CN108830034A

CN108830034A - A kind of medicine clinical development information processing system and its method

Info

Publication number: CN108830034A
Application number: CN201810516753.6A
Authority: CN
Inventors: 陈育聪
Original assignee: Individual
Current assignee: Individual
Priority date: 2018-05-25
Filing date: 2018-05-25
Publication date: 2018-11-16
Anticipated expiration: 2038-05-25
Also published as: WO2019223794A1; CN108830034B

Abstract

The invention discloses a kind of medical clinical development information processing system and its method, which includes research and development bulk end, which there is first communication module, first information reception classification storage module, the first information to call analysis and processing module and report generation module；With held by each medical clinical test subject or medical user, for acquiring typing, storage, the subject's special-purpose terminal for transmitting all kinds of clinical trial informations of subject, information exchange is realized by internet between subject's special-purpose terminal and the first communication module for researching and developing bulk end.The present invention can significantly extend medical clinical development relevant information source and type, improve information collection timeliness, systematicness and integrality, expand research and development depth, range significantly, to significantly improve the efficiency of medicine research and development.

Description

A kind of medicine clinical development information processing system and its method

Technical field

The present invention relates to medicine to research and develop technical field of information processing, more particularly to a kind of medical clinical development information processing System and method.

Background technique

State food Drug Administration general bureau enables No. 3《Drug clinical trial quality management practices》, state food drug prison Pipe general bureau, national health family planning appointment No. 25th number《Medical Deuice Clinical Trial quality control procedure》Deng medical clinical trial management In regulation and international pertinent literature, the clinical testing procedure and process of all kinds of medicine are standardized.Currently, passing through in the world The research and development method such as all kinds of medical clinical tests including drug, medical instrument and consumptive material, all kinds of Clinics etc. made Clinical trial information depends on the clinical trial information during follow-up especially follow-up subject to subject Acquisition, analysis and management.This method although professional, the accuracy and reliability of clinical testing data can be ensured effectively, But it is examined since test data information is mainly derived from researcher's follow-up subject and its checks accordingly, and follow-up The time coordination mutual by subject and researcher, inspection examine the factors such as facility accessibility to be limited again, because This, there are problems and limitation for conventional medical clinical testing procedure：First is that the gap periods of follow-up are often longer, Especially when subject receives medical clinical test, to the vital clinical response information of clinical research often can not and When, it is complete, effectively recorded；Second is that due to being examined facility accessibility etc. by researcher and subject's time coordination and inspection Factor limitation, subject's follow-up check the time of inspection and receive the best follow-up or inspection after medical clinical test Looking into Check-Out Time often has an obvious deviation, follow-up or checks that the relevant clinical reaction information examined often is distorted Problem；Third is that clinical trial protocol, which often considers to check in design, examines the factors such as facility accessibility, and limit subject Project is examined in the inspection of follow-up, thus be unfavorable for more comprehensively, system, dynamically acquire and to record subject all kinds of clinical anti- Answer information；Fourth is that the research and development of the traditional medicines such as traditional Chinese medicine are then because the syndrome of subject's clinical response and the inspection of non-biochemical analysis refer to Mark is difficult to carry out in time, effectively detection being examined to face bigger difficulty by modern medicine means.

Summary of the invention

It is an object of the invention to overcome the deficiency of the prior art, provide it is a kind of include drug, medical instrument and consumptive material, it is each All kinds of medical clinical development information processing systems and its method including class Clinics etc., significantly to expand medical clinical development Information source, type and range, and by extensively, dynamic realtime, system effectively acquire typing, analysis processing and management prison Control participates in all kinds of clinical trial informations of each subject of clinical test during medical clinical test, to face for medicine Bed research and development offer is richer, more system is complete, basic data and scientific basis more promptly and accurately.

The technical solution adopted by the present invention to solve the technical problems is：A kind of medicine clinical development information processing system, Including researching and developing bulk end, which there is first communication module, the first information to receive classification storage module, the first information is called and analyzed Processing module and report generation module；With subject end, the end is tested by the whole or specific part for participating in medical clinical test Person or medical user hold, and have second communication module, information collection recording module, storage and processing module, the first display Module；It researches and develops and realizes that information is handed over by internet between the first communication module of bulk end and the second communication module at subject end Mutually；

Subject end acquires all kinds of during medical clinical development of typing subject by information collection recording module and faces Bed Test Information, and be stored in the storage and processing module at subject end；Subject end will be tested by second communication module All kinds of clinical trial informations of subject of the acquisition typing of person end and stored processing are sent to research and development bulk end；Research and develop bulk end First communication module receive all kinds of clinical trial informations after, classification storage module pair is received by the first information of research and development bulk end All kinds of clinical trial informations carry out classification preservation, and the first information for researching and developing bulk end calls analysis and processing module to all kinds of clinical examinations It tests information to be analyzed and processed, is sent to report generation module to number needed for research report for meeting the information that research and development require It is believed that breath is updated.

All kinds of clinical trial informations of the subject include by all kinds of quantitative of intelligent biological sensor automatic collection Biophysical chemistry information needs to make a report on typing by the subject end timing or not timing by subject according to clinical development Its receive medicine test the case where, test front and back and test during self all kinds of perception information, to particular body portion and body The shooting pictorial information of secretion, excreta, and needed according to research and development by the various specified clinics of subject end acquisition typing One of Test Information is a variety of.

The subject end further includes that module is instructed in the second security assurance information module and/or clinical test；Described second Security assurance information module is connected with the information collection recording module, storage and processing module and second communication module, and second Security assurance information module be used to ensure the acquired typing of information collection recording module acquisition typing of the information at subject end, Storage and tracing back property, authenticity, reliability and security in transmission overall process；The clinical test instructs module to deposit with described Storage and processing module, second communication module, the first display module are connected, and clinical test instructs module to be loaded with subject's clinical test Guidance and prompting scheme can receive the case where medicine is tested, acquisition to subject in the overall process or part stage of clinical test The quality and quantity element of all kinds of clinical trial informations of typing is compared with standard value, generates prompting in due course or instruction is logical The first display module is crossed to remind or instruct subject to improve perfect information acquisition typing work or improve the compliance of clinical test, And when adverse reaction occur, alarm signal is issued to research and development bulk end by second communication module automatic or manual.

The subject end is dedicated hardware terminal, and the information collection recording module of the dedicated hardware terminal includes can be certainly The intelligent biological sensors of dynamic all kinds of quantitative biophysical chemistry information of acquisition subject and be able to carry out text, picture, video, The input unit of voice messaging typing；The output of intelligent biological sensor and input unit connects storage and processing module respectively, deposits Storage and processing module are connected with second communication module, the first display module.

The intelligent biological sensor is internally-arranged type, is mounted in the dedicated hardware terminal；And/or the intelligent biological Sensor is externally positioned type, is equipped in the dedicated hardware terminal and is used to realize that data pass with the intelligent biological sensor of externally positioned type Defeated data transmission interface, the data transmission interface are cable port or radio port；The intelligent biological of the externally positioned type senses Device is connected by data transmission interface with storage and processing module.

It is described be able to carry out text, picture, video, voice input input unit be keyboard, mouse, touch screen, camera shooting One of head or microphone are a variety of.

The subject end includes the included communication device of the held mobile terminal of subject, data transmission interface, input dress Set and display device, the dedicated APP in subject end being loaded on the held mobile terminal of subject and mobile terminal built-in and/ Or external intelligent biological sensor；The dedicated APP in subject end includes the storage and processing module, and the second information security is protected Module is instructed in barrier module and/or clinical test；The first communication module at the subject end uses the held mobile terminal of subject Included communication device；The information collection recording module is using the included input unit of the held mobile terminal of subject, data Coffret and its built-in and/or external intelligent biological sensor；First display module holds shifting using subject The included display device of dynamic terminal；The dedicated APP in subject end by the held mobile terminal of subject carry input unit, Subject's mobile terminal carry the external intelligent biological sensor acquisition typing of intelligent biological sensor and/or subject wears by All kinds of clinical trial informations of examination person, and be stored in its storage and processing module；The external intelligent biological of the subject wears The wired or wireless data transmission port and the dedicated APP in subject end that sensor is carried by the held mobile terminal of subject carry out Information exchange；The communication function module and research and development bulk end that the dedicated APP in subject end is carried by subject's mobile terminal Information exchange is realized by internet.

Further, the research and development bulk end further includes emergency disposal module and/or first information safety guarantee module, institute It states emergency disposal module and calls analysis and processing module to be connected with the first communication module, the first information；Research and development bulk end receives After the adverse reaction alarm signal that the subject end is sent, analysis and processing module analysis processing is called through its first information, it is right Conventional alarm signal generates emergency disposal guidance program by emergency disposal module, is sent to first display module at subject end, Subject or its guardian is instructed to carry out emergency disposal；The first information safety guarantee module and first communication module, first Information receives classification storage module, the first information calls analysis and processing module, emergency disposal module is connected, for ensuring to research and develop master Body end handles tracing back property, authenticity, reliability and peace in all kinds of clinical trial information's overall processes in its reception, storage, analysis The authenticity of full property and emergency disposal tutorial message record.

Further, the research and development bulk end is sponsor's bulk end, Contract Research Organization or all kinds of specified thirds One of medicine research and development institution of side bulk end, researcher's bulk end are a variety of；Researcher's bulk end by internet with Realize information exchange, sponsor's bulk end and/or Contract Research Organization or all kinds of specified third parties in the subject end Medical research and development institution's bulk end realizes information exchange via researcher's bulk end and the subject end again；Either, sponsor Bulk end, Contract Research Organization or all kinds of specified third party's medicine research and development institution bulk ends, researcher's bulk end pass through respectively Information exchange directly is realized with the subject end in internet.

Further, the research and development bulk end is medical institutions' bulk end, pharmaceutical manufacturer's bulk end, health care administration One of management subject end is a variety of；Medical institutions' bulk end, which passes through, realizes letter between internet and the subject end Breath interaction, pharmaceutical manufacturer's bulk end and/or health care subject of administration end are again via medical institutions' bulk end and institute It states and realizes information exchange between subject end；Either, pharmaceutical manufacturer's bulk end, medical institutions' bulk end, health care Subject of administration end passes through internet respectively and directly realizes information exchange with the subject end.

Further, further include being held by researcher or research staff, be used to realize that data transmission connects with subject end The researcher connect manages Specialised mobile terminal or is loaded with researcher's mobile terminal that researcher manages dedicated APP comprising the Three communication modules, the second information receive classification storage module, the second information calls analysis and processing module, third security assurance information Module and the second display module；It is realized and is believed by internet between its third communication module and the second communication module at subject end Breath interaction；After its third communication module receives all kinds of clinical trial informations of subject end transmission, received through its second information After the storage of classification storage module and the second information call analysis and processing module analysis processing, with regard to the test compliance, no of subject Good response situation, all kinds of clinical trial informations acquire the quality and quantity of typing, by its second display module to the researcher It is reminded；The third security assurance information module and third communication module, the second information receive classification storage module, second Information calls analysis and processing module to be connected, for ensuring that researcher manages Specialised mobile terminal in its reception, storage, analysis processing All kinds of clinical trial informations and the tracing back property for instructing the information of subject's emergency disposal overall process to record, authenticity, reliability with Safety；Certainly, researcher manages Specialised mobile terminal or is loaded with researcher's mobile terminal that researcher manages dedicated APP It can be connected by its third communication module with the first communication module of research and development bulk end, it is more powerful to obtain research and development bulk end Integrated information is supported.

Further, further include being held by inspection personnel or inspector, be used to real with research and development bulk end, subject end The inspection management of existing data transmission connection or checking and administration Specialised mobile terminal are loaded with inspection management or checking and administration is dedicated The inspection personnel of APP and/or inspector's mobile terminal comprising fourth communication module, third information receive classification storage mould Block, third information call analysis and processing module and third display module；Its fourth communication module is communicated with research and development bulk end first Module, subject end second communication module between information exchange realized by internet；Its fourth communication module, which receives, grinds Study carefully bulk end, all kinds of clinical trial informations of subject end transmission and its reception, storage, analysis processing, the number for transmitting overall process After the information of quality and safety, the storage of classification storage module is received through its third information and third information calls analysis processing mould After block analysis compares, tested with regard to whether researcher and subject carry out in strict accordance with clinical trial protocol, clinical trial information's number According to reliability, safety, accuracy the case where, the monitor or inspector are mentioned in time by its third display module It wakes up.

A kind of medicine clinical development information processing method, including：

It researches and develops main body and works out medical clinical research test scheme, and determine that medicine faces according to clinical research test solution development Bed research and development information management system and research and development bulk end research and development information processing subsystem, subject end research and develop information processing subsystem, And it obtains mechanism examination & approval authorization of having the right and passes through；

Research and development main body recruits training subject and establishes subject information's database in research and development bulk end；

Research and development bulk end record storage subject receives the information of various medical clinical tests；

Researcher follow-up subject, and according to follow-up situation and check that inspection result makes a report on subject's case report form (CRF)；

To during writing medical Clinical Report after subject receives all kinds of medical clinical test trainings, subject's root According to clinical trial protocol and it is corresponding require, by subject end in real time, timing or sporadically acquisition, typing subject is all kinds of faces Bed Test Information；And it stores and handles at subject end；Then it is transferred to by mobile Internet timing or sporadically Research and develop bulk end；Research and develop bulk end to all kinds of clinical trial informations of the subject received carry out classification storage, analysis processing with Afterwards, report generation module is sent to be updated to data information needed for research report for meeting the information that research and development require； During this period, researcher's follow-up subject, research and development main body make a report on subject's case report form (CRF) link still press research and development needs It is normally carried out, it is unaffected；

After clinical test, the comprehensive follow-up subject situation of research and development main body, case report form (CRF) and in real time or fixed When all kinds of clinical trial informations of subject that receive of not timing and its analysis and processing result, summary write medical clinical research report It accuses.

All kinds of clinical trial informations of the subject include by the built-in intelligence biosensor at subject end and/or All kinds of quantitative biophysical chemistry information of external intelligent biological sensor automatic collection, need according to clinical development by subject By subject end timing or not timing make a report on typing its receive medicine test the case where, during test front and back and test Self all kinds of perception information of various main suit's situations believe the shooting picture of particular body portion and body exudates, excreta Breath, and needed according to research and development by one of various specified clinical trial informations of subject end acquisition typing or a variety of.

Further, further comprising the steps of：Subject end acquires typing, all kinds of clinical test letters of storage processing subject It after breath, analyses and compares with the clinical test guidance program for loading on subject end, when the information content or matter of acquisition typing When amount and clinical test require deviation occur or prompt specific clinical reaction occur, the clinical test at subject end instructs module logical Crossing the first display module reminds or instructs in time subject to improve acquisition record by research and development requirement enhancing clinical test compliance, adjustment Enter work or scientific and normal disposition is carried out to specific clinical reaction.

Further, further comprising the steps of：Subject end acquires typing, all kinds of clinical test letters of storage processing subject It after breath, analyses and compares with the clinical test guidance program for loading on subject end, when corresponding informance prompt appearance is bad anti- At once, alarm signal is issued from trend research and development bulk end, after researching and developing bulk end receive the alarm signal, is called at analysis through its information Manage module analysis differentiate, to conventional alarm signal by its emergency disposal module generate emergency disposal guidance program, by its first Communication module and subject end second communication module, the first display module instruct subject or its guardian to carry out emergency disposal； When to the emergency alarm that serious adverse reaction occurs, urgent intervention is taken to the subject by research and development main body, is organized the rescue work Medical first aid measure.

Further, further comprising the steps of：Pharmaceutical manufacturer's bulk end, medical institutions' bulk end, health care administration tube Manage one of bulk end or a variety of research and development bulk ends, receive the subject end second communication module transmit it is all kinds of Clinical trial information, collect each subject's clinical trials condition extensively or listed the service condition of medical user, curative effect, Adverse reaction information, and being analyzed and researched by big data technology, with the later period for medicine further research and develop improvement, using or Supervision provides basic data and scientific basis.

Compared with prior art, the beneficial effects of the invention are as follows：

The present invention by the subject end through its information collection recording module in real time or timing not timing acquire typing by All kinds of clinical trial informations during examination person's medicine clinical development, and preservation processing is carried out in its storage and processing module, pass through it Second security assurance information module ensures that all kinds of clinical trial informations of the acquired typing of information collection recording module adopt at it Collect typing, storage and tracing back property, authenticity, reliability and security in transmission overall process；Subject end is second logical by it Subject end is acquired typing by letter module, all kinds of clinical trial informations of preservation processing are sent to research and development bulk end；Research and develop main body After the first communication module at end receives relevant information, the first information for researching and developing bulk end receives classification storage module for all kinds of clinics Test Information carries out classification preservation, research and develop bulk end the first information call analysis and processing module to all kinds of clinical trial informations into Row analysis processing is sent to the report generation module of research and development bulk end to research report institute for meeting the information that research and development require The data information needed is updated；When research and development bulk end receives the alarm signals such as the adverse reaction that subject end is sent, grind The first information of hair bulk end calls analysis and processing module to be analyzed and processed alarm signal, to conventional alarm signal by meeting an urgent need It disposes module and generates emergency disposal guidance program, by its first communication module and subject end second communication module, first aobvious Show module, subject or its guardian is instructed to carry out emergency disposal；When to the emergency alarms such as serious adverse reaction occur, by Research and development main body such as takes urgent intervention, organizes the rescue work at the medical first aids measure to the subject；Research and develop the first information peace of bulk end All risk insurance barrier module is then used to ensure to research and develop bulk end and handles in all kinds of clinical trial information's overall processes in its reception, storage, analysis Tracing back property, authenticity, reliability and security and emergency disposal tutorial message record authenticity；Can especially pass through by It is pharmaceutical manufacturer's bulk end, medical institutions' bulk end, health care subject of administration that research and development bulk end, which further extends expansion, One of end is a variety of, passes through internet and the subject end or certain listing held mobile terminal of medical product user Between realize information exchange, collect each subject's clinical trials condition extensively or listed the use feelings of medical user The information such as condition, curative effect, adverse reaction, and at the medical clinical development information for the composition that by big data technology analyze and research etc. System and method are managed, information source, type and the range of medical clinical development relevant clinical test is greatly expanded, significantly improves each Class medicine clinical trial information acquires timeliness, validity, systematicness and the integrality of typing, to grind for all kinds of medical clinics Hair provides more systematic, complete, objective, timely, the accurate firsthand information and foundation, expands the side of medical clinical development significantly Formula and depth, range, significantly improve the efficiency of medical clinical development, effective by modern western medicine clinical testing procedure to being difficult to The clinical developments such as the traditional Chinese medicine and medical instrument of development especially have important application and promotional value.

Invention is further described in detail with reference to the accompanying drawings and embodiments；But medical clinical development letter of the invention Breath processing system and its method are not limited to the embodiment.

Detailed description of the invention

Fig. 1 is the functional block diagram of the embodiment one of medical clinical development information processing system of the invention；

Fig. 2 is the functional block diagram of the embodiment two of medical clinical development information processing system of the invention；

Fig. 3 is the functional block diagram of the embodiment three of medical clinical development information processing system of the invention.

Specific embodiment

Embodiment one

A kind of medical clinical development information processing system shown in Figure 1, of the invention, including：

Bulk end 1 is researched and developed, which there is first communication module 11, the first information to receive the letter of classification storage module 12, first Breath calls analysis and processing module 13, report generation module 14, emergency disposal module 15 and first information safety guarantee module 16；Its In, first communication module 11, which receives classification storage module 12, emergency disposal module 15 and the first information with the first information respectively, pacifies All risk insurance barrier module 16 is connected, and the first information calls analysis and processing module 13 to receive classification storage module with the first information respectively 12, report generation module 14, emergency disposal module 15 are connected with first information safety guarantee module 16；

Subject end 2, the end have second communication module 21, information collection recording module, storage and processing module 22, the Module 28 is instructed in one display module 23, the second security assurance information module 24 and clinical test；Wherein, information collection recording module Output be connected to storage and processing module 22 and the second security assurance information module 24, storage and the output of processing module 22 are connected to Second communication module 21, storage and processing module 22 are also connected with the first display module 23, the second security assurance information module 24 It connects, second communication module 21 instructs module 28 to be connected with the second security assurance information module 24, clinical test respectively, clinic examination It tests and module 28 is instructed to be connected respectively with storage and processing module 22, the first display module 23, information collection recording module, second Security assurance information module 24 is connected with information collection recording module, storage and processing module 22, second communication module 21 respectively It connects；

It researches and develops and passes through internet between the first communication module 11 of bulk end 1 and the second communication module 21 at subject end 2 Realize information exchange；

All kinds of clinical examinations during acquiring typing subject medicine clinical development by information collection recording module of subject end 2 Information is tested, and is stored in the storage and processing module 22 at subject end, the second security assurance information module 24 at subject end For ensuring that all kinds of clinical trial informations of the acquired typing of information collection recording module are complete in its acquisition typing, storage and transmission Tracing back property in the process, authenticity, reliability and security；Clinical test instructs module 28 to be instructed according to built-in clinical test With prompting scheme, subject is received into the case where medicine is tested, the quality and quantity of acquisition all kinds of clinical trial informations of typing is wanted Element is compared with standard value, and compliance and relevant clinical information the acquisition typing of automatic discrimination subject's clinical test upload Timeliness, accuracy and integrality, in due course generate remind or instruction, and by the first display module 23 remind guidance by Examination person improves perfect information acquisition typing work or improves the compliance of clinical test；When the correlation of subject end acquisition typing is faced When adverse reaction occurs in bed Test Information prompt, clinical test instructs 28 automatic or manual of module through its second communication module 21 By internet to research and development bulk end 1 11 alert of first communication module；Subject end 2 passes through second communication module All kinds of clinical trial informations during subject's medicine clinical development of subject end acquisition typing are sent to research and development bulk end by 21 1；The first communication module 11 for researching and developing bulk end 1 receives the relevant information, and the first information of research and development bulk end 1 receives classification storage All kinds of clinical trial informations are carried out classification preservation by module 12, and the first information of research and development bulk end 1 calls analysis and processing module 13 All kinds of clinical trial informations are analyzed and processed, are sent to report generation module 14 for meeting the information that research and development require with right Data information needed for research report is updated；

When researching and developing bulk end 1 and receiving subject end and send the alarm signals such as adverse reaction, research and development bulk end 1 through its After one information calls 13 analysis of analysis and processing module processing, emergency disposal tutorial message is generated by its emergency disposal module 15, is led to It crosses first communication module 11 and is sent to subject end 2, pass through after the instruction of the reception of subject end 2 research and development bulk end 1 tested First display module 23 at person end 2 is shown, subject is instructed to carry out scientific disposition in time；Research and develop the first information of bulk end Safety guarantee module 16 is used to ensure to research and develop bulk end and handles all kinds of clinical trial information's overall processes in its reception, storage, analysis In tracing back property, authenticity, reliability and security and emergency disposal tutorial message record authenticity.

In the present embodiment, the subject end 2 is dedicated hardware terminal, the information collection typing mould of the dedicated hardware terminal Block include be capable of the intelligent biological sensors of all kinds of related quantitative biophysical chemistry information of automatic collection and be able to carry out text, Picture, video, voice input input unit 29；The output of intelligent biological sensor and input unit connects storage and processing respectively Module 28, storage and processing module 22, the second information peace are instructed in module 22, the second security assurance information module 24 and clinical test All risk insurance barrier module 24 and clinical test instruct module 28 to be connected respectively with second communication module 21, the first display module 23.

It is described be able to carry out text, picture, video, voice input input unit 29 be keyboard or mouse or touch screen or One of camera or microphone are a variety of.

Input unit 29 is used to make a report on, typing subject receives the correlation circumstance of medicine test, tests front and back and experimental period Between self all kinds of perception information such as related main suit's situation, picture is shot to particular body portion and body exudates, excreta etc. Information and other kinds of relevant clinical reaction information.

In the present embodiment, subject end is equipped with internally-arranged type intelligent biological sensor 25, is used to the quantitative biological object of automatic collection Physicochemical information, internally-arranged type intelligent biological sensor 25 are mounted in the dedicated hardware terminal, internally-arranged type intelligent biological sensing The output of device 25 is respectively connected to storage and processing module 22 and the second security assurance information module 24.

In the present embodiment, it is additionally provided with externally positioned type intelligent biological sensor 26, is equipped with and is used in the dedicated hardware terminal 2 Realize that the data transmission interface 27 of data transmission, the data transmission interface 27 are to have line end with externally positioned type intelligent biological sensor 26 Mouth or radio port；The externally positioned type intelligent biological sensor 26 by data transmission interface 27 respectively with storage and processing module 22 are connected with the second security assurance information module 24.

In the present embodiment, all kinds of clinical trial informations of the subject include passing through built-in intelligence biosensor 25 And/or all kinds of quantitative biophysical chemistry information of external 26 automatic collection of intelligent biological sensor, according to clinical development needs Mutually concerning feeling for its receiving medicine test of typing is made a report on by 29 timing of subject end input unit or not timing by subject Self all kinds of perception information such as related main suit's situation during condition, test front and back and test, to particular body portion and body secretes Object, excreta etc. shoot pictorial information, and are needed according to research and development by the other types clinical response of subject end acquisition typing One of information is a variety of.

The present embodiment further includes being held by researcher or research staff, is used to realize that data transmission connects with subject end 2 The researcher connect manages Specialised mobile terminal 3, naturally it is also possible to be to be loaded with researcher to manage researcher's movement of dedicated APP eventually End, it includes third communication module 31, the second information reception classification storage module 32, second that researcher, which manages Specialised mobile terminal 3, Information calls analysis and processing module 33, third security assurance information 34 and the second display module 35；Its third communication module 31 with Information exchange is realized by internet between the second communication module 21 at subject end 2；Its third communication module 31 receive by After all kinds of clinical trial informations that examination person end 2 is transmitted, the storage of classification storage module 32 and the second information are received through its second information After calling 33 analysis of analysis and processing module processing, the test compliance, adverse reaction situation, all kinds of clinical tests of subject are believed The quality and quantity of breath acquisition typing, reminds the researcher by its second display module 35, so that researcher is to facing The dynamic of bed test is tracked in time, is monitored, and carries out clinical guidance to subject if necessary；The third information security Assurance module 34 and third communication module 31, the second information receive classification storage module 32, the second information calls analysis processing mould Block 33 is connected, and handles all kinds of clinical test letters in its reception, storage, analysis for ensuring that researcher manages Specialised mobile terminal 3 Cease and instruct subject's emergency disposal overall process information record in tracing back property, authenticity, reliability and security；Certainly, Researcher, which manages Specialised mobile terminal 3 or is loaded with researcher and manages researcher's mobile terminal of dedicated APP, can also pass through it Third communication module 31 is connected with the first communication module 11 of research and development bulk end 1, to obtain the more powerful synthesis of research and development bulk end 1 Informational support.

The present embodiment further includes being held by inspection personnel or inspector, is used to and research and development bulk end 1, subject end 2 Inspection or the checking and administration Specialised mobile terminal 4 of data transmission connection are realized, it is of course also possible to be to be loaded with inspection or inspection pipe Inspection personnel or the inspector's mobile terminal of dedicated APP are managed, inspection or checking and administration Specialised mobile terminal 4 include fourth communication Module 41, third information receive classification storage module 42, third information calls analysis and processing module 43 and third display module 44； Its fourth communication module 41 and research and develop the first communication module 11 of bulk end 1, subject end 2 second communication module 21 between lead to It crosses internet and realizes information exchange；Its fourth communication module 41 receives all kinds of the facing at study subject end 1, the transmission of subject end 2 After bed Test Information, the storage of classification storage module 42 is received through its third information and third information calls analysis and processing module 43 to divide After analysis compares, tested with regard to whether researcher and subject carry out in strict accordance with clinical trial protocol, clinical test relevant information number According to reliability, safety, accuracy and emergency disposal instruct the authenticity and validity of work situations such as, it is aobvious by its third Show that module 44 reminds the monitor or inspector in time, so as to its to the authenticity of medical clinical test, reliability, by Examination person tests compliance and clinical test quality is monitored in real time or supervised, checked.

In the present embodiment, subject end is acquired typing by its second communication module 21 by subject end 2, storage is handled All kinds of relevant clinical Test Informations are sent to research and development bulk end 1, researcher manages Specialised mobile terminal 3 and supervise or inspection pipe Manage Specialised mobile terminal 4；Research and develop bulk end 1, researcher manages Specialised mobile terminal 3 and supervises or checking and administration special mobile is whole After the communication module at end 4 receives relevant information, the first information of research and development bulk end 1 receives classification storage module 12, researcher's pipe The second information for managing Specialised mobile terminal 3 receives classification storage module 32 and inspection or checking and administration Specialised mobile terminal 4 Third information receives classification storage module 42 and relevant information is carried out classification preservation, and the first information of research and development bulk end 1, which calls, to be divided The second information that analysis processing module 13, researcher manage Specialised mobile terminal 3 is called analysis and processing module 33 and inspection or is checked The third information for checking reason Specialised mobile terminal 4 calls analysis and processing module 43 to be analyzed and processed respectively to relevant information, grinds The first information of hair bulk end 1 calls analysis and processing module 13 that the information for meeting R & D Report content is sent to research and development bulk end 1 report generation module 15 is to be updated data information needed for research report；When research and development bulk end 1, researcher's management Specialised mobile terminal 3 and inspection management or checking and administration Specialised mobile terminal 4 receive the adverse reaction that subject end is sent Etc. alarm signals when, research and development bulk end 1 the first information call analysis and processing module 13, researcher manage Specialised mobile terminal 3 The second information call analysis and processing module 33 and inspection or checking and administration Specialised mobile terminal 4 third information call analysis Processing module 43 is analyzed and processed alarm signal, to conventional alarm signal by the emergency disposal module 15 of research and development bulk end 1 Or researcher manages Specialised mobile terminal 3 and generates emergency disposal guidance program, passes through the first communication mould of research and development bulk end 1 respectively Block 11 or researcher manage the third communication module 31 of Specialised mobile terminal 3, via the second communication module 21 at subject end 2, First display module 23 instructs subject or its guardian to carry out emergency disposal；Subject end 2 receives research and development bulk end 1 or grinds The person of studying carefully manages the emergency disposal instruction of Specialised mobile terminal 3 and is shown by the first display module 23；It is tight to occurring Again when the emergency alarms such as adverse reaction, the medical treatment such as the subject is taken urgent intervention, is organized the rescue work anxious by research and development main body Rescue measure；Research and develop the first information safety guarantee module 16 of main body 1,24 and of the second security assurance information module at subject end 2 The third security assurance information module 34 that researcher manages Specialised mobile terminal 3 is respectively intended to ensure research and development bulk end 1, subject End 2, researcher manage the acquisition record for the record information that Specialised mobile terminal 3 is instructed in all kinds of clinical trial informations and emergency disposal Enter, receive, saving tracing back property, the authenticity, reliability and security of processing and transmission overall process；Meanwhile it supervising management or checking It checks 4 pairs of special-purpose terminal research and development main bodys 1 of reason or researcher manages the emergency disposal information record of special-purpose terminal 3 and journey of organizing the rescue work Science, compliance, the legitimacy of sequence measure are instructed, supervised or are checked.

Medical clinical development information processing method in the present embodiment, including method and step is as follows in detail below：

Study subject recruits training subject and establishes subject information's database in research and development bulk end；

To during writing medical Clinical Report after subject receives all kinds of medical clinical test trainings, subject's root According to clinical trial protocol and related request, by subject end, in real time, periodically or sporadically acquisition, typing subject include logical Cross the built-in intelligence biosensor at subject end and/or all kinds of related quantitative lifes of external intelligent biological sensor automatic collection Object physical chemistry information, according to clinical development need by subject through the subject end periodically or not timing make a report on typing its Receive self all kinds of perception information such as related main suit's situation during correlation circumstance, test front and back and the test of medicine test, to body Body privileged site and body exudates, excreta etc. shoot pictorial information, and need to be acquired by subject end according to research and development and record All kinds of clinical trial informations such as the other types clinical response information entered；And it stores and handles at subject end.

After subject end acquires typing, storage processing all kinds of clinical trial informations of subject, and subject end is loaded on Clinical test guidance program is analysed and compared, when the quantity or quality of the relevant information of acquisition typing will be found out with clinical test When there is specific clinical reaction in existing deviation or prompt, the clinical test at subject end instruct module by its first display module and When remind or instruct subject by research and development requirements enhancing clinical test compliance, adjustment improve acquisition typing work or face specific Bed reaction carries out scientific and normal disposition.When adverse reaction occurs in relevant information prompt, bulk end is researched and developed from trend in subject end Alarm signal is issued, after researching and developing bulk end receive the alarm signal, analysis and processing module analysis and distinguishing is called through its information, to routine Alarm signal generates emergency disposal guidance program by emergency disposal module, logical by its first communication module and subject end second Believe module, the first display module, subject or its guardian is instructed to carry out emergency disposal；It is urgent to serious adverse reaction etc. occurs When alarm signal, the medical first aids measure such as the subject is taken urgent intervention, is organized the rescue work by research and development main body.Subject adopts at end After collecting typing, storage processing all kinds of clinical trial informations of subject, transmitted by the timing of the modes such as mobile Internet or not timing Research and development bulk end is given, research and development bulk end carries out classification storage to all kinds of clinical trial informations of the subject received, analysis is handled After, report generation module is sent to for meeting the information that research and development require to carry out more to data information needed for research report Newly.During this period, researcher's follow-up subject, research and development main body make a report on the links such as subject's case report form (CRF) and still press research and development It needs to be normally carried out, it is unaffected；

The present embodiment passes through above-mentioned apparatus, the medical clinical development information processing system of system and method step composition and side Method can greatly expand medical clinical research relevant clinical Test Information source, type and range, significantly improve medical clinical examination Timeliness, validity, systematicness and the integrality of information collection typing are tested, provides for the clinical development of all kinds of medicine and is more System, complete, objective, timely, the accurate firsthand information and foundation, thus expand significantly the depth of all kinds of medical clinical developments, Range significantly improves the efficiency of medical clinical development, in being difficult to effectively to carry out by modern western medicine clinical testing procedure The research and development such as medicine and medical instrument especially have important application and promotional value.

The subject end 2 of the present embodiment is dedicated hardware terminal, and certainly, subject end is also possible to include that subject is held Mobile terminal included communication device, data transmission interface, input unit and display device, are loaded in the held movement of subject The built-in and/or external intelligent biological sensor of the dedicated APP in subject end and mobile terminal in terminal；The subject Holding dedicated APP includes that module is instructed in the storage and processing module, the second security assurance information module and/or clinical test；Institute State the communication device that the first communication module at subject end uses the held mobile terminal of subject to carry；The information collection typing Input unit, data transmission interface and its built-in and/or external intelligence that module is carried using the held mobile terminal of subject It can biosensor；The display device that first display module uses the held mobile terminal of subject to carry；The subject The included intelligent biological of input unit, the subject's mobile terminal for holding dedicated APP to carry by the held mobile terminal of subject passes Sensor and/or the external intelligent biological sensor of subject wears acquire all kinds of clinical trial informations of typing subject, and save In its storage and processing module；The external intelligent biological sensor of the subject wears passes through the held mobile terminal of subject Included wired or wireless data transmission port and subject end professional APP carries out information exchange；The dedicated APP in subject end The communication function module and research and development bulk end carried by subject's mobile terminal realizes information exchange by internet.

Embodiment two

It is shown in Figure 2, of the invention a kind of medical clinical development information processing system and its method, with embodiment one The difference is that the research and development bulk end is further prolonged according to the property of clinical development and the functional localization of research and development main body Stretching expansion is sponsor's bulk end 5, Contract Research Organization (CRO) or other types third party's medicine clinical development mechanism body end 6, researcher's bulk end 7；In the present embodiment, researcher's bulk end 7 realizes that information is handed over by internet and the subject end 2 Mutually, sponsor's bulk end 5 and Contract Research Organization (CRO) or other types third party's medicine clinical development mechanism body end 6 realize information exchange, sponsor's bulk end 5 and Contract Research Organization via researcher's bulk end 7 and the subject end 2 again (CRO) or between other types third party's medicine clinical development mechanism body end 6 information exchange is realized also by internet；When So, it is also possible to sponsor's bulk end 5, Contract Research Organization (CRO) or other types third party medicine clinical development mechanism master Body end 6, researcher's bulk end 7 directly realize information exchange with the subject end 2 by internet respectively, to realize each research and development Main body ensures information in first time synchronous sharing, the relevant clinical reaction information of monitoring subject end transmission and dynamic Authenticity and checking property.Certainly, it can also realize that information is handed over by internet through respective communication module between each bulk end Mutually, and to subject's clinical development information especially alarm signal is received it shares, study and judge, cooperate with and monitors.

Embodiment three

It is shown in Figure 3, of the invention a kind of medical clinical development information processing system and its method, with embodiment one The difference is that it is medical institutions' bulk end 81, pharmaceutical manufacturer's bulk end that the research and development bulk end, which further extends expansion, 82, one of health care subject of administration end 83 or a variety of；In the present embodiment, medical institutions' bulk end 81 passes through Information exchange, pharmaceutical manufacturer's bulk end 82 and health care administration are realized between internet and the subject end 2 Bulk end 83 realizes information exchange via between medical institutions' bulk end 81 and the subject end 2 again；It is of course also possible to be institute It is straight by internet respectively to state medical institutions' bulk end 81, pharmaceutical manufacturer's bulk end 82, health care subject of administration end 83 It connects and realizes that information exchange, medical institutions' bulk end 81, pharmaceutical manufacturer's bulk end 82, health care are administrative with the subject end 2 It can also be further connected with each other by internet between 83 three of management subject end, to collect extensively, share subject's clinic The information such as test situation or the service condition, curative effect, adverse reaction that have listed medical user, and carried out by big data technology Analysis and research further research and develop improvement, use or supervision with the later period for medicine and provide basic data and scientific basis.

Above-mentioned only presently preferred embodiments of the present invention, is not intended to limit the present invention in any form.Although of the invention It is disclosed as above with preferred embodiment, however, it is not intended to limit the invention.Anyone skilled in the art is not taking off In the case where from technical solution of the present invention range, all technical solution of the present invention is made perhaps using the technology contents of the disclosure above Mostly possible changes and modifications, or it is revised as equivalents equivalent embodiment.Therefore, all without departing from technical solution of the present invention Content, technical spirit any simple modifications, equivalents, and modifications made to the above embodiment, should all fall according to the present invention In the range of technical solution of the present invention protection.

Claims

1. a kind of medicine clinical development information processing system, it is characterised in that：Including researching and developing bulk end, which has the first communication Module, the first information receive classification storage module, the first information calls analysis and processing module and report generation module；And subject End, the end are held by the whole of the medical clinical test of participation or specific part subject or medical user, have the second communication Module, information collection recording module, storage and processing module, the first display module；Research and develop bulk end first communication module with Information exchange is realized by internet between the second communication module at subject end；

Subject end acquires all kinds of clinical examinations of the typing subject during medical clinical development by information collection recording module Information is tested, and is stored in the storage and processing module at subject end；Subject end passes through second communication module for subject end All kinds of clinical trial informations of subject of acquisition typing and stored processing are sent to research and development bulk end；Research and develop the of bulk end After one communication module receives all kinds of clinical trial informations, classification storage module is received to all kinds of by the first information of research and development bulk end Clinical trial information carries out classification preservation, and the first information for researching and developing bulk end calls analysis and processing module to believe all kinds of clinical tests Breath is analyzed and processed, and is sent to report generation module for meeting the information that research and development require to believe data needed for research report Breath is updated.

2. medicine clinical development information processing system according to claim 1, it is characterised in that：The subject is all kinds of Clinical trial information includes all kinds of quantitative biophysical chemistry information by intelligent biological sensor automatic collection, according to clinic Research and development need the case where making a report on its receiving medicine test of typing by the subject end timing or not timing by subject, test Self all kinds of perception information during front and back and test believe the shooting picture of particular body portion and body exudates, excreta Breath, and needed according to research and development by one of various specified clinical trial informations of subject end acquisition typing or a variety of.

3. medicine clinical development information processing system according to claim 1, it is characterised in that：It also wraps at the subject end It includes the second security assurance information module and/or module is instructed in clinical test；The second security assurance information module and the letter Breath acquisition recording module, storage and processing module and second communication module are connected, and the second security assurance information module is used to ensure The information of the acquired typing of information collection recording module tracing back in the acquisition typing at subject end, storage and transmission overall process Property, authenticity, reliability and security；The clinical test instructs module and the storage and processing module, second communicates mould Block, the first display module are connected, and clinical test instructs module to be loaded with subject's clinical test guidance and prompting scheme, can be in clinic The overall process or part stage of test receive the case where medicine is tested to subject, acquire all kinds of clinical trial informations' of typing Quality and quantity element is compared with standard value, generates prompting or instruction in due course and reminds or refer to by the first display module It leads subject to improve perfect information acquisition typing work or improve the compliance of clinical test, and when there is adverse reaction, leads to It crosses second communication module automatic or manual and issues alarm signal to research and development bulk end.

4. medicine clinical development information processing system according to claim 1 or 3, it is characterised in that：The subject end For dedicated hardware terminal, the information collection recording module of the dedicated hardware terminal include can automatic collection subject it is all kinds of quantitative The intelligent biological sensor of biophysical chemistry information and be able to carry out text, picture, video, voice messaging typing input dress It sets；The output of intelligent biological sensor and input unit connects storage and processing module, the second security assurance information module respectively, deposits Storage and processing module are connected with second communication module, the first display module.

5. medicine clinical development information processing system according to claim 4, it is characterised in that：The intelligent biological sensing Device is internally-arranged type, is mounted in the dedicated hardware terminal；And/or the intelligent biological sensor is externally positioned type, described hard Part special-purpose terminal is equipped with the data transmission interface for being used to that data transmission is realized with the intelligent biological sensor of externally positioned type, the data Coffret is cable port or radio port；The intelligent biological sensor of the externally positioned type passes through data transmission interface and storage And processing module is connected.

6. medicine clinical development information processing system according to claim 4, it is characterised in that：It is described to be able to carry out text Word, picture, video, voice input input unit be one of keyboard, mouse, touch screen, camera or microphone or more Kind.

7. medicine clinical development information processing system according to claim 1 or 3, it is characterised in that：The subject end Including the held mobile terminal of subject carry communication device, data transmission interface, input device and display device, be loaded in by The built-in and/or external intelligent biological sensor of the dedicated APP in subject end and mobile terminal on the held mobile terminal of examination person； The dedicated APP in subject end includes the storage and processing module, and the second security assurance information module and/or clinical test refer to Guide module；The communication device that the first communication module at the subject end uses the held mobile terminal of subject to carry；The letter Breath acquisition recording module using the held mobile terminal of subject carry input unit, data transmission interface and its it is described built in And/or external intelligent biological sensor；The display device that first display module uses the held mobile terminal of subject to carry； The dedicated APP in subject end carries intelligence by the included input unit of the held mobile terminal of subject, subject's mobile terminal Energy biosensor and/or all kinds of clinical tests letters of the external intelligent biological sensor of subject wears acquisition typing subject Breath, and be stored in its storage and processing module；The external intelligent biological sensor of the subject wears passes through subject institute It holds the included wired or wireless data transmission port of mobile terminal and the dedicated APP in subject end carries out information exchange；It is described tested The communication function module and research and development bulk end that the dedicated APP in person end is carried by subject's mobile terminal realize information by internet Interaction.

8. medicine clinical development information processing system according to claim 1, it is characterised in that：Further, described to grind Hair bulk end further includes emergency disposal module and/or first information safety guarantee module, the emergency disposal module and described the One communication module, the first information call analysis and processing module to be connected；Research and development bulk end receive the subject end send it is bad After reacting alarm signal, analysis and processing module analysis processing is called through its first information, to conventional alarm signal by emergency disposal Module generate emergency disposal guidance program, be sent to first display module at subject end, instruct subject or its guardian into Row emergency disposal；The first information safety guarantee module and first communication module, the first information receive classification storage module, the One information calls analysis and processing module, emergency disposal module to be connected, for ensuring to research and develop bulk end in its reception, storage, analysis Handle tracing back property, authenticity, reliability and security and the emergency disposal tutorial message in all kinds of clinical trial information's overall processes The authenticity of record.

9. medical clinical development information processing system according to claim 1 or 8, it is characterised in that：Further, described Research and development bulk end be sponsor's bulk end, Contract Research Organization or all kinds of specified third party's medicine research and development institution bulk ends, One of researcher's bulk end is a variety of；Researcher's bulk end realizes that information is handed over by internet and the subject end Mutually, sponsor's bulk end and/or Contract Research Organization or all kinds of specified third party's medicine research and development institution bulk ends pass through again Information exchange is realized by researcher's bulk end and the subject end；Either, sponsor's bulk end, Contract Research Organization or each The specified third party's medicine research and development institution bulk end of class, researcher's bulk end pass through respectively internet directly with the subject end Realize information exchange.

10. medical clinical development information processing system according to claim 1 or 8, it is characterised in that：Further, institute The research and development bulk end stated is one of medical institutions' bulk end, pharmaceutical manufacturer's bulk end, health care subject of administration end Or it is a variety of；Medical institutions' bulk end is by realizing information exchange, the medicine enterprise between internet and the subject end Owner's body end and/or health care subject of administration end are realized via between medical institutions' bulk end and the subject end again Information exchange；Either, pharmaceutical manufacturer's bulk end, medical institutions' bulk end, health care subject of administration end difference Information exchange directly is realized with the subject end by internet.

11. medicine clinical development information processing system according to claim 1, it is characterised in that：Further, further include Held by researcher or research staff, for realizing that it is whole that the researcher of data transmission connection manages special mobile with subject end Hold or be loaded with researcher's mobile terminal that researcher manages dedicated APP comprising third communication module, the second information, which receive, divides Class memory module, the second information call analysis and processing module, third security assurance information module and the second display module；Its third Information exchange is realized by internet between communication module and the second communication module at subject end；Its third communication module receives After all kinds of clinical trial informations transmitted to subject end, the storage of classification storage module and the second information are received through its second information After calling analysis and processing module analysis processing, with regard to the test compliance, adverse reaction situation, all kinds of clinical trial informations of subject The quality and quantity for acquiring typing, reminds the researcher by its second display module；The third information security is protected Barrier module receives classification storage module with third communication module, the second information, the second information calls analysis and processing module to be connected, and uses To ensure that it is tested in its reception, storage, all kinds of clinical trial informations of analysis processing and guidance that researcher manages Specialised mobile terminal Tracing back property, the authenticity, reliability and security of the information record of person's emergency disposal overall process；Certainly, researcher's management is dedicated Mobile terminal or be loaded with researcher manage dedicated APP researcher's mobile terminal can also by its third communication module with grind The first communication module for sending out bulk end is connected, and is supported with obtaining the more powerful integrated information of research and development bulk end.

12. medicine clinical development information processing system according to claim 1, it is characterised in that：Further, further include Held by inspection personnel or inspector, for realizing the inspection pipe of data transmission connection with research and development bulk end, subject end Reason or checking and administration Specialised mobile terminal are loaded with inspection management or inspection personnel and/or the inspection of the dedicated APP of checking and administration Personnel's mobile terminal comprising fourth communication module, third information receive classification storage module, third information calls analysis processing Module and third display module；Its fourth communication module and research and development bulk end first communication module, subject end second communicate Information exchange is realized by internet between module；Its fourth communication module receives study subject end, subject end and transmits All kinds of clinical trial informations and its reception, storage, analysis processing, the quality of data of transmission overall process are passed through with after the information of safety Its third information receive classification storage module storage and third information call analysis and processing module analyse and compare after, with regard to researcher with Whether subject is in strict accordance with clinical trial protocol development test, the reliability of clinical trial information's data, safety, accuracy The case where, the monitor or inspector are reminded in time by its third display module.

13. a kind of medicine clinical development information processing method, it is characterised in that：Including：

It researches and develops main body and works out medical clinical research test scheme, and determine that medical clinic is ground according to clinical research test solution development Photos and sending messages management system and research and development bulk end research and development information processing subsystem, subject end are researched and developed information processing subsystem, and are obtained The mechanism that has the right examination & approval authorization passes through；

To during writing medical Clinical Report after subject receives all kinds of medical clinical test trainings, subject is according to facing Bed testing program and corresponding requirement, in real time, the periodically or sporadically acquisition, all kinds of clinical examinations of typing subject by subject end Test information；And it stores and handles at subject end；Then research and development are transferred to by mobile Internet timing or sporadically Bulk end；It is right after bulk end is researched and developed to all kinds of clinical trial informations of the subject received progress classification storage, analysis processing Report generation module is sent in meeting the information that research and development require to be updated to data information needed for research report；In this phase Between, researcher's follow-up subject, research and development main body make a report on subject's case report form (CRF) link still press research and development need normally into Row, it is unaffected；

After clinical test, the comprehensive follow-up subject situation of research and development main body, case report form (CRF) and real-time or timing are not Medical Clinical Report is write in all kinds of clinical trial informations of the subject that timing receipt arrives and its analysis and processing result, summary.

14. medicine clinical development information processing method according to claim 13, it is characterised in that：The subject is each Class clinical trial information includes automatic by the built-in intelligence biosensor at subject end and/or external intelligent biological sensor All kinds of quantitative biophysical chemistry information of acquisition, needed by subject according to clinical development through the subject end timing or Not timing make a report on typing its receive medicine test the case where, test front and back and test during various main suit's situations it is all kinds of self Perception information, to the shooting pictorial information of particular body portion and body exudates, excreta, and according to research and development need by by Examination person end acquires one of various specified clinical trial informations of typing or a variety of.

15. medicine clinical development information processing method according to claim 13, it is characterised in that：Further, it also wraps Include following steps：After subject end acquires typing, storage processing all kinds of clinical trial informations of subject, and subject end is loaded on Clinical test guidance program analyse and compare, when the information content of acquisition typing or quality and clinical test require to occur it is inclined When specific clinical reaction occur in difference or prompt, the clinical test at subject end instructs module to remind in time by the first display module Or subject is instructed to improve acquisition typing work by research and development requirement enhancing clinical test compliance, adjustment or react specific clinical Carry out scientific and normal disposition.

16. medicine clinical development information processing method according to claim 13, it is characterised in that：Further, it also wraps Include following steps：After subject end acquires typing, storage processing all kinds of clinical trial informations of subject, and subject end is loaded on Clinical test guidance program analyse and compare, when corresponding informance prompt there is adverse reaction when, from trend research and develop bulk end Alarm signal is issued, after researching and developing bulk end receive the alarm signal, analysis and processing module analysis and distinguishing is called through its information, to routine Alarm signal generates emergency disposal guidance program by its emergency disposal module, passes through its first communication module and subject end second Communication module, the first display module instruct subject or its guardian to carry out emergency disposal；To the tight of generation serious adverse reaction When anxious alarm signal, urgent intervention is taken to the subject by research and development main body, is organized the rescue work medical first aid measure.

17. medicine clinical development information processing method according to claim 13, it is characterised in that：Further, it also wraps Include following steps：One of pharmaceutical manufacturer's bulk end, medical institutions' bulk end, health care subject of administration end are a variety of Bulk end is researched and developed, the second communication module for receiving the subject end transmits all kinds of clinical trial informations come, collects extensively Each subject's clinical trials condition or the service condition, curative effect, adverse reaction information for having listed medical user, and by big Data technique is analyzed and researched, and is further researched and developed improvement, use or supervision with the later period for medicine and is provided basic data and section Learn foundation.