as a supplementary event corresponding to the compensation account after the attribution confirmation operation, the amount shall be determined according to the corresponding benchmark amount. Unconfirmed ones are marked as pending amount. When the condition type is voucher verification, and the voucher verification result is passed, the expected payable amount for the accounting unit is... Determine by the following formula: in, This is the number of the unit to be calculated. This refers to the compensation account number to which the unit to be accounted for belongs. The amount of the voucher corresponding to the unit to be accounted for. This is the reimbursement limit for the compensation account; when the voucher verification result is incomplete, the expected amount payable is marked as pending; when the voucher verification result is unsuccessful, the expected amount payable is set to zero.

[0013] Based on the above technical solutions, preferably, step S43 specifically includes: Units whose expected payable amount is marked as pending amount are classified as units pending verification. Cases where the expected payable amount is zero but the claimed amount is greater than zero are classified into the rejection unit. If the expected payable amount is determined and greater than zero, and the claimed amount is greater than zero, the portion of the claimed amount exceeding the expected payable amount is placed in the rejection unit, and the portion not exceeding it is placed in the payable unit. The payable amount in the payable unit... Determine by the following formula: in, The amount claimed by the unit to be accounted for. This represents the expected amount payable by the unit to be accounted for. Expected payable amounts that are already determined and greater than zero, and claims for amounts of zero, are classified into the pending confirmation supplementary entry unit.

[0014] Furthermore, step S5 specifically includes: Import the pending verification unit, rejection unit, payable unit and pending confirmation supplementary unit into independent processing flow respectively; A confirmation operation is initiated for the included pending accounting unit. After the confirmation operation is approved, an electronic payment is initiated. If there are pending accounting units in the same payment application that are included in the pending certification or pending confirmation supplementary classification, it will not be used as a condition for the confirmation operation or electronic payment of pending accounting units in the payable classification. For the accounting units to be included in the pending certification category, initiate evidence supplementation or attribution confirmation operations. After the operation is completed, based on the condition type to which they belong, redetermine the corresponding performance status, recalculate the expected amount payable, and redetermine the classification. The payment process for pending accounting units that fall into the rejection category will be terminated. For accounting units that are classified as pending confirmation and supplementary entries, in response to the confirmation operation, they are reclassified into the payable category according to the corresponding expected payable amount and the confirmation operation and electronic payment are executed; in response to the closing operation, their payment process is terminated.

[0015] In addition, the present invention also provides an electronic payment system for clinical trial participants to implement the above-described electronic payment method for clinical trial participants, comprising: The subject configuration module is used to configure the conditions for establishment, aggregation method and amount parameters of each compensation subject according to the subject compensation standards confirmed by ethics review, and obtain subject configuration information; The status acquisition module is used to receive payment applications for subjects, obtain the application information and status data corresponding to the payment applications, the application information includes the application amount of one or more units to be calculated, and the status data is used to characterize the completion progress of each unit to be calculated. The performance determination module is used to determine the performance of each unit to be accounted for based on the status data, and to obtain the performance status of each unit to be accounted for. The performance status is either performed, not occurred, or pending. The pending status indicates that the status data is insufficient to determine whether the corresponding unit to be accounted for has performed. The accounting module is used to calculate the expected amount payable for each accounting unit based on the account configuration information and performance status. It compares the claimed amount of each accounting unit with the corresponding expected amount payable, and, in combination with the performance status, classifies each accounting unit into one of the following categories: pending certification, rejected, payable, or pending confirmation. The accounting unit classified into the pending certification category has a performance status of pending status. The payment module is used to determine the units that meet the payment conditions based on the classification results of each unit to be accounted for, initiate electronic payments to them, and obtain payment results.

[0016] The present invention has the following advantages over the prior art: (1) The calculation and payment of subject compensation are split into units to be calculated, so that the units to be calculated that have the conditions for payment are not affected by other units to be calculated in the same payment application that are still in the state of pending certification or pending confirmation, thereby improving the overall processing efficiency while ensuring the accuracy of the calculation. (2) The subject configuration information is set to configurable parameters including the establishment conditions, aggregation method and base amount / reimbursement limit, so that the pricing rules for different compensation subjects can be set separately according to the standards confirmed by ethical review, which improves the compatibility between accounting rules and compensation standards and reduces accounting deviations caused by differences in subject nature. (3) Based on the comparison results of the claimed amount and the expected payable amount, and in combination with the performance status, each unit to be accounted for is divided into independent categories, and a corresponding independent processing flow is set for each category, so that the processing progress or processing result of any category does not affect the classification result and processing progress of other categories, thereby improving the overall feasibility of the accounting and payment process when there are some abnormalities or pending verification situations. Attached Figure Description

[0017] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0018] Figure 1 This is a flowchart of a clinical trial participant electronic payment method according to the present invention; Figure 2 This is a schematic diagram of the subject configuration information structure for an electronic payment method for clinical trial participants according to the present invention; Figure 3 This is a flowchart illustrating the matching and determination process between triggering events and planned nodes in an electronic payment method for clinical trial participants according to the present invention. Figure 4 This is a payment flowchart for an electronic payment method for clinical trial participants according to the present invention; Figure 5 This is a schematic block diagram of a clinical trial participant electronic payment method according to the present invention. Detailed Implementation

[0019] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0020] As will be understood by those skilled in the art, the technical solution of this invention pre-defines five business roles: subjects, trial researchers, institutional administrators, pharmaceutical company inspectors, and financial personnel. These roles are further isolated by project. The same user can have different roles on different projects and can only access the application information, status data, performance status, expected payment amount, and classification results corresponding to the authorized project. Subjects can only query their own application information, submitted vouchers, and the payment status of their corresponding accounting units. They do not have the authority to fill in the application amount, confirm the classification results, or view the accounting units of other participants. Trial researchers can initiate payment applications, fill in the application amount, upload vouchers, perform evidence supplementation or attribution confirmation operations on the units to be verified, and view the accounting results under their responsible projects and the classification of each accounting unit. They do not have the authority to confirm payable units, initiate electronic payments, or modify account configuration information. Institutional administrators receive and process tasks that are classified into pending certification units or have abnormal classification results requiring manual judgment, and can approve or reject them. They can maintain the subject configuration information for their institution's projects and view the institution's application information, performance status, and classification results. They do not have the authority to directly initiate electronic payments. Changes to subject configuration information must be executed according to the approval process; changes without approval are not effective and will not be included in accounting. Pharmaceutical company inspectors can only query payment applications, performance judgment basis, payment vouchers, and audit evidence under their authorized projects. They do not have the authority to fill in the application amount, perform confirmation operations on classification results, or modify application information or subject configuration information. When reading subject-related information, they do not obtain the subject's original identity identifier. Financial personnel can only execute single or batch electronic payments for pending accounting units that have passed the confirmation operation and are classified into payable units. They can view payment records and payment results, but they do not have the authority to modify application information or skip the confirmation operation to directly initiate electronic payments. If a role or set of permissions changes, a permission change application must be submitted. The change will take effect after approval by a higher-level administrator. The applicant, the permission sets before and after the change, the approver, and the timestamp will all be recorded.

[0021] The above-mentioned permission isolation settings allow the filling, confirmation and payment to be performed by different roles, avoiding the same role from having the permission to fill in the application amount and the permission to initiate electronic payment at the same time. In addition, the changes to the account configuration information are independent of the daily accounting operations, which is in line with the settings that the units to be accounted for are processed separately according to the classification results and the processing flow corresponding to each classification result in step S5 is independent of each other.

[0022] like Figure 1 and Figure 2 As shown, the present invention provides an electronic payment method for clinical trial participants, comprising: S1. Based on the subject compensation standards confirmed through ethical review, configure the establishment conditions, aggregation methods, and amount parameters of each compensation item to obtain the item configuration information.

[0023] Understandably, the subject configuration information originates from the subject cost standard text confirmed by the ethics review, i.e., the costs payable to subjects explicitly listed in the ethics approval document. The configuration process involves users with the appropriate permissions entering each item in the configuration interface provided by the system and submitting it for approval. Configurations before approval are not effective, and the subject configuration information after approval is frozen and saved together with the corresponding protocol version and ethics approval document version. Within the same protocol version, any changes to the frozen establishment conditions, aggregation methods, or benchmark amounts are recorded, including the value before the change, the value after the change, the reason for the change, and the approval information. The changed configuration only applies to newly included participants after the change takes effect, and no retrospective recalculation is performed on payment applications that have already been submitted or pending accounting units that have already been paid. Settlement payments between hospitals and sponsors for examination and testing items, as well as compensation payments for trial-related damages, are not considered costs payable to subjects as listed in the ethics approval document, and therefore are not loaded into the subject configuration information as compensation items. The subject configuration information also includes the effective status, which marks whether the corresponding subject configuration has been approved and is available for accounting under the current scheme version. The values ​​include "under approval", "effective", and "invalid". The effective status of the subject configuration before approval is "under approval" and it does not participate in the accounting of the unit to be accounted for. After approval, the effective status is updated to "effective". Subject configurations that are no longer applicable due to changes in the scheme version or configuration invalidation are updated to "invalid". The effective status of invalid subject configuration information is no longer used for the accounting of newly submitted payment applications, but the historical records that have been completed are not affected.

[0024] Specifically, step S1 includes: Load the compensation items that have been confirmed through ethical review, and configure the establishment conditions, aggregation methods, and amount parameters for each compensation item to obtain the item parameters for each compensation item; wherein the establishment conditions are taken from the condition type set, which includes node completion type, on-site event type, operation completion type, supplementary event confirmation type, and voucher verification type; the aggregation method includes counting once for each bound plan node, counting once for each trigger event, and counting once for each calendar day; the amount parameter is the base amount or the reimbursement limit; Number the planned milestones specified in the clinical trial protocol in chronological order, and denote them as milestones. The time reference point for each planned node is: The half-width of the time tolerance interval is For each planned node, a time reference point and a time tolerance range are configured to obtain the node parameters for each planned node; where the time tolerance range is... This time tolerance range is the time range of the corresponding planned node. For compensation items whose establishment condition is node completion type, a benchmark amount is configured for each planned node to obtain the benchmark amount of the node completion type compensation item under each planned node. For compensation items whose establishment conditions are on-site event type, operation completion type, or supplementary event confirmation type, corresponding benchmark amounts shall be configured respectively; For compensation accounts whose establishment condition is voucher verification type, configure corresponding reimbursement limits to cap the amount of vouchers that have passed verification.

[0025] The reimbursement categories are limited to expenses explicitly listed in the approval document as payable to the subjects. Settlement payments between hospitals and sponsors for examinations and tests, as well as compensation for trial-related damages, are not included in the category configuration information of this method. The same base amount applies to the same reimbursement category under different triggering events or different supplementary events. The reimbursement cap can be configured as a whole for the reimbursement category or separately in conjunction with the planned nodes.

[0026] The condition type set includes: Node Completion Type, which corresponds to compensation items calculated based on whether the planned node is fulfilled (e.g., participation compensation); On-site Event Type, which corresponds to compensation items calculated based on whether on-site attendance occurs (e.g., transportation allowance); Operation Completion Type, which corresponds to compensation items calculated based on whether a specified operation is completed; Supplementary Event Confirmation Type, which corresponds to compensation items calculated based on whether triggering events other than planned nodes are confirmed as valid; and Voucher Verification Type, which corresponds to compensation items calculated based on the audit results of invoices or other vouchers and have a reimbursement cap (e.g., actual reimbursement for transportation or accommodation expenses). "Calculated once per bound planned node" means that multiple planned nodes bound within the same calendar day are calculated separately; "Calculated once per triggering event" means that the same triggering event is calculated only once regardless of whether it is bound to one or more planned nodes; and "Calculated once per calendar day" means that multiple eligible planned nodes within the same calendar day are calculated with only one base amount.

[0027] The time reference point and time tolerance range are derived from the pre-defined plan nodes in the clinical trial protocol and are static configuration information. This invention does not impose specific restrictions on them.

[0028] This invention sets the subject configuration information to configurable parameters including establishment conditions, aggregation method, and base amount / reimbursement limit, so that the pricing rules for different compensation subjects can be set separately according to the standards confirmed by ethical review, instead of relying on applying the same pricing method to all subjects. This improves the compatibility between accounting rules and compensation standards and reduces accounting deviations caused by differences in subject nature.

[0029] S2. Receive payment requests for subjects, obtain the corresponding claim information and status data for payment requests. The claim information includes the claim amount for one or more units to be accounted for, and the status data is used to characterize the completion progress of each unit to be accounted for.

[0030] Understandably, the status data is obtained from clinical trial management systems, electronic data acquisition systems, hospital information systems, or other business systems with equivalent fields that interface with this invention. This invention reads the fields already recorded in the aforementioned systems through an interface. Specifically, the completion status of an operation comes from the completion status field marked by the trial investigator in the clinical trial management system or electronic data acquisition system for each operation-related compensation item (such as puncture, medication administration, follow-up phone calls, etc., corresponding to a single operation allowance). The completion status includes three values: completed, confirmed but not completed, and unknown completion status. An unknown completion status corresponds to the operation not yet marked by the trial investigator or the marked information being incomplete. The voucher verification result comes from the verification conclusion obtained by financial personnel or institutional administrators after manually verifying or automatically verifying the reimbursement vouchers (such as invoices and receipts) submitted by the subjects. The verification result includes three values: passed, not completed, and failed. "Not completed" corresponds to the situation where the voucher has been submitted but the verification has not yet been completed, and "failed" corresponds to the situation where the voucher does not meet the reimbursement requirements after verification.

[0031] like Figure 3 As shown, specifically, step S2 includes: Receive payment applications and determine the claim amount for each pending accounting unit according to the planned nodes or unassigned trigger events and corresponding compensation items. The amount claimed by any unit that has not been reported will be recorded as zero. For compensation item serial number, This is the identifier for the unit to be accounted for; the unassigned triggering event is a triggering event that is not bound to any plan node. Acquire status data, including trigger event details, plan node status, subject recording start and end status, evidence closure status, operation completion status, and voucher verification results. Trigger event details include the occurrence time of each trigger event, the method of participation (on-site or off-site), and the attribution markers assigned to each trigger event by the processing end. Attribution markers include binding markers, missing markers, invalid markers, and supplementary markers. Plan node status includes the completion status markers for each plan node, with values ​​including missing, no longer incomplete, or default. Subject recording start and end status includes the subject's start recording time, end recording time, and exit recording time. Evidence closure status includes event record submission status, objection closed status, record locked status, and consistency between on-site records and event completion status when on-site participation is required by plan nodes. Event completion status values ​​include completed and incomplete, and on-site records indicate whether the subject attended the event and whether the corresponding event was completed on-site. Operation completion status includes operation completed, confirmed but not completed, or completion status unknown. Voucher verification results include verification passed, verification incomplete, or verification failed. For each triggering event, if a binding marker exists, the planned node to which the triggering event is bound is determined based on the binding marker; if a missing marker exists, the corresponding relationship is determined to be a missing planned node; if an invalid marker exists, the corresponding relationship is determined to be invalid; if a supplementary marker exists, the corresponding relationship is determined to be a supplementary event; if no attribution marker exists, the time range of each planned node is first determined, and then the occurrence time of the triggering event is compared with the time range of each planned node; the time range of each planned node is the time tolerance interval of that planned node, which extends to both sides of the time reference point of the planned node by a preset half-width to form a closed interval; if the occurrence time falls within the time range of only one planned node, the triggering event is bound to that planned node; if the occurrence time falls within the time range of two or more planned nodes simultaneously, or if the occurrence time does not fall within the time range of any planned node, the corresponding relationship of the triggering event is determined to be pending confirmation.

[0032] Understandably, the timing of the triggering event, and whether the participation method is on-site or off-site, comes from the attendance information and manual annotation results recorded in the clinical trial management system or electronic data acquisition system. The arrival time can also refer to the arrival date in the hospital information system, access control, or registration records. The binding marker indicates that the triggering event is bound to one or more planning nodes; the missing marker indicates that the corresponding planning node was not completed through the triggering event; the invalid marker indicates that the triggering event does not have the effect of fulfilling the contract; and the supplementary marker indicates that the triggering event is a supplementary event outside the planning node. The completion status marker in the planning node status is used to indicate whether the corresponding planning node has been confirmed as missing or no longer to be completed by the business system, and is a record of the overall status of the planning node by the processing end. The subject's start recording time, end recording time, and exit recording time come from the recording times of business nodes such as enrollment, completion of trial, dropout, or early withdrawal in the clinical trial management system. The consistency between the event record submission status, objection closure status, record locking status, and the on-site record and event completion status when on-site participation is required at planned nodes in the evidence closure process corresponds to whether the visit record or event record has been submitted to the electronic data collection system, whether all related objections to the record have been closed, whether the record has entered the locking status, and whether the record of on-site or off-site participation is consistent with the event completion status. The time reference point is the time point at which the planned node is scheduled to occur; the time tolerance interval is a closed interval that allows the actual occurrence time to deviate from the time reference point. The time range of each planned node is the time tolerance interval, and no additional comparison objects are set outside the time range.

[0033] In one embodiment of the present invention, when determining the correspondence of each triggering event, the binding mark, missing mark, invalid mark, and supplementary mark have higher priority than time comparison. Once the processing end marks any of the above marks, the correspondence is determined by the marking result, and time comparison is no longer performed. Only when there is no belonging mark will the occurrence time of the triggering event be compared with the time reference point and time tolerance range of each planned node one by one.

[0034] S3. Based on the status data, determine the performance of each unit to be accounted for, and obtain the performance status of each unit to be accounted for, where the performance status is performed, not occurred, or pending; where pending status is used to indicate that the status data is insufficient to determine whether the corresponding unit to be accounted for has performed. Specifically, step S3 includes: The performance status of the unit to be accounted for is taken from the performance status of its corresponding planned node or the corresponding triggering event; If the correspondence between the triggering event and the planned node is pending confirmation, then the accounting unit corresponding to the planned node will be classified as pending confirmation and placed in the pending state; triggering events with a correspondence that do not produce performance effect will not participate in the performance determination. For planned nodes whose corresponding relationships are not yet confirmed, determine whether the planned node meets the termination conditions. The termination conditions include the following four items. If any one of them is met, the performance status of the unit to be calculated corresponding to the planned node is determined to be "not occurred": (1) The subject's exit record time is earlier than the time reference point of the program node; (2) The correspondence between this triggering event and the planned node is that the planned node is missing; (3) The completion status of the planned node is marked as missing; (4) The time tolerance interval of the planned node has expired, and the completion status of the planned node is marked as no longer to be completed; For planned nodes that do not meet the termination conditions, the performance status is determined based on the closure of evidence: if the closure conditions are met, it is determined to be performed; if the closure conditions are not met, it is considered as insufficient evidence and is classified as pending.

[0035] Understandably, the above four termination conditions are independent of each other and do not require them to be met simultaneously. In item (4), "the time tolerance interval has passed" and "the completion status is marked as no longer complete" must be met simultaneously to constitute the termination condition for this item.

[0036] This invention sets the performance status to three values: performed, not occurred, or pending. When the status data is insufficient to support the determination of performed or not occurred, the performance status is kept as pending instead of being directly assigned a value of zero. This avoids misjudging a unit that should be valid as invalid because the evidence has not yet been closed, thereby reducing erroneous accounting caused by the lag in the flow of evidence.

[0037] In one embodiment of the present invention, the closure condition must simultaneously satisfy the following: (1) The event log submission status is "submitted", the objection closure status is "no unclosed objections", and the log lock status is "locked". (2) When the planned node requires on-site participation, the on-site record must be consistent with the event completion status, or the planned node must have been confirmed as being completed off-site; If the above conditions are met, the performance status is determined to be "performed"; if any condition is not met, it is considered insufficient evidence and the status is classified as "pending".

[0038] In one embodiment of the present invention, the duration by which a triggering event occurs outside the time tolerance interval corresponding to a planned node is not used as a basis for determining the performance status or for calculating the expected amount payable. That is, as long as the triggering event is bound to the corresponding planned node and the evidence is closed, its performance status is determined according to the same rules as if the event occurred within the time tolerance interval. The duration exceeding the time tolerance interval does not cause a downgrade in the performance status or a proportional reduction in the expected amount payable. This ensures that attendance records outside the time tolerance interval can still obtain accounting results consistent with the prescribed conditions based on established criteria, avoiding inconsistencies in accounting caused by simply calculating based on the duration exceeding the time tolerance interval. The comparison result between the occurrence time of the triggering event and the time tolerance interval is used only once when determining the correspondence, to determine whether the triggering event uniquely falls within the time range of a certain planned node. It is not reused in the performance status determination or expected amount payable calculation stages, preventing window deviation from being directly linked to cost accounting.

[0039] S4. Based on the account configuration information and performance status, calculate the expected amount payable for each accounting unit, compare the claimed amount of each accounting unit with the corresponding expected amount payable, and in combination with the performance status, classify each accounting unit into one of the following categories: pending certification, rejected, payable, or pending confirmation. The accounting unit classified into the pending certification category has a performance status of pending status. Specifically, step S4 includes: S41. Based on the establishment conditions in the subject configuration information, determine the condition type to which the establishment conditions of each accounting unit belong; the condition type includes node completion type, on-site event type, operation completion type, supplementary event confirmation type, and voucher verification type; S42. Based on the condition type, and according to the performance status of the corresponding plan node, the evidence closure of the corresponding triggering event, the completion status of the corresponding operation, the confirmation status of the corresponding relationship, or the voucher verification result, determine the expected amount payable for each accounting unit. The expected amount payable for accounting units with a performance status of pending status is marked as pending amount. S43. Compare the claimed amount with the expected payable amount, and determine the category to which each accounting unit belongs based on the comparison results.

[0040] In one embodiment of the present invention, step S42 specifically includes: For conditions of node completion type, the expected amount payable is determined based on the performance status of the corresponding planned node. For nodes that have been performed, the amount is determined according to the corresponding benchmark amount. For nodes that have not occurred, the amount is determined to be zero. Nodes with pending status are marked as having pending amount. Aggregation is only performed on planned nodes. For conditions classified as on-site events, the evidence closure status is determined according to the corresponding benchmark amount if it is closed and involves on-site participation, and zero if it involves non-on-site participation. If the evidence closure status is not closed, the amount is marked as pending. For conditions of type "operation completion", the amount is determined according to the corresponding benchmark if the operation has been completed, zero if it has been confirmed but not completed, and the amount is marked as pending if the completion status is unknown. If the condition type is a supplementary event confirmation type, and the corresponding relationship is a supplementary event, or if the corresponding relationship was originally pending confirmation but was confirmed as a supplementary event corresponding to the compensation account after the attribution confirmation operation, the amount shall be determined according to the corresponding benchmark amount. Unconfirmed ones are marked as pending amount. When the condition type is voucher verification, and the voucher verification result is passed, the expected payable amount for the accounting unit is... Determine by the following formula: ; in, This is the number of the unit to be calculated. This refers to the compensation account number to which the unit to be accounted for belongs. The amount of the voucher corresponding to the unit to be accounted for. This is the reimbursement limit for the compensation account; when the voucher verification result is incomplete, the expected amount payable is marked as pending; when the voucher verification result is unsuccessful, the expected amount payable is set to zero.

[0041] Understandably, when aggregating planned nodes that have been fulfilled, aggregation is performed according to the aggregation method pre-set in the subject configuration information. The aggregation method of counting each planned node once is mainly applicable to compensation subjects of node completion type; the method of counting once by trigger event is applicable to compensation subjects of on-site event type, operation completion type, and supplementary event confirmation type, meaning that the same compensation subject is only accounted for once for the same trigger event, the same operation item, or the same supplementary event, and will not be repeatedly reimbursed due to multiple pending accounting units under the same event; the method of counting once by calendar day is applicable to compensation subjects of voucher verification type, meaning that the same compensation subject is only accounted for once for multiple vouchers submitted within the same calendar day, and the reimbursement limit is uniformly capped after aggregation by calendar day.

[0042] In one embodiment of the present invention, step S43 specifically includes: Units whose expected payable amount is marked as pending amount are classified as units pending verification. Cases where the expected payable amount is zero but the claimed amount is greater than zero are classified into the rejection unit. If the expected payable amount is determined and greater than zero, and the claimed amount is greater than zero, the portion of the claimed amount exceeding the expected payable amount is placed in the rejection unit, and the portion not exceeding it is placed in the payable unit. The payable amount in the payable unit... Determine by the following formula: ; in, The amount claimed by the unit to be accounted for. This represents the expected amount payable by the unit to be accounted for. Expected payable amounts that are already determined and greater than zero, and claims for amounts of zero, are classified into the pending confirmation supplementary entry unit.

[0043] S5. Based on the classification results of each accounting unit, determine the accounting units that meet the payment conditions and initiate electronic payments to them to obtain payment results.

[0044] like Figure 4 As shown, specifically, step S5 includes: Import the pending verification unit, rejection unit, payable unit and pending confirmation supplementary unit into independent processing flow respectively; A confirmation operation is initiated for the included pending accounting unit. After the confirmation operation is approved, an electronic payment is initiated. If there are pending accounting units in the same payment application that are included in the pending certification or pending confirmation supplementary classification, it will not be used as a condition for the confirmation operation or electronic payment of pending accounting units in the payable classification. For the accounting units to be included in the pending certification category, initiate evidence supplementation or attribution confirmation operations. After the operation is completed, based on the condition type to which they belong, redetermine the corresponding performance status, recalculate the expected amount payable, and redetermine the classification. The payment process for pending accounting units that fall into the rejection category will be terminated. For accounting units that are classified as pending confirmation and supplementary entries, in response to the confirmation operation, they are reclassified into the payable category according to the corresponding expected payable amount and the confirmation operation and electronic payment are executed; in response to the closing operation, their payment process is terminated.

[0045] Understandably, after the evidence supplementation or attribution confirmation operation is completed, the expected amount payable is recalculated according to the condition type of the unit to be verified: If the condition type is a node completion type or a field event type, the performance status of the corresponding planned node or the evidence closure status of the corresponding triggering event is re-determined, and the expected amount payable is recalculated based on the re-determined result; if the condition type is an operation completion type, the experimental researcher supplements the completion status of the operation item, and the expected amount payable is recalculated based on the supplemented completion status; if the condition type is a supplementary event confirmation type, the institution administrator or experimental researcher completes the attribution confirmation operation for the triggering event to be confirmed, and after confirmation, the triggering event is removed from the attribution confirmation status and becomes a valid supplementary event, and the expected amount payable is recalculated based on the result after becoming a valid supplementary event; if the condition type is a voucher verification type, the financial personnel supplement the verification of the incomplete vouchers, and the expected amount payable is recalculated based on the verification result of the supplemented vouchers. After the above recalculation is completed, the units to be verified are reclassified based on the newly obtained expected amount payable.

[0046] This invention breaks down the calculation and payment of subject compensation into separate units. Each unit determines its expected payable amount based on its performance status and account configuration, and is categorized accordingly. This ensures that units ready for payment are not affected by other units in the same payment application that are still pending verification or confirmation, thereby improving overall processing efficiency while maintaining accuracy. Simultaneously, based on the comparison between the claimed amount and the expected payable amount, and considering the performance status, each unit is divided into independent categories, with corresponding independent processing flows for each category. This ensures that the processing progress or result of one category does not affect the classification results or processing progress of other categories, thus improving the overall executability of the calculation and payment process even in cases of anomalies or pending verification.

[0047] The following is an illustration of a specific embodiment, in which the ethics approval document for a certain project stipulates: For each planned node accepted by the processing end, a participant receives a compensation of 200 yuan, calculated once for each bound planned node; for each on-site participant, a transportation subsidy of 50 yuan is provided, paid only once for the same triggering event; no separate allowance is listed for subjects undergoing examinations or tests; and damage compensation is not included in the compensation category of this method. The planned nodes in the scheme... With planned nodes The time ranges partially overlap, allowing for merging: The subject participated in an on-site event once on a certain day, and the processing terminal marked this triggering event as being simultaneously bound to [the relevant data]. and Furthermore, the event logs for both planned nodes have been submitted, and all objections related to attendance have been closed. One approval document, which did not include participant allowances, remains under objection and is not closed. This does not alter the compensation categories already configured in this invention. The researchers applied for two participation compensations and two transportation subsidies for this triggering event. Performance determination uses a binding flag on the processing end. and All have been confirmed as fulfilled, with each participating compensation unit expected to pay 200 yuan. The transportation subsidy, calculated once per trigger event, has an expected payable amount of 50 yuan. Compensation participation is calculated once per planned node; V2 and V3 each generate a pending calculation unit, with a claim amount of 200 yuan and an expected payable amount of 200 yuan for each. Both are categorized as payable, with payable amounts of [amount missing]. Yuan. Transportation subsidies are counted once per triggering event, and each attendance corresponds to only one transportation subsidy calculation unit; the two transportation subsidies reported by the researcher for this triggering event are combined into the claim amount for that unit. Yuan, expected amount payable Yuan, this unit is categorized under the payable category, payable amount Amounts exceeding 50 yuan will not be paid, and no separate rejection category will be generated. Total payable categories After confirmation by the finance staff, electronic payments were initiated for the three payable amounts. In the case where the researcher did not report the "two unclaimed compensation claims," ​​the corresponding accounting unit with a claim amount of zero and an expected payable amount of 200 yuan was categorized as pending confirmation and supplementary entries, and the confirmation and payment of the aforementioned 450 yuan was not prevented. If the processing terminal does not mark the binding flag, and the timing of this triggering event falls within the same period... and The time range, then and All performance statuses are pending confirmation of attribution. The corresponding units to be calculated are assigned to units pending verification. Before confirmation, attribution is not automatically selected based on the time of occurrence. After confirmation, recalculation is performed according to the same rules as when there are existing binding tags. If a researcher only applied for transportation subsidies and did not apply for the two established participation compensations, the two participation compensations are assigned to units pending confirmation. After the researcher confirms, a payable unit is generated. Once closed, no further payments will be made.

[0048] This embodiment corresponds to the scenario of confirming the attribution of triggered events under the node completion type and the on-site event type. For the case where the triggered event itself is marked as pending confirmation under the supplementary event confirmation type, the attribution of the triggered event is also manually confirmed by the institution administrator or experimental researcher. After that, the pending confirmation status is lifted and the event is converted into a valid supplementary event. Then, the expected amount payable is recalculated according to the rules corresponding to the supplementary event confirmation type, and it is no longer automatically assigned to a certain plan node according to the time of occurrence.

[0049] In one embodiment of the present invention, an electronic payment method for clinical trial participants further includes archiving the data and operations generated in each step to form a traceable evidence record. The archived data and operations are not modified once saved, and only new records can be added to meet the requirements for traceability of accounting input conditions, accounting basis and operations.

[0050] The present invention also provides an electronic payment system for clinical trial participants, for implementing the above-described electronic payment method for clinical trial participants, comprising: The subject configuration module is used to configure the conditions for establishment, aggregation method and amount parameters of each compensation subject according to the subject compensation standards confirmed by ethics review, and obtain subject configuration information; The status acquisition module is used to receive payment applications for subjects, obtain the application information and status data corresponding to the payment applications, the application information includes the application amount of one or more units to be calculated, and the status data is used to characterize the completion progress of each unit to be calculated. The performance determination module is used to determine the performance of each unit to be accounted for based on the status data, and to obtain the performance status of each unit to be accounted for. The performance status is either performed, not occurred, or pending. The pending status indicates that the status data is insufficient to determine whether the corresponding unit to be accounted for has performed. The accounting module is used to calculate the expected amount payable for each accounting unit based on the account configuration information and performance status. It compares the claimed amount of each accounting unit with the corresponding expected amount payable, and, in combination with the performance status, classifies each accounting unit into one of the following categories: pending certification, rejected, payable, or pending confirmation. The accounting unit classified into the pending certification category has a performance status of pending status. The payment module is used to determine the units that meet the payment conditions based on the classification results of each unit to be accounted for, initiate electronic payments to them, and obtain payment results.

[0051] like Figure 5As shown, the electronic payment system of this invention includes, at the physical deployment level, a subject terminal, a researcher terminal, an institution administrator terminal, a pharmaceutical company monitor terminal, a finance personnel terminal, a network, a server, a subject configuration library, a pending accounting unit library, an operation log library, and a third-party payment platform. The subject terminal, researcher terminal, institution administrator terminal, pharmaceutical company monitor terminal, and finance personnel terminal correspond to five roles: subject, researcher, institution administrator, pharmaceutical company monitor, and finance personnel, respectively. Each terminal establishes a communication connection with the server via the network and is used to initiate payment applications, fill in or mark status data, approve subject configurations, conduct monitoring and verification, and execute payment confirmations, etc., corresponding to their respective role permissions. The server, as the core processing unit of the system, is used to implement the various processing logics described in the subject configuration module, status acquisition module, performance judgment module, accounting module, and payment module, and communicates with the subject... The system reads and writes data to the configuration library, the unit to be accounted for library, and the operation log library. The account configuration library stores account configuration information and its change approval records. The unit to be accounted for library stores the application information, status data, performance status, expected payable amount, and classification results of each unit to be accounted for. The operation log library archives account configuration changes, accounting processes, and the operational behaviors of each role in an unmodifiable and append-only manner, forming traceable evidence records. After determining that an independent unit meets the payment conditions, the server interacts with the third-party payment platform through the network, sends a payment instruction to initiate electronic payment, and receives the payment result returned by the third-party payment platform.

[0052] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A method for electronic payment to clinical trial participants, characterized in that, include: S1. Based on the subject compensation standards confirmed through ethical review, configure the establishment conditions, aggregation methods, and amount parameters of each compensation item to obtain the item configuration information; S2. Receive payment requests for subjects, obtain the corresponding claim information and status data for payment requests. The claim information includes the claim amount for one or more units to be accounted for, and the status data is used to characterize the completion progress of each unit to be accounted for. S3. Based on the status data, determine the performance of each unit to be accounted for, and obtain the performance status of each unit to be accounted for, where the performance status is performed, not occurred, or pending; where pending status is used to indicate that the status data is insufficient to determine whether the corresponding unit to be accounted for has performed. S4. Based on the account configuration information and performance status, calculate the expected amount payable for each accounting unit, compare the claimed amount of each accounting unit with the corresponding expected amount payable, and in combination with the performance status, classify each accounting unit into one of the following categories: pending certification, rejected, payable, or pending confirmation. The accounting unit classified into the pending certification category has a performance status of pending status. S5. Based on the classification results of each accounting unit, determine the accounting units that meet the payment conditions and initiate electronic payments to them to obtain payment results.

2. The electronic payment method for clinical trial participants as described in claim 1, characterized in that: Step S1 specifically includes: Load the compensation items that have been confirmed through ethical review, and configure the establishment conditions, aggregation methods, and amount parameters for each compensation item to obtain the item parameters for each compensation item; wherein the establishment conditions are taken from the condition type set, which includes node completion type, on-site event type, operation completion type, supplementary event confirmation type, and voucher verification type; the aggregation method includes counting once for each bound plan node, counting once for each trigger event, and counting once for each calendar day; the amount parameter is the base amount or the reimbursement limit; The planned nodes specified in the clinical trial protocol are numbered in sequence, and a time reference point and time tolerance range are configured for each planned node to obtain the node parameters of each planned node. For compensation items whose establishment condition is node completion type, a benchmark amount is configured for each planned node to obtain the benchmark amount of the node completion type compensation item under each planned node. For compensation items whose establishment conditions are on-site event type, operation completion type, or supplementary event confirmation type, corresponding benchmark amounts shall be configured respectively; For compensation accounts whose establishment condition is voucher verification type, configure the corresponding reimbursement limit; the account parameters and node parameters together constitute the account configuration information.

3. The electronic payment method for clinical trial participants as described in claim 2, characterized in that: Step S2 specifically includes: Upon receiving a payment application, the claim amount for each accounting unit is determined according to the planned node or unassigned trigger event and the corresponding compensation item. The claim amount for an unassigned accounting unit is recorded as zero. The unassigned trigger event is a trigger event that is not bound to any planned node. Acquire status data, including trigger event details, plan node status, subject recording start and end status, evidence closure status, operation completion status, and voucher verification results. Trigger event details include the occurrence time of each trigger event, the method of participation (on-site or off-site), and the attribution markers assigned to each trigger event by the processing end. Attribution markers include binding markers, missing markers, invalid markers, and supplementary markers. Plan node status includes the completion status markers for each plan node, with values ​​including missing, no longer incomplete, or default. Subject recording start and end status includes the subject's start recording time, end recording time, and exit recording time. Evidence closure status includes event record submission status, objection closed status, record locked status, and consistency between on-site records and event completion status when on-site participation is required by plan nodes. Event completion status values ​​include completed and incomplete, and on-site records indicate whether the subject attended the event and whether the corresponding event was completed on-site. Operation completion status includes operation completed, confirmed but not completed, or completion status unknown. Voucher verification results include verification passed, verification incomplete, or verification failed. For each triggering event, if a binding marker exists, the planned node to which the triggering event is bound is determined based on the binding marker; if a missing marker exists, the corresponding relationship is determined to be a missing planned node; if an invalid marker exists, the corresponding relationship is determined to be invalid; if a supplementary marker exists, the corresponding relationship is determined to be a supplementary event; if no attribution marker exists, the time range of each planned node is first determined, and then the occurrence time of the triggering event is compared with the time range of each planned node; the time range of each planned node is the time tolerance interval of that planned node, which extends to both sides of the time reference point of the planned node by a preset half-width to form a closed interval; if the occurrence time falls within the time range of only one planned node, the triggering event is bound to that planned node; if the occurrence time falls within the time range of two or more planned nodes simultaneously, or if the occurrence time does not fall within the time range of any planned node, the corresponding relationship of the triggering event is determined to be pending confirmation.

4. The electronic payment method for clinical trial participants as described in claim 3, characterized in that: Step S3 specifically includes: The performance status of the unit to be accounted for is taken from the performance status of its corresponding planned node or the corresponding triggering event; If the correspondence between the triggering event and the planned node is pending confirmation, then the accounting unit corresponding to the planned node will be classified as pending confirmation and placed in the pending state; triggering events with a correspondence that do not produce performance effect will not participate in the performance determination. For planned nodes whose corresponding relationships are not yet confirmed, determine whether the planned node meets the termination conditions. The termination conditions include the following four items. If any one of them is met, the performance status of the unit to be calculated corresponding to the planned node is determined to be "not occurred": The subject's exit record was earlier than the time reference point of the program node; The corresponding relationship between this triggering event and the planned node is that the planned node is missing; The completion status of this plan node is marked as missing; The time tolerance period for this planned node has expired, and the completion status of this planned node has been marked as no longer incomplete; For planned nodes that do not meet the termination conditions, the performance status is determined based on the closure of evidence: if the closure conditions are met, it is determined to be performed; if the closure conditions are not met, it is considered as insufficient evidence and is classified as pending.

5. The electronic payment method for clinical trial participants as described in claim 4, characterized in that: The closure condition must simultaneously satisfy the following: The event log submission status is "Submitted", the objection closure status is "No unclosed objections", and the log lock status is "Locked". When a planned node requires on-site participation, the on-site record must be consistent with the event completion status, or the planned node must have been confirmed as being completed off-site. If the above conditions are met, the performance status is determined to be "performed"; if any condition is not met, it is considered insufficient evidence and the status is classified as "pending".

6. The electronic payment method for clinical trial participants as described in claim 4, characterized in that: Step S4 specifically includes: S41. Based on the establishment conditions in the subject configuration information, determine the condition type to which the establishment conditions of each accounting unit belong; the condition type includes node completion type, on-site event type, operation completion type, supplementary event confirmation type, and voucher verification type; S42. Based on the condition type, and according to the performance status of the corresponding plan node, the evidence closure of the corresponding triggering event, the completion status of the corresponding operation, the confirmation status of the corresponding relationship, or the voucher verification result, determine the expected amount payable for each accounting unit. The expected amount payable for accounting units with a performance status of pending status is marked as pending amount. S43. Compare the claimed amount with the expected payable amount, and determine the category to which each accounting unit belongs based on the comparison results.

7. The electronic payment method for clinical trial participants as described in claim 6, characterized in that: Step S42 specifically includes: For conditions of node completion type, the expected amount payable is determined based on the performance status of the corresponding planned node. For nodes that have been performed, the amount is determined according to the corresponding benchmark amount. For nodes that have not occurred, the amount is determined to be zero. Nodes with pending status are marked as having pending amount. Aggregation is only performed on planned nodes. For conditions classified as on-site events, the evidence closure status is determined according to the corresponding benchmark amount if it is closed and involves on-site participation, and zero if it involves non-on-site participation. If the evidence closure status is not closed, the amount is marked as pending. For conditions of type "operation completion", the amount is determined according to the corresponding benchmark if the operation has been completed, zero if it has been confirmed but not completed, and the amount is marked as pending if the completion status is unknown. If the condition type is a supplementary event confirmation type, and the corresponding relationship is a supplementary event, or if the corresponding relationship was originally pending confirmation but was confirmed as a supplementary event corresponding to the compensation account after the attribution confirmation operation, the amount shall be determined according to the corresponding benchmark amount. Unconfirmed ones are marked as pending amount. When the condition type is voucher verification, and the voucher verification result is passed, the expected payable amount for the accounting unit is... Determine by the following formula: ； in, This is the number of the unit to be calculated. This refers to the compensation account number to which the unit to be accounted for belongs. The amount of the voucher corresponding to the unit to be accounted for. This is the reimbursement limit for the compensation account; when the voucher verification result is incomplete, the expected amount payable is marked as pending; when the voucher verification result is unsuccessful, the expected amount payable is set to zero.

8. The electronic payment method for clinical trial participants as described in claim 7, characterized in that: Step S43 specifically includes: Units whose expected payable amount is marked as pending amount are classified as units pending verification. Cases where the expected payable amount is zero but the claimed amount is greater than zero are classified into the rejection unit. If the expected payable amount is determined and greater than zero, and the claimed amount is greater than zero, the portion of the claimed amount exceeding the expected payable amount is placed in the rejection unit, and the portion not exceeding it is placed in the payable unit. The payable amount in the payable unit... Determine by the following formula: ； in, The amount claimed by the unit to be accounted for. This represents the expected amount payable by the unit to be accounted for. Expected payable amounts that are already determined and greater than zero, and claims for amounts of zero, are classified into the pending confirmation supplementary entry unit.

9. The electronic payment method for clinical trial participants as described in claim 8, characterized in that: Step S5 specifically includes: Import the pending verification unit, rejection unit, payable unit and pending confirmation supplementary unit into independent processing flow respectively; A confirmation operation is initiated for the included pending accounting unit. After the confirmation operation is approved, an electronic payment is initiated. If there are pending accounting units in the same payment application that are included in the pending certification or pending confirmation supplementary classification, it will not be used as a condition for the confirmation operation or electronic payment of pending accounting units in the payable classification. For the accounting units to be included in the pending certification category, initiate evidence supplementation or attribution confirmation operations. After the operation is completed, based on the condition type to which they belong, redetermine the corresponding performance status, recalculate the expected amount payable, and redetermine the classification. The payment process for pending accounting units that fall into the rejection category will be terminated. For accounting units that are classified as pending confirmation and supplementary entries, in response to the confirmation operation, they are reclassified into the payable category according to the corresponding expected payable amount and the confirmation operation and electronic payment are executed; in response to the closing operation, their payment process is terminated.

10. An electronic payment system for clinical trial participants, characterized in that, The system is used to implement an electronic payment method for clinical trial participants as described in any one of claims 1-9, comprising: The subject configuration module is used to configure the conditions for establishment, aggregation method and amount parameters of each compensation subject according to the subject compensation standards confirmed by ethics review, and obtain subject configuration information; The status acquisition module is used to receive payment applications for subjects, obtain the application information and status data corresponding to the payment applications, the application information includes the application amount of one or more units to be calculated, and the status data is used to characterize the completion progress of each unit to be calculated. The performance determination module is used to determine the performance of each unit to be accounted for based on the status data, and to obtain the performance status of each unit to be accounted for. The performance status is either performed, not occurred, or pending. The pending status indicates that the status data is insufficient to determine whether the corresponding unit to be accounted for has performed. The accounting module is used to calculate the expected amount payable for each accounting unit based on the account configuration information and performance status. It compares the claimed amount of each accounting unit with the corresponding expected amount payable, and, in combination with the performance status, classifies each accounting unit into one of the following categories: pending certification, rejected, payable, or pending confirmation. The accounting unit classified into the pending certification category has a performance status of pending status. The payment module is used to determine the units that meet the payment conditions based on the classification results of each unit to be accounted for, initiate electronic payments to them, and obtain payment results.

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