A subject screening system suitable for multi-center research

Abstract

The present invention relates to a subject screening system suitable for multi-center research, including a regional scientific research management platform, a plurality of hospital subject screening management systems interacting with the regional scientific research management platform, and a universal health information platform; after adopting the above system and steps, the present invention has the following advantages: the system makes good use of regional platform data to assist clinical research, and the introduction of regional data significantly expands the screening coverage and number of potential subjects found, shortening the research enrollment cycle. It provides support for regional multi-center research, improves research efficiency and level, and solves the conflict between patient privacy protection and clinical research needs, pays more attention to patient privacy protection, and focuses on solving the problem of patient privacy protection in the application of regional health data in clinical research through reasonable technical solutions and business process design, providing a new idea and method for the shared application of regional data in clinical research.

Description

Technical Field

[0001] The present invention relates to the technical field of information management, and in particular to a subject screening system suitable for multi-center research. Background Art

[0002] At present, multi-center clinical research has become a trend, but most of the existing process methods, platform construction plans, and design implementations based on clinical big data to support scientific research are single-center implementation plans based on a single system, and there is little research on scientific research support systems that use regional health information platform data.

[0003] A considerable number of researchers have encountered difficulties in recruiting subjects during the research process. Traditional methods of recruiting subjects mainly include: doctors discover the source of the disease during diagnosis and treatment and recommend it to researchers; post "recruitment advertisements" through websites, official accounts, and social media. However, these traditional methods have many obvious disadvantages, such as: it is impossible for doctors to know the inclusion conditions of all clinical studies conducted by the hospital, and to promptly realize that the current patient meets the inclusion requirements of a specific study during diagnosis and treatment; "recruitment advertisements" may not be effectively spread to potential subjects, and promote their active contact and participation in the research; there are many people who consult through "recruitment advertisements", but few who actually meet the conditions, causing researchers to spend a lot of unnecessary extra energy. This leads to a long enrollment period for subjects, increased costs, low controllability, and even research delays. This phenomenon is more obvious in multi-center research collaborations. Summary of the invention

[0004] The present invention aims to solve the above technical problems and provide a subject screening and privacy protection method and system suitable for multi-center research. While ensuring the accuracy and timeliness of the screening results, it improves the screening and sharing of subjects for clinical research projects among centers to improve research efficiency.

[0005] In order to solve the above technical problems, the technical solution provided by the present invention is:

[0006] A subject screening system suitable for multi-center research, comprising the following modules:

[0007] Main research center control module: configure basic information, ensure correct data interaction and synchronization between sub-centers, generate and save basic key pairs.

[0008] Clinical information storage module: collects and stores clinical records such as medical records, auxiliary examination information, and medical order and treatment record information.

[0009] Screening condition management module: used to establish, verify, store and manage subject screening conditions.

[0010] Potential subject screening module: used to screen and integrate potential subject information to form a matching list, and encrypt key information of potential subjects to achieve privacy protection;

[0011] Screening rule package management module: used to associate scientific research project information, screening rules, and potential subject lists to form a screening rule package and publish it to each research center.

[0012] Information synchronization module: used to synchronize subject screening conditions and subject matching lists between centers;

[0013] Potential subject screening and monitoring module: connects with the information system of each research center, screens and matches the information of visiting patients, and notifies researchers when eligible potential subjects are found.

[0014] The main research center control module includes a main parameter configuration unit, which is used to configure and determine the system's communication address, data storage method (whether the clinical case data is synchronized to the main research center), information transmission method and other information. User management module: manages each center's account, user role, and user account. Message notification module: announcements and message notifications. Basic key management unit: generates an RSA key pair when the system is initialized, the private key is stored in the main research center, and the public key is published to each sub-center for encrypted communication.

[0015] The clinical information storage module is a clinical information data warehouse consisting of a medical record homepage table, an outpatient medical record original information table, an outpatient prescription information table, an inpatient medical record original information table, a medical record summary table, an outpatient visit table, a general treatment and disposal record table, a midwifery record table, a nursing operation record table, a nursing assessment and plan table, an informed consent form, an admission record table, an inpatient course record table, a referral (hospital) record table, an infection information record table, a clinical pathway status table, an infectious disease reporting information table, an adverse event reporting information table, a high-value consumables usage record table, an allergy information record table, a medical record quality control record table, an operation record table, an operation blood transfusion information table, anesthesia record table, anesthesia signs table, an operation medication list table, anesthesia resuscitation information table, an operation analgesia treatment information table, an interventional material and medication information table, and the like.

[0016] The screening condition management module includes: a screening condition configuration unit: to establish and verify the subject screening conditions, and convert the screening conditions into a screening condition information group in json format; a screening condition verification unit, which uses the screening condition information group to query the cases that meet the conditions through the clinical information storage module, and feeds back the results to the user for verification. A screening condition storage unit: to store the screening conditions that are being edited or have been completed.

[0017] Preferably, the screening condition information class group consists of one or more screening condition information classes, and the screening condition information classes are combined into a union.

[0018] Preferably, the screening condition information class includes: a demographic condition group, a diagnostic judgment condition group, an auxiliary examination judgment condition group, a medical record judgment condition group, etc., and the intersection between each condition group is taken.

[0019] Furthermore, the demographic condition group includes demographic information such as age (range value), gender, marital status, and ethnicity, and whether to include each demographic information in the judgment condition is optional.

[0020] Furthermore, the diagnosis judgment condition group is composed of one or more diagnosis conditions, and the multiple diagnosis conditions are combined;

[0021] Preferably, the diagnostic condition is composed of one or more diagnostic codes (ICD-10), surgical operation codes (IDC-9), and pathological codes, connected by conditional operators: and (preferred expression & or and), or (preferred expression | or or), nested (preferred expression "[]"), and starting with XXX code (preferred expression @), etc., to form a complete diagnostic condition.

[0022] Furthermore, the auxiliary examination judgment condition group is composed of one or more diagnosis conditions, and the auxiliary examination judgment conditions are combined;

[0023] Preferably, the auxiliary inspection judgment condition includes auxiliary inspection item type, data type, judgment type, and judgment value.

[0024] The types of auxiliary examination items generally include: laboratory tests, imaging diagnosis, pathological diagnosis, and other physiological indicators.

[0025] The data types include: number, and the corresponding judgment types include: greater than, greater than or equal to, less than, less than or equal to, between, not between; the corresponding judgment conditions of text include, does not include, starts with X, and ends with X;

[0026] The judgment value is composed of 1 or 2 data items. When the judgment type is between or not between, 2 data items need to be filled in.

[0027] Furthermore, the medical record judgment condition group is composed of one or medical record judgment conditions, and the medical record judgment conditions are combined;

[0028] Preferably, the medical record judgment conditions include: information data source classification, field name, data type, judgment type, and judgment value. Information data source classification includes: medical record components such as the first medical record, the first ward round record, and the operation record.

[0029] Field names include: chief complaint, admission diagnosis, blood pressure, heart rate, weight and other medical record fields; if the information source is an unstructured field, it will be processed as a text string.

[0030] The data type, judgment type, and judgment value are the same as the corresponding fields of the auxiliary inspection judgment conditions.

[0031] The potential subject screening module includes: a previous patient screening unit: configure the traceability period of the case, call one or more screening condition information groups (take the union), and query the potential subjects who meet the conditions among the previous patients in the main research center or each branch research center. Potential subject encryption unit: encrypt the patient information returned by the previous patient screening unit of this center. Potential subject feedback unit: send the encrypted potential subject information of this center to the main research center server. Potential subject list management unit: integrate potential subject information and manage the version number of the potential subject list.

[0032] Furthermore, the subject encryption module encrypts the scrambling code (required), the patient's ID number (required), the patient's name (optional), and the patient's health code (optional) using a one-way hash algorithm.

[0033] Furthermore, the data elements selected by the encryption method are set when the system is initialized and asymmetrically encrypted using the basic key.

[0034] Preferably, the one-way hash algorithm is the MD5 algorithm, and other one-way hash algorithms such as SHA may also be selected.

[0035] Preferably, the scrambling code is generated by the main research center and is used to encrypt the basic information of potential subjects.

[0036] Furthermore, the potential subject list management unit receives and integrates the potential subject information fed back by each sub-center, records it in the potential subject record table, and updates the subject list version number according to the data refresh status.

[0037] Preferably, the potential subject record table includes at least four fields: ID number, associated scientific research project number, expiration date, and list version number.

[0038] Preferably, the scrambled ciphertext is encrypted by an RSA base private key.

[0039] Screening rule package management module: used to associate scientific research project information, screening rules, and potential subject lists to form a screening rule package and publish it to each research center.

[0040] The information synchronization module includes: an information synchronization configuration unit: used to configure the method and time of information synchronization. A synchronization control unit: records the synchronization status information of each sub-center, and controls the information interaction synchronization between each subsystem regularly or through manual operation. An information synchronization unit: encrypts the data between each center and completes various types of data transmission, and synchronizes the data to the corresponding table. An information synchronization monitoring unit: monitors the process of information synchronization and handles abnormal situations during the synchronization process.

[0041] Furthermore, the synchronization control unit determines the synchronization status and starts the sub-center to update the data as needed by checking the project code, sub-center code, sub-center data version number and other fields in the synchronization control table.

[0042] The potential subject screening monitoring module includes: an information interface unit, which is connected to the institutional information system for retrieval and transmission; a potential subject monitoring unit: verifies the information retrieved by the information system, and sends a message to notify the researcher through the server when a potential subject who meets the conditions is found. Notification unit: when a potential subject who meets the conditions is found, the researcher is notified through the message notification system. The monitoring unit should also include a screening result recording unit: records the screening process and results for subsequent analysis and optimization.

[0043] Furthermore, the potential subject data verification unit will use two methods for verification:

[0044] 1: By matching with the screening rule set, patients whose current diseases, test indicators, and clinical characteristics meet the screening rules can be obtained as potential subjects;

[0045] 2: Although the patient does not meet the requirements of situation 1, the one-way hash value is calculated according to the system rules based on the patient's basic information. If it is successfully matched in the one-way hash value hash table of potential subjects, it means that the patient meets the inclusion requirements of the current clinical research based on the previous medical information of the regional platform.

[0046] Preferably, researchers are informed of the hospital, department, and attending physician of potential subjects by push messaging.

[0047] After adopting the above system and steps, the present invention has the following advantages:

[0048] This system makes good use of the data from each research center to assist clinical research. The introduction of multi-center data significantly expands the screening coverage and number of potential subjects, shortens the research enrollment cycle, provides support for multi-center research cooperation, improves research enrollment efficiency, and resolves the conflict between patient privacy protection and clinical research needs.

[0049] The above summary is for illustrative purposes only and is not intended to be limiting in any way. In addition to the illustrative aspects, embodiments and features described above, further aspects, embodiments and features of the present invention will be readily apparent by reference to the accompanying drawings and the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0050] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or technical descriptions will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0051] Figure 1 It is a schematic diagram of the system architecture of the present invention;

[0052] Figure 2 It is a flow chart of the screening method of the present invention. DETAILED DESCRIPTION

[0053] Specific embodiments of the present invention will now be mentioned in detail. Although the present invention is described in conjunction with these specific embodiments, it should be appreciated that it is not intended to limit the present invention to these specific embodiments. On the contrary, these embodiments are intended to cover substitutions, changes or equivalent embodiments that may be included in the spirit and scope of the invention defined by the claims. In the following description, a large number of specific details are set forth in order to provide a comprehensive understanding of the present invention. The present invention can be implemented without some or all of these specific details. In other cases, in order not to make the present invention unnecessarily obscure, well-known process operations are not described in detail.

[0054] When used in conjunction with "including," "methods comprising," or similar language in this specification and the appended claims, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

[0055] The present invention is further described in detail below in conjunction with the full text.

[0056] Combined with Figure 1 and Figure 2 ,A subject screening system suitable for multi-center research, main research center control module: configures basic information, and ensures the correct interaction and synchronization of data among the sub-centers, generates and saves basic key pairs;

[0057] Clinical information storage module: collects and stores clinical records of medical records, auxiliary examination information, and medical advice and treatment records;

[0058] Screening condition management module: used to establish, verify, store and manage subject screening conditions;

[0059] Potential subject screening module: used to screen and integrate potential subject information to form a matching list, and encrypt key information of potential subjects to achieve privacy protection;

[0060] Screening rule package management module: used to associate scientific research project information, screening rules, and potential subject lists to form a screening rule package and publish it to each research center;

[0061] Information synchronization module: used to synchronize subject screening conditions and subject matching lists between centers;

[0062] Potential subject screening and monitoring module: connects with the information systems of each research center, screens and matches the information of the patients, and notifies the researchers when potential subjects who meet the conditions are found;

[0063] The main research center control module includes a main parameter configuration unit for configuring and determining the communication address, data storage method, and information transmission method of the system;

[0064] User management module: manages the accounts of each center, user roles, and user accounts; message notification module: announcements and message notifications; basic key management unit: generates RSA key pairs during system initialization, with the private key stored in the main research center and the public key published to each sub-center for encrypted communication;

[0065] The clinical information storage module is a clinical information data warehouse consisting of a medical record homepage table, an outpatient medical record original information table, an outpatient prescription information table, an inpatient medical record original information table, a medical record summary table, an outpatient visit table, a general treatment and disposal record table, a midwifery record table, a nursing operation record table, a nursing assessment and plan table, an informed consent form, an admission record table, an inpatient course record table, a referral record table, an infection information record table, a clinical pathway status table, an infectious disease reporting information table, an adverse event reporting information table, a high-value consumables usage record table, an allergy information record table, a medical record quality control record table, an operation record table, an operation blood transfusion information table, an anesthesia record table, an anesthesia sign table, an operation medication list table, an anesthesia resuscitation information table, an operation analgesia treatment information table, and an interventional material and medication information table;

[0066] The screening condition management module includes: a screening condition configuration unit, which establishes and verifies the subject screening conditions, and converts the screening conditions into screening condition information groups in JSON format; a screening condition verification unit, which uses the screening condition information groups to query qualified cases through the clinical information storage module, and feeds back the results to the user for verification; a screening condition storage unit, which stores the screening conditions that are being edited or have been completed.

[0067] The screening condition information class group is composed of one or more screening condition information classes, and the screening condition information classes are combined into a union.

[0068] The screening condition information class includes: a demographic condition group, a diagnostic judgment condition group, an auxiliary examination judgment condition group, and a medical record judgment condition group, and the intersection of each condition group is taken.

[0069] The demographic condition group includes: age, gender, marital status, and ethnic demographic information. Whether each demographic information is included in the judgment condition is optional. The diagnosis judgment condition group is composed of one or more diagnosis conditions, and the union of multiple diagnosis conditions is taken.

[0070] The subject screening management system includes screening rule set management, potential subject screening and potential subject information encryption synchronization.

[0071] The auxiliary inspection judgment conditions are combined to form a union, and the auxiliary inspection judgment conditions include auxiliary inspection item type, data type, judgment type, and judgment value.

[0072] The data types include: numbers, and the corresponding judgment types include: greater than, greater than or equal to, less than, less than or equal to, between, and not between; the corresponding judgment conditions of text include, not included, starts with X, and ends with X, and the judgment value is composed of 1 or 2 data items. When the judgment type is between or not between, 2 data items need to be filled in.

[0073] The medical record judgment condition group is composed of one or medical record judgment conditions, and the medical record judgment conditions are combined; the medical record judgment conditions include: information data source classification, field name, data type, judgment type, and judgment value. The information data source classification includes: medical record first journey, first ward round record, operation record and other medical record constituent elements.

[0074] The potential subject screening module includes: a previous patient screening unit: configuring a case traceability period, calling one or more screening condition information groups, querying qualified potential subjects among previous patients in the main research center or each branch research center, a potential subject encryption unit: encrypting the patient information returned by the previous patient screening unit of this center, a potential subject feedback unit: sending the encrypted potential subject information of this center as feedback to the main research center server, and a potential subject list management unit: integrating potential subject information and managing the version number of the potential subject list.

[0075] The potential subject data verification unit will use two methods for verification:

[0076] 1: By matching with the screening rule set, patients whose current diseases, test indicators, and clinical characteristics meet the screening rules can be obtained as potential subjects;

[0077] 2: Although the patient does not meet the requirements of situation 1, the one-way hash value is calculated according to the system rules based on the patient's basic information. If it is successfully matched in the one-way hash value hash table of potential subjects, it means that the patient meets the inclusion requirements of the current clinical research based on the previous medical information of the regional platform.

[0078] Preferably, researchers are informed of the hospital, department, and attending physician of potential subjects by push messaging.

[0079] Researchers will be informed of the potential subjects’ hospitals, departments and attending physicians’ information through push notifications.

[0080] This system does not directly return patient-related information for potential subjects obtained through big data matching on the regional health information platform. Instead, it uses the MD5 information digest algorithm to one-way encrypt the patient's unified index, name and other basic information to generate a one-way hash value. Due to the algorithm characteristics of the one-way hash information digest, the same information can obtain a consistent one-way hash information digest, but it is impossible to use technical means to reversely obtain the original information. In the system application, the one-way hash information digest is only published to each hospital participating in the study. When the hospital receives the corresponding patient, it can obtain patient-related information for one-way hash information digest calculation to verify whether the patient is in the list of potential subjects. The introduction of the one-way hash summary algorithm eliminates the possibility of the participating institutions and researchers obtaining the information of potential subjects by viewing the underlying data during the operation of the entire system from a technical perspective, thereby effectively protecting the privacy and security of potential subjects.

[0081] An important feature of this system is the use of big data matching to find potential subjects. The use of this method involves the issue of whether patient privacy is violated. Therefore, all projects that plan to use this system to screen potential subjects must conduct an ethical justification for whether previous medical record data can be used for screening during the ethical review. After evaluating factors such as the social value of the project and its benefits to patients, an ethical judgment must be made to determine whether this system can be used to match previous medical record data to find potential subjects.

[0082] When each research center uses the subject screening system, in order to further protect the rights of patients, not all medical patients can use the system for direct screening and verification. The hospital should fully inform the subjects and obtain their informed consent before using the patients' basic information and medical information to screen potential subjects, thereby ensuring the patients' right to know and right to choose.

[0083] Build a regional scientific research management platform for clinical research, which is used to integrate regional health information platform data, provide data resources for clinical research and clinical research management in the region; the subject screening management system relies on the regional scientific research management platform, which is used for the screening, interaction, synchronization of potential subjects, and management of multi-center research. The research institution side of the subject screening management system deployed in the hospital is used for the monitoring and discovery of potential subjects, and collaborates with the regional platform to achieve multi-center research management; it also provides certain assistance for diagnosis and treatment behaviors; it can also manage and support the screening of subjects for single-center research within the institution separately. The specific architecture is as follows Figure 1 shown.

[0084] The system's business process is mainly divided into two stages: screening rule setting and potential subject monitoring and inclusion. The system's business process is as follows: Figure 2 As shown:

[0085] According to the requirements for subject selection of specific research projects, researchers provide information such as age range, diagnostic ICD code, test indicators, pathological results, clinical characteristics, and past history. According to the inclusion and exclusion conditions of the research plan, data screening rules are compiled and verified in the subject screening system of the institution or region. According to the case data fed back by the system, the conformity of the cases fed back by the rules with the subject selection conditions is verified, the suitability of the rules is evaluated, and the inclusion and exclusion conditions are adjusted and improved so that the sensitivity and specificity of the extraction rules are within a reasonable range. At the same time, the progress of the test project can be estimated based on the number of cases retrieved. After completing the rule verification, other research-related information, such as experimental frequency, validity period, etc., are supplemented to form a screening rule set.

[0086] Submit the screening rule set to the data system of the regional health information platform, and use the regional health information platform big data matching to perform data augmentation. The specific process is as follows:

[0087] Use the information provided: provide age range, diagnostic ICD code, test indicators, pathological results, clinical characteristics, past medical history and other information, and obtain a list of eligible potential subjects in the entire region based on the inclusion and exclusion criteria of the study plan;

[0088] The regional platform will use a specific algorithm to perform one-way hashing and one-way encryption on the unified index, name and other basic information of eligible potential subjects to form a one-way hash table of potential subjects and store it in the database.

[0089] Associates the project information with a one-way hash of potential subjects. Returns a one-way hash of potential subjects.

[0090] The filtering rule set and the one-way hash table are integrated and packaged into a filtering rule package.

[0091] Through the data interface, the screening rule package will be released to all hospitals participating in the study.

[0092] Monitoring and enrollment of potential subjects

[0093] The research institution of the subject screening system screens patients who have obtained informed consent for clinical research screening in the hospital every day according to the rule package. There are two situations at this time: Situation 1, by matching with the screening rule set, patients whose current medical diseases, test indicators, and clinical characteristics meet the screening rules can be obtained as potential subjects; Situation 2, although the patient does not meet Situation 1, the one-way hash value is calculated according to the system rules through the patient's basic information. If it is successfully matched in the one-way hash value hash table of potential subjects, it means that the patient meets the inclusion requirements of the current clinical research in combination with the previous medical information of the regional platform. The system informs the researcher of the hospital, department, and bed physician information of the potential subject through message push. After the researcher communicates with the bed physician, the bed physician assists or acts as the researcher in further doctor-patient communication to confirm whether the selection criteria are met. After obtaining the patient's consent, the patient will be included in the clinical study.

[0094] Example:

[0095] Take a certain disease study as an example (Table 1). If the subjects are recruited according to the traditional way, the subjects are generally patients admitted to the department where the initiator is located. Then the number of potential subjects who meet the recruitment conditions in 3 years is only 23 (accounting for 0.010% of discharged patients). If the system is used to assist in screening, the number of potential subjects who meet the recruitment conditions is 247 (accounting for 0.109% of discharged patients), which is significantly better than the traditional recruitment method. The annual data and the Pearson chi-square test were tested, and the test results were all P<0.001, indicating that more potential subjects can be obtained by using the system.

[0096] Table 1 Number of subjects that can be recruited by different methods and their proportion of discharged patients

[0097]

[0098]

[0099] This system makes good use of multi-center data to assist clinical research. The introduction of multi-center data significantly expands the screening coverage and number of potential subjects, shortening the research enrollment cycle. It pays more attention to patient privacy protection, and through reasonable technical solutions and business process design, focuses on solving the problem of patient privacy protection in the application of regional health data in clinical research, providing a new idea and method for the shared application of multi-center data in clinical research.

[0100] The main purpose of the subject screening system is to find potential subjects for researchers. Through practical verification, it can significantly improve the screening ability of clinical research, shorten the case collection time, and the improvement effect is more obvious in multicenter studies. At the same time, the system can also provide useful help for patients seeking medical treatment. For example, due to the rarity and specificity of some diseases, doctors may not be able to accurately diagnose them at the first time; or the patient seeks treatment because of the pain caused by secondary diseases, and this secondary disease itself corresponds to other common diseases. If the patient's medical history is incomplete, it is likely that the doctor will not be able to accurately determine the true cause of the disease, resulting in delayed diagnosis and treatment. In these cases, the subject screening system can also provide prompts and assistance for doctors' diagnosis, which is conducive to the correct diagnosis of the disease and targeted treatment.

[0101] The deployment and use of the subject screening system has successfully promoted the full integration and utilization of big data accumulated by hospitals and regions over the years. The application of the system has injected new vitality into clinical research and disease diagnosis and treatment, especially in multi-center research. It has provided useful inspiration for regional big data to empower scientific research and is a successful practice of medical and health big data to empower scientific research.

[0102] The present invention and its embodiments are described above, and such description is not restrictive. What is shown in the full text is only one of the embodiments of the present invention, and the actual structure is not limited thereto. In short, if ordinary technicians in the field are inspired by it, without departing from the purpose of the invention, they can design a structure and embodiment similar to the technical solution without creativity, which should belong to the protection scope of the present invention.

Claims

1. A subject screening system suitable for multi-center research, characterized in that: Main research center control module: configure basic information, ensure correct data interaction and synchronization between sub-centers, generate and save basic key pairs; Clinical information storage module: collects and stores clinical records of medical records, auxiliary examination information, and medical treatment records; Screening condition management module: used to establish, verify, store and manage subject screening conditions; Potential subject screening module: used to screen and integrate potential subject information to form a matching list, and encrypt key information of potential subjects to achieve privacy protection; Screening rule package management module: used to associate scientific research project information, screening rules, and potential subject lists to form a screening rule package and publish it to each research center; Information synchronization module: used to synchronize subject screening conditions and subject matching lists between centers; Potential subject screening and monitoring module: connects with the information systems of each research center, screens and matches the information of the patients, and notifies the researchers when potential subjects who meet the conditions are found; There are two ways to verify: 1: By matching with the screening rule set, patients whose current diseases, test indicators, and clinical characteristics meet the screening rules can be obtained as potential subjects; 2: Although the patient does not meet the requirements of situation 1, the one-way hash value is calculated according to the system rules based on the patient's basic information. If it is successfully matched in the one-way hash value hash table of potential subjects, it means that the patient meets the inclusion requirements of the current clinical study in combination with the previous medical information of the regional platform; The main research center control module includes a main parameter configuration unit for configuring and determining the communication address, data storage method, and information transmission method of the system; User management module: manages the accounts of each center, user roles, and user accounts; message notification module: announcements and message notifications; basic key management unit: generates RSA key pairs during system initialization, with the private key stored in the main research center and the public key published to each sub-center for encrypted communication; The clinical information storage module is a clinical information data warehouse consisting of a medical record homepage table, an outpatient medical record original information table, an outpatient prescription information table, an inpatient medical record original information table, a medical record summary table, an outpatient visit table, a general treatment and disposal record table, a midwifery record table, a nursing operation record table, a nursing assessment and plan table, an informed consent form, an admission record table, an inpatient course record table, a referral record table, an infection information record table, a clinical pathway status table, an infectious disease reporting information table, an adverse event reporting information table, a high-value consumables usage record table, an allergy information record table, a medical record quality control record table, an operation record table, an operation blood transfusion information table, an anesthesia record table, an anesthesia sign table, an operation medication list table, an anesthesia resuscitation information table, an operation analgesia treatment information table, and an interventional material and medication information table; The screening condition management module includes: a screening condition configuration unit, which establishes and verifies the subject screening conditions and converts the screening conditions into a screening condition information group in JSON format; a screening condition verification unit, which uses the screening condition information group to query the cases that meet the conditions through the clinical information storage module and feeds back the results to the user for verification; a screening condition storage unit, which stores the screening conditions that are being edited or have been completed; The potential subject screening module includes: a previously visited patient screening unit: configuring the traceability period of the case, calling one or more screening condition information groups, querying the previously visited patients in the main research center or each branch research center for potential subjects that meet the conditions, a potential subject encryption unit: encrypting the patient information returned by the previously visited patient screening unit of this center, a potential subject feedback unit: sending the encrypted potential subject information of this center back to the main research center server, a potential subject list management unit: integrating the potential subject information and managing the version number of the potential subject list; The potential subject encryption module encrypts the patient's scrambling code, ID number, patient name, and health code using a one-way hash algorithm, where the one-way hash algorithm is an MD5 algorithm or a SHA one-way hash algorithm; The scrambling code is generated by the main research center and is used to encrypt the basic information of potential subjects. The potential subject list management unit receives and integrates the potential subject information fed back by each branch center, records it in the potential subject record table, and updates the subject list version number according to the data refresh status. The potential subject record table includes at least four fields: ID number, associated scientific research project number, expiration date and list version number. The scrambled code ciphertext is encrypted using the RSA basic private key.

2. A subject screening system suitable for multi-center research according to claim 1, characterized in that: The screening condition information class group is composed of one or more screening condition information classes, and the screening condition information classes are combined into a union.

3. A subject screening system suitable for multi-center research according to claim 2, characterized in that: The screening condition information class includes: a demographic condition group, a diagnostic judgment condition group, an auxiliary examination judgment condition group, and a medical record judgment condition group, and the intersection of each condition group is taken.

4. A subject screening system suitable for multi-center research according to claim 3, characterized in that: The demographic condition group includes: age, gender, marital status, and ethnic demographic information. Whether each demographic information is included in the judgment condition is optional. The diagnosis judgment condition group is composed of one or more diagnosis conditions, and the union of multiple diagnosis conditions is taken.

5. A subject screening system suitable for multi-center research according to claim 1, characterized in that: The subject screening management system includes screening rule set management, potential subject screening and potential subject information encryption synchronization.

6. A subject screening system suitable for multi-center research according to claim 3, characterized in that: The auxiliary inspection judgment conditions are combined to form a union, and the auxiliary inspection judgment conditions include auxiliary inspection item type, data type, judgment type, and judgment value.

7. A subject screening system suitable for multi-center research according to claim 6, characterized in that: The data types include: numbers, and the corresponding judgment types include: greater than, greater than or equal to, less than, less than or equal to, between, and not between; the corresponding judgment conditions of text include, not included, starts with X, and ends with X, and the judgment value is composed of 1 or 2 data items. When the judgment type is between or not between, 2 data items need to be filled in.

8. A subject screening system suitable for multi-center research according to claim 3, characterized in that: The medical record judgment condition group is composed of one or medical record judgment conditions, and the medical record judgment conditions are combined; Medical record judgment conditions include: information data source classification, field name, data type, judgment type, and judgment value composition. Information data source classification includes: medical record first journey, first ward round record, and surgical record medical record constituent elements.

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