Clinical test system and method based on hospital HIS system design
By designing a clinical trial system in the hospital HIS system, the offline paper-based problem of clinical trial recording and statistics is solved, the standardized management and safety of clinical trial data is achieved, and the workload and data risks of researchers are reduced.
Patent Information
- Application Number
- CN202411473923.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-10-22
- Publication Date
- 2025-01-10
AI Technical Summary
The existing hospital HIS system cannot support zero billing for subjects' medical orders, resulting in clinical trial records and statistics relying on offline paper operations, increasing clinical trial risks, reducing data quality, and improving funding statistics error rates and researcher work quantity.
Design a clinical trial system based on the hospital HIS system, including outpatient and inpatient modules, and by adding clinical trial subjects as key patient types in the backend of the doctor's workstation, doctor's authority allocation, and achieve trial project marking and authority control, and distinguish clinical trials The flag is settled separately, and the logical unification of the code of each business module is achieved through unified objects.
It realizes standardized management of clinical trial data, improves data quality and security, reduces the workload of researchers, and enhances data traceability and security through logging and backup modules.
Smart Images
Figure CN119296747A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of clinical trials, and in particular to a clinical trial system and method designed based on a hospital HIS system. Background Art
[0002] Clinical trials refer to trials with human subjects (patients or healthy subjects) as the subjects, which are intended to discover or verify the clinical medicine, pharmacology and other pharmacodynamic effects, adverse reactions, or absorption, distribution, metabolism and excretion of a certain experimental drug, so as to determine the efficacy and safety of the drug. The core is to ensure the standardization of the drug clinical trial process, the scientific, authentic and reliable data and results, and protect the rights and safety of the subjects. Source data refers to all information recorded in the original records or certified copies of clinical trials, including clinical findings, observations and other related activity records required for reconstruction and evaluation of clinical trials. In order to strengthen the supervision and management of drug clinical trial institutions, with the approval of the National Medical Products Administration, the "Key Points and Judgment Principles for Supervision and Inspection of Drug Clinical Trial Institutions" will be issued and implemented from March 1, 2024. This document puts forward higher requirements for the management of source data, and the source data collected in clinical trials can be traced. Scientific, authentic, reliable, complete and accurate drug clinical trial data is the guarantee for the correct evaluation of the quality of new drugs.
[0003] At present, the existing HIS system of the hospital does not support zero billing of medical order fees for subjects for daily operations, and the medical technology platform connected to the HIS system cannot identify and manage subjects, resulting in that some records and statistics of clinical trials are still offline paper operations, which not only increases the risk of clinical trials and reduces data quality, but also leads to a high error rate in funding statistics and increases the workload of researchers. Therefore, a clinical trial system and method based on the design of the hospital HIS system is proposed to solve the above problems. Summary of the invention
[0004] The technical problem to be solved by the present invention is to provide a clinical trial system and method based on the hospital HIS system design in view of the deficiencies in the above-mentioned prior art.
[0005] In order to solve the above technical problems, the technical solution adopted by the present invention is: a clinical trial system designed based on the hospital HIS system, including an outpatient clinical trial system and an inpatient clinical trial system; The outpatient clinical trial system includes a registration module, an outpatient doctor station and an outpatient billing module, wherein the registration module is connected to the outpatient doctor station, and the outpatient doctor station is connected to the outpatient billing module; The inpatient clinical trial system includes a login module, an inpatient system module, an admission registration module, an appointment registration module, a patient management module, a settlement management module and a patient account data module; The hospitalization system module includes a ticket management module, a group maintenance module, a bed setting module, a room setting module, an insurance module and a report module; The patient management module includes a collection management module, an account unfreezing module, a fee accounting module, a payment management module and a bed management module.
[0006] Preferably, the outpatient doctor station includes a prescription module, an inspection module, a testing module, a treatment module, a diagnosis module and a case module, the diagnosis module is connected to the medical history module, and the case module is connected to the medical history module.
[0007] Preferably, the outpatient billing module includes a radiology module, a laboratory module and a pharmacy module, and the outpatient billing module is connected to the medical history module.
[0008] Preferably, the appointment registration module is connected to the appointment management module, the appointment registration module is connected to the patient transfer module, the patient transfer module is connected to the admission registration module, the admission registration module is connected to the patient file creation module, and the patient file creation module is connected to the file management module.
[0009] Preferably, the expense accounting module is connected to a refund processing module, and the refund processing module is connected to a patient account data module.
[0010] Preferably, the payment management module is connected to the patient account data module, the settlement management module is connected to the refund settlement module, and the refund settlement module is connected to the patient account data module.
[0011] Preferably, the archive management module includes a data management module, a retrieval module, a backup module, a log recording module, a confidentiality level setting module and a data export module.
[0012] Preferably, the data management module is used to manage archive data packets, workflows and information resources, the retrieval module is used to quickly retrieve stored archive data packets, and the backup module is used to burn stored archive data packets.
[0013] Preferably, the log recording module is used to record the time, operation commands and operation data of the system user name login, the confidentiality setting module is used to set the user level and authority, the confidentiality level of the file, and the data export module is used to export the data in the archive.
[0014] A method for using a clinical trial system designed based on a hospital HIS system comprises the following steps: S1: Expand by utilizing the key patient function in the hospital HIS system; S2: Add clinical trial patients as key patient types; S3: Allocate the first-level operation authority of doctors in the medical authority maintenance; S4: The clinical trial management department screens the professionals who have passed the clinical trial filing; S5: Authorized doctors must hold a GCP certificate within the past 3 years and have the qualification to practice in this hospital; S6: Secondary operation authority allocation realizes patient test project labeling and doctor authority control; S7: Authorized physician is the research physician authorized for this clinical trial; S8: Clinical trial project marking is performed on the outpatient examination, test application form, and prescription disposal interface; S9: The clinical trial mark is distinguished when charging for outpatient services, and clinical trial projects are settled separately; S10: Clinical trial project marking on the hospitalization examination and testing application form and doctor's order interface; S11: When settling hospital bills, part of the project costs will be settled midway according to the clinical trial mark; S12: All clinical trial project-related parameters and permissions are obtained through a unified object; S13: Realize the unification of code logic for outpatient and inpatient business modules.
[0015] The present invention adopts the above technical solution to bring the following beneficial effects: 1. The clinical trial system and method designed based on the hospital HIS system, by adding clinical trial subjects as key patient types in the background of the doctor's workstation of the hospital HIS system, allocating the first-level operation authority of the doctor in the medical authority maintenance, adding the second-level type maintenance according to the specific clinical trial project, so as to realize the test project marking of the subjects and the authority control of the doctor, adding the clinical trial mark selection through the outpatient examination application form, the test application form, the disposal and cost, and the prescription interface to mark the test project, distinguishing the clinical trial mark during the outpatient fee settlement, and making separate fee settlement for the clinical trial project, adding the clinical trial mark selection through the inpatient examination application form, the test application form, and the general medical order interface to mark the clinical trial project, and using the mid-term settlement to settle part of the cost of the clinical trial project according to the clinical trial mark during the inpatient settlement, so that all clinical trial project-related parameters and authority acquisition are realized through a unified object, thereby realizing the unified code logic of each business module of outpatient and inpatient.
[0016] 2. The clinical trial system and method designed based on the hospital HIS system can record the modified data in the archive data through the set log recording module, which is convenient for the later staff to trace the modified data and query the original data, so that the archive room staff can grasp the data status in the archive module at any time, thereby improving the security of the archive data. The archive data can be backed up by setting the backup module to avoid the problem of data loss caused by data failure. BRIEF DESCRIPTION OF THE DRAWINGS
[0017] Figure 1 This is a schematic diagram of the process of outpatient subjects visiting the hospital for treatment in the present invention; Figure 2 This is a schematic diagram of the process of hospitalized subjects visiting the hospital for treatment according to the present invention; Figure 3 This is a schematic diagram of the framework of the outpatient clinical trial system of the present invention; Figure 4 This is a schematic diagram of the framework of the inpatient clinical trial system of the present invention; Figure 5 It is a schematic diagram of the archive management module framework of the present invention. DETAILED DESCRIPTION
[0018] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.
[0019] See also Figure 1-5 ,An embodiment of the present invention is: a clinical trial system designed based on a hospital HIS system, including an outpatient clinical trial system and an inpatient clinical trial system; The outpatient clinical trial system includes a registration module, an outpatient doctor station and an outpatient charging module. The registration module is connected to the outpatient doctor station, and the outpatient doctor station is connected to the outpatient charging module. The inpatient clinical trial system includes a login module, an inpatient system module, an admission registration module, an appointment registration module, a patient management module, a settlement management module, and a patient account data module; The inpatient system module includes ticket management module, group maintenance module, bed setting module, room setting module, insurance module and report module; The patient management module includes the collection management module, account unfreezing module, expense accounting module, payment management module and bed management module.
[0020] The outpatient doctor station includes a prescription module, an inspection module, a testing module, a disposal module, a diagnosis module and a case module. The diagnosis module is connected to the medical history module, and the case module is connected to the medical history module.
[0021] The outpatient billing module includes a radiology module, a laboratory module and a pharmacy module, and the outpatient billing module is connected to the medical history module.
[0022] By adding clinical trial subjects as key patient types in the background of the doctor's workstation in the hospital HIS system, the first-level operation authority of the doctor is allocated in the medical authority maintenance, and the second-level type maintenance is added according to the specific clinical trial projects to realize the trial project marking of the subjects and the authority control of the doctor. The clinical trial mark selection is added through the outpatient examination application form, test application form, disposal and cost, and prescription interface to mark the trial project. The clinical trial mark is distinguished during the outpatient fee settlement, and the clinical trial project is charged and settled separately; the clinical trial mark selection is added to the inpatient examination application form, test application form, and general medical order interface to mark the clinical trial project. During the inpatient settlement, according to the clinical trial mark, mid-term settlement is used to settle part of the clinical trial project fees mid-term, so that all clinical trial project-related parameters and authority acquisition are realized through a unified object, thereby realizing the unified code logic of each outpatient and inpatient business module.
[0023] The appointment registration module is connected to the appointment management module, the appointment registration module is connected to the patient transfer module, the patient transfer module is connected to the admission registration module, the admission registration module is connected to the patient file creation module, and the patient file creation module is connected to the file management module.
[0024] The expense accounting module is connected to the refund processing module, and the refund processing module is connected to the patient account data module.
[0025] The payment management module is connected to the patient account data module, the settlement management module is connected to the refund settlement module, and the refund settlement module is connected to the patient account data module.
[0026] The archive management module includes data management module, retrieval module, backup module, log recording module, confidentiality setting module and data export module. The log recording module can record the modified data in the archive data, which is convenient for the later staff to trace the modified data and query the original data, so that the archive staff can grasp the data status in the archive module at any time, thereby improving the security of the archive data. The backup module can be used to back up the archive data to avoid data loss due to data failure.
[0027] The data management module is used to manage the archive data packets, workflows and information resources; the retrieval module is used to quickly retrieve the stored archive data packets; and the backup module is used to burn the stored archive data packets.
[0028] The log recording module is used to record the system user name login time, operation commands and operation data. The confidentiality setting module is used to set the user level and authority, and the confidentiality level of the file. The data export module is used to export the data in the archive.
[0029] A method for using a clinical trial system designed based on a hospital HIS system comprises the following steps: S1: Expand by utilizing the key patient function in the hospital HIS system; S2: Add clinical trial patients as key patient types; S3: Allocate the first-level operation authority of doctors in the medical authority maintenance; S4: The clinical trial management department screens the professionals who have passed the clinical trial filing; S5: Authorized doctors must hold a GCP certificate within the past 3 years and have the qualification to practice in this hospital; S6: Secondary operation authority allocation realizes patient test project labeling and doctor authority control; S7: Authorized physician is the research physician authorized for this clinical trial; S8: Clinical trial project marking is performed on the outpatient examination, test application form, and prescription disposal interface; S9: The clinical trial mark is distinguished when charging for outpatient services, and clinical trial projects are settled separately; S10: Clinical trial project marking on the hospitalization examination and testing application form and doctor's order interface; S11: When settling hospital bills, part of the project costs will be settled midway according to the clinical trial mark; S12: All clinical trial project-related parameters and permissions are obtained through a unified object; S13: Realize the unification of code logic for outpatient and inpatient business modules.
[0030] The present invention adds clinical trial subjects as key patient types in the background of the doctor workstation of the hospital HIS system, distributes the first-level operation authority of the doctor in the medical authority maintenance, and adds second-level type maintenance according to the specific clinical trial project to realize the test project marking of the subject and the authority control of the doctor, and adds the clinical trial mark selection through the outpatient examination application form, the test application form, the disposal and cost, and the prescription interface to mark the test project, distinguish the clinical trial mark during the outpatient fee settlement, and perform separate fee settlement for the clinical trial project; adds the clinical trial mark selection to the inpatient examination application form, the test application form, and the general doctor's order interface to mark the clinical trial project, and uses the mid-term settlement to perform mid-term settlement of part of the cost of the clinical trial project according to the clinical trial mark during the inpatient settlement, so that all clinical trial project-related parameters and authority acquisition are realized through a unified object, thereby realizing the code logic unification of each outpatient and inpatient business module.
[0031] The present invention provides a clinical trial system and method based on the design of the hospital HIS system. There are many methods and ways to implement the technical solution. The above is only the preferred implementation of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the protection scope of the present invention. All components not specified in this embodiment can be implemented by existing technologies.
Claims
1. A clinical trial system designed based on the hospital HIS system, characterized in that: Including outpatient clinical trial system and inpatient clinical trial system; The outpatient clinical trial system includes a registration module, an outpatient doctor station and an outpatient billing module, wherein the registration module is connected to the outpatient doctor station, and the outpatient doctor station is connected to the outpatient billing module; The inpatient clinical trial system includes a login module, an inpatient system module, an admission registration module, an appointment registration module, a patient management module, a settlement management module and a patient account data module; The hospitalization system module includes a ticket management module, a group maintenance module, a bed setting module, a room setting module, an insurance module and a report module; The patient management module includes a collection management module, an account unfreezing module, a fee accounting module, a payment management module and a bed management module.
2. The clinical trial system designed based on the hospital HIS system according to claim 1 is characterized by: The outpatient doctor station includes a prescription module, an inspection module, a testing module, a treatment module, a diagnosis module and a case module. The diagnosis module is connected to a medical history module, and the case module is connected to the medical history module.
3. The clinical trial system designed based on the hospital HIS system according to claim 2 is characterized by: The outpatient billing module includes a radiology module, a laboratory module and a pharmacy module, and the outpatient billing module is connected to the medical history module.
4. The clinical trial system designed based on the hospital HIS system according to claim 1 is characterized by: The appointment registration module is connected to the appointment management module, the appointment registration module is connected to the patient transfer module, the patient transfer module is connected to the admission registration module, the admission registration module is connected to the patient file creation module, and the patient file creation module is connected to the file management module.
5. The clinical trial system designed based on the hospital HIS system according to claim 1 is characterized by: The expense accounting module is connected to a refund processing module, and the refund processing module is connected to a patient account data module.
6. The clinical trial system designed based on the hospital HIS system according to claim 1 is characterized by: The payment management module is connected to the patient account data module, the settlement management module is connected to the refund settlement module, and the refund settlement module is connected to the patient account data module.
7. The clinical trial system designed based on the hospital HIS system according to claim 4 is characterized by: The archive management module includes a data management module, a retrieval module, a backup module, a log recording module, a confidentiality level setting module and a data export module.
8. The clinical trial system designed based on the hospital HIS system according to claim 7 is characterized by: The data management module is used to manage the archive data packets, workflows and information resources; the retrieval module is used to quickly retrieve the stored archive data packets; and the backup module is used to burn the stored archive data packets.
9. The clinical trial system designed based on the hospital HIS system according to claim 7 is characterized by: The log recording module is used to record the time, operation commands and operation data of the system user name login, the confidentiality setting module is used to set the user level and authority, and the confidentiality level of the file, and the data export module is used to export the data in the archive.
10. A method for using the clinical trial system designed based on the hospital HIS system according to claims 1-9, characterized in that: The following steps are involved: S1: Expand by utilizing the key patient function in the hospital HIS system; S2: Add clinical trial patients as key patient types; S3: Allocate the first-level operation authority of doctors in the medical authority maintenance; S4: The clinical trial management department screens the professionals who have passed the clinical trial filing; S5: Authorized doctors must hold a GCP certificate within the past 3 years and have the qualification to practice in this hospital; S6: Secondary operation authority allocation realizes patient test project labeling and doctor authority control; S7: Authorized physician is the research physician authorized for this clinical trial; S8: Clinical trial project marking is performed on the outpatient examination, test application form, and prescription disposal interface; S9: The clinical trial mark is distinguished when charging for outpatient services, and clinical trial projects are settled separately; S10: Clinical trial project marking on the hospitalization examination and testing application form and doctor's order interface; S11: When settling hospital bills, part of the project costs will be settled midway according to the clinical trial mark; S12: All clinical trial project-related parameters and permissions are obtained through a unified object; S13: Realize the unification of code logic for outpatient and inpatient business modules.