CN102667782A

CN102667782A - Methods and system for implementing a clinical trial

Info

Publication number: CN102667782A
Application number: CN2009801617773A
Authority: CN
Inventors: R·R·斯波尔丁; B·海因茨; P·B·舒尔茨
Original assignee: SPAULDING CLINICAL RESEARCH LLC
Current assignee: SPAULDING CLINICAL RESEARCH LLC
Priority date: 2009-09-04
Filing date: 2009-09-04
Publication date: 2012-09-12
Also published as: EP2473953A1; MX2012002770A; WO2011028205A1; AU2009351929A1; CA2773216A1

Abstract

A system and method for automating the implementation of and collection of data during a clinical trial on living subjects includes a computer-based clinical trial management system, programmed to define clinical trial protocols and to store subject data, including a subject identifier; an electronic subject monitoring system, for acquiring physiological data from the subject during the clinical trial; and an electronic subject polling device. The electronic polling device is programmed to acquire physiological data from the monitoring system in accordance with the clinical trial protocols, automatically, electronically associate the physiological data with an appropriate subject ID and transmit the physiological data to the clinical trial management system for storage.

Description

Be used to implement the method and system of clinical testing

Background technology

The present invention relates to the live body curee is implemented the method and system of clinical testing, relate in particular to the electron collection and the management of workflow and data during the clinical testing.

Summary of the invention

In one embodiment, the invention provides a kind of system that is used for during live body curee clinical testing, making enforcement and data aggregation robotization.This system comprises: computer based clinical trial management system, programming Control its with definition clinical testing rules and store curee's data, it comprises curee's identifier; Electronics curee monitoring system is used for during said clinical testing, gathering physiological data from said curee; And electronics curee polling set-up; Programming Control its to gather physiological data from said curee's monitoring system according to said clinical testing rules; Automatically with the electronics mode said physiological data is associated with suitable curee's identifier, and sends said physiological data to store to said clinical trial management system.

In another embodiment, the invention provides a kind of method of implementing clinical testing and during clinical testing, collecting physiological data.This method comprises: the electronic databank that develops potential clinical testing curee; Utilize clinical testing rules programming Control clinical trial management system; Based on said rules and said database select to be used for the curee of clinical testing with the electronics mode from said database more automatically, and the curee of every selection is associated with identifier; Utilize said curee's identifier programming Control curee's monitoring system and selected curee is connected to said curee's monitoring system; Gather the ECG data from said curee's monitoring system; And send said ECG data to said clinical trial management system according to said rules.

Through considering detailed description and accompanying drawing, it is obvious that other aspects of the present invention will become.

Description of drawings

Fig. 1 is a synoptic diagram of realizing system of the present invention.

Fig. 2 is the part of synoptic diagram shown in Figure 1, shows how to test some details that the curee is connected to curee's monitoring system.

Embodiment

Before illustrated in detail any embodiment of the present invention, be appreciated that the present invention is not limited in the following description to set forth or the details of illustrative unit architecture and layout in following accompanying drawing in its application facet.The present invention can have other embodiment and put into practice or carry out through variety of way.And, be appreciated that wording used herein and term are in order to describe, should not to be regarded as restriction.Here use " comprising " or " having " and change and be intended to contain the project of listing thereafter and its equivalent and extra items.Term " installation ", " connection " and " coupling " are widely used, and contain direct with indirect installation, be connected and coupling.In addition, " connection " and " coupling " is not limited to physics or mechanical connection or coupling, can comprise being electrically connected or coupling, and be no matter direct or indirect.And, can utilize any any means known such as comprising direct connection, wireless connections to carry out electronic communication and notice.

Should be pointed out that and to utilize a plurality of device and a plurality of different structure parts to come embodiment of the present invention based on hardware and software.In addition, of subsequent paragraph, illustrative concrete configuration is for the illustration embodiments of the invention in the accompanying drawing, and other alternative arrangements are possible.

Shown in Fig. 1 is the synoptic diagram of system 10, and system 10 makes clinical testing service provider 12, is also referred to as Research on Contract tissue (" CRO ") sometimes, the enforcement of the clinical testing of execution with during the data aggregation robotization.The commercially available embodiment of system 10 is by Wisconsin, the Spaulding Clinical Research LLC exploitation of West Bend and Electronic Data Capture (" the EDC ") application integrating system of selling.Substantially, system 10 comprises a plurality of

application 1s

4,18,22,26,30,34 of communicating with one another through network and 38 and curee's database 42.Application comprises that clinical trial management system (CTMS) 14, curee's poll module (SPM) 18, curee's monitoring system (SMS) 22, recruitment module (RM) 26, laboratory scheduling and result receive (LSRR) module 30, the cardiologist distributes and reexamination (CAR) module 34 and camera network (VCN) 38.Each of these systems or module can both run on independently on the server or take the circumstances into consideration with any combination to run on one or more servers.Network can be wide area network or LAN, any combination of other networks that VPN, interconnection network (for example the Internet, extranets or in-house network) or these or allow are communicated by letter between hardware and software device and the module.In addition, can communicate through special-purpose Wireline or through cordless communication network or device.

System 10 comprises portal website 46, is convenient to system 10 and external device (ED) through Internet traffic.Preferably allow closely to watch in real time the form of the data of collecting the clinical testing from the data of system's 10 outputs, this system 10 supports to be used to analyze and inquire about the based on network instrument of expected data.More specifically, in one embodiment, can be with data model (" SDTM ") the form output data set of tabulating, and can in statistical analysis system (" SAS ") programming environment, import through minimum workload.This function has reduced the time that is associated with the data of exporting from CRO traditionally.Curee's database 42 comprises the information to the curee, and the curee can participate in or have neither part nor lot in the clinical testing that utilizes system 10 to implement.

CTMS 14 is software programs and the linked database that is used to store with clinical testing curee 44 related datas.The commercially available example of this program is AlphaDAS, and this is the CTMS based on software by Logos Technologies exploitation and sale.The artificial rules that are used for clinical testing of in CTMS 14, importing.This rules definition clinical testing; Promptly hope curee's overview of participation, administered agents to handle the curee's medical parameter that to monitor; Curee's recipe; Duration of clinical testing and when give drug-treated, when give food, and when measure medical parameter etc. from the curee.This overview also defines comprising and exclusion standard of the test curee that will participate in clinical testing.For example, clinical testing possibly only need the male sex or only need the women, or the people of specific health overview etc.CTMS 14 is also to each test curee 44 generation record and to every curee 44 distribution markers (" ID ").Curee ID is secret, even also conceals for clinical testing service provider 12 staff, so that clinical testing is complete " blindness ".To in whole clinical testing, use identical ID so that the ECG reading is matched test curee 44 with other clinical informations, laboratory result and cardiologist 62 for this test curee 44.

Curee's poll module is the software module that between each module of system 10, forms main communication, especially between CTMS 14 and SMS 22, sets up integrated point.SPM 18 also serve as association system 10 each module and program mechanism and allow them to utilize the unified data collection to communicate by letter.Eliminated the data repetition like this, allowed real-time processing data and make the clinical testing process automation.And 18 pairs of SMS 22 programming Control of SPM for example produce ten seconds ECG data sampling from test curee 44 to observe cover rules.This comprises curee ID is programmed among the SMS 22.

SPM 18 inquiry CTMS databases and from CTMS 14 inspection procedure specifications.SPM 18 input automatically is programmed among the SMS 22 from curee's demography data of CTMS 14 and with curee's demography data.During clinical testing, SPM 18 implements based on the polling routine of software or intercepts routine to produce intercepting thread, in ECG or the generation in real time of other physiological events, intercepts these incidents among the SMS 22.This is intercepted routine and between SMS 22 and CTMS 14, sets up integrated point.When ECG or other physiological data incidents took place, SPM intercepted the routine image data and transmits data from SMS 22 to CTMS 14 automatically with CTMS 14 acceptable data layouts.SPM 18 also provides based on network instrument panel, and wherein clinical staff can be watched all details of other physiological datas of ECG waveform or SPM 18 processing.Can when handling the ECG waveform, observe them in real time, thereby if replacement ECG and the transmission that will replace ECG are related to CTMS 14 when the cardiologist refuses raw data.SPM18 also allows to open or close based on given rules requirement the aspect of the function of SMS 22.The information of SPM 18 integrated CAR modules and data and CTMS 14 and SMS 22 guarantee in whole clinical testing by the ECG of same cardiologist's dissecting needle to given test curee data.

SMS 22 is the health care patient monitoring systems that are used to monitor clinical trial testing curee 44 clinical parameter.Monitored parameter can comprise ECG, heart rate, blood pressure, blood oxygen etc.Although do not specifically illustrate, SMS 22 comprises hardware and software, is used to gather monitored parameter, and some algorithms based on software are provided, and is used for explaining and analyzing monitored parameter.Among the embodiment of (more specifically illustrating among Fig. 2) shown in the figure, SMS 22 is based on the patient monitoring system of telemetry, allows near the test curee 44 free movement clinical testing environment, and is simultaneously still monitored.The commercially available example of this system is the Surveyor Telemetry Central System that comprises Veritas ECG analysis software, and the both is by Mortara Instrument, the Inc. produce and market.The test curee is connected to telemetering transmiter 40, and it is wireless and send monitored parameter to SMS 22 continuously.

SMS 22 collects the ECG data from test curee 44 continuously.But, in a preferred embodiment, SMS 22 is programmed and is controlled in the discrete cycle (for example ten seconds) of the ECG waveform of testing the curee, together with the decryption relevant with the ECG waveform, to SPM 18 emission ECG data.The timing in these cycles and duration are confirmed by rules, typically, but may not be associated with curee 44 administration all the time.The data that SMS 22 produces comprise text, the for example file of XML form, and image file, the for example file of PDF or JEPG form.The XML file comprises the clinical measurement result's that SMS 22 gathers numeric representation, and the text data of the explanation of the analysis carried out of expression 22 pairs of ECG waveforms of SMS or other clinical parameters and generation.For example, the XML file comprises the data at interval etc. relevant with QT interval, QRS duplex measurement, RR and based on the low-level cardiac diagnosis of those measurement results.Pdf document is the visual representation of ECG waveform.File is resolved to discrete XML and pdf document automatically and with stored program control system by SPM 18, and relevant with the ID that is directed against this test curee 44 by SPM 18, is transmitted into CTMS 14 by SPM 18 then, is used for storing explicitly with test curee 44.

As stated, system 10 also comprises recruitment module 26.RM 26 is connected to curee's database 42.Test curee 44 through access to the Internet RM 26, can submit personal information through its test curee 44 through portal website 46, in curee's database 42, stores personal information then.Personal information comprises that individual demography data are with healthy historical.In case in the input curee database 42, just examine this information to guarantee that this information is complete by clinical staff.Can and inquire about this information by the staff of managing clinical trials management, can be before clinical testing through phone screening 52 or interview test curee 44 in person, to guarantee to test the demography requirement that curee 44 meets the clinical testing requirement.Can carry out the phone screening by clinical testing service provider 12 or by the staff of independent body's (not shown).RM 26 comprises follower, allows test curee 44 is carried out statistical study, follows the tracks of every bit test curee and participates in the frequency of other tests and the identification of those tests.After clinical staff examination, with the form of Excel to the data of CTMS 14 outputs from RM 26.When its information of test curee 44 input, or the test of the individuality in the curee's database 42 curee 44 expectation demography that satisfies clinical testing can be sent email notification by configuration concurrency when requiring.Test curee's overview is the part of clinical testing rules, and the sponsor 48 by clinical testing develops usually.In addition, can be by some aspects of U.S. food and FAD (" FDA ") regulation rules.

During assessment test curee 44 participates in clinical testing and during the clinical testing, according to the rules of clinical testing, possibly gather the health sample from test curee 44, for example blood, urine, saliva etc. are used for lab investigation.The arrangement of laboratory order produces with the HL7 form by the definition of clinical testing rules and by CTMS 14.LSRR module 30 is based on the HL7 engine of software, receives order and sends order through FTP over SSL port 54 to laboratory service supplier 58 from CTMS 14.When laboratory service supplier 58 received order, service supplier 58 sent express mail and returns sample with collect specimen and to laboratory service supplier 58.When the test of accomplishing sample, laboratory service supplier 58 puts up the result on the server (not shown), pick up result through FTP port 54 with programming mode by LSRR module 30, and be transferred to CTMS 14, there according to curee ID storage they.Can forbid order and result treatment to satisfy clinical requirement.In addition, can on the instrument panel that LSRR module 30 provides, observe the details of order and result treatment.LSRR module 30 allows the state or the result of people's Search of Individual order, also allows to divide single the checking in the parts among the CTMS 14 with laboratory result, eliminates the needs that data are transcribed thus.Message exchange between CTMS 14 control LSRR modules 30 and the laboratory service supplier 58.

During clinical testing, the examination of the ECG waveform of gathering during must making an experiment according to federal guide.This guide comprises following requirement etc.: all ECG waveforms will be by cardiologist's examination of permission; During clinical testing, can distribute the test curee 44 who is no more than specific quantity to given cardiologist; Distribution be the total blindness's and original allocation be at random, same cardiologist examination is to given test curee's 44 ECG waveform.That is, when arranging given test curee's ECG waveform to let the cardiologist examine, must carry out examination by same cardiologist at every turn.Abide by federal guide entad popular name for expert 62 (in Fig. 1 from the conceptive group that is shown) distribute the ECG waveform to be undertaken by CAR module 34, be what to utilize simply based on the modulus algorithm realization of software.Can use other algorithms for this purpose, the specific algorithm of use is not crucial for the work of the present invention or system 10.This guide is also specified; Again read the ECG waveform of some quantity; In the waveform that those are read again, must read specific quantity (intersect and read) again by all cardiologists, another number percent is only read (internal read) by same cardiologist simply again.CAR module 34 is read according to the guide arrangement automatically again and the cardiologist distributes and every cardiologist (with the Excel form) of examination provides the statistics of explaining otherness about cardiologist ECG in order to participate in.As LSRR module 30, clinical staff can be observed the details that the cardiologist examines by the instrument panel that clinical staff is observed through what computing machine produced.

Through the communication between 46 execution cardiologists 62 (telework) of portal website and the CAR module 34.The cardiologist utilizes software package to carry out their evaluation (being also referred to as " excessively reading ") usually, for example by Mortara Instrument, and the E-sribe ECG data management system of Inc. development and sale.Certainly substitute with other ECG data managements and auditing system.The cardiologist has several selections when submitting to the ECG waveform to estimate.At first, the cardiologist can accept waveform and the clinical interpretation (perhaps, confirm simply provide through SMS 22 explanation) of waveform is provided to CAR module 34 through portal website 46., store explicitly to this explanation of CTMS 14 transmission from CAR module 34 with the ID that tests the curee.Simultaneously, SPM 18 receives the affirmation of ECG data from CAR module 34, and the affirmation within the CTMS 14 is correlated with is used for the time slot of these ECG data with " closing ".By the rules definition time slot (for example, ten of the ECG data second period was used for assessment) that is programmed among the CTMS 14.

Perhaps, the cardiologist can refuse the ECG waveform.In this case, send notice to CAR module 34, and send to the auxiliary technician who is rejected the waveform clinical testing by CAR module 34 through portal website 46.The technician can examine refusal and reason for rejection, and examination ECG Wave data (by SMS 22 continuous acquisition) is to select the different windows of ECG Wave data.

In case selected the ECG data of revision, it resend cardiologist 62 to examine and to explain.In another embodiment, can select the ECG data of revision automatically, be chosen in automatically before or after ten seconds cycle datas by system 10.In case by cardiologist's approval, SPM 18 just gathers new ECG waveform also with (at this time slot and to this ID) the old ECG data of storing the new ECG waveform replacement CTMS 14 from SMS 22.Automatically distribute the cardiologist to examine data with the electronics mode, automatically with the electronics mode entad the popular name for expert procedural representation cardiologist (although they work and parallel) that presents data and gather cardiologist's evaluation with the electronics mode automatically in the other places can when carrying out clinical testing, accomplish the ECG assessment in real time.

As shown in fig. 1, system 10 and camera network (VCN) 38 are integrated, utilize common clock, for example are connected to the server of atomic clock via satellite, to the Servers-all and the module of system 10, comprise that VCN 38 carries out synchronously.VCN 38 comprises a plurality of video camera (not shown), and each video camera is placed on test curee's room and networks each other through the public server (not shown).Each video camera of VCN 38 all has the IP address, and the test curee's 44 that the IP address is associated with the room that is used for installing with video camera ID is relevant.Can gather patient's image like this and make the ECG waveform of patient's image and preset time relevant with other patient datas.For example, if test curee 44 has changed the position at the correct time of gathering waveform, the ECG waveform possibly look like different.The image that VCN 38 gathers allow clinician or clinical testing ISP staff see when gathering ECG waveform or other data test curee WKG working what.

In operation, pharmaceuticals or test sponsor 48 provide clinical testing or research rules for the clinical testing ISP.In CTMS 14, import rules by clinical testing ISP staff.In other embodiments, sponsor 48 can pass through portal website 46, FTP port 54 or another Web portal node (not shown) direct input rules information in CTMS 14.For example, if research sponsor 48 hopes to have every day the ECG incident 10 times, before and after making up a prescription 10-15 minute and per hour repeat at interval for the test curee, then with this message composition in CTMS 14.

SPM 18 inquiry CTMS databases and the input that becomes SMS 22 and RM 26 to read the rules information translation.RM 26 realizes one group of test curee's 44 automatic selection based on the research rules.

Clinical testing ISP's staff examines information relevant with this group in curee's database 42, through phone filler test curee 44 with the refinement testing group.Collect urine and blood sample from possible test curee 44.Through the lab investigation that LSRR module 30 is arranged sample, LSRR module 30 is sent test request through FTP over SSL port 54 to laboratory service supplier 58.Laboratory service supplier 58 arranges express mail, collects sample and accomplishes test.With HL7 form mailing test result, LSRR module 30 is through FTP port 54 access servers then to server for laboratory service supplier 58.LSRR module 30 imports the data of self-sizing and analysis then in trend CTMS 14.If in test curee's laboratory result, do not have unfavorable discovery, can select to test curee 44 so and participate in research.The clinical staff examination result also identifies the qualified final set of carrying out the individuality of clinical testing.At this moment, in CTMS 14, produce the identifier (" ID ") of testing the curee, gather ID automatically, in SMS22, write ID by SPM 18 by SPM 18 to each test curee 44.

SPM 18 automatically performs the demography data transcription from CTMS 14 to SMS 22.Test curee ID has connected the communication gap between CTMS 14 and the SMS 22, and SPM 18 uses ID with two systems, and promptly the data between SMS 22 and the CTMS 14 shut away mutually.The automatic character of transcription has been eliminated any demand to the artificial data input.In case accomplish this process, SPM 18 just produces the rules file, is used for SMS 22 is carried out programming Control.Through program control inspection CTMS research data base and calculate ECG and the output time of other physiological datas produces this file.In case produce this file and upload among the SMS 22, will be based on the rules output curee ECG of sponsor's 48 appointments.

For curee 44 distributes the room in the clinical testing facility and is connected to SMS 22, normally above-described ECG transmitter based on telemetry.Room and transmitter are associated with curee ID.During from patient's image data, transmitter is to SMS 22 continuous broadcast ECG data at transmitter.22 pairs of data of SMS are carried out some explanatory algorithms and are produced the XML file that comprises decryption, also produce pdf document, and this is the visual representation of ECG waveform.

SPM 18 is through its intercepting thread or intercept routine and gather the ECG data file according to test procedure.SPM 18 automatically with programming mode from pdf document analyzing XML file, curee ID and file group merged to CTMS 14 send all data.Utilize modulus algorithm among the SPM 18 to realize the related of data file and curee ID, this algorithm is relevant with known curee ID with data.Utilization is attached to ECG waveform and the decryption of correct curee ID, and cardiologist's examination and assessment can begin.CAR 34 snugly entad popular name for expert 62 distribute the ECG waveforms to analyze.Cardiologist 62 judge the given sample of ECG data invalid, inaccurate or because of the unacceptable situation of other causes under, he can refuse the ECG data and change ten seconds data segment automatically.In one embodiment, substitute the selection of ECG data by staff's manual work of clinical testing ISP.The staff utilizes instrument panel to carry out this function to examine data and to select better data sample to send to cardiologist's 62 examinations.In another embodiment, the data of time supplied examination before or after SPM 18 can select automatically.As the primary data sample, new samples is sent to portal website 46, can watch and explain sample by cardiologist 62 at this.

All data storage of gathering during the clinical testing are associated in CTMS 14 and with curee ID.Can the ability through portal website's 46 access system 10 be provided for sponsor 48 and FDA 50.Such visit can allow sponsor 48 or FDA 50, or both watch clinical testing process and data acquisition in real time when carrying out clinical testing.Perhaps, can the ability of only when accomplishing, just visiting clinical test results (therefore reporting the result automatically) be provided to sponsor 48 or FDA 50.This possibly be passive process, the access ability of carrying out password protection for thus sponsor 48 or 50 pairs of systems of FDA 10, and watching the result as required, or process initiatively, wherein send clinical test results to sponsor 48 or FDA 50 by system 10.

This system 10 provides useful system and method, so that the enforcement of clinical testing and from collection, explanation, storage and the report robotization of the data of clinical testing.This system 10 also allows robotization, real-time and parallel activity, for example examines ECG and other physiological datas with the mode that is associated with given test curee ID, accomplishes lab investigation, report laboratory result and all results of storage.In following claim, set forth various characteristic of the present invention.

Claims

1. system that is used for during live body curee clinical testing, making the enforcement of data and collects robotization, said system comprises:

Computer based clinical trial management system, programming Control its with definition clinical testing rules and store curee's data, said curee's data comprise curee's identifier;

Electronics curee monitoring system is used for during said clinical testing, gathering physiological data from said curee; And

Electronics curee poll module; Programming Control its to gather said physiological data from said curee's monitoring system according to said clinical testing rules; Automatically with the electronics mode said physiological data is associated with suitable curee's identifier, and sends said physiological data to store to said clinical trial management system.

2. system according to claim 1, the physiological data of wherein said electronics curee monitoring system collection is the ECG data.

3. system according to claim 2, wherein said ECG data comprise the numeric representation of ECG data of visual representation and text file format of the ECG waveform of image file format.

4. system according to claim 3, wherein the said curee's monitoring system of programming Control is to comprise curee ID in text.

5. system according to claim 2, wherein said ECG data comprise the numeric representation of ECG data of visual representation and XML file layout of the ECG waveform of pdf document form.

6. system according to claim 1, wherein said system comprises the HL7 engine, programming Control its to carry out the automatic arrangement of lab investigation by the laboratory service supplier.

7. system according to claim 6; Wherein said HL7 engine receives laboratory result from said laboratory service supplier automatically, and said laboratory result is associated with curee's identifier and the said laboratory result of storage in said clinical trial management system.

8. system according to claim 1, wherein said system comprise the digital video camcorder network synchronous with said curee's monitoring system.

9. system according to claim 1; Wherein said system comprises the digital video camcorder network, and wherein said digital video camcorder network, said clinical trial management system, said curee's monitoring system and said curee's poll module and common clock are synchronous.

10. system according to claim 1, wherein said system comprise that the cardiologist distributes and examines module, and it examines said ECG data to distribute the cardiologist programming Control.

11. system according to claim 10, wherein said cardiologist distribute and the examination module is distributed same cardiologist from the same curee of trend when needing the cardiologist to analyze at every turn.

12. system according to claim 1; Also comprise can be through web portal access the recruitment module, and wherein said recruitment module is programmed control and receives the data relevant with the curee and select one group of curee to participate in clinical testing based on said rules with the electronics mode.

13. system according to claim 1, wherein by single server to all carry out based on the application of server synchronously in said system and the said system.

14. system according to claim 1, wherein said clinical trial management system is programmed clinical testing is reported in control to the sponsor with the electronics mode result.

15. a system that is used for during live body curee clinical testing, making the enforcement of data and collects robotization, said system comprises:

Electronics curee monitoring system is used for during said clinical testing, gathering the ECG data from said curee, and said ECG data comprise the image file of expression ECG waveform and the text that expression ECG measured and analyzed data;

Electronics curee poll module; Programming Control its to gather said ECG data from said curee's monitoring system according to said clinical testing rules; Automatically with the electronics mode physiological data is associated with suitable curee's identifier, and sends said physiological data to store to said clinical trial management system; And

The cardiologist distributes and the examination module, programming Control its to distribute the cardiologist to examine said ECG data with the electronics mode automatically according to said rules.

16. system according to claim 15, wherein said cardiologist distribute and the examination module is distributed same cardiologist from the same curee of trend when needing the cardiologist to analyze at every turn.

17. system according to claim 15; Wherein said system comprise can be through web portal access the recruitment module, and wherein said recruitment module is programmed control and receives the data relevant with the curee and select one group of curee to participate in clinical testing based on said rules with the electronics mode.

18. system according to claim 15, wherein by single server to all carry out based on the application of server synchronously in said system and the said system.

19. system according to claim 15, wherein said clinical trial management system is programmed clinical testing is reported in control to the sponsor with the electronics mode result.

20. a method of during clinical testing, implementing and collecting physiological data, said method comprises:

Develop potential clinical testing curee's electronic databank;

Utilize clinical testing rules programming Control clinical trial management system;

Based on said rules and said database select to be used for the curee of clinical testing with the electronics mode from said database more automatically, and the curee of every selection is associated with identifier;

Utilize said curee's identifier programming Control curee's monitoring system and selected curee is connected to said curee's monitoring system;

Gather the ECG data from said curee's monitoring system; And

Send said ECG data according to said rules to said clinical trial management system.