CN112489774B - Clinical trial subject recruitment system - Google Patents
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Abstract
The invention relates to the technical field of medical treatment, in particular to a clinical trial subject recruitment system, which comprises a researcher terminal, a doctor terminal, a patient terminal and a server, wherein the server comprises: the release module is used for acquiring and displaying project information initiated by the researcher terminal; the screening module is used for receiving recommended patient information sent by the doctor terminal according to the project information, judging whether the patient meets the conditions according to preset inclusion criteria and exclusion criteria, if so, recording the patient information and storing the patient information into the database, and generating an informed consent form to be signed; the informed consent module is used for correspondingly sending the informed consent to be signed to the patient terminal meeting the conditions, inputting the confirmation information of the patient and generating a signed informed consent; binding the signed informed consent with the patient information and storing the bound informed consent into a preset selected patient information base; the problem of low subject recruitment efficiency can be solved by adopting the scheme.
Description
Technical Field
The invention relates to the technical field of medical treatment, in particular to a clinical trial subject recruitment system.
Background
Clinical trials refer to prospective studies in human subjects, pre-assigning a subject or group of subjects to receive one or more medical interventions to assess the impact of the medical intervention on a healthy outcome. Where "medical intervention" includes, but is not limited to, drugs, cells and other biologicals, surgical treatments, radiation treatments, medical devices, behavioral therapies, changes in the course of treatment, preventive care, etc. The definition includes phase 1 through phase 4 trials. The subject recruitment, which is a pre-work in the clinical trial during the study conduct phase, is a very important step in the clinical trial and mainly consists of recruiting subjects, screening qualified subjects, obtaining informed consent of the subjects. Whether a subject recruits a sufficient number of subjects meeting the test requirements will have an important effect on the quality of the test, and also an important factor in the progress of the test, and if a sufficient number of suitable subjects cannot be recruited, the clinical test has to be paused or even terminated.
In this regard, a system for rapidly matching patient recruitment and cases in clinical trials is disclosed in the document CN110415772a, which includes a storage module, in which project information of clinical trials (including the basic requirements of the project) and medical record information received by the storage module are pre-stored; the release module is used for releasing the project information; the receiving module is used for receiving medical record information of a patient; the matching module is used for matching the medical record information according to the project information; and the pushing module is used for pushing the matched medical record information to project personnel when the medical record information corresponding to the project information is matched.
By adopting the scheme, the medical record information of the patient can be matched with the project information of the clinical test, and the personnel meeting the clinical test conditions can be selected; however, investigation shows that the best mode of recruiting patients is recommended by doctors or medical staff of the patients, the acceptance of the patients is high, the patients better meet the protection of privacy and awareness of the patients, and the recruitment success rate is highest. Meanwhile, due to the continuous expansion of clinical tests and the continuous development of various rare disease clinical tests, the demands on the tested personnel are increasingly improved, the medical records systems of all hospitals are relatively closed, the complete intercommunication cannot be realized temporarily, and if the tested patients are screened only by the researchers or project personnel specially responsible for recruitment work, the utilization of doctor resources or nurse resources which are in contact with the patients is neglected, so that the problem of low efficiency exists.
Disclosure of Invention
The invention aims to provide a clinical trial subject recruitment system which can solve the problem of low recruitment efficiency.
The basic scheme provided by the invention is as follows: a clinical trial subject recruitment system comprising a researcher terminal, a doctor terminal, a patient terminal, and a server, the server comprising:
The release module is used for acquiring and displaying project information initiated by the researcher terminal;
The screening module is used for receiving recommended patient information sent by the doctor terminal according to the project information, judging whether the patient meets the conditions according to preset inclusion criteria and exclusion criteria, if so, recording the patient information and storing the patient information into the database, and generating an informed consent form to be signed;
The informed consent module is used for correspondingly sending the informed consent to be signed to the patient terminal meeting the conditions, inputting the confirmation information of the patient and generating a signed informed consent; binding the signed informed consent with the patient information and storing the bound informed consent into a preset selected patient information base;
And the output module is used for pushing the patient information in the selected patient information base and the signed informed consent to the researcher terminal.
The working principle and the advantages of the invention are as follows:
Compared with the prior recruitment work, in the scheme, project information initiated by a terminal of a researcher can be acquired and disclosed through a release module, so that more doctors can know project conditions of clinical research, the tradition of recruiting patients by taking the patients as break-over in the past is broken, and the recruitment success rate is improved by recruiting the patients by the doctors; acquiring recommended patient information sent by a doctor according to project information by setting a screening module, and recording the patient information in a database if the recommended patient meets screening conditions; then, the informed consent module sends the informed consent to be signed to a patient terminal conforming to the condition, and after the patient inputs the confirmation information, the signed informed consent can be generated, so that the workload of a recruitment doctor is reduced, and the informed rights of the patient are fully ensured; after the patient enters the confirmation information, the patient information and signed informed consent are recorded in an enrolled patient database; and finally, sending the selected patient information and the informed consent to a researcher terminal through an output module for the researcher to check.
In sum, the scheme can improve the diffuseness of clinical research project information among different medical institutions, and besides researchers specially responsible for recruitment work, more doctors can know what patients and recruitment progress the project needs to recruit at any time; and the doctor is mobilized to assist the recruitment of the patient, so that the limitation that the outpatient or rare disease can not be screened due to the matching of medical records is solved; the screening module and the informed consent module standardize the selection process, so that the workload of doctors for learning and executing project screening schemes is reduced, and different effects caused by different medical backgrounds in doctor-patient communication are reduced. Thereby guaranteeing the breadth of information resources, preventing the misreading of project information, guaranteeing standardization and normalization, and further improving the efficiency of patient recruitment.
Further, the screening module is also used for comparing the patient information with the selection standard to obtain the matching degree; and judging the matching degree according to the preset recommended proportion information, if the matching degree is greater than the recommended proportion, judging that the patient meets the condition, pushing the patient information to a researcher terminal, calculating the labor service reward according to the matching degree, and paying the labor service reward to a doctor.
The beneficial effects are that: generating a matching degree according to a comparison result of the patient information and the selection standard by setting a screening module, and if the matching degree is greater than preset recommended specific gravity information, indicating that the patient basically accords with the condition, pushing the patient to a terminal of a researcher for the researcher to further perfect verification; so far, as the doctor has assisted in completing a part of the work, a patient meeting the selection condition is recommended, and the consideration can be calculated according to the matching degree, and paid to the doctor; thereby stimulating the doctor and mobilizing and improving the enthusiasm of the doctor to participate in the recruitment of the subjects.
Further, the screening module is further used for obtaining patient medical record pictures uploaded by the doctor terminal, processing the medical record pictures according to an image processing algorithm to obtain text information, and judging that the patient meets the selection condition if the text information is matched with the selection standard.
The beneficial effects are that: a doctor can take a picture of the medical record of the patient, and the screening module extracts the text information in the picture according to the image processing algorithm and matches the text information with the selection standard, so that whether the patient meets the condition or not is judged, and the doctor can use the medical record conveniently.
Further, the database is also used for storing a plurality of pieces of video information introducing clinical tests and standard solution information in advance;
the informed consent module further comprises an item introduction sub-module which is used for pushing video information of the clinical trial to the patient terminal when the informed consent to be signed is sent;
The project introduction sub-module is also used for collecting voice information of the patient question, converting the voice into text information through a voice recognition algorithm, matching standard answer information from a database according to the text information, synthesizing the standard answer information into sound, and playing the sound by the patient terminal.
The beneficial effects are that: because the specific schemes and the target degrees of doctors with different backgrounds are inconsistent with each other in clinical tests, the scheme collects the voice information of the patient questions through a video description and an intelligent voice response mode, and after the voice information is converted into characters, the corresponding response information can be matched from a database and finally played through a terminal; therefore, the problem of doctor-patient communication is solved, and the patient can watch project introduction videos and questions, know corresponding rights and obligations, and conveniently and efficiently complete informed consent.
Further, the screening module is also used for acquiring doctor-patient question-answering information input by the doctor terminal, extracting text information in the doctor-patient question-answering information, and judging that the patient does not accord with the selection condition if the text information is matched with the exclusion standard.
The beneficial effects are that: correspondingly, doctors can also take the form of oral questions and answers with patients when recruiting subjects, the questions and answers information is required to be input into a screening module, text information in the questions and answers information is matched with exclusion criteria, and patients which do not meet the conditions are determined.
Further, the system also comprises a nurse terminal; the screening module is also used for acquiring patient laboratory sheet pictures and medical history information uploaded by the nurse terminal.
The beneficial effects are that: by adopting the scheme, the nurse resource can be fully utilized, the nurse terminal sends the laboratory sheet pictures and the medical history information of the patient to the screening module, the recruitment of the subjects is assisted, and the recruitment efficiency is improved.
Further, the recommended patient information includes an identification card number; the screening module is also used for inquiring a database according to the identification card numbers, and prompting the patient to be selected if the same identification card number exists in the database; otherwise, the ID card number is recorded in the database.
The beneficial effects are that: the identification card number is used as a unique identifier of a person, and can be used in the scheme to inquire whether a patient has selected according to the identification card, so that the method meets the actual requirement and is convenient to operate.
Furthermore, the researcher terminal, the doctor terminal, the patient terminal and the nurse terminal are all mobile phone terminals.
The beneficial effects are that: the mobile phone has portability and perfect functions, and is convenient for doctors and nurses to collect and send pictures and text information.
Further, the validation information includes a fingerprint and a signature.
The beneficial effects are that: in the scheme, the electronic form of the informed consent is sent to the patient terminal, and compared with the traditional paper informed consent, the patient does not need to carry the informed consent at any time and any place; moreover, by adopting a fingerprint and signature mode, the operation can be directly performed through the mobile phone, so that the workload is saved, and the user experience of a patient is improved; thus, the paperless, standardized and intelligent advantages are presented.
Further, the informed consent module is further used for starting timing after sending the informed consent to be signed, and generating waiting time; and if the waiting time is greater than the preset time threshold, sending prompt information to the patient terminal.
The beneficial effects are that: by adopting the scheme, the situation that the patient does not process the informed consent for a long time or forgets to process the informed consent can be avoided, so that the recruitment efficiency and progress of the subjects are ensured.
Drawings
Fig. 1 is a system block diagram of a first embodiment of a clinical trial subject recruitment system of the present invention.
Detailed Description
The following is a further detailed description of the embodiments:
Example 1
A clinical trial subject recruitment system, as shown in fig. 1, comprising a researcher terminal, a doctor terminal, a patient terminal, and a server, wherein: the researcher terminal, the doctor terminal and the patient terminal are mobile phone terminals; the server comprises:
The release module is used for acquiring and displaying project information initiated by the researcher terminal; through the public project information, medical staff of all cooperative medical institutions can timely know the disease condition of the research project and the recruitment progress, so that proper subjects can be purposefully excavated in the subsequent diagnosis and treatment process of the medical staff;
The screening module is used for receiving recommended patient information sent by the doctor terminal according to the project information, judging whether the patient meets the conditions according to preset inclusion criteria and exclusion criteria, if so, recording the patient information and storing the patient information into the database, and generating an informed consent form to be signed; specifically, the inclusion criteria in this embodiment may be predefined as "1" according to actual needs, male or female, age is greater than or equal to 18 years; 2. is taking an antiplatelet agent "and may also be defined as" 1 "in other embodiments, has HF symptoms at visit 1 (NYHA class II-iv); 2. evidence of structural heart disease is one or more of the following echocardiographic abnormalities; accordingly, the exclusion criteria in this example may be defined as "1. The severe disease is combined and life expectancy is less than or equal to 6 months; 2. in another embodiment, the exclusion criteria are defined as "1. Any prior LVEF detection value < 45%;2. patients with a history of vascular oedema are known.
In this way, after the doctor discovers the patient, the doctor obtains the consent of the patient by oral sign, and the doctor can acquire the patient information by photographing the medical record of the patient and also adopting the form of oral question and answer with the patient; the screening module is also used for acquiring patient medical record pictures uploaded by the doctor terminal, processing the medical record pictures according to an image processing algorithm to obtain text information, and judging that the patient meets the selection condition if the text information is matched with the selection standard; the screening module is also used for acquiring doctor-patient question-answering information input by the doctor terminal, extracting text information in the doctor-patient question-answering information, and judging that the patient does not accord with the selection condition if the text information is matched with the exclusion standard.
In another embodiment, the system further comprises a nurse terminal, wherein the nurse terminal is a mobile phone terminal; after the nurse finds out a suitable patient, the nurse gives oral sign to obtain the consent of the patient, and the screening module is also used for obtaining the patient laboratory sheet picture and the medical history information uploaded by the nurse terminal; can utilize the nurse resource, send patient's laboratory sheet picture and medical history information to the screening module by the nurse terminal, help carrying out the recruitment of subject, promote recruitment efficiency.
In order to facilitate searching whether the patient is in the selected group, the recommended patient information in the scheme comprises an identity card number; the screening module is also used for inquiring a database according to the identification card numbers, and prompting the patient to be selected if the same identification card number exists in the database; otherwise, the ID card number is recorded in the database. By using the patient identification card as the identification condition, the probability that different centers and different doctors select the same patient to enter the group can be reduced.
The informed consent module is used for sending video item introduction to the patient meeting the selection condition, explaining the rights and obligations of participating in the item, providing online intelligent answering and completing the doctor-patient communication process; after the patient finishes knowing the project, correspondingly sending the to-be-signed informed consent to a patient terminal meeting the condition, inputting the confirmation information of the patient, and generating a signed informed consent; binding the signed informed consent with the patient information and storing the bound informed consent into a preset selected patient information base; specifically, in order to facilitate the patient to understand the project, the database is also used for storing a plurality of video information introducing clinical trials and standard solution information in advance; the right and obligation of the patient to participate in the project are introduced in the video information;
The informed consent module further comprises an item introduction sub-module which is used for pushing video information of the clinical trial to the patient terminal when the informed consent to be signed is sent; according to the scheme, the clinical test project is introduced to the patient by pushing the video description, so that the patient can know more information about the project, and the follow-up test work can be conveniently carried out.
The project introduction sub-module is also used for collecting voice information of the patient question, converting the voice into text information through a voice recognition algorithm, matching standard answer information from a database according to the text information, synthesizing the standard answer information into sound, and playing the sound by the patient terminal. Wherein: the conversion of the voice to the text or the generation of the text to the voice can be realized by the existing scientific large message flying voice engine, and the description is omitted here; the standard answer information is matched from the database according to the text information mainly by adopting a keyword matching technology, and the intelligent voice answer mode can solve the doctor-patient communication problem and is convenient for efficiently completing the informed consent.
The to-be-signed informed consent form comprises elements such as a study project name, a subject undertaking unit, a contact person of a hospital, a contact phone, a consent statement, a subject signature, a date, a phone and the like; the patient's confirmation information includes fingerprint and signature, and the patient can be through the cell-phone operation, utilizes fingerprint input or signature collection's means to accomplish signing of informed consent form, makes informed consent link not receive the restriction in place, does not receive the restriction of recruitment doctor or nurse medical background, and the operation flow is more convenient and fast, saves work load greatly, can promote patient user experience.
And the output module is used for pushing the patient information in the selected patient information base and the signed informed consent to the researcher terminal.
Example two
Compared with the first embodiment, the difference is that the screening module is also used for comparing the patient information with the selection standard to obtain the matching degree; and judging the matching degree according to preset recommended specific gravity information (45% in the embodiment), if the matching degree is larger than the recommended specific gravity, judging that the patient meets the condition, pushing the patient information to a researcher terminal, calculating the labor compensation according to the matching degree, and paying the labor compensation to a doctor. For example, if the recommended doctor matches 50%, patient information may be sent to the researcher; subsequent researchers are responsible for follow-up, perfecting the selection, and finally selecting. The recommended doctor can obtain 50% of recommended labor cost; therefore, doctors are stimulated in time, the enthusiasm of the doctors to participate in the recruitment of the clinical scientific research subjects is mobilized and promoted, and the recruitment efficiency of clinical experiments is remarkably improved.
The informed consent module is further used for starting timing after sending the informed consent to be signed to ensure the recruitment efficiency and progress of the subjects and generating waiting time; if the waiting time is greater than the preset time threshold (preset as 2 days), a prompt message "please sign informed consent in time" is sent to the patient terminal.
Example III
Compared with the first embodiment, the difference is that the patient terminal is also used for acquiring the requirement file of the clinical test program, reading the requirement file and generating a detection instruction according to the keyword information in the standard file; for example, in a clinical trial with respect to drugs, a document is required to prescribe that the subject's diet cannot drink alcohol; therefore, after the requirement file is read, the detection instruction generated according to the keyword 'diet' can be 'shooting the diet condition of the subject by the camera at the meal time'; the server is used for receiving the detection instruction and prompting the patient according to the detection instruction; the prompting means in this embodiment may be sending a push message to the patient terminal, and in other embodiments, a similar manner to the existing robot phone may be adopted, where the technology is the prior art, and will not be described herein again; compared with the general message pushing, the method can give better prompting effect to the subjects.
The server is also used for acquiring the sound information uploaded by the pick-up at the mobile phone end of the patient, converting the sound information into characters according to a voice recognition algorithm (adopting a scientific large-scale flying voice recognition technology), and generating a detection instruction according to keywords in the characters; for example, if the subject speaks keywords similar to "eat", the subject wakes up a camera on the mobile phone end to collect the eating condition; the problem of power consumption of the camera in a working state all the time can be avoided, and the image privacy of a user can be effectively protected.
The patient mobile phone end is also used for acquiring image information through the camera and sending the image information to the server; the server is used for judging whether the image information is an illegal object image or not, and if so, generating alarm information 'the illegal operation of the subject' and generating the alarm information to the terminal of the researcher. Specifically, a database of the server is pre-stored with a plurality of illegal item images and names thereof, the function of screening the illegal item images from the images can be realized through the existing image comparison algorithm, and finally, a requirement file is compared, if the names of the illegal items specified in the requirement file are the same as the names of the items identified by the images, the images are indicated as illegal items; to avoid that items in the image information are not stored in the database, detection of illegal items is invalid; in the embodiment, if the image information is not recognized as the illegal object image, judging whether the illegal object image which is the same as the image information is stored in the database, if not, transmitting the image information to the doctor terminal, and receiving the object name transmitted by the doctor terminal; the database is also used for receiving and storing the image information and the names of the articles, completing self-learning, enhancing the recognition capability of the database and facilitating the next judgment.
By adopting the scheme, the irregular behaviors are identified by shooting the images of the work and rest conditions of the subjects, so that the irregular behaviors are avoided in the preparation stage of the clinical test, and the effective performance of the test is influenced.
The foregoing is merely an embodiment of the present application, and a specific structure and characteristics of common knowledge in the art, which are well known in the scheme, are not described herein, so that a person of ordinary skill in the art knows all the prior art in the application date or before the priority date, can know all the prior art in the field, and has the capability of applying the conventional experimental means before the date, and a person of ordinary skill in the art can complete and implement the present embodiment in combination with his own capability in the light of the present application, and some typical known structures or known methods should not be an obstacle for a person of ordinary skill in the art to implement the present application. It should be noted that modifications and improvements can be made by those skilled in the art without departing from the structure of the present application, and these should also be considered as the scope of the present application, which does not affect the effect of the implementation of the present application and the utility of the patent. The protection scope of the present application is subject to the content of the claims, and the description of the specific embodiments and the like in the specification can be used for explaining the content of the claims.
Claims (10)
1. A clinical trial subject recruitment system comprising a researcher terminal, a doctor terminal, a patient terminal, and a server, the server comprising:
The release module is used for acquiring and displaying project information initiated by the researcher terminal;
The screening module is used for receiving recommended patient information sent by the doctor terminal according to the project information, judging whether the patient meets the conditions according to preset inclusion criteria and exclusion criteria, if so, recording the patient information and storing the patient information into the database, and generating an informed consent form to be signed;
The informed consent module is used for correspondingly sending the informed consent to be signed to the patient terminal meeting the conditions, inputting the confirmation information of the patient and generating a signed informed consent; binding the signed informed consent with the patient information and storing the bound informed consent into a preset selected patient information base;
The output module is used for pushing the patient information in the selected patient information base and the signed informed consent to the researcher terminal;
the patient terminal is used for acquiring a requirement file of a clinical test program, reading the requirement file, and generating a detection instruction according to keyword information in a standard file; the server is used for receiving the detection instruction and prompting the patient according to the detection instruction;
The server is used for acquiring the sound information uploaded by the pick-up at the mobile phone end of the patient, converting the sound information into characters according to a voice recognition algorithm, and generating a detection instruction according to keywords in the characters; the patient mobile phone end is used for acquiring image information through the camera and sending the image information to the server; the server is used for judging whether the image information is an illegal item image, a plurality of illegal item images and names thereof are stored in a database of the server in advance, the function of screening the illegal item images from the images can be realized through the existing image comparison algorithm, and finally, a request file is compared, and if the name of the illegal item specified in the request file is the same as the name of the item identified by the image, the image is indicated as the illegal item; if the image information is not recognized as the illegal object image, judging whether the illegal object image which is the same as the image information is stored in the database, if not, transmitting the image information to a doctor terminal, and receiving the object name transmitted by the doctor terminal; the database is used for receiving and storing the image information and the names of the articles and completing self-learning.
2. The clinical trial subject recruitment system of claim 1, wherein: the screening module is also used for comparing the patient information with the selection standard to obtain the matching degree; and judging the matching degree according to the preset recommended proportion information, if the matching degree is greater than the recommended proportion, judging that the patient meets the condition, pushing the patient information to a researcher terminal, calculating the labor service reward according to the matching degree, and paying the labor service reward to a doctor.
3. The clinical trial subject recruitment system of claim 1, wherein: the database is also used for storing a plurality of video information introducing clinical tests and standard solution information in advance;
the informed consent module further comprises an item introduction sub-module which is used for pushing video information of the clinical trial to the patient terminal when the informed consent to be signed is sent;
The project introduction sub-module is also used for collecting voice information of the patient question, converting the voice into text information through a voice recognition algorithm, matching standard answer information from a database according to the text information, synthesizing the standard answer information into sound, and playing the sound by the patient terminal.
4. The clinical trial subject recruitment system of claim 1, wherein: the screening module is also used for obtaining the patient medical record picture uploaded by the doctor terminal, processing the medical record picture according to the image processing algorithm to obtain text information, and judging that the patient meets the selection condition if the text information is matched with the selection standard.
5. The clinical trial subject recruitment system of claim 4, wherein: the screening module is also used for acquiring doctor-patient question-answering information input by the doctor terminal, extracting text information in the doctor-patient question-answering information, and judging that the patient does not accord with the selection condition if the text information is matched with the exclusion standard.
6. The clinical trial subject recruitment system of claim 1, wherein: the system also comprises a nurse terminal; the screening module is also used for acquiring patient laboratory sheet pictures and medical history information uploaded by the nurse terminal.
7. The clinical trial subject recruitment system of claim 1, wherein: the recommended patient information comprises an identity card number; the screening module is also used for inquiring a database according to the identification card numbers, and prompting the patient to be selected if the same identification card number exists in the database; otherwise, the ID card number is recorded in the database.
8. The clinical trial subject recruitment system of claim 6, wherein: the researcher terminal, the doctor terminal, the patient terminal and the nurse terminal are all mobile phone terminals.
9. The clinical trial subject recruitment system of claim 1, wherein: the validation information includes a fingerprint and a signature.
10. The clinical trial subject recruitment system of claim 1, wherein: the informed consent module is further used for starting timing after sending the informed consent to be signed, and generating waiting time; and if the waiting time is greater than the preset time threshold, sending prompt information to the patient terminal.
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| CN113257377B (en) * | 2021-06-04 | 2024-05-24 | 联仁健康医疗大数据科技股份有限公司 | Method, device, electronic equipment and storage medium for determining target user |
| CN113380354B (en) * | 2021-06-16 | 2024-05-24 | 联仁健康医疗大数据科技股份有限公司 | Personnel recruitment method, device, system, electronic equipment and storage medium |
| CN113782122B (en) * | 2021-08-09 | 2024-04-16 | 中国中医科学院中医药信息研究所 | Electronic informed consent method and system |
| CN113889205A (en) * | 2021-09-30 | 2022-01-04 | 上海柯林布瑞信息技术有限公司 | Screening method and corresponding device for clinical research patient |
| CN115662554A (en) * | 2022-12-28 | 2023-01-31 | 北京求臻医疗器械有限公司 | Multi-group clinical trial subject matching method and device |
| CN116957519A (en) * | 2023-09-19 | 2023-10-27 | 省多多(天津)有限公司 | Clinical trial subject recruitment method, device and server based on AI |
| CN117854659B (en) * | 2024-03-08 | 2024-08-09 | 厦门茶蕊生物医药科技有限公司 | AI interaction method and system for clinical trial |
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