A clinical trial document controlled management system, device, medium and product

Abstract

A clinical trial file controlled management system, device, medium and product relate to the field of file controlled management, in the system, the application generates file authorization information by configuring multiple role collaborative approval processes based on file risk levels through a file application approval module, a controlled printing module executes controlled printing and generates a file identification containing a verification code according to the authorization information, an intelligent distribution module establishes a responsibility association chain and records real-time file status through a code scanning confirmation mechanism, a real-time monitoring module monitors the file use process and generates graded early warning information, a differentiated recovery module executes differentiated recovery strategies and performs integrity checking, a classified archiving module executes classified archiving processing according to the recovery results, and a central control engine coordinates data flow and state synchronization among modules, thereby improving the differentiated control capability, inter-linkage collaborative efficiency and intelligent monitoring level of file management, and realizing the safe, traceable and compliant controlled management of clinical trial files.

Description

Technical Field

[0001] This application falls within the field of controlled document management, and particularly relates to a controlled management system, device, medium, and product for clinical trial documents. Background Technology

[0002] Drug clinical trials are essential for determining drug efficacy and safety. Paper documents, as original records generated during the trial, possess characteristics such as standardization, rationality, and uniqueness, and can elucidate the results obtained or provide evidence of the trial's completion. As the trial progresses, the number of paper documents increases, and their controlled status and management constantly change, making effective controlled management of GCP paper documents particularly important.

[0003] Related technologies include document management systems based on barcodes or QR codes, which track document status and location information by scanning identification codes. Some electronic document management systems also employ access control and approval processes to manage document creation, modification, and distribution. Some systems also integrate print control functions, which can limit the number of times a document can be printed and print permissions, and add watermarks or identification information during printing.

[0004] However, existing technologies lack a differentiated management mechanism based on risk levels, making it impossible to dynamically adjust control strategies according to the importance of documents; the issuance, use, and retrieval of documents lack effective linkage, and the monitoring mechanism is simplistic and lacks early warning functions, making it difficult to promptly detect and handle abnormal situations such as expired or lost documents. This situation needs further improvement. Summary of the Invention

[0005] This application provides a controlled management system for clinical trial documents, enabling controlled management of the entire lifecycle of clinical trial paper documents, from application approval, controlled printing, intelligent distribution, real-time monitoring, differentiated collection, to classification and archiving. The system achieves a controlled management process throughout the entire lifecycle from application approval to classification and archiving by establishing a risk-level-based differentiated management mechanism and a responsibility chain; and solves the technical problems of independent management links and lack of effective linkage in existing technologies by coordinating data flow and status synchronization between modules through a central control engine.

[0006] Firstly, this application provides a controlled management system for clinical trial documents, including: The document application and approval module is used to receive clinical trial document applications and configure a multi-role collaborative approval process based on the document risk level, and generate document authorization information including the usage period. The controlled printing module is used to perform controlled document printing operations according to the document authorization information and generate a unique document identifier containing a verification code, and output an identifiered paper controlled document; The intelligent distribution module is used to perform distribution operations based on the identified paper controlled documents through a barcode confirmation mechanism and establish a responsibility association chain, and record the real-time usage status and location tracking information of the documents; The real-time monitoring module is used to monitor the file usage process in real time and detect overdue anomalies based on the real-time usage status and the location tracking information using a preset rule base, and generate file status change records and hierarchical early warning information. The differentiated recycling module is used to execute a differentiated document recycling strategy based on the status change record and the hierarchical early warning information, perform integrity verification, and output recycling confirmation results and compliance assessment information. The classification and archiving module is used to perform classification and archiving processing and establish a complete document lifecycle record based on the recycling confirmation results and the compliance assessment information. The central control engine is used to coordinate the data flow and status synchronization among the document application and approval module, the controlled printing module, the intelligent distribution module, the real-time monitoring module, the differentiated recycling module, and the classification and archiving module.

[0007] In the above implementation, the document application and approval module generates document authorization information by configuring a multi-role collaborative approval process based on the document risk level. The controlled printing module performs controlled printing according to the authorization information and generates a unique document identifier containing a verification code. The intelligent distribution module establishes a responsibility association chain and records the real-time status of the document through a code scanning confirmation mechanism. The real-time monitoring module monitors the document usage process using a preset rule base and generates graded early warning information. The differentiated recycling module executes differentiated recycling strategies based on the early warning information and performs integrity verification. The classification and archiving module performs classification and archiving processing according to the recycling results. The central control engine coordinates the data flow and status synchronization between the modules, thereby improving the differentiated control capability of document management, the collaborative efficiency between links, and the level of intelligent monitoring, and realizing the safe, traceable, and compliant controlled management of clinical trial documents.

[0008] In one implementation, the document application approval module specifically includes: The project risk assessment unit is used to calculate the project risk level based on the trial phase, drug type, and number of subjects of the clinical trial project, and generate a risk assessment report that includes risk coefficients and compliance requirements. The template association unit is used to automatically match the corresponding set of document templates based on the compliance requirements in the risk assessment report, and output a list of available templates and template priority sorting. The process configuration unit is used to automatically generate differentiated approval processes based on the project risk level and the file types in the available template list, and output a complete process plan including approval role sequence, approval time limit and required field configuration. The state transition unit is used to perform state transition control based on the approval role sequence in the complete process scheme, and to trigger timeout warning business logic according to the approval time limit; An integrated notification unit is used to monitor state change events of the state transition unit and push personalized task notifications and reminders to the corresponding roles based on the approval role sequence.

[0009] In the above embodiments, this application automatically calculates the risk level based on the specific characteristics of the clinical trial project, and intelligently matches document templates and generates personalized approval processes based on the risk level. At the same time, it ensures the standardized execution and timely response of the approval process through status flow control and integrated notification mechanisms. This improves the adaptability and intelligence of the approval process, and can provide differentiated management strategies for projects with different risk levels, thereby improving approval efficiency and compliance assurance capabilities.

[0010] In one implementation, the process configuration unit specifically includes: The role mapping subunit is used to determine the approval level requirements from a preset role weight table based on the project risk level, and to match specific approval roles with the file types in the available template list to generate an approval role sequence; The time limit calculation subunit is used to query the baseline time limit configuration table according to the project risk level, calculate the processing time limit of each approval node based on the number of roles in the approval role sequence, and output the node time limit allocation scheme. The form generation sub-unit is used to extract standard field templates for each file type from the available template list, add mandatory field verification rules based on the compliance requirements, and generate a customized approval form. The process orchestration subunit is used to arrange the approval role sequence according to the node time limit allocation scheme, embed the customized approval form at each node, and assemble it into an executable approval workflow. The process deployment subunit is used to convert the approval workflow into a process execution script and deploy it to the workflow engine, while extracting key parameters to form a complete process solution.

[0011] In the above embodiments, this application achieves refined automatic construction and dynamic deployment of the approval process through collaborative processing of role mapping, time limit calculation, form generation, process orchestration and process deployment. It intelligently determines the approval level, reasonably allocates processing time limits, generates customized forms and assembles them into an executable workflow based on the project risk level and document type. This improves the accuracy and automation of process configuration, provides the optimal approval strategy for combinations of different risk levels and document types, effectively balances the requirements of rigor and efficiency in the approval process, and ensures the adaptability and reliability of the approval process in complex and ever-changing clinical trial scenarios.

[0012] In one embodiment, the controlled printing module specifically includes: The authorization verification unit is used to parse the usage period and permission scope in the file authorization information, verify the legality of the current print request, and output authorization parameters and print license token; The identifier generation unit is used to generate a unique file number based on the file type, project information and current timestamp in the authorization parameters, and generate an anti-counterfeiting verification code by combining the print license token with a hash algorithm, and output a unique file identifier containing the verification code; The watermark processing unit is used to dynamically generate digital watermark content based on the usage period and permission information in the authorization parameters, embed the unique file identifier into the watermark, and output a print template with the watermark identifier. The printing execution unit is used to perform physical printing operations based on the printing template with the watermark, record the printing time and operation information in real time, and output a confirmation of printing completion. The identifier binding unit is used to bind the unique document identifier to the actual paper document based on the printing completion confirmation, thereby generating an identifiable paper controlled document.

[0013] In the above embodiments, this application achieves secure conversion and unique identification from digital authorization to physical documents through full-process control of authorization verification, identifier generation, watermark processing, printing execution, and identifier binding. It generates anti-counterfeiting verification codes based on hash algorithms and embeds dynamic watermarks to ensure that each printed document has an unforgeable identity and a traceable source of authorization. This improves the security protection capability and identity recognition accuracy of paper documents and effectively prevents security risks such as unauthorized printing, document forgery, and identity confusion.

[0014] In one implementation, the intelligent distribution module adopts a distribution control mechanism based on a responsibility association chain. It identifies the identifiable paper controlled documents by scanning the code and verifies the recipient's permissions, establishes a multi-dimensional responsibility association chain that includes distribution time, recipient identity, document destination, and responsibility level, and tracks the document location and usage status in real time based on the responsibility association chain to generate a traceable document flow trajectory.

[0015] In the above embodiments, this application establishes a multi-dimensional responsibility chain that includes time, personnel, destination and hierarchy by combining QR code recognition and permission verification. This enables precise control and clear responsibility in the document distribution process. Based on the responsibility chain, the real-time location and usage status of the document are continuously tracked, forming a complete traceable circulation trajectory. This improves the security of document distribution and the ability to trace responsibility.

[0016] In one implementation, the real-time monitoring module adopts a dynamic monitoring strategy based on risk level. It dynamically adjusts the monitoring frequency and warning threshold according to the real-time usage status and the location tracking information combined with the file risk level. Through a multi-level warning mechanism, it triggers reminders, warnings and emergency handling processes in stages before the file expires, and automatically generates an intelligent monitoring report containing anomaly type, risk assessment and handling suggestions.

[0017] In the above embodiments, this application combines the document risk level with real-time status information to achieve intelligent dynamic adjustment of monitoring frequency and early warning threshold. It adopts a multi-level early warning mechanism of reminders, warnings, and emergency handling for phased risk control and automatically generates intelligent monitoring reports containing anomaly analysis and handling suggestions, thereby improving the adaptability and early warning accuracy of the monitoring system.

[0018] In one implementation, an external system integration module is also included, which is used to interact with WeChat for Enterprise and medical information systems, realize user identity synchronization, message push and business data sharing through a unified interface standard, and provide file status query and compliance verification services to external systems based on the file lifecycle record.

[0019] In the above embodiments, this application establishes a data interaction channel with WeChat Work and medical information systems through a unified interface standard, realizing automatic synchronization of user identities, real-time push of messages, and seamless sharing of business data. At the same time, based on complete file lifecycle records, it provides accurate file status query and compliance verification services for external systems, thereby improving the collaborative efficiency and data consistency between systems.

[0020] In a second aspect, embodiments of this application provide a controlled management device for clinical trial documents, comprising: one or more processors and a memory; the memory is coupled to one or more processors, the memory being used to store computer program code, the computer program code including computer instructions, and the one or more processors invoking the computer instructions to cause the device to perform the functions of the system as described in the first aspect and any possible implementation thereof.

[0021] Thirdly, embodiments of this application provide a computer-readable storage medium including instructions that, when executed on a device, cause the device to perform the functions of the system described in the first aspect and any possible implementation thereof.

[0022] Fourthly, embodiments of this application provide a computer program product that, when run on a device, causes the device to perform the functions of the system as described in the first aspect and any possible implementation thereof.

[0023] One or more technical solutions provided in the embodiments of this application have at least the following technical effects or advantages: 1. This application provides a controlled management system for clinical trial documents. The system utilizes a document application and approval module to generate document authorization information through a multi-role collaborative approval process configured based on document risk levels. A controlled printing module executes controlled printing based on the authorization information and generates a unique document identifier containing a verification code. An intelligent distribution module establishes a responsibility chain through a barcode confirmation mechanism and records the real-time status of documents. A real-time monitoring module monitors document usage using a preset rule base and generates tiered early warning information. A differentiated retrieval module executes differentiated retrieval strategies based on early warning information and performs integrity verification. A classification and archiving module performs classification and archiving processing based on the retrieval results. A central control engine coordinates data flow and status synchronization between modules, thereby improving the differentiated control capabilities of document management, the efficiency of inter-process collaboration, and the level of intelligent monitoring. This achieves safe, traceable, and compliant controlled management of clinical trial documents.

[0024] 2. This application provides a controlled management system for clinical trial documents, which automatically calculates the risk level based on the specific characteristics of the clinical trial project, and intelligently matches document templates and generates personalized approval processes based on the risk level. At the same time, it ensures the standardized execution and timely response of the approval process through status flow control and integrated notification mechanisms. It improves the adaptability and intelligence level of the approval process, and can provide differentiated management strategies for projects with different risk levels, thereby improving approval efficiency and compliance assurance capabilities.

[0025] 3. This application provides a controlled management system for clinical trial documents. Through full-process control of authorization verification, identifier generation, watermark processing, printing execution, and identifier binding, it realizes the secure conversion and unique identification of digital authorization to physical documents. Based on a hash algorithm, it generates anti-counterfeiting verification codes and embeds dynamic watermarks to ensure that each printed document has an unforgeable identity and a traceable source of authorization. This improves the security protection capability and identity recognition accuracy of paper documents and effectively prevents security risks such as unauthorized printing, document forgery, and identity confusion. Attached Figure Description

[0026] Figure 1 This is a schematic diagram of a module of a controlled management system for clinical trial documents in an embodiment of this application.

[0027] Figure 2 This is a schematic diagram of a controlled management device for clinical trial documents provided in an embodiment of this application. Detailed Implementation

[0028] The terminology used in the following embodiments of this application is for the purpose of describing particular embodiments only and is not intended to be limiting of this application. As used in the specification and appended claims of this application, the singular expressions “a,” “an,” “the,” “the,” “the,” and “this” are intended to include the plural expressions as well, unless the context clearly indicates otherwise. It should also be understood that the term “and / or” as used in this application refers to any or all possible combinations including one or more of the listed items.

[0029] Hereinafter, the terms "first" and "second" are used for descriptive purposes only and should not be construed as implying or suggesting relative importance or implicitly indicating the number of indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature, and in the description of the embodiments of this application, unless otherwise stated, "multiple" means two or more.

[0030] In the field of drug clinical trials, paper documents, as original records and evidence generated during the trial process, are crucial for the authenticity, completeness, and compliance of trial data. With the continuous expansion of clinical trials and increasingly stringent regulatory requirements, traditional manual management methods can no longer meet the GCP (Good Clinical Practice) requirements for full lifecycle document control.

[0031] In related technologies, existing document management systems mostly adopt a single control strategy, lacking a differentiated management mechanism based on risk levels. Furthermore, each management link is independent, making it difficult to form a complete chain of accountability. At the same time, the monitoring mechanisms are relatively simple, lacking intelligent early warning and dynamic adjustment capabilities, and unable to promptly detect and handle anomalies during document usage.

[0032] This application is primarily applied to scenarios involving clinical trials conducted in hospitals, CRO companies, and drug development enterprises, covering various trial phases from Phase I to Phase III and different types of drug research projects. In these application scenarios, strict controlled management of various paper documents, such as informed consent forms, case report forms, trial protocols, and examination reports, is required to ensure the compliant use and secure transfer of these documents. To address the aforementioned technical issues, this application provides a controlled management system, device, medium, and product for clinical trial documents. An embodiment is described below in conjunction with… Figure 1 The controlled management system for clinical trial documents in this application embodiment is described below: Please see Figure 1 This is a schematic diagram of a module of a controlled management system for clinical trial documents in an embodiment of this application.

[0033] A controlled management system for clinical trial documents includes a document application and approval module, a controlled printing module, an intelligent distribution module, a real-time monitoring module, a differentiated retrieval module, a classification and archiving module, and a central control engine. The central control engine coordinates the data flow and status synchronization between the document application and approval module, the controlled printing module, the intelligent distribution module, the real-time monitoring module, the differentiated retrieval module, and the classification and archiving module to perform full lifecycle management of clinical trial documents and ensure the compliance and traceability of document use.

[0034] Specifically, the document application and approval module includes a project risk assessment unit, a template association unit, a process configuration unit, a status transition unit, and an integrated notification unit.

[0035] The project risk assessment unit calculates the project risk level based on the trial stage, drug type, and number of participants in the clinical trial. For example, projects in the later stages of clinical trials, involving high-risk drugs, and with a large number of participants will have a relatively high risk level. This unit generates a risk assessment report that includes risk coefficients and compliance requirements. The risk coefficients can be expressed numerically, while the compliance requirements specify the rules that document management must follow. In some embodiments, in addition to calculating the project risk level based on the trial stage, drug type, and number of participants, the drug's R&D costs and market competition are also considered to comprehensively assess the project risk level. This allows for a more comprehensive consideration of project risk factors, making the approval process more rational. Specifically, the project risk level is calculated using a multi-factor comprehensive assessment method. The system sets different weight coefficients for the trial stage, drug type, and number of participants, and calculates the comprehensive risk score through a weighted summation. For example, projects in early trial stages, innovative drugs, and with large sample sizes typically have higher risk coefficients. The system classifies projects into high, medium, and low risk levels based on the scoring results, and can adjust the scoring criteria and level classification thresholds as needed.

[0036] The template association unit automatically matches the corresponding set of document templates based on the compliance requirements in the risk assessment report. For example, if the compliance requirements involve specific document formats and content specifications, this unit will find suitable templates from a pre-set template library. It outputs a list of available templates and a priority ranking of the templates, facilitating selection in subsequent approval processes. Optionally, the template list can also be manually filtered and adjusted.

[0037] The process configuration unit automatically generates differentiated approval processes based on the project's risk level and file types in the available template list, outputting a complete process plan that includes approval role sequences, approval time limits, and required field configurations. Specifically, it includes a role mapping subunit, a time limit calculation subunit, a form generation subunit, a process orchestration subunit, and a process deployment subunit. The role mapping subunit determines the approval level requirements from a preset role weight table based on the project's risk level and matches specific approval roles with file types from the available template list to generate an approval role sequence. For example, high-risk projects may require more levels of approval and involve personnel from different specialties. The time limit calculation subunit queries a baseline time limit configuration table based on the project's risk level and calculates the processing time limit for each approval node based on the number of roles in the approval role sequence, outputting a node time limit allocation scheme. The form generation subunit extracts standard field templates for each file type from the available template list and adds required field validation rules based on compliance requirements to generate customized approval forms. The process orchestration subunit arranges the approval role sequence according to the node time limit allocation scheme and embeds customized approval forms at each node, assembling an executable approval workflow. The process deployment subunit converts the approval workflow into a process execution script and deploys it to the workflow engine, while extracting key parameters to form a complete process solution. In some embodiments, machine learning algorithms can be used to dynamically adjust the approval roles and time limits based on historical data when determining them. For example, the system can analyze the approval duration, role participation, and approval effectiveness of similar past projects, and predict the optimal time limit configuration through regression analysis; at the same time, based on the historical performance of different roles in terms of approval quality and response speed, the system can dynamically adjust role weights and priority rankings to improve the accuracy and efficiency of the approval process.

[0038] The state transition unit executes state transition control based on the approval role sequence in the complete process plan, and triggers timeout warning business logic according to the approval time limit. When an approval node fails to complete the approval within the specified time limit, a timeout warning will be issued.

[0039] The integrated notification unit listens for status change events in the status flow unit and pushes personalized task notifications and reminders to the corresponding roles based on the approval role sequence. For example, when a document enters a certain approval stage, the relevant approver will be notified in a timely manner. These units combined enable the document application approval process to be configured differently based on project risk and document type, improving the accuracy and efficiency of the approval process.

[0040] Specifically, the controlled printing module includes an authorization verification unit, an identifier generation unit, a watermark processing unit, a printing execution unit, and an identifier binding unit.

[0041] The authorization verification unit parses the usage period and permission scope in the file authorization information to verify the legality of the current print request, and outputs authorization parameters and a print license token. If the requested file exceeds the authorized usage period or permission scope, this unit will reject the print request. The identifier generation unit generates a unique file number based on the file type, project information, and current timestamp in the authorization parameters, and combines it with the print license token to generate an anti-counterfeiting verification code using a hash algorithm, outputting a unique file identifier containing the verification code. Specifically, the unique file number adopts a multi-segment encoding structure, including project identifier, file type, time information, and random sequence components, ensuring the uniqueness and readability of the identifier. The anti-counterfeiting verification code is generated by hashing the file number, authorization information, and system key. The watermark processing unit dynamically generates digital watermark content based on the usage period and permission information in the authorization parameters, embeds the unique file identifier into the watermark, and outputs a print template with the watermarked identifier. The watermark can contain key information about the file, such as the usage period and permission scope, serving both anti-counterfeiting and providing relevant file information. It is understandable that the watermark generation method can be adjusted according to different needs, such as using invisible watermark technology. The printing execution unit performs physical printing operations based on a watermarked printing template, records printing time and operation information in real time, and outputs a printing completion confirmation. The identification binding unit binds a unique document identifier to the actual paper document based on the printing completion confirmation, generating an identifiable, controlled paper document.

[0042] Specifically, the intelligent distribution module is used to execute distribution operations based on identifiable paper-based controlled documents through a barcode scanning confirmation mechanism, establishing a responsibility chain and recording the real-time usage status and location tracking information of the documents. The intelligent distribution module employs a responsibility chain-based distribution control mechanism, identifying identifiable paper-based controlled documents by scanning barcodes and verifying the recipient's permissions, establishing a multi-dimensional responsibility chain that includes distribution time, recipient identity, document destination, and responsibility level. For example, when distributing a document, scanning the identifier on the document verifies the recipient's permissions. If the permissions are valid, the system records the distribution time, recipient identity, and other information, establishing a responsibility chain. In one specific embodiment, the responsibility chain uses a chain-like data structure to record key node information during the document flow process, including operation time, responsible personnel, operation type, and document status. Each node uses digital signatures and timestamp technology to ensure the authenticity and immutability of the data.

[0043] Specifically, the real-time monitoring module uses a preset rule base to monitor file usage and detect expired anomalies based on real-time usage status and location tracking information, generating file status change records and tiered early warning information. The real-time monitoring module employs a dynamic monitoring strategy based on risk levels, dynamically adjusting monitoring frequency and early warning thresholds according to real-time usage status, location tracking information, and file risk levels. For high-risk files, the monitoring frequency is increased and the early warning threshold is lowered. Through a multi-level early warning mechanism, reminders, warnings, and emergency handling processes are triggered in stages before files expire, automatically generating intelligent monitoring reports that include anomaly types, risk assessments, and handling suggestions.

[0044] Specifically, the differentiated document retrieval module executes differentiated document retrieval strategies and performs integrity checks based on status change records and tiered early warning information, outputting retrieval confirmation results and compliance assessment information. For example, different retrieval methods are used for overdue documents and normal documents, and the integrity of the documents is checked after retrieval. An alternative feature is the ability to further refine the retrieval strategy based on the importance and risk level of the documents.

[0045] Specifically, the classification and archiving module performs classification and archiving processing based on the recovery confirmation results and compliance assessment information, and establishes a complete document lifecycle record. Documents are archived according to different categories and attributes for easy subsequent retrieval and management. An alternative feature is the potential use of intelligent classification algorithms to improve archiving accuracy.

[0046] Furthermore, it also includes an external system integration module for data interaction with WeChat for Enterprise and medical information systems. It enables user identity synchronization, message push and business data sharing through a unified interface standard, and provides file status query and compliance verification services to external systems based on file lifecycle records.

[0047] The apparatus in the embodiments of this invention are described below from the perspective of hardware processing. Please refer to [link / reference needed]. Figure 2 This is a schematic diagram of a controlled management device for clinical trial documents provided in an embodiment of this application.

[0048] It should be noted that, Figure 2 The structure of the device shown is merely an example and should not impose any limitation on the functionality and scope of use of the embodiments of the present invention.

[0049] like Figure 2 As shown, the device includes a CPU, which can perform various appropriate actions and processes based on a program stored in the ROM or a program loaded into the RAM from a storage portion, such as performing the functions of the system in the above embodiment. The RAM also stores various programs and data required for system operation. The CPU, ROM, and RAM are interconnected via a bus. An I / O interface is also connected to the bus.

[0050] The following components are connected to the I / O interface: input sections including cameras, infrared sensors, etc.; output sections including liquid crystal displays (LCDs) and speakers, etc.; storage sections including hard drives, etc.; and communication sections including network interface cards such as LAN (Local Area Network) cards and modems, etc. The communication section performs communication processing via a network such as the Internet. Drives are also connected to the I / O interface as needed. Removable media, such as disks, optical disks, magneto-optical disks, semiconductor memories, etc., are installed on the drive as needed so that computer programs read from them can be installed into the storage section as needed.

[0051] In particular, according to embodiments of the present invention, the processes described above with reference to the flowcharts can be implemented as computer software programs. For example, embodiments of the present invention include a computer program product comprising a computer program carried on a computer-readable medium, the computer program containing computer programs for performing the methods shown in the flowcharts. In such embodiments, the computer program can be downloaded and installed from a network via a communication component, and / or installed from a removable medium. When the computer program is executed by a CPU, it performs the various functions defined in the present invention.

[0052] It should be noted that the computer-readable medium shown in the embodiments of the present invention can be a computer-readable signal medium or a computer-readable storage medium, or any combination thereof. A computer-readable storage medium can be, for example,—but not limited to—an electrical, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any combination thereof. More specific examples of a computer-readable storage medium may include, but are not limited to: an electrical connection having one or more wires, a portable computer disk, a hard disk, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM), flash memory, optical fiber, portable compact disc read-only memory (CD-ROM), optical storage device, magnetic storage device, or any suitable combination thereof. In the present invention, a computer-readable storage medium can be any tangible medium containing or storing a program that can be used by or in conjunction with an instruction execution system, apparatus, or device. In the present invention, a computer-readable signal medium can include a data signal propagated in baseband or as part of a carrier wave, wherein a computer-readable computer program is carried. The transmitted data signal can take many forms, including but not limited to electromagnetic signals, optical signals, or any suitable combination thereof.

[0053] The flowcharts and block diagrams in the accompanying drawings illustrate the architecture, functionality, and operation of possible implementations of systems, methods, and computer program products according to various embodiments of the present invention. Each block in a flowchart or block diagram may represent a module, segment, or portion of code, which contains one or more executable instructions for implementing a specified logical function. It should also be noted that in some alternative implementations, the functions indicated in the blocks may occur in a different order than those indicated in the drawings. For example, two consecutively indicated blocks may actually be executed substantially in parallel, and they may sometimes be executed in reverse order, depending on the functions involved. It should also be noted that each block in a block diagram or flowchart, and combinations of blocks in a block diagram or flowchart, may be implemented using a dedicated hardware-based system that performs the specified function or operation, or using a combination of dedicated hardware and computer instructions.

[0054] In another aspect, the present invention also provides a computer-readable storage medium, which may be included in the system described in the above embodiments; or it may exist independently and not assembled into the system. The storage medium carries one or more computer programs that, when executed by a system processor, cause the system to perform the functions of the system provided in the above embodiments.

[0055] The above-described embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit it. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this application.

[0056] As used in the above embodiments, depending on the context, the term "when..." can be interpreted as "if...", "after...", "in response to determining...", or "in response to detecting...". Similarly, depending on the context, the phrase "when determining..." or "if (the stated condition or event) is interpreted as "if determining...", "in response to determining...", "when (the stated condition or event) is detected", or "in response to detecting (the stated condition or event)".

[0057] In the above embodiments, implementation can be achieved entirely or partially through software, hardware, firmware, or any combination thereof. When implemented using software, it can be implemented entirely or partially in the form of a computer program product. The computer program product includes one or more computer instructions. When the computer program instructions are loaded and executed on a computer, all or part of the processes or functions described in the embodiments of this application are generated. The computer can be a general-purpose computer, a special-purpose computer, a computer network, or other programmable device. The computer instructions can be stored in a computer-readable storage medium or transmitted from one computer-readable storage medium to another. For example, the computer instructions can be transmitted from one website, computer, server, or data center to another website, computer, server, or data center via wired (e.g., coaxial cable, fiber optic, digital subscriber line) or wireless (e.g., infrared, wireless, microwave, etc.) means. The computer-readable storage medium can be any available medium that a computer can access or a data storage device such as a server or data center that integrates one or more available media. The available medium can be a magnetic medium (e.g., floppy disk, hard disk, magnetic tape), an optical medium (e.g., DVD), or a semiconductor medium (e.g., solid-state drive), etc.

[0058] Those skilled in the art will understand that all or part of the processes in the methods of the above embodiments can be implemented by a computer program instructing related hardware. This program can be stored in a computer-readable storage medium, and when executed, it can include the processes described in the above method embodiments. The aforementioned storage medium includes various media capable of storing program code, such as ROM or random access memory (RAM), magnetic disks, or optical disks.

Claims

1. A controlled management system for clinical trial documents, characterized in that, include: The document application and approval module is used to receive clinical trial document applications and configure a multi-role collaborative approval process based on the document risk level, and generate document authorization information including the usage period. The controlled printing module is used to perform controlled document printing operations according to the document authorization information and generate a unique document identifier containing a verification code, and output an identifiered paper controlled document; The intelligent distribution module is used to perform distribution operations based on the identified paper controlled documents through a barcode confirmation mechanism and establish a responsibility association chain, and record the real-time usage status and location tracking information of the documents; The real-time monitoring module is used to monitor the file usage process in real time and detect overdue anomalies based on the real-time usage status and the location tracking information using a preset rule base, and generate file status change records and hierarchical early warning information. The differentiated recycling module is used to execute a differentiated document recycling strategy based on the status change record and the hierarchical early warning information, perform integrity verification, and output recycling confirmation results and compliance assessment information. The classification and archiving module is used to perform classification and archiving processing and establish a complete document lifecycle record based on the recycling confirmation results and the compliance assessment information; The central control engine is used to coordinate the data flow and status synchronization among the document application and approval module, the controlled printing module, the intelligent distribution module, the real-time monitoring module, the differentiated recycling module, and the classification and archiving module.

2. The system according to claim 1, characterized in that, The document application and approval module specifically includes: The project risk assessment unit is used to calculate the project risk level based on the trial phase, drug type, and number of subjects of the clinical trial project, and generate a risk assessment report that includes risk coefficients and compliance requirements. The template association unit is used to automatically match the corresponding set of document templates based on the compliance requirements in the risk assessment report, and output a list of available templates and template priority sorting. The process configuration unit is used to automatically generate differentiated approval processes based on the project risk level and the file types in the available template list, and output a complete process plan including approval role sequence, approval time limit and required field configuration. The state transition unit is used to perform state transition control based on the approval role sequence in the complete process scheme, and to trigger timeout warning business logic according to the approval time limit; An integrated notification unit is used to monitor state change events of the state transition unit and push personalized task notifications and reminders to the corresponding roles based on the approval role sequence.

3. The system according to claim 2, characterized in that, The process configuration unit specifically includes: The role mapping subunit is used to determine the approval level requirements from a preset role weight table based on the project risk level, and to match specific approval roles with the file types in the available template list to generate an approval role sequence; The time limit calculation subunit is used to query the baseline time limit configuration table according to the project risk level, calculate the processing time limit of each approval node based on the number of roles in the approval role sequence, and output the node time limit allocation scheme. The form generation sub-unit is used to extract standard field templates for each file type from the available template list, add mandatory field verification rules based on the compliance requirements, and generate a customized approval form. The process orchestration subunit is used to arrange the approval role sequence according to the node time limit allocation scheme, embed the customized approval form at each node, and assemble it into an executable approval workflow. The process deployment subunit is used to convert the approval workflow into a process execution script and deploy it to the workflow engine, while extracting key parameters to form a complete process solution.

4. The system according to claim 1, characterized in that, The controlled printing module specifically includes: The authorization verification unit is used to parse the usage period and permission scope in the file authorization information, verify the legality of the current print request, and output authorization parameters and print license token; The identifier generation unit is used to generate a unique file number based on the file type, project information and current timestamp in the authorization parameters, and generate an anti-counterfeiting verification code by combining the print license token with a hash algorithm, and output a unique file identifier containing the verification code; The watermark processing unit is used to dynamically generate digital watermark content based on the usage period and permission information in the authorization parameters, embed the unique file identifier into the watermark, and output a print template with the watermark identifier. The printing execution unit is used to perform physical printing operations based on the printing template with the watermark, record the printing time and operation information in real time, and output a confirmation of printing completion. The identifier binding unit is used to bind the unique document identifier to the actual paper document based on the printing completion confirmation, thereby generating an identifiable paper controlled document.

5. The system according to claim 1, characterized in that, The intelligent distribution module adopts a distribution control mechanism based on a responsibility association chain. It identifies the identifiable paper controlled documents by scanning the code and verifies the recipient's permissions. It establishes a multi-dimensional responsibility association chain that includes distribution time, recipient identity, document destination, and responsibility level. Based on the responsibility association chain, it tracks the document location and usage status in real time and generates a traceable document flow trajectory.

6. The system according to claim 1, characterized in that, The real-time monitoring module adopts a dynamic monitoring strategy based on risk level. It dynamically adjusts the monitoring frequency and warning threshold according to the real-time usage status, the location tracking information, and the file risk level. Through a multi-level warning mechanism, it triggers reminders, warnings, and emergency handling processes in stages before the file expires, and automatically generates an intelligent monitoring report containing anomaly type, risk assessment, and handling suggestions.

7. The system according to claim 1, characterized in that, It also includes an external system integration module for data interaction with WeChat for Enterprise and medical information systems. It enables user identity synchronization, message push and business data sharing through a unified interface standard, and provides file status query and compliance verification services to external systems based on the file lifecycle record.

8. A controlled management device for clinical trial documents, characterized in that, The system includes: One or more processors and a memory; the memory is coupled to the one or more processors, the memory being used to store computer program code, the computer program code including computer instructions, the one or more processors invoking the computer instructions to cause the device to perform the functions of the system as described in any one of claims 1-7.

9. A computer-readable storage medium comprising instructions, characterized in that, When the instructions are executed on the device, the device causes the device to perform the functions of the system as described in any one of claims 1-7.

10. A computer program product, characterized in that, When the computer program product is run on the device, the device enables the device to perform the functions of the system as described in any one of claims 1-7.

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