CN107657986A - Clinical testing data check method, system and electronic equipment - Google Patents
Clinical testing data check method, system and electronic equipment Download PDFInfo
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- CN107657986A CN107657986A CN201710864533.8A CN201710864533A CN107657986A CN 107657986 A CN107657986 A CN 107657986A CN 201710864533 A CN201710864533 A CN 201710864533A CN 107657986 A CN107657986 A CN 107657986A
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- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06F—ELECTRIC DIGITAL DATA PROCESSING
- G06F21/00—Security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
- G06F21/60—Protecting data
- G06F21/62—Protecting access to data via a platform, e.g. using keys or access control rules
- G06F21/6218—Protecting access to data via a platform, e.g. using keys or access control rules to a system of files or objects, e.g. local or distributed file system or database
- G06F21/6245—Protecting personal data, e.g. for financial or medical purposes
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- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06F—ELECTRIC DIGITAL DATA PROCESSING
- G06F2221/00—Indexing scheme relating to security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
- G06F2221/21—Indexing scheme relating to G06F21/00 and subgroups addressing additional information or applications relating to security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
- G06F2221/2107—File encryption
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Abstract
The invention discloses a kind of clinical testing data check method, system, electronic equipment and computer-readable storage medium.This method is applied to block chain network, wherein, method includes：Sponsor's node, researcher's node and Ethics Committee's node receive the file in each clinical experimental stage respectively, and the file in each clinical experimental stage of reception is encrypted and stored, the file after encryption is sent to block chain network；Medicine supervises node and the encryption file listened to is stored to medicine to the Service Database for supervising node, the intelligent contract pre-set by running medicine prison node supervises the file that node receives to medicine and carries out data check, generate and store verification report, the authenticity of file in each clinical experimental stage can be ensured, so as to improve the accuracy of later data verification, data check is combined by verifying to be changed into verify in real time stage by stage according to verification demand afterwards with verifying afterwards, reduces the management cost of verification.
Description
Technical field
The present invention relates to data check technical field, and in particular to a kind of clinical testing data check method, system, electronics
Equipment and computer-readable storage medium.
Background technology
Clinical drug trial, refer to any systematic Study that medicine is carried out in human body (patient or healthy volunteer), with card
Effect, adverse reaction and/or the absorption of trial drug, distribution, metabolism and excretion real or that disclose trial drug, it is therefore an objective to it is determined that
The effect of trial drug and security, thus it is guaranteed that the real importance of clinical testing data is self-evident.
The verification to clinical drug trial data domestic at present supervises general bureau by the way of verify afterwards by food and medicine
Field data verification, clinical test process record and clinical test number are carried out on the basis of being checked oneself to applicant's clinical drug data
According to authenticity questions have become site inspection discovery subject matter.
The content of the invention
In view of the above problems, it is proposed that the present invention so as to provide one kind overcome above mentioned problem or at least in part solve on
State clinical testing data check method, system, electronic equipment and the computer-readable storage medium of problem.
According to an aspect of the invention, there is provided a kind of clinical testing data check method, this method is applied to block
Chain network, block chain network include：Sponsor's node, researcher's node, medicine prison node, Ethics Committee's node, wherein, method
Including：
Sponsor's node, researcher's node and Ethics Committee's node receive the file in each clinical experimental stage respectively,
File in each clinical experimental stage of reception is encrypted and stored, the file after encryption is sent to block chain network；
Medicine supervises node and the encryption file listened to is stored to medicine to the Service Database for supervising node, and node is supervised by running medicine
The file that the intelligent contract pre-set receives to medicine prison node carries out data check, generates and stores verification report, wherein, intelligence
Include the generation of data check project, the checking item issue, code verification formulated according to verification request the cycle of activity of energy contract
Performed with code.
According to another aspect of the present invention, there is provided a kind of clinical testing data checking system, the system are applied to block
Chain network, wherein, system includes：
Sponsor's node, for receiving the file in each clinical experimental stage, in each clinical experimental stage of reception
File is encrypted and stored, and the file after encryption is sent to block chain network；
Researcher's node, for receiving the file in each clinical experimental stage, in each clinical experimental stage of reception
File is encrypted and stored, and the file after encryption is sent to block chain network；
Ethics Committee's node, for receiving the file in each clinical experimental stage, to each clinical experimental stage of reception
In file be encrypted and store, the file after encryption is sent to block chain network；
Medicine supervises node, the Service Database of node is supervised for the encryption listened to file to be stored to medicine, by running medicine
The file that the intelligent contract that prison node is pre-set receives to medicine prison node carries out data check, generates and stores verification report,
Wherein, the generation of data check project, the checking item issue, generation formulated according to verification request are included the cycle of activity of intelligent contract
Code checking and code perform.
According to another aspect of the invention, there is provided a kind of electronic equipment, including：Processor, memory, communication interface and
Communication bus, processor, memory and communication interface complete mutual communication by communication bus；
Memory is used to deposit an at least executable instruction, and executable instruction makes the above-mentioned clinical testing data of computing device
Operated corresponding to check method.
In accordance with a further aspect of the present invention, there is provided a kind of computer-readable storage medium, be stored with least one in storage medium
Executable instruction, executable instruction make computing device be operated as corresponding to above-mentioned clinical testing data check method.
According to scheme provided by the invention, sponsor's node, researcher's node and Ethics Committee's node receive respectively respectively
File in clinical experimental stage, the file in each clinical experimental stage of reception is encrypted and stored, after encryption
File is sent to block chain network；Medicine supervises node and the encryption file listened to is stored to medicine to the Service Database for supervising node, leads to
Cross the file that the intelligent contract that operation medicine prison node is pre-set receives to medicine prison node and carry out data check, generate and store core
Report is looked into, wherein, the cycle of activity of intelligent contract includes the generation of data check project, the checking item formulated according to verification request
Issue, code verification and code perform, and can ensure the authenticity of file in each clinical experimental stage, so as to improve rear issue
According to the accuracy of verification, in addition, by data check by verify afterwards be changed into according to verification demand stage by stage in real time verify and thing
Verify and be combined afterwards, reduce the management cost of verification.
Described above is only the general introduction of technical solution of the present invention, in order to better understand the technological means of the present invention,
And can be practiced according to the content of specification, and in order to allow above and other objects of the present invention, feature and advantage can
Become apparent, below especially exemplified by the embodiment of the present invention.
Brief description of the drawings
By reading the detailed description of hereafter preferred embodiment, it is various other the advantages of and benefit it is common for this area
Technical staff will be clear understanding.Accompanying drawing is only used for showing the purpose of preferred embodiment, and is not considered as to the present invention
Limitation.And in whole accompanying drawing, identical part is denoted by the same reference numerals.In the accompanying drawings：
Fig. 1 shows a kind of flow signal of the according to embodiments of the present invention one clinical testing data check method provided
Figure；
Fig. 2 shows a kind of flow signal of the according to embodiments of the present invention two clinical testing data check methods provided
Figure；
Fig. 3 shows a kind of structural representation of the according to embodiments of the present invention three clinical testing data checking systems provided
Figure；
Fig. 4 shows the structural representation of according to embodiments of the present invention five a kind of electronic equipment.
Embodiment
The exemplary embodiment of the disclosure is more fully described below with reference to accompanying drawings.Although the disclosure is shown in accompanying drawing
Exemplary embodiment, it being understood, however, that may be realized in various forms the disclosure without should be by embodiments set forth here
Limited.On the contrary, these embodiments are provided to facilitate a more thoroughly understanding of the present invention, and can be by the scope of the present disclosure
Completely it is communicated to those skilled in the art.
Embodiment one
Fig. 1 shows a kind of flow signal of the according to embodiments of the present invention one clinical testing data check method provided
Figure.This method is applied to block chain network, and block chain network includes：Sponsor's node, researcher's node, medicine prison node, ethics
Committee's node, as shown in figure 1, this method comprises the following steps：
Step S100, sponsor's node, researcher's node and Ethics Committee's node receive each clinical experimental stage respectively
In file, the file in each clinical experimental stage of reception is encrypted and stored, the file after encryption is sent to area
Block chain network.
Specifically, clinical experimental stage generally comprises：Clinical test preparatory stage, clinical test carry out stage and clinical examination
Test the completion stage.Wherein, the file in the clinical test preparatory stage may include：Researcher's handbook, testing program, notice of knowing
Book, multilateral accord (researcher, sponsor, CRO signatures), Ethics Committee's official written reply, food Bureau of Drugs Supervision of country official written reply, researcher carry out
Go through, medical procedure Quality Control proves, test drug and relevant supplies transport manifest, trial drug medicine inspection prove etc.；Clinical test is entered
File in row order section may include：The renewal of researcher's handbook, new researcher's resume, medical science/laboratory examination normal value model
Enclose renewal, the medicine inspection of new lot number experiment is proved, monitor's interview is reported, the informed consent form of signature, original medical file, case history
Report, the serious adverse events report that researcher causes the adverse events report of sponsor, sponsor to cause Bureau of Drugs Supervision and Ethics Committee
Announcement, annual report etc.；File in the clinical test completion stage may include：Researcher's trial drug, which is destroyed, to be proved, completes examination
Test subject and encode catalogue, inspection proof, final monitoring report, experiment completion report, final report etc..
Sponsor's node, researcher's node and Ethics Committee's node will receive each clinical test according to the file deadline
File in stage, then the file received is encrypted according to the file acquisition time, the file after encryption is stored to right
The node answered, in addition, also needing to send the file after encryption into block chain network, each node in block chain network can
Get the file after encryption to carry out depositing card, so as to ensure that the unalterable feature of data in file, improve the true of data
Property, and then improve the accuracy that later data verifies report.
Step S101, medicine supervise node and the encryption file listened to are stored to medicine to the Service Database for supervising node, pass through fortune
The file that the intelligent contract that row medicine prison node is pre-set receives to medicine prison node carries out data check, generates and stores verification report
Accuse, wherein, the cycle of activity of intelligent contract includes the generation of data check project, the checking item hair formulated according to verification request
Cloth, code verification and code perform.
File after encryption is sent to block chain network, and medicine prison node monitors block chain network in real time, if listening to
File is encrypted, then the encryption file listened to is stored to medicine to the Service Database for supervising node, then supervises node by running medicine
The file that the intelligent contract pre-set receives to medicine prison node carries out data check, generates and stores verification report, wherein, number
Mainly verify whether file in each clinical experimental stage meets regulation according to verifying, file whether there is defect, and whether data deposit
In obvious careless mistake, block chain technology can provide visual two-way proof so that clinical laboratory data obtains multi-party common prison
Superintend and direct, data are positioned and played back according to the requirement of the process audit of data check, reduce the hidden danger that data are broken one's promise, reduce simultaneously
The risk that numeral is faked.
Wherein, verification request is specifically as follows：Whether research approach quality requirement is met, if fill in disease as requested
Example account (CRF) etc., is merely illustrative of without any restriction effect, in addition, verification request can be related to facing here
Bed medical science, pharmacy, bioanalysis, medical inspection, medical statistics, Medical Ethics etc..
Intelligent contract is pre-set on medicine prison node, is verified with the interim dynamic realized in clinical drug experimentation
And the data checking system before on-site verification is finally verified, so as to improve verification efficiency, the intelligence of data checking system is improved
Energyization is horizontal.
To sum up, a kind of clinical testing data check method provided in an embodiment of the present invention can ensure each clinical experimental stage
The authenticity of middle file, so as to improve the accuracy of later data verification, in addition, data check is changed into by verifying afterwards
Verify according to verification demand and be combined with verifying afterwards in real time stage by stage, reduce the management cost of verification.
Embodiment two
Fig. 2 shows a kind of flow signal of the according to embodiments of the present invention two clinical testing data check methods provided
Figure.This method is applied to block chain network, and block chain network includes：Sponsor's node, researcher's node, medicine prison node, ethics
Committee's node, as shown in Fig. 2 this method comprises the following steps：
Step S200, sponsor's node, researcher's node and Ethics Committee's node receive each clinical experimental stage respectively
In file, according to obtain the time in each clinical experimental stage of reception file carry out Hash processing, obtain corresponding Kazakhstan
Uncommon value.
Wherein, the file in each clinical experimental stage can be from Service Database outside chain corresponding to sponsor's node, grind
The outer Service Database of chain obtains corresponding to the outer Service Database of chain corresponding to the person's of studying carefully node and Ethics Committee's node, can also
It is to be uploaded by sponsor, researcher and Ethics Committee, does not limit sponsor's node, researcher's node and human relations specifically here
The source mode of file in each clinical experimental stage that reason committee node is received, in addition, each clinical test in the step
File in stage is similar with the file in the step S100 in embodiment illustrated in fig. 1, repeats no more here.
The file of sponsor's node, researcher's node and Ethics Committee's node in each clinical experimental stage is received
Afterwards, Hash processing can be carried out to file according to file acquisition time utilization SHA algorithms or MD5 algorithms, obtains corresponding Hash
Value.
Step S201, sponsor's node, researcher's node and Ethics Committee's node are utilized respectively the respective private key of node
Signature processing is carried out to cryptographic Hash, obtains signing messages.
Specifically, sponsor's node can utilize randomizer to generate the private key of the node, and then, the sponsor saves
Point carries out signature processing using the private key generated to resulting cryptographic Hash, i.e., cryptographic Hash is encrypted place using private key
Reason, obtains signing messages.
Researcher's node can utilize randomizer to generate the private key of the node, and then, researcher's node utilizes
The private key generated carries out signature processing to resulting cryptographic Hash, obtains signing messages.
Ethics Committee's node can generate the private key of the node, then, the Ethics Committee using randomizer
Node carries out signature processing using the private key generated to resulting cryptographic Hash, obtains signing messages.
Step S202, sponsor's node, researcher's node and Ethics Committee's node are utilized respectively the first preset algorithm pair
The private key of respective node is handled, and obtains corresponding public key.
Public key forms a key pair with private key, and sponsor's node, researcher's node and Ethics Committee's node are utilized respectively
Cryptographic Hash is encrypted node respective private key, obtains signing messages, medicine supervise node after file is got, it is necessary to
Signing messages is verified using public key, to determine whether file is changed.
For example, sponsor's node, researcher's node and Ethics Committee's node are utilized respectively Secp256K1 algorithm process pair
The private key of respective node is handled, and obtains corresponding public key, and it is asymmetric encryption processing procedure to generate public key process by private key,
, certainly, can be with here in addition to it can use Secp256K1 algorithms that is, private key can not be obtained according to public key
Using other rivest, shamir, adelmans, for example, RSA Algorithm, DSA algorithms, are merely illustrative of here, make without any limit
With.
Step S203, sponsor's node, researcher's node and Ethics Committee's node are utilized respectively the calculation of the second predetermined encryption
Method is handled public key, obtains corresponding node identification.
Specifically, sponsor's node can utilize Hash256 algorithm process public keys, generate cryptographic Hash corresponding to public key, profit
Public key cryptographic Hash is encoded with Base58 encryption algorithms, obtains node identification corresponding to sponsor's node, the node identification
It can be used for the source side for identifying file.
Researcher's node can utilize Hash256 algorithm process public keys, cryptographic Hash corresponding to generation public key, utilize Base58
Encryption algorithm encodes to public key cryptographic Hash, obtains node identification corresponding to researcher's node, and the node identification can be used for
Identify the source side of file.
Ethics Committee's node can utilize Hash256 algorithm process public keys, generate cryptographic Hash corresponding to public key, utilize
Base58 encryption algorithms encode to public key cryptographic Hash, obtain node identification corresponding to Ethics Committee's node, the node mark
Know the source side that can be used for identifying file.
In addition to it can use Hash256 algorithm process public keys, Ripemd160 algorithms can also be used, are only to lift here
Example explanation, without any restriction effect.
In embodiments of the present invention, step S200- step S201 can be first carried out, are performing step S202- step S203,
Step S202- step S203 can also be first carried out, then perform step S200- step S201, execution sequence does not limit.
Step S204, sponsor's node, researcher's node and Ethics Committee's node are respectively by corresponding signing messages, each
File, public key, the processing of node identification packaging ciphering in clinical experimental stage, obtain decrypting the packet of examination, and can
The packet of decryption examination is sent to block chain network.
Step S205, sponsor's node, researcher's node respectively store the file after respective encryption to corresponding to node
The outer Service Database of chain.
Specifically, sponsor's node, researcher's node respectively store cryptographic Hash corresponding to file to chain corresponding to node
Outer Service Database, make chain corresponding to node it is outer have encryption between Service Database and sponsor's node, researcher's node can
The data contact of inquiry.
The outer Service Database of chain corresponding to node can be the LIMS that clinical test carries out unit, with
Exemplified by hospital, LIMS not only includes clinical drug trial data, also other test datas comprising hospital,
Refer to file in clinical experimental stage in step s 200 can derive from the outer Service Database of chain corresponding to node, its with
The higher frequency saves data during clinical test, that is to say, that the outer Service Database of chain corresponding to node is on file
Locally stored database before chain, maintained between the file and LIMS of cochain of being packed by experimental stage
Contact logically between file, while after packaging file cochain, there is also laboratory information for the cryptographic Hash of corresponding document
In management system, so as to offline search.
Step S206, medicine supervise node and the packet for decrypting examination listened to are stored to medicine to the business datum for supervising node
Storehouse.
Medicine prison node is verified to the packet that can verify that, it is specific to confirm that the file in each clinical experimental stage comes from
Node.
Step S207, medicine are supervised node and public key are verified using node identification, if unanimously, using public key to A.L.S.
Breath is verified, if unanimously, the intelligent contract pre-set by running medicine prison node is supervised the file that node receives to medicine and entered
Row is sorted out, and data check is carried out to the file after classification according to the requirement of default data check, generates and stores verification report.
Medicine supervises node and carries out decoding process to node identification, obtains the cryptographic Hash of public key, public key is obtained after this is decoded
Cryptographic Hash is compared with the cryptographic Hash for the public key being initially obtained, if unanimously, by checking, then can utilize public key to label
Name information is verified that specifically, signing messages is decrypted using public key for medicine prison node, obtains the cryptographic Hash of file, medicine
Supervise node and Hash processing is carried out to file, obtain the cryptographic Hash of a file, the cryptographic Hash of two files is consistent, then by testing
Card, shows that file was not modified, then, the intelligent contract that pre-sets of node is supervised in each experimental stage by running medicine
File carries out verification processing, generates and stores verification report, specifically, the intelligence that can be supervised node by running medicine and pre-set
Contract is sorted out come the file received to medicine prison node, such as is sorted out according to clinical experimental stage, is convenient for the stage
Property data check, then according to default data check requirement to after classification file carry out data check, generation verify report,
And stored report is verified to the Service Database of medicine prison node, wherein, default data check requirement is not done specifically here
It is bright, verification request is tested according to medicine etc. and is configured.Medicine prison node can also send the verification report of generation to block chain
Network, supervised for sponsor's node, researcher's node, Ethics Committee's node.
Intelligent contract is run on medicine prison node, the chain code of intelligent contract interacts with bottom block chain network, accesses shape
State variable, trade context, called side identity and attribute, and call other chain codes to perform other operations.The work of intelligent contract
The generation of data check project, the checking item issue, code verification and the code that the dynamic cycle includes being formulated according to verification request perform.
Project generation refers to the template for filling in the checking item, including the checking item sequence number, verification people ID, project implementation ambient parameter, item
Mesh code and its Hash and project Hash.Project Hash is the Hash of the following, i.e. Item number, verification people ID, project
Performing environment parameter, item code Hash and contract code Hash.The major function of item code is generation contract and modification
Project status；The major function of contract code is to perform verification task, completes to verify function.
When block chain, which is added medicine to, supervises node triggering verification condition, intelligent contract is based on verifying content, contract state and the external world
Information performs code, and the intelligent contract-defined interface provided by block chain node inquires about block chain information and simultaneously implementing result is returned
Onto block chain.
When verifying transaction triggering, block chain calculate node can read code and execution in chain.Below with Java language
Illustrate to trigger execution mechanism：
The intelligent contract-defined interface that block chain provides
| Interface name | Input | Output |
| Obtain Transaction Identification Number ID | Null | txid |
| Obtain sender ID | Null | sender |
| Acquisition state | Key | State |
| More new state | Key | Null |
| Deletion state | Key | Null |
| Range query state | Startkey,endkey | Statearray |
| Checking signature | Cert,sig,message | result |
Storage of the block chain to contract code and state ensure that the reliability and observability of contract storage.
The contract template of data check business tine does not describe herein.
Wherein, the Service Database of medicine prison node provides data query service, for demand data querying node data.Medicine
The data query service that the Service Database of prison node provides is to meet the result of other departments inquiry clinical drug trial
Open up, the Service Database that node is supervised by medicine opens to outside, and open object can be R＆D institution, other hospitals, learn
Art unit, commercial undertaking etc..
In the present embodiment, the execution sequence of step is not specifically limited.
To sum up, a kind of clinical testing data check method provided in an embodiment of the present invention can ensure each clinical experimental stage
The authenticity of middle file, so as to improve the accuracy of later data verification, in addition, data check is changed into by verifying afterwards
Verify according to verification demand and be combined with verifying afterwards in real time stage by stage, reduce the management cost of verification.
Embodiment three
Fig. 3 shows a kind of structural representation of the according to embodiments of the present invention three clinical testing data checking systems provided
Figure.The system is applied to block chain network, as shown in figure 3, the system includes：Sponsor's node 300, researcher's node 310, human relations
Reason committee node 320, medicine prison node 330.
Sponsor's node 300, for receiving the file in each clinical experimental stage, in each clinical experimental stage of reception
File be encrypted and store, the file after encryption is sent to block chain network.
Researcher's node 310, for receiving the file in each clinical experimental stage, in each clinical experimental stage of reception
File be encrypted and store, the file after encryption is sent to block chain network；
Ethics Committee's node 320, for receiving the file in each clinical experimental stage, to each clinical test rank of reception
File in section is encrypted and stored, and the file after encryption is sent to block chain network；
Medicine supervises node 330, and the Service Database of node is supervised for the encryption listened to file to be stored to medicine, passes through operation
The file that the intelligent contract that medicine prison node is pre-set receives to medicine prison node carries out data check, generates and stores verification report
Accuse, wherein, the cycle of activity of intelligent contract includes the generation of data check project, the checking item hair formulated according to verification request
Cloth, code verification and code perform.
Pre-set intelligent contract on medicine prison node, realize the interim dynamic in clinical drug experimentation verify with
And the data checking system before on-site verification is finally verified, so as to improve verification efficiency, the intelligence of data checking system is improved
Change horizontal.
Alternatively, sponsor's node 300 is further used for：File after encryption is stored to chain corresponding to sponsor's node
Outer Service Database 340；
Researcher's node 310 is further used for：File after encryption is stored to business outside chain corresponding to researcher's node
Database 350.
Alternatively, sponsor's node 300, researcher's node 310, Ethics Committee's node 320 are further used for：Press respectively
Hash processing is carried out to the file in each clinical experimental stage of reception according to the time is obtained, obtains corresponding cryptographic Hash；
It is utilized respectively node respective private key and signature processing is carried out to cryptographic Hash, obtains signing messages；
It is utilized respectively the first preset algorithm to handle the private key of respective node, obtains corresponding public key；
It is utilized respectively the second predetermined encryption algorithm to handle public key, obtains corresponding node identification；
Respectively by the file in corresponding signing messages, each clinical experimental stage, public key, node identification packaging ciphering
Reason, obtains decrypting the packet of examination, and the packet that can decrypt examination is sent to block chain network.
Alternatively, medicine prison node 330 is further used for：The packet for decrypting examination listened to is stored to medicine to supervise and saved
The Service Database 360 of point；Public key is verified using node identification, if unanimously, being carried out using public key to signing messages
Checking, if unanimously, the intelligent contract pre-set by running medicine prison node is verified the file in each experimental stage
Processing, generate and store verification report.
Alternatively, medicine prison node 330 is further used for：The intelligent contract pre-set by running medicine prison node is supervised to medicine
The file that node receives is sorted out；
Data check is carried out to the file after classification according to the requirement of default data check, generates and stores verification report.
Alternatively, the Service Database of medicine prison node provides data query service, for demand data querying node data.
To sum up, a kind of clinical testing data checking system provided in an embodiment of the present invention can ensure each clinical experimental stage
The authenticity of middle file, so as to improve the accuracy of later data verification, in addition, data check is changed into by verifying afterwards
Verify according to verification demand and be combined with verifying afterwards in real time stage by stage, reduce the management cost of verification.
Example IV
The embodiment of the present application four provides a kind of nonvolatile computer storage media, the computer-readable storage medium storage
There is an at least executable instruction, the computer executable instructions can perform the clinical testing data in above-mentioned any means embodiment
Check method.
Embodiment five
Fig. 4 shows the structural representation of according to embodiments of the present invention five a kind of electronic equipment, present invention specific implementation
Specific implementation of the example not to electronic equipment limits.
As shown in figure 4, the electronic equipment can include：Processor (processor) 402, communication interface
(Communications Interface) 404, memory (memory) 406 and communication bus 408.
Wherein：
Processor 402, communication interface 404 and memory 406 complete mutual communication by communication bus 408.
Communication interface 404, for being communicated with the network element of miscellaneous equipment such as client or other servers etc..
Processor 402, for configuration processor 410, it can specifically perform above-mentioned clinical testing data check method embodiment
In correlation step.
Specifically, program 410 can include program code, and the program code includes computer-managed instruction.
Processor 402 is probably central processor CPU, or specific integrated circuit ASIC (Application
Specific Integrated Circuit), or it is arranged to implement the integrated electricity of one or more of the embodiment of the present invention
Road.The one or more processors that electronic equipment includes, can be same type of processor, such as one or more CPU；Also may be used
To be different types of processor, such as one or more CPU and one or more ASIC.
Memory 406, for depositing program 410.Memory 406 may include high-speed RAM memory, it is also possible to also include
Nonvolatile memory (non-volatile memory), for example, at least a magnetic disk storage.
Program 410 specifically can be used for causing processor 402 to perform the method in embodiment one to embodiment two.
Algorithm and display be not inherently related to any certain computer, virtual system or miscellaneous equipment provided herein.
Various general-purpose systems can also be used together with teaching based on this.As described above, required by constructing this kind of system
Structure be obvious.In addition, the present invention is not also directed to any certain programmed language.It should be understood that it can utilize various
Programming language realizes the content of invention described herein, and the description done above to language-specific is to disclose this hair
Bright preferred forms.
In the specification that this place provides, numerous specific details are set forth.It is to be appreciated, however, that the implementation of the present invention
Example can be put into practice in the case of these no details.In some instances, known method, structure is not been shown in detail
And technology, so as not to obscure the understanding of this description.
Similarly, it will be appreciated that in order to simplify the disclosure and help to understand one or more of each inventive aspect,
Above in the description to the exemplary embodiment of the present invention, each feature of the invention is grouped together into single implementation sometimes
In example, figure or descriptions thereof.However, the method for the disclosure should be construed to reflect following intention：I.e. required guarantor
The application claims of shield features more more than the feature being expressly recited in each claim.It is more precisely, such as following
Claims reflect as, inventive aspect is all features less than single embodiment disclosed above.Therefore,
Thus the claims for following embodiment are expressly incorporated in the embodiment, wherein each claim is in itself
Separate embodiments all as the present invention.
Those skilled in the art, which are appreciated that, to be carried out adaptively to the module in the equipment in embodiment
Change and they are arranged in one or more equipment different from the embodiment.Can be the module or list in embodiment
Member or component be combined into a module or unit or component, and can be divided into addition multiple submodule or subelement or
Sub-component.In addition at least some in such feature and/or process or unit exclude each other, it can use any
Combination is disclosed to all features disclosed in this specification (including adjoint claim, summary and accompanying drawing) and so to appoint
Where all processes or unit of method or equipment are combined.Unless expressly stated otherwise, this specification (including adjoint power
Profit requires, summary and accompanying drawing) disclosed in each feature can be by providing the alternative features of identical, equivalent or similar purpose come generation
Replace.
In addition, it will be appreciated by those of skill in the art that although some embodiments described herein include other embodiments
In included some features rather than further feature, but the combination of the feature of different embodiments means in of the invention
Within the scope of and form different embodiments.For example, in the following claims, embodiment claimed is appointed
One of meaning mode can use in any combination.
The all parts embodiment of the present invention can be realized with hardware, or to be run on one or more processor
Software module realize, or realized with combinations thereof.It will be understood by those of skill in the art that it can use in practice
Microprocessor or digital signal processor (DSP) are realized in clinical testing data verification equipment according to embodiments of the present invention
Some or all parts some or all functions.The present invention is also implemented as being used to perform side as described herein
The some or all equipment or program of device (for example, computer program and computer program product) of method.It is such
Realizing the program of the present invention can store on a computer-readable medium, or can have the shape of one or more signal
Formula.Such signal can be downloaded from internet website and obtained, and either be provided or with any other shape on carrier signal
Formula provides.
It should be noted that the present invention will be described rather than limits the invention for above-described embodiment, and ability
Field technique personnel can design alternative embodiment without departing from the scope of the appended claims.In the claims,
Any reference symbol between bracket should not be configured to limitations on claims.Word "comprising" does not exclude the presence of not
Element or step listed in the claims.Word "a" or "an" before element does not exclude the presence of multiple such
Element.The present invention can be by means of including the hardware of some different elements and being come by means of properly programmed computer real
It is existing.In if the unit claim of equipment for drying is listed, several in these devices can be by same hardware branch
To embody.The use of word first, second, and third does not indicate that any order.These words can be explained and run after fame
Claim.
Claims (14)
1. a kind of clinical testing data check method, it is characterised in that this method is applied to block chain network, the block link network
Network includes：Sponsor's node, researcher's node, medicine prison node, Ethics Committee's node, wherein, methods described includes：
Sponsor's node, researcher's node and Ethics Committee's node receive the file in each clinical experimental stage respectively, docking
File in each clinical experimental stage received is encrypted and stored, and the file after encryption is sent to block chain network；
Medicine supervises node and the encryption file listened to is stored to medicine to the Service Database for supervising node, advance by running medicine prison node
The file that the intelligent contract of setting receives to medicine prison node carries out data check, generates and stores verification report, wherein, intelligence is closed
Include the generation of data check project, the checking item issue, code verification and the generation formulated according to verification request cycle of activity about
Code performs.
2. according to the method for claim 1, it is characterised in that methods described also includes：Sponsor's node, researcher's node
The file after respective encryption is stored to Service Database outside chain corresponding to node respectively.
3. method according to claim 1 or 2, it is characterised in that sponsor's node, researcher's node and ethics committee
Member can node the file in each clinical experimental stage of reception is encrypted and stored respectively, by the file after encryption send to
Block chain network further comprises：
Sponsor's node, researcher's node and Ethics Committee's node are respectively according to obtaining the time to each clinical test rank of reception
File in section carries out Hash processing, obtains corresponding cryptographic Hash；
Sponsor's node, researcher's node and Ethics Committee's node are utilized respectively node respective private key and cryptographic Hash are signed
Name processing, obtains signing messages；
Sponsor's node, researcher's node and Ethics Committee's node are utilized respectively private key of first preset algorithm to respective node
Handled, obtain corresponding public key；
Sponsor's node, researcher's node and Ethics Committee's node be utilized respectively the second predetermined encryption algorithm to public key at
Reason, obtains corresponding node identification；
Sponsor's node, researcher's node and Ethics Committee's node are respectively by corresponding signing messages, each clinical experimental stage
In file, public key, the processing of node identification packaging ciphering, obtain decrypting the packet of examination, and will described in can decrypt examination
Packet send to block chain network.
4. according to the method for claim 3, it is characterised in that medicine prison node by the encryption file listened to store to
Medicine supervises the Service Database of node, and the intelligent contract pre-set by running medicine prison node is supervised the file that node receives to medicine and entered
Row data check, generate and store verify report further comprise：
Medicine supervises node and the packet for decrypting examination listened to is stored to medicine to the Service Database for supervising node；
The medicine prison node is verified using node identification to public key, if unanimously, being tested using public key signing messages
Card, if unanimously, the intelligent contract pre-set by running medicine prison node is carried out at verification to the file in each experimental stage
Reason, generate and store verification report.
5. method according to claim 1 or 2, it is characterised in that the intelligence conjunction supervised node by running medicine and pre-set
Data check about is carried out to the file that receives of medicine prison node, generates and stores and verify report and further comprise：
The intelligent contract pre-set by running medicine prison node is supervised the file that node receives to medicine and sorted out；
Data check is carried out to the file after classification according to the requirement of default data check, generates and stores verification report.
6. method according to claim 1 or 2, it is characterised in that the Service Database of the medicine prison node provides data
Inquiry service, for demand data querying node data.
7. a kind of clinical testing data checking system, it is characterised in that the system is applied to block chain network, the system bag
Include：
Sponsor's node, for receiving the file in each clinical experimental stage, to the file in each clinical experimental stage of reception
It is encrypted and stores, the file after encryption is sent to block chain network；
Researcher's node, for receiving the file in each clinical experimental stage, to the file in each clinical experimental stage of reception
It is encrypted and stores, the file after encryption is sent to block chain network；
Ethics Committee's node, for receiving the file in each clinical experimental stage, in each clinical experimental stage of reception
File is encrypted and stored, and the file after encryption is sent to block chain network；
Medicine supervises node, and the Service Database of node is supervised for the encryption listened to file to be stored to medicine, by running medicine prison section
The file that the intelligent contract that point is pre-set receives to medicine prison node carries out data check, generates and stores verification report, wherein,
The data check project that the cycle of activity of intelligent contract includes being formulated according to verification request is generated, the checking item is issued, code is tested
Card and code perform.
8. system according to claim 7, it is characterised in that sponsor's node is further used for：After encryption
File is stored to Service Database outside chain corresponding to sponsor's node；
Researcher's node is further used for：File after encryption is stored to business datum outside chain corresponding to researcher's node
Storehouse.
9. the system according to claim 7 or 8, it is characterised in that sponsor's node, researcher's node, ethics committee
Member's meeting node is further used for：
Respectively according to the time is obtained to the file progress Hash processing in each clinical experimental stage of reception, corresponding Hash is obtained
Value；
It is utilized respectively node respective private key and signature processing is carried out to cryptographic Hash, obtains signing messages；
It is utilized respectively the first preset algorithm to handle the private key of respective node, obtains corresponding public key；
It is utilized respectively the second predetermined encryption algorithm to handle public key, obtains corresponding node identification；
Respectively by the file in corresponding signing messages, each clinical experimental stage, public key, the processing of node identification packaging ciphering, obtain
Sent to the packet that can decrypt examination, and by the packet for decrypting examination to block chain network.
10. system according to claim 9, it is characterised in that the medicine prison node is further used for：
The packet for decrypting examination listened to is stored to the Service Database of medicine prison node；
Public key is verified using node identification, if unanimously, being verified using public key to signing messages, if unanimously,
The intelligent contract pre-set by running medicine prison node carries out verification processing to the file in each experimental stage, generates and stores
Verify report.
11. the system according to claim 7 or 8, it is characterised in that the medicine prison node is further used for：Pass through operation
The file that the intelligent contract that medicine prison node is pre-set receives to medicine prison node is sorted out；
Data check is carried out to the file after classification according to the requirement of default data check, generates and stores verification report.
12. the system according to claim 7 or 8, it is characterised in that the Service Database of the medicine prison node provides data
Inquiry service, for demand data querying node data.
13. a kind of electronic equipment, it is characterised in that including：Processor, memory, communication interface and communication bus, the processing
Device, the memory and the communication interface complete mutual communication by the communication bus；
The memory is used to deposit an at least executable instruction, and the executable instruction makes the computing device such as right will
Ask and operated corresponding to the clinical testing data check method any one of 1-6.
14. a kind of computer-readable storage medium, it is characterised in that an at least executable instruction, institute are stored with the storage medium
State corresponding to the clinical testing data check method that executable instruction makes computing device as any one of claim 1-6
Operation.
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