Clinical test data storage method, electronic equipment and storage medium

Abstract

The invention provides a clinical test data storage method, electronic equipment and a storage medium. The method is applied to the technical field of data processing. Classifying the clinical test data based on a data sensitivity level and a preset storage period threshold to obtain a sensitive data subset and a conventional data subset; storing the sensitive data subset in a preset encryption storage node; storing the conventional data subset in a preset distributed storage node; monitoring the data access frequency and the data integrity check value of each storage node in real time, and generating a storage state log; and according to the storage state log, adjusting the access authority timeliness of the encrypted storage node and the redundant backup number of the distributed storage node. In this way, the clinical test data storage efficiency can be improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of data processing, and in particular to a clinical trial data storage method, an electronic device and a storage medium. BACKGROUND

[0002] In the current field of clinical research, with the popularization of precision medicine and large-scale multi-center clinical trials, the clinical trial data generated presents an explosive growth trend. These data are not only large in quantity, but also complex in type, containing not only highly sensitive data such as subjects' personal identity, medical history, and genomics, but also a large number of routine test reports and image data. How to efficiently and safely store and manage these massive data has become a key link restricting the efficiency and quality of clinical research.

[0003] Currently, the storage solutions commonly used in the industry have the following limitations: (1) Most existing storage systems use a single storage strategy. Either all data is stored with high encryption, which ensures security but significantly increases system overhead during encryption and decryption, leading to access delays and reducing the efficiency of using routine data with high frequency of access; or all data is placed in a normal storage environment, which improves access speed but cannot meet the high security and privacy protection requirements of sensitive data, cannot differentiate resource allocation according to the characteristics of the data itself, and causes waste of storage resources and low overall storage efficiency; (2) In the traditional storage architecture, the storage location, backup strategy, and access rights are usually fixed after the data is stored. The system cannot real-time perceive the state changes of the storage nodes, and some subsets of routine data may be frequently accessed at a certain stage of research analysis, but then become dormant; or the storage nodes may have a higher risk of data integrity due to hardware failure, and the existing technology cannot adaptively adjust according to these dynamic changes, cannot realize intelligent scheduling and optimization of storage resources, and thus affects the long-term stability and efficiency of the system. The storage efficiency of clinical trial data is low. SUMMARY

[0004] To solve the problems existing in the prior art, the present application provides a clinical trial data storage method, an electronic device and a storage medium.

[0005] According to a first aspect of the present application, a clinical trial data storage method is provided. The method comprises:

[0006] obtaining clinical trial data;

[0007] classifying the clinical trial data based on a data sensitivity level and a preset storage period threshold to obtain a sensitive data subset and a routine data subset;

[0008] store the sensitive data subset in a preset encrypted storage node, and store the regular data subset in a preset distributed storage node;

[0009] monitor the data access frequency and data integrity check value of each storage node in real time to generate a storage state log;

[0010] adjust the access permission time limit of the encrypted storage node and the redundant backup quantity of the distributed storage node according to the storage state log.

[0011] Further, the classification of the clinical trial data based on the data sensitivity level and the preset storage period threshold comprises:

[0012] extracting subject identification information, detection index privacy level, and data usage range in each clinical trial data;

[0013] determining the clinical trial data with subject identification information coverage greater than a preset identification coverage and detection index privacy level higher than a preset privacy level as sensitive data, and the corresponding sensitive level is level one; and determining the remaining clinical trial data as regular data, and the corresponding sensitive level is level two;

[0014] The preset identification coverage is determined based on the privacy leakage risk assessment result of historical clinical trial data.

[0015] Further, the classification of the clinical trial data based on the data sensitivity level and the preset storage period threshold further comprises:

[0016] for sensitive data, a first storage period threshold is set, and data integrity check is performed once every first preset time;

[0017] for regular data, a second storage period threshold is set, and data integrity check is performed once every second preset time;

[0018] The first storage period threshold is less than the second storage period threshold, and the first preset time is less than the second preset time.

[0019] Further, the real-time monitoring of the data access frequency of each storage node comprises:

[0020] recording the access frequency, access duration, and access data type of each storage node within a preset monitoring duration;

[0021] the ratio of the access frequency to a preset access frequency threshold is taken as an access frequency coefficient, and the ratio of the access duration to a preset access duration threshold is taken as an access duration coefficient;

[0022] If the access frequency coefficient is greater than the access frequency coefficient threshold or the access duration coefficient is greater than the access duration coefficient threshold, it is determined that there is an abnormal access behavior, access warning information is generated and recorded to the storage state log, and the access permission of the access subject is temporarily frozen.

[0023] Further, the data integrity verification includes:

[0024] The SHA-256 algorithm is used to perform hash operation on the data in each storage node to obtain an initial verification value.

[0025] The current verification value is recalculated after each data access and compared with the initial verification value.

[0026] If the current verification value does not match the initial verification value and there is an abnormal access behavior record, the redundant backup data of the distributed storage node is called to recover the data, the verification value is recalculated after the recovery is completed until it is consistent with the initial verification value, and the verification record in the storage state log is updated.

[0027] Further, the calling of the redundant backup data of the distributed storage node for data recovery includes:

[0028] The redundant copy with the shortest physical distance from the original storage node and the data synchronization time less than the synchronization time threshold is preferentially selected.

[0029] After the recovery is completed, the content difference between the recovered data and the original data is compared, and if the difference rate is less than the difference rate threshold, it is determined that the recovery is successful, and the data version number of each associated storage node is updated.

[0030] If the number of recoveries of a storage node within a preset period exceeds 2 times, the number of redundant backups of the storage node is increased by 2, and the hardware of the node is detected for failure.

[0031] Further, the adjustment of the access permission time limit of the encrypted storage node and the number of redundant backups of the distributed storage node according to the storage state log includes:

[0032] For the encrypted storage node of sensitive data, a hardware encryption module is used in combination with dynamic key management, the dynamic key is updated every 72 hours, and the key update needs to be triggered through double identity authentication of account password + biometric recognition.

[0033] For the distributed storage node of regular data, software encryption is used in combination with multiple copy backups, the number of copies is determined according to the access frequency coefficient, the number of copies is increased by 1 for each increase of k in the access frequency coefficient, and each copy is stored in a node in a different physical region.

[0034] Wherein, k is an increment threshold and 0 < k < 0.5.

[0035] Further, the adjusting the access permission time limit of the encrypted storage node and the redundant backup quantity of the distributed storage node according to the storage state log further comprises:

[0036] counting the average access frequency coefficient and the data transmission delay of each storage node in a recent storage period;

[0037] if the average access frequency coefficient of a certain storage node is greater than the average threshold value and the data transmission delay is greater than the preset delay threshold value, increasing the storage bandwidth of the storage node;

[0038] if there is no access record in the preset access permission time limit of the encrypted storage node, shortening the next permission time limit to m times of the original time limit;

[0039] wherein m is a proportion threshold value and 60% < m < 85%.

[0040] According to a second aspect of the present application, an electronic device is provided. The electronic device comprises a memory and a processor, wherein the memory stores a computer program, and the processor executes the program to realize the method.

[0041] According to a third aspect of the present application, a computer readable storage medium is provided, which stores a computer program, and the program is executed by a processor to realize the method.

[0042] The present application classifies based on sensitivity level and storage period, uses encrypted storage for sensitive data to ensure security, and uses distributed storage for regular data to improve access speed and cost efficiency; stores sensitive data in special encrypted nodes to reduce security overhead, and stores regular data in distributed nodes to improve retrieval efficiency through parallel processing and redundancy; monitors access frequency and data integrity, generates a log to identify hot data or potential problems, and optimizes access permissions and redundant backups; adjusts the redundant backup quantity according to the access frequency, reduces the storage overhead of low-access data, increases the availability of high-access data, improves the overall system response speed and reliability, and improves the storage efficiency of clinical trial data.

[0043] It should be understood that the content described in the summary section is not intended to limit the key or important features of the embodiments of the present application, nor to limit the scope of the present application. Other features of the present application will become apparent through the following description. BRIEF DESCRIPTION OF DRAWINGS

[0044] The above and other features, advantages and aspects of the embodiments of the present application will become more apparent by describing in detail the following embodiments with reference to the attached drawings. The accompanying drawings are intended to better understand the present application and do not limit the present application. In the drawings, the same or similar reference numerals refer to the same or similar elements, wherein:

[0045] Figure 1 A flow chart of a clinical trial data storage method according to an embodiment of the present application is shown;

[0046] Figure 2 A block diagram of an exemplary electronic device capable of implementing an embodiment of the present application is shown. DETAILED DESCRIPTION

[0047] To make the objects, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are some but not all of the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by a person of ordinary skill in the art without creative work fall within the scope of protection of the present application.

[0048] In addition, the term “and / or” in the present document merely describes an association relationship of associated objects, and indicates that there can be three relationships, for example, A and / or B can represent three cases of existence of A alone, existence of A and B simultaneously, and existence of B alone. In addition, the character “ / ” in the present document generally represents an “or” relationship between the front and rear associated objects.

[0049] Figure 1 A flow chart of a clinical trial data storage method according to an embodiment of the present application is shown, which comprises:

[0050] S101, acquiring clinical trial data;

[0051] In some embodiments, the clinical trial data comprises a case report form, laboratory test data, a subject informed consent document, and drug safety data.

[0052] S102, classifying the clinical trial data based on a data sensitivity level and a preset storage period threshold to obtain a sensitive data subset and a routine data subset;

[0053] In some embodiments, the classifying the clinical trial data based on the data sensitivity level and the preset storage period threshold comprises: extracting subject identification information, a detection index privacy level, and a data use range in each clinical trial data; determining clinical trial data with subject identification information coverage greater than a preset identification coverage and a detection index privacy level higher than a preset privacy level as sensitive data, and the corresponding sensitive level is level one; and determining the rest of the clinical trial data as regular data, and the corresponding sensitive level is level two; wherein the preset identification coverage is determined based on a privacy leakage risk assessment result of historical clinical trial data. According to the embodiments of the present application, by classifying the clinical trial data according to the sensitivity level, and implementing differentiated storage strategies according to different levels, the storage resource allocation is optimized, unnecessary storage overhead is reduced, and the storage efficiency is improved.

[0054] For example, assuming that the privacy leakage risk assessment result of historical clinical trial data determines that the preset identification coverage is 80%, and the preset privacy level is level 4 (the privacy level range is level 1 to level 5, and level 5 is the highest privacy level). For the clinical trial data of the case report form (CRF), the CRF contains 100 data fields, of which 85 fields contain subject identification information (such as name, ID number, medical record number), and the subject identification information coverage is (85 / 100) × 100% = 85%. The detection index in the CRF includes “HIV viral load”, and the privacy level is evaluated as level 5. Since the subject identification information coverage is greater than the preset identification coverage, and the detection index privacy level is higher than the preset privacy level, the clinical trial data of the case report form (CRF) is determined as sensitive data, and the sensitive level is level one.

[0055] In some embodiments, the classifying the clinical trial data based on the data sensitivity level and the preset storage period threshold further comprises: setting a first storage period threshold for sensitive data, and performing a data integrity check once every first preset time; and setting a second storage period threshold for regular data, and performing a data integrity check once every second preset time; wherein the first storage period threshold is less than the second storage period threshold, and the first preset time is less than the second preset time. According to the embodiments of the present application, by dynamically adjusting the storage period threshold according to the data access frequency, the lower the access frequency, the greater the threshold adjustment, and the shorter the storage period, thereby reducing the storage overhead of low-access data and optimizing the storage resource allocation. At the same time, different storage period thresholds and check frequencies are set for sensitive data and regular data, further avoiding unnecessary waste of storage resources and improving the overall storage efficiency.

[0056] For example, assume that there is a case report form (CRF) judged as sensitive data, with a subject identifier information coverage rate of 85%, a detection index privacy level of 5 (the privacy level ranges from 1 to 5, with level 5 being the highest), and a sensitivity level of level 1; and another laboratory test data judged as regular data, with a subject identifier information coverage rate of 50%, a detection index privacy level of 3, and a sensitivity level of level 2. For the case report form (CRF), a first storage period threshold is set to 6 months, and a data integrity check is performed every 3 months. For the laboratory test data, a second storage period threshold is set to 2 years, and a data integrity check is performed every 6 months. The storage period threshold is adjusted once a year, and the adjustment range is based on the access frequency of the data in the past year. The adjustment range (Δ, unit: year) is negatively correlated with the access frequency (F, unit: times / year), and the specific formula is: Δ = 2 / F (where 2 is a constant used to quantify the adjustment range). After adjustment, the new storage period threshold = current storage period threshold - Δ, but the storage period threshold cannot be lower than the minimum retention period (assuming the minimum retention period is 1 year, which is used for compliance requirements).

[0057] S103, storing the subset of sensitive data in a preset encrypted storage node; storing the subset of regular data in a preset distributed storage node;

[0058] For example, the subset of case report form (CRF) data with a sensitivity level of level 1 (size: 150 GB) is stored in a special encrypted storage server node configured with AES-256 encryption algorithm, which has a storage capacity of 500 GB and access permissions are set to allow only 5 specific authorized accounts to access through two-factor authentication. The subset of laboratory test data with a sensitivity level of level 2 (size: 1.2 TB) is stored in a preset distributed storage cluster composed of 3 storage servers, which has a total storage capacity of 5 TB, adopts a three-replica redundancy storage strategy, and distributes data blocks on servers in different racks.

[0059] S104, real-time monitoring of data access frequency and data integrity check value of each storage node, and generating a storage state log;

[0060] In some embodiments, the real-time monitoring of the access frequency of each storage node comprises: recording the number of accesses, the access duration and the access data type of each storage node by a single access subject within a preset monitoring duration; taking the ratio of the number of accesses to a preset number of access threshold as an access frequency coefficient, and taking the ratio of the access duration to a preset access duration threshold as an access duration coefficient; if the access frequency coefficient is greater than an access frequency coefficient threshold or the access duration coefficient is greater than an access duration coefficient threshold, it is determined that there is an abnormal access behavior, an access warning information is generated and recorded to a storage state log, and the access permission of the access subject is temporarily frozen. According to the embodiment of the present application, by monitoring the access frequency in real time and freezing the abnormal access behavior, the invalid load and resource consumption of the storage system are reduced, the storage performance decline and additional overhead caused by malicious or abuse access are avoided, thereby optimizing the use of storage resources and improving the storage efficiency.

[0061] For example, the preset monitoring duration is set to 1 hour, the preset number of access threshold is set to 120 times, the preset access duration threshold is set to 30 minutes, the access frequency coefficient threshold is set to 1.5, and the access duration coefficient threshold is set to 2.0; the access record of the access subject "UserA" to the storage node "Node_Encrypted_01" within the monitoring duration of 1 hour is that the number of accesses is 250 times, the total access duration is 80 minutes, the access frequency coefficient is calculated as 250 / 120≈2.08, and the access duration coefficient is calculated as 80 / 30≈2.67. Since the access frequency coefficient 2.08>1.5, it is determined that there is an abnormal access behavior, and an access warning information is generated, the content of which is "AlertID:20241010T1530,User:UserA,Node:Node_Encrypted_01,Violation:HighAccessFrequencyCoefficient(2.08)", and the information is recorded to the storage state log. At the same time, the access permission of the access subject "UserA" is temporarily frozen for 72 hours.

[0062] In some embodiments, the data integrity check comprises: performing a hash operation on the data in each storage node using a SHA-256 algorithm to obtain an initial check value; recalculating a current check value after each data access and comparing it with the initial check value; if the current check value does not match the initial check value and there is an abnormal access behavior record, calling the redundant backup data of the distributed storage node for data recovery, recalculating the check value after the recovery is completed until it is consistent with the initial check value, and updating the check record in the storage state log. According to the embodiment of the present application, the SHA-256 algorithm is used to quickly calculate the check value, the calculation overhead is minimized, and the data integrity is efficiently verified; the data damage or tampering accumulation is prevented through immediate checking after each access, and large-scale repair costs are avoided; the time and resources required for data loss or reconstruction are reduced through the use of redundant backup for quick data recovery; unnecessary operations are avoided and resource use is optimized through the use of abnormal access records to trigger recovery; manual intervention is reduced and overall storage management efficiency is improved through the use of updated storage state logs for automated management.

[0063] In some embodiments, the calling of the redundant backup data of the distributed storage node for data recovery comprises: preferentially selecting a redundant copy that is closest in physical distance to the original storage node and has a data synchronization time less than a synchronization time threshold; after the recovery is completed, comparing the content difference between the recovered data and the original data, if the difference rate is less than a difference rate threshold, determining that the recovery is successful, updating the data version number of each associated storage node; if the number of recoveries of a certain storage node within a preset period exceeds 2 times, increasing the number of redundant backups of the storage node by 2, and performing fault detection on the hardware of the node. According to the embodiment of the present application, by preferentially selecting a redundant copy that is closest in physical distance and has a small data synchronization time, network delay and data transmission time are reduced, and recovery speed is accelerated; by comparing the content difference and setting a difference rate threshold, the accuracy of the recovered data is ensured, repeated recovery operations are avoided, time and resources are saved, and overall storage management efficiency is improved.

[0064] For example, assuming that the preset synchronization time threshold is 50 milliseconds, the difference rate threshold is 0.1%, the original storage node (node A, located in the Beijing data center) has data damage, and three available redundant copies are detected: copy 1 is located in the Tianjin data center, the physical distance is 120 kilometers, the data synchronization time is 30 milliseconds, copy 2 is located in the Guangzhou data center, the physical distance is 2000 kilometers, the data synchronization time is 90 milliseconds, and copy 3 is located in the Shanghai data center, the physical distance is 1300 kilometers, and the data synchronization time is 45 milliseconds. The copy with the shortest physical distance and the synchronization time less than 50 milliseconds is selected, that is, copy 3 (Shanghai data center) is selected for data recovery; after the recovery is completed, the binary contents of the recovered data and the original data are compared, the total size of the original data is 500MB (524,288,000 bytes), and it is found that the difference part is 400,000 bytes. The difference rate is calculated as: (400,000 / 524,288,000) x 100% ≈ 0.076%, since the difference rate 0.076% is less than the difference rate threshold 0.1%, it is determined that the data recovery is successful; after the recovery is successful, the version number of the data in each associated storage node is updated from V3.5 to V3.6.

[0065] S105, according to the storage state log, adjust the access permission time limit of the encryption storage node and the redundancy quantity of the distributed storage node.

[0066] In some embodiments, the adjusting the access permission time limit of the encryption storage node and the redundancy quantity of the distributed storage node according to the storage state log comprises: for the encryption storage node of sensitive data, using a hardware encryption module combined with dynamic key management, the dynamic key is updated every 72 hours, and the key update needs to be triggered through double identity authentication of account password and biometric recognition; for the distributed storage node of regular data, using software encryption combined with multiple copy backup, the number of copies is determined according to the access frequency coefficient of the data, and the number of copies increases by 1 for every k increase in the access frequency coefficient, and each copy is stored in a node in a different physical region; wherein k is an incremental threshold and 0 < k < 0.5. According to the embodiment of the application, for sensitive data, a hardware encryption module and a dynamic key are used to update every 72 hours, combined with double identity authentication, which reduces the risk of unauthorized access and data leakage, avoids the data recovery or reconstruction overhead caused by security incidents, and thus maintains the efficient operation of the storage system; for regular data, the number of copies is dynamically increased according to the access frequency coefficient, which ensures that high-access data has more copies, improves access speed and load balancing, reduces access delay, and improves overall storage management efficiency.

[0067] In some embodiments, the adjusting the access permission time limit of the encrypted storage node and the redundant quantity of the distributed storage node according to the storage state log further comprises: counting the average access frequency coefficient and the data transmission delay of each storage node in a recent storage period; if the average access frequency coefficient of a certain storage node is greater than an average threshold and the data transmission delay is greater than a preset delay threshold, increasing the storage bandwidth of the storage node; if there is no access record in the preset access permission time limit of the encrypted storage node, shortening the next permission time limit to m times of the original time limit; wherein m is a proportion threshold and 60% < m < 85%.

[0068] According to the embodiments of the present application, the present application further provides an electronic device and a readable storage medium.

[0069] Figure 2 A schematic block diagram of an electronic device that can be used to implement embodiments of the present application is shown. The electronic device is intended to represent various forms of digital computers, such as laptops, desktops, tablets, personal digital assistants, servers, blade servers, mainframes, and other appropriate computers. The electronic device can also represent various forms of mobile devices, such as personal digital assistants, cellular telephones, smartphones, wearable devices, and other similar computing devices. The components shown here, their connections and relationships, and their functions, are meant to be examples only, and are not meant to limit implementations of the present application described and / or claimed in this document.

[0070] The electronic device includes a computing unit 201 that can perform various appropriate actions and processes according to a computer program stored in a ROM 202 or a computer program loaded from a storage unit 208 into a RAM 203. Various programs and data required for operation of the electronic device can also be stored in the RAM 203. The computing unit 201, the ROM 202, and the RAM 203 are connected to each other through a bus 204. An I / O interface 205 is also connected to the bus 204.

[0071] Various components in the electronic device are connected to the I / O interface 205, including: an input unit 206, such as a keyboard, a mouse, etc.; an output unit 207, such as various types of displays, speakers, etc.; a storage unit 208, such as a magnetic disk, an optical disk, etc.; and a communication unit 209, such as a network card, a modem, a wireless communication transceiver, etc. The communication unit 209 allows the electronic device to exchange information / data with other devices through a computer network, such as the Internet, and / or various telecommunications networks.

[0072] The computing unit 201 can be various general and / or special purpose processing components with processing and computing capabilities. Some examples of the computing unit 201 include, but are not limited to, a central processing unit (CPU), a graphics processing unit (GPU), various specialized artificial intelligence (AI) computing chips, various computing units running machine learning model algorithms, a digital signal processor (DSP), and any suitable processor, controller, microcontroller, etc. The computing unit 201 performs various methods and processes described above, such as the clinical trial data storage method. For example, in some embodiments, the clinical trial data storage method can be implemented as a computer software program tangibly embodied in a machine-readable medium, such as the storage unit 208. In some embodiments, part or all of the computer program can be loaded and / or installed onto the electronic device via the ROM 202 and / or the communication unit 209. When the computer program is loaded onto the RAM 203 and executed by the computing unit 201, one or more steps of the clinical trial data storage method described above can be performed. Alternatively, in other embodiments, the computing unit 201 can be configured to perform the clinical trial data storage method by any other suitable means, such as by means of firmware.

[0073] Various implementations of the systems and techniques described above can be realized in digital electronic circuitry, integrated circuitry, a field programmable gate array (FPGA), an application specific integrated circuit (ASIC), a system on a chip (SOC), a programmable logic device (CPLD), computer hardware, firmware, software, and / or combinations thereof. These various implementations can include implementation in one or more computer programs that are executable and / or interpretable on a programmable system including at least one programmable processor, which can be special or general purpose, coupled to receive data and instructions from, and to transmit data and instructions to, a storage system, at least one input device, and at least one output device.

[0074] Program code for carrying out methods of the present application can be written in any combination of one or more programming languages. The program code can be provided to a processor or controller of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the program code, when executed by the processor or controller, produces a means for implementing the functions / acts specified in the flowcharts and / or block diagrams. The program code can be executed entirely on a machine, partially on a machine, partially on a machine as a stand-alone software package, partially on a machine and partially on a remote machine or entirely on a remote machine or server.

[0075] In the context of the present application, a readable storage medium can be a tangible medium that can contain or store a program for use by or in connection with an instruction execution system, apparatus, or device. The readable storage medium can be a machine-readable signal medium or a machine-readable storage medium. The readable storage medium can include, but is not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing. More specific examples of a readable storage medium would include one or more lines of electrical wire, a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing.

[0076] To provide for interaction with a user, the systems and techniques described here can be implemented on a computer having a display device for displaying information to the user and a keyboard and a pointing device (e.g., a mouse or a trackball) by which the user can provide input to the computer. Other kinds of devices can be used to provide for interaction with a user as well; for example, feedback provided to the user can be any form of sensory feedback (e.g., visual feedback, auditory feedback, or tactile feedback); and input from the user can be received in any form, including acoustic, speech, or tactile input.

[0077] The systems and techniques described here can be implemented in a computing system that includes a back end component (e.g., as a data server), or that includes a middleware component (e.g., an application server), or that includes a front end component (e.g., a user computer having a graphical user interface or a Web browser through which a user can interact with an implementation of the systems and techniques described here), or any combination of such back end, middleware, or front end components. The components of the system can be interconnected by any form or medium of digital data communication (e.g., a communication network). Examples of communication networks include a local area network (LAN), a wide area network (WAN), and the Internet.

[0078] The computer system can include clients and servers. A client and server are generally remote from each other and typically interact through a communication network. The relationship of client and server can arise by virtue of computer programs running on the respective computers and having a client-server relationship to each other. The server can be a cloud server, a server of a distributed system, or a server combined with a blockchain.

[0079] It should be understood that the above-described procedures can be used to reorder, add, or delete steps. For example, the steps described in the present application can be performed in parallel, sequentially, or in a different order, as long as the desired results of the technical solutions of the present application can be achieved, which is not limited herein.

[0080] The above detailed description does not constitute a limitation on the protection scope of the present application. Those skilled in the art should understand that various modifications, combinations, sub-combinations, and substitutions can be made according to design requirements and other factors. Any modifications, equivalent replacements, and improvements made within the spirit and principles of the present application shall be included in the protection scope of the present application.

Claims

1. A method of storing clinical trial data, characterized by, The method comprises the following steps: obtaining clinical trial data; classifying the clinical trial data based on the data sensitivity level and a preset storage period threshold to obtain a sensitive data subset and a regular data subset; storing the sensitive data subset in a preset encrypted storage node; storing the regular data subset in a preset distributed storage node; monitoring the data access frequency and data integrity check value of each storage node in real time to generate a storage state log; adjusting the access permission time limit of the encrypted storage node and the redundancy quantity of the distributed storage node according to the storage state log.

2. The clinical trial material storage method of claim 1, wherein, The classification of the clinical trial data based on the data sensitivity level and the preset storage period threshold comprises the following steps: extracting the subject identification information, detection index privacy level and data usage range in each clinical trial data; judging the clinical trial data corresponding to the subject identification information coverage rate greater than a preset identification coverage rate and the detection index privacy level higher than a preset privacy level as sensitive data, and the corresponding sensitive level is level one; judging the rest of the clinical trial data as regular data, and the corresponding sensitive level is level two; wherein, the preset identification coverage rate is determined based on the privacy leakage risk assessment result of the historical clinical trial data.

3. The clinical trial material storage method of claim 2, wherein, The classification of the clinical trial data based on the data sensitivity level and the preset storage period threshold further comprises the following steps: for sensitive data, a first storage period threshold is set, and data integrity check is performed once every first preset time; for regular data, a second storage period threshold is set, and data integrity check is performed once every second preset time; wherein, the first storage period threshold is less than the second storage period threshold, and the first preset time is less than the second preset time.

4. The clinical trial material storage method of claim 3, wherein, The real-time monitoring of the data access frequency of each storage node comprises the following steps: recording the access times, access duration and access data types of each storage node within a preset monitoring time by a single access subject; taking the ratio of the access times to a preset access times threshold as the access frequency coefficient, and taking the ratio of the access duration to a preset access duration threshold as the access duration coefficient; if the access frequency coefficient is greater than the access frequency coefficient threshold or the access duration coefficient is greater than the access duration coefficient threshold, it is judged that there is an abnormal access behavior, access warning information is generated and recorded to the storage state log, and the access permission of the access subject is temporarily frozen.

5. The clinical trial material storage method of claim 4, wherein, The data integrity check comprises the following steps: performing hash operation on the data in each storage node by using SHA-256 algorithm to obtain an initial check value; recalculating the current check value after each data access and comparing it with the initial check value; if the current check value does not match the initial check value and there is an abnormal access behavior record, the redundancy backup data of the distributed storage node is called to recover the data, the check value is recalculated after the recovery is completed until it is consistent with the initial check value, and the check record in the storage state log is updated.

6. The clinical trial material storage method of claim 5, wherein, The calling of the redundancy backup data of the distributed storage node for data recovery comprises the following steps: preferentially selecting the redundancy copy closest to the original storage node in physical distance and having a data synchronization time less than a synchronization time threshold; After the recovery is completed, the content difference between the recovery data and the original data is compared. If the difference rate is less than the difference rate threshold, it is determined that the recovery is successful, and the data version number of each associated storage node is updated. If the number of recoveries of a storage node within a preset period exceeds 2 times, the number of redundant backup numbers of the storage node is increased by 2, and the hardware of the node is detected for failure.

7. The clinical trial material storage method of claim 6, wherein, The method comprises: For the encryption storage node of sensitive data, a hardware encryption module is combined with dynamic key management. The dynamic key is updated every 72 hours, and the key update needs to be triggered through double identity authentication of account password and biometric recognition. For the distributed storage node of regular data, software encryption is combined with multiple copy backup. The number of copies is determined according to the data access frequency coefficient. The access frequency coefficient is increased by k, and the number of copies is increased by 1. Each copy is stored in a node in a different physical region. Wherein, k is an incremental threshold and 0 < k < 0.

5.

8. The clinical trial material storage method of claim 7, wherein, The method further comprises: Statistical average access frequency coefficient and data transmission delay of each storage node in a recent storage period; If the average access frequency coefficient of a storage node is greater than the average threshold and the data transmission delay is greater than the preset delay threshold, the storage bandwidth of the storage node is increased; If there is no access record in the preset access permission time limit of the encryption storage node, the next permission time limit is shortened to m times of the original time limit; Wherein, m is a proportion threshold and 60% < m < 85%.

9. An electronic device, comprising: It comprises: At least one processor; The memory is in communication connection with the at least one processor; The memory stores instructions executable by the at least one processor. The instructions are executed by the at least one processor to enable the at least one processor to execute the method of any one of claims 1-8.

10. A non-transitory computer-readable storage medium having stored thereon computer instructions, wherein, The computer instructions are used to make the computer execute the method according to any one of claims 1-8. The computer instructions are used to make the computer execute the method according to any one of claims 1-8.

Images