CN115440332A - Clinical test data storage and sharing method based on public chain and alliance chain - Google Patents
Clinical test data storage and sharing method based on public chain and alliance chain Download PDFInfo
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Abstract
The invention belongs to the field of clinical tests, and relates to a method for storing and sharing clinical test data based on a public chain and a alliance chain, which meets the storage requirements of a large amount of information of reporters in the recruitment stage of clinical tests and the storage and sharing requirements of data of testees in the test stage; the data transfer verification method based on the multi-party digital signature and the intelligent contract realizes the safe and efficient screening requirement on the data of the testees, and realizes the safe and efficient transfer of the data of the testees entering a test stage from a clinical test recruitment stage by combining a data transfer contract on a public chain and a data receiving contract on a alliance chain; the data isolation and sharing method based on the secondary encryption of the authority public and private key pair and the clinical trial number realizes the safe sharing of the clinical trial data of the testee by each node in the clinical trial process. The invention realizes the non-tampering and traceability of the clinical test data by utilizing the characteristic of the block chain, and ensures the privacy of the data of the testee by adopting the characteristic of asymmetric encryption.
Description
Technical Field
The invention belongs to the field of clinical tests, relates to technologies such as a public chain and a alliance chain in a block chain technology, asymmetric encryption and the like, and particularly relates to a method for storing and sharing clinical test data based on the public chain and the alliance chain.
Background
The data of the traditional clinical trials are all stored in a traditional single database, and the risk of data leakage and data loss exists, for example, the technical scheme disclosed in the invention patent with the application number of 202010699691.4 entitled "method and device for recruiting subjects, terminal equipment and storage medium". Hospitals involved in clinical trials store trial data of the subjects in own databases, so that the subject data cannot be efficiently shared in the clinical trial process, and the trial progress and trial quality of the clinical trials are affected by the sharing efficiency of the subject data. Meanwhile, due to the particularity of the clinical test data, the privacy of the data of the testee in the sharing process needs to be ensured.
In addition, the prior art has few methods for storing and sharing clinical trial data, mainly focuses on data management in the clinical trial stage, and does not consider the processing of the information of the registrars in the clinical trial recruitment stage. The prior art lacks an efficient method for screening and confirming the information of the testee, which results in slow progress of clinical trials. The protection of the sensitive data of the subject in the prior art is still to be improved, and in view of the importance and privacy of the clinical test data, a method for protecting the clinical test data of the subject is needed.
The block chain technology packs information to be stored into blocks, and then connects the blocks in a time sequence to form a chain. The blockchain will be stored in all servers, and as long as one server is working properly, the data on the blockchain is secure. At the same time, the blockchain has decentralized and non-tamperable properties. Therefore, the block chain technology can well meet the storage requirement of clinical trial data. The asymmetric encryption technology ensures that only a user with a corresponding private key can decrypt the encrypted ciphertext to obtain the plaintext of the data desired by the user, and ensures the privacy of the data in the sharing process. Meanwhile, the blockchain is further divided into an unlicensed chain and a licensed chain, the unlicensed chain refers to a blockchain network in which any user can freely join, and the licensed chain refers to a blockchain network in which only authenticated users can join.
Disclosure of Invention
In order to solve the technical problems, the invention discloses a method for storing and sharing clinical test data based on a public chain and a alliance chain, which meets the storage requirements of a large amount of information of reporters in a clinical test recruitment stage and the storage and sharing requirements of data of testees in a test stage; the data transfer verification method based on the multi-party digital signature and the intelligent contract meets the requirement for safely and efficiently screening the data of the testees, and realizes the safe and efficient transfer of the data of the testees from a clinical test recruitment stage to a test stage by combining a data transfer contract on a public chain and a data receiving contract on a alliance chain; the data isolation and sharing method based on the secondary encryption of the authority public and private key pair and the clinical test number realizes the safe and efficient sharing of the clinical test data of the testee by each node in the clinical test process.
The invention adopts the following specific technical scheme:
a storing and sharing method of clinical test data based on public chain and alliance chain comprises a recruitment phase of clinical test and a test phase of clinical test; in the recruitment stage of the clinical test, a public chain mode is adopted for storing entry information of an entry in the clinical test recruitment stage; in the test stage of the clinical test, a alliance chain mode is adopted for storing test medical data of a subject in the test stage of the clinical test; nodes of a public chain in the recruitment phase of the clinical test comprise an enrollee node and an examination node of a clinical test project group, wherein the enrollee node refers to a potential subject willing to join the clinical test, and the examination node refers to a staff of the clinical test project group for examining and screening the information of the enrollee; in the test stage of the clinical test, the nodes of the alliance chain comprise a subject node, a sponsor node, a researcher node and a clinical test management department node, wherein the subject node refers to an enrollee which has signed an informed consent and added into the clinical test, the sponsor node refers to a worker of the sponsor initiating the clinical test, the researcher node refers to a relevant doctor participating in the clinical test, and the clinical test management department node refers to a worker responsible for reviewing and supervising the clinical test process in the government aspect.
In the recruitment stage of the clinical test, a public chain for storing the registration information of the registration person is created by a clinical test management department, the clinical test number, the entry and discharge standard, the deselection standard, the informed consent, the registration information table, the patient basic information public key and the patient medical information public key of the clinical test are written into the creation block, the patient medical information private key is granted to an examination node, all potential subjects with registration willingness freely add into the public chain network to check the information disclosed on the creation block and preliminarily judge whether the information meets the requirements of the clinical test according to the entry and discharge standard and the deselection standard provided by a clinical test panel, the registration person meets the entry and discharge standard and voluntarily wants to join the clinical test, the basic information and the medical information of the registration person are respectively filled according to the registration information table provided on the creation block, and then a submission button is clicked, and the information of the registration person is encrypted through encryption contract deployed on the public chain.
In the test stage of the clinical test, an application party submits a clinical test application to a clinical test management department, after the application is passed, the clinical test management department generates three pairs of public and private key pairs for the clinical test, the public keys are respectively used as the test number of the clinical test, the basic information of a patient and the medical information of the patient, and the corresponding private keys are stored in a private server of the method.
The invention further improves the method, when the recruitment stage is finished, the clinical trial project group screens the information of the registrars and transfers the data of the enrolled test subjects to the alliance chain from the public chain, a screening contract is deployed on the public chain in the data screening stage for preliminary screening, the screened data of the registrars are pushed to a review node in the system, the review node reviews the information of the registrars, after the review is finished, the review node signs the data of the enrolled registrars, the signature content is the public key of the registrars plus right/false, the signature is stored in a signature column of the data of the registrars, and other review nodes review the data of the same registrars again to circulate. The examination process is synchronous, and a plurality of examination nodes can simultaneously examine the information of the same registrant. And deploying a review contract on the public chain, wherein after a review node reviews the information of an entry, the review contract checks the review result of the review node and carries out priority sequencing on the pushing of the entry data, and the higher the signature number of the review node with the review result of right, the higher the priority of the entry data. Meanwhile, in the method, a review standard reaching threshold n is set for the clinical test, and when the number of the data review results of the registrars is right and reaches the threshold n, a data transfer contract on the public chain is triggered.
In the early stage of the data transfer stage, a data transfer contract on a public chain continuously monitors the data of the registrants meeting the conditions, then the data of the registrants meeting the clinical test conditions are integrated, hash calculation is carried out on the integrated information to obtain a data transfer hash, finally the data transfer contract encrypts the integrated information of the registrants and the data transfer hash by using clinical test numbers, and a data transfer request is sent to a server of the alliance chain by a server address of the alliance chain stored in the data transfer contract. When a data receiving contract deployed on a alliance chain receives a data transfer request initiated by a public chain, a received ciphertext is decrypted by a clinical test private key stored in a private server, then the received data is subjected to hash processing to obtain a data receiving hash, and whether the data receiving hash is equal to the data transfer hash is verified. If the data are equal, the received data are proved to be not tampered, and the data receiving contract stores the data uplink of the subject and informs the public chain that the data transfer is completed; if the data transfer contract is not equal to the public link data transfer contract, the public link data transfer contract informs that the public link data transfer fails, and after receiving the notice, the data transfer contract needs to reinitiate the data transfer request until the data transfer is completed.
The invention has the beneficial effects that: the invention meets the storage requirements of a large amount of information of the reporters in the clinical trial recruitment stage and the storage and sharing requirements of the data of the testees in the trial stage; the data transfer verification method based on the multi-party digital signature and the intelligent contract meets the requirement for safely and efficiently screening the data of the testees, and realizes the safe and efficient transfer of the data of the testees from a clinical test recruitment stage to a test stage by combining a data transfer contract on a public chain and a data receiving contract on a alliance chain; the data isolation and sharing method based on the secondary encryption of the authority public and private key pair and the clinical test number realizes the safe sharing of the clinical test data of the testee by each node in the clinical test process and protects the privacy of the data of the testee.
Drawings
Fig. 1 is an overall framework diagram of the present invention.
FIG. 2 is a flowchart of the common chain of the present invention.
Fig. 3 is a specific flowchart of data uploading in the present invention.
FIG. 4 is a process flow diagram of the federation chain of the present invention.
FIG. 5 is an examination flowchart of the present invention.
FIG. 6 is a flow chart of data transfer in the present invention.
Fig. 7 is an encryption contract diagram of the present invention.
FIG. 8 is a flow chart of data request in the present invention.
Detailed Description
For the purpose of enhancing the understanding of the present invention, the present invention will be described in further detail with reference to the accompanying drawings and examples, which are provided for the purpose of illustration only and are not intended to limit the scope of the present invention.
Example (b): a method for storing and sharing clinical test data based on public chains and alliance chains is provided, and the overall framework is shown in figure 1:
in the recruitment phase of clinical trials, the panel of clinical trial projects is required to recruit subjects to the public. Because the number of the roll-in people is large and the authority of the roll-in people is single, the roll-in people is only limited to fill in the basic information and the medical information of the roll-in people. And if the entry is not successfully selected finally, the waste of clinical test data storage resources is caused, so the method adopts a public chain mode for storing the entry information of the entry in the clinical test recruitment stage. The nodes of the public chain comprise an enrollee node and a review node of the clinical trial project group. The reporter node refers to potential subjects willing to participate in the clinical test, and the examination node refers to staff of a clinical test project group for examining and screening reporter information.
In the test stage of the clinical test, nodes related to the clinical test, such as a subject, a sponsor, a researcher, a clinical test management department and the like, are determined. The method proposes to use a federation chain approach for storing trial medical data of the subjects in the clinical trial phase. Nodes of the federation chain include a subject node, a sponsor node, a researcher node, and a clinical trial administration node. The subject node refers to an enroller who has signed an informed consent and added to a clinical trial; the sponsor node refers to a worker of a sponsor who initiates clinical tests, such as a pharmaceutical factory or a medical instrument factory; the researcher node refers to a relevant doctor participating in the clinical test; clinical trial authority node refers to a government worker responsible for reviewing and supervising the clinical trial process.
Specifically, the applicant submits a clinical trial application to a clinical trial administration. After the application is passed, the clinical trial management department generates three pairs of public and private key pairs for the clinical trial, the public keys are respectively used as the trial number of the clinical trial, the basic information for encrypting the patient and the medical information for encrypting the patient, and the corresponding private keys are stored in the private server of the method.
In the recruitment stage, a public chain for storing the registration information of the registration person is created by a clinical trial management department, and the clinical trial number, the entry and discharge standard, the deselection standard, the informed consent, the registration information table, the patient basic information public key and the patient medical information public key of the clinical trial are written into the creation block. Meanwhile, the private key of the medical information of the patient is granted to the examination node. All potential subjects with registration will can freely join the public link network to check the information disclosed on the founding block, and preliminarily judge whether the potential subjects meet the requirements of the clinical test according to the entry and exit criteria and the deselection criteria provided by the clinical test item group. If the entry-and-discharge standard of the entry-and-exit applicant is satisfied and the entry-and-exit applicant wishes to join the clinical test voluntarily, the basic information and the medical information of the entry-and-exit applicant are respectively filled in according to an entry-and-exit information table provided on the creature block, and then a submission button is clicked, so that the information of the entry-and-exit applicant is encrypted through an encryption contract deployed on a public chain. The recruitment phase flow is shown in fig. 2.
In the trial phase, a federation chain for subject clinical trial data storage and sharing is created by the clinical trial administration. Then, after the identity of the user involved in the clinical test is confirmed to be correct, the user creates own node on the alliance chain, and the system grants the corresponding private key according to the data authority of the node. For the subject, the federation chain will continue to use the subject's public-private key pair on the public chain. The public keys of all subjects will be stored in the system in the form of a list for the user to retrieve the subject's data. With respect to data collection during a trial by a subject, the subject performs the corresponding operations according to a clinical trial protocol, and there are two sources of the type of data generated, one being instrumental data and one being physician diagnostic data. For instrumental measurement data, the measurement terminal requires the subject to enter his or her public key, and the terminal needs to distinguish his or her data. After the measurement is finished, the encrypted appointment deployed in the terminal system encrypts medical data obtained by the measurement of the subject to obtain a ciphertext, and the ciphertext is uplink stored together with the public key and the timestamp of the subject. Aiming at doctor diagnosis data, a doctor needs to sign uploaded data by a private key of the doctor, the signature content is a test number and a time stamp, the signature is stored in a signature column of data of a subject, then the doctor submits the test data of the subject and a public key of the corresponding subject to a system, and the system encrypts the data through an encryption contract and stores the data in an uplink mode. Similarly, the subject attaches the signature of the subject to the test process data to be uploaded, the signature content is the test number and the time stamp, then the data is submitted to the system, and the system encrypts and uplink stores the data through an encryption contract, as shown in fig. 3. When test data of a subject is stored, the system stores the test data according to a public key of the subject, and the public key is also the only way for a user to retrieve the data of the subject in the method. And when the encryption is performed, the adverse events are monitored in real time, if the adverse events are monitored, the notification is triggered, and the message is notified to the node corresponding to the data uploading and the subject himself through the signature of the uploaded test data and the public key of the subject. The experimental phase flow is shown in figure 4.
When the recruitment phase is over, the clinical trial team needs to screen the information of the registrants and transfer the data of the enrolled subjects from the public chain to the alliance chain. In the screening and transferring process of the data, it is required to ensure that the data is not tampered, and meanwhile, the security of the data is also required to be ensured.
In the data screening stage, a screening contract is deployed on a public chain for preliminary screening, and screened data of the registrant is pushed to a review node in the system. The examination node examines the information of the registration, and after the examination is completed, the examination node signs the data of the selected registration. The signature content is the public key of the applicant + right/false, and the signature is stored in the signature column of the data of the applicant. And other examining nodes can examine the data of the same applicant again, and the process is repeated. The checking process is carried out synchronously, and a plurality of checking nodes can simultaneously check the information of the same applicant. And arranging a review contract on the public chain, wherein after a review node reviews the information of an entry, the review contract checks the review result of the review node and carries out priority sequencing on the pushing of entry data, and the higher the number of signatures of the review node with the review result of right is, the higher the priority of the entry data is. Meanwhile, in the method, a review standard threshold n is set for the clinical trial, and when the number of the entry data review result is right and reaches the threshold n, a data transfer contract on the public chain is triggered, as shown in fig. 5.
In the early stage of the data transfer stage, a data transfer contract on a public chain continuously monitors the data of the registration workers meeting the conditions, then integrates the data of the registration workers meeting the clinical test conditions, carries out hash calculation on the integrated information to obtain a data transfer hash, finally encrypts the integrated registration workers and the data transfer hash by using the clinical test serial number through the data transfer contract, and sends a data transfer request to a server of the alliance chain through the address of the server of the alliance chain stored in the data transfer contract. When a data receiving contract deployed on a alliance chain receives a data transfer request initiated by a public chain, a received ciphertext is decrypted by a clinical test private key stored in a private server, then the received data is subjected to hash processing to obtain a data receiving hash, and whether the data receiving hash is equal to the data transfer hash is verified. If the data are equal, the received data are proved not to be tampered, and the data receiving contract stores the data of the testee in an uplink mode and informs the public chain that data transfer is completed; if the data transfer contract does not receive the notification, the data transfer contract needs to reinitiate the data transfer request until the data transfer is completed, as shown in fig. 6.
Because the operation of data transfer is automatically executed through the data transfer contract on the public chain and the data receiving contract on the alliance chain, the possibility of artificially carrying out data tampering in the process of data transfer does not exist. Meanwhile, the data and the data transfer hash of the subject are encrypted through the clinical test number, so that an attacker cannot steal the data in the data transfer process. The attacker is also ineffective to tamper with the transferred data due to the hash validation of the data receiving contract.
The clinical trial process involves multiple parties, and the parties have differences in data acquisition rights during the clinical trial process. For example, the basic information of the subject belongs to the privacy of the subject, and the sponsor cannot view the basic information of the subject at will. Furthermore, the subjects cannot also view any information between each other. However, all users are nodes on the same federation chain. Therefore, aiming at the problem of data security sharing in the clinical test process, the method provides a data isolation sharing method based on the secondary encryption of the authority public and private key pair and the clinical test serial number, ensures the security of data sharing and improves the efficiency of data sharing.
Specifically, the applicant submits a clinical trial application to a clinical trial management department, after the application is passed, the clinical trial management department generates three pairs of public and private key pairs for the clinical trial, the public keys are respectively used as a trial number of the clinical trial, used for encrypting basic information of a patient and used for encrypting medical information of the patient, and the corresponding private keys are stored in a private server of the method.
In the recruitment stage, when a clinical test project group creates a public chain, the project group stores public keys of two pairs of authority public and private key pairs on a creation block of the public chain, and simultaneously stores the private keys in a private server. In the recruitment phase, the encryption contract deployed on the public chain performs primary encryption processing on data of the registration applicant respectively by using the basic information public key and the medical information public key to obtain a primary encryption ciphertext of the basic information and a primary encryption ciphertext of the medical information, performs secondary encryption on the information of the registration applicant by using the clinical trial number to obtain a secondary encryption ciphertext, and finally stores the secondary encryption ciphertext in a cochain manner as shown in fig. 7.
In the test stage, a clinical test item group continues to use a clinical test number, a basic information public and private key pair and a medical information public and private key pair, public keys of three pairs of public and private key pairs are stored in an creature block of a alliance chain, and the private keys respectively grant nodes with corresponding authorities and are stored in a private server. When a node initiates a data request, the node needs to submit a public key of data of a subject to be inquired to the system, and after the system receives the data request initiated by the node, a decryption contract can carry out information retrieval and simultaneously judge whether a data requester is the subject. If the testee requests data, the decryption contract decrypts the secondary encrypted ciphertext of the data of the testee for the first time through a clinical test private key in the private server to obtain a primary encrypted ciphertext, then decrypts the primary encrypted ciphertext for the second time through a basic information private key and a medical information private key stored in the private server to obtain a data plaintext of the testee, and returns the data plaintext of the testee to the testee; if the data is not requested by the subject himself, the decryption contract decrypts the secondary encrypted ciphertext of the data of the subject through the clinical test private key stored in the private server for the first time to obtain the primary encrypted ciphertext, and then returns the primary encrypted ciphertext to the user, if the user really has the corresponding data authority, the user can decrypt the data by using the existing private key of the corresponding data in the hands of the user, and accordingly the data desired by the user is obtained, as shown in fig. 8. All the user's request records are stored in the upper chain by log contract.
Because the data authority private key has been granted to the node with the corresponding authority, and all nodes in the alliance chain can directly see the ciphertext stored on the chain, if only the corresponding authority public key is used for carrying out primary encryption processing, the node can take the primary encrypted ciphertext of the data of the subject without a request, and then the plaintext can be directly obtained by decrypting through the private key in the node. Therefore, the method carries out secondary encryption on the data of the testee through the clinical trial number, and realizes a non-transparent decryption process through a decryption contract to ensure the security of data sharing of the testee and the traceability of node operation. Meanwhile, when the node initiates a request, the log contract records a public key and a timestamp of the node initiating the request to form a log, and then the log is linked up for storage so as to meet the requirement of the node on operation traceability.
In general, the present embodiment specifically includes the following steps:
step 1, an application is made by a clinical trial management department of an application side, and a clinical trial is initiated;
step 2, after the application of the application side is passed, the clinical trial management department creates three pairs of public and private key pairs for the clinical trial, wherein a public key of one pair is used as the clinical trial number of the clinical trial, the private key is stored in the private server, the other two pairs are respectively used as authority public and private key pairs of the basic information and the medical information of the subject, and the private key is stored in the private server;
step 3, a clinical test management department creates a public chain for storing the registration information of the registration person, writes the clinical test number, the entering and discharging standard, the deselection standard, the informed consent, the registration information table, the patient basic information public key and the patient medical information public key of the clinical test into an creature block, and creates a alliance chain for storing test data of the subject in the test stage;
step 4, staff of the clinical trial management department creates an examination node on the public chain;
step 5, the registration person adds a public chain to check the entering and discharging standard and the deselecting standard in the created area, if the registration person agrees to add the clinical test, the registration person signs an informed consent and fills in an registration form to complete registration;
step 6, the encryption contract encrypts the information of the registration person and stores the information in a chain way;
7, primarily screening the information of the registrant according to the ranking value standard by the screening contract;
step 8, the examination node secondarily confirms the information of the registrant after the preliminary screening and attaches a signature, wherein the signature content is the public key of the registrant + right/false;
step 9, the right label of the inspection contract monitoring information of the entry reaches the inspection threshold value n, and the information of the entry is informed to the data transfer contract;
step 10, the data transfer contract collects a sufficient number of the information of the registrars, hash calculation is carried out on all the information of the registrars which meet the conditions to obtain a data transfer hash, then the information of the registrars and the data transfer hash are encrypted by using clinical test numbers, and finally a data transfer request is sent to the alliance chain server, wherein the request content is a ciphertext obtained after encryption;
step 11, the data receiving contract receives a data transfer request initiated by the data transfer contract, a clinical test private key in a private server is called to decrypt a received ciphertext to obtain information of all the registrants and corresponding data transfer hashes, the data receiving contract calculates the hash of the data of the registrants to obtain a data receiving hash, the data receiving hash is compared with the data transfer hash to judge whether the data of the registrants are tampered or not, if the data are not tampered, the data receiving contract carries out uplink storage on the data of the registrants on a alliance chain and returns data transfer completion to the public chain, if the data are tampered, the data transfer contract returns data transfer failure to the public chain, and the data transfer contract initiates the data transfer request again;
step 12, a subject, a sponsor, a researcher and a clinical trial management department create own nodes on the alliance chain, and the subject continues to use a public and private key pair on the public chain to create own nodes on the alliance chain;
step 13, the clinical trial management department grants the data authority private key to the node with the corresponding authority on the alliance chain;
step 14, during data encryption, the encryption contract respectively performs primary encryption processing on the data of the subject by using the corresponding data authority public key to obtain primary encryption ciphertexts, then performs secondary encryption processing on the primary encryption ciphertexts by using clinical test numbers to obtain secondary encryption ciphertexts, and finally stores the secondary encryption ciphertexts in a chain manner;
step 15, when the node requests the data of the subject, the decryption contract can judge whether the subject requests the data by himself;
step 16, if the subject requests data, the decryption contract calls a private key corresponding to the clinical test number in the private server to decrypt the secondary encrypted ciphertext of the subject data for the first time to obtain a primary encrypted ciphertext, then calls a data authority private key in the private server to decrypt the primary encrypted ciphertext for the second time to obtain a subject data plaintext, and finally returns the plaintext data to the subject;
step 17, if the data is not requested by the subject himself, the decryption contract calls a private key corresponding to the clinical test number in the private server to decrypt the secondary encrypted ciphertext of the subject for the first time to obtain a primary encrypted ciphertext, and then the primary encrypted ciphertext is returned to the data request node;
and 18, after the data request node receives the primary encrypted ciphertext, decrypting the primary encrypted ciphertext through a data authority private key granted by the system to obtain a data plaintext with authority.
The foregoing description has described the general principles, essential features, and advantages of the invention. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, which are given by way of illustration of the principles of the present invention, but that various changes and modifications may be made without departing from the spirit and scope of the invention, and such changes and modifications are within the scope of the invention as claimed. The scope of the invention is defined by the appended claims and equivalents thereof.
Claims (8)
1. A method for storing and sharing clinical test data based on public chains and alliance chains is characterized by comprising a recruitment phase of clinical tests and a test phase of the clinical tests; the recruitment stage of the clinical trial adopts a public chain mode to store the registration information of the registration person in the recruitment stage of the clinical trial; and in the test stage of the clinical test, a alliance chain mode is adopted for storing test medical data of a test subject in the test stage of the clinical test.
2. The method of claim 1, wherein the nodes of the public chain in the recruitment phase of the clinical trial comprise an enrollee node and a review node of a clinical trial team, the enrollee node refers to a potential subject willing to participate in the clinical trial, and the review node refers to a staff of the clinical trial team who performs review screening on the enrollee information.
3. The method of claim 2, wherein the nodes of the federation chain in the testing phase of the clinical test include a subject node, a sponsor node, a researcher node and a clinical test management department node, the subject node is a reporter that has signed an informed consent and joined the clinical test, the sponsor node is a worker of the sponsor who initiated the clinical test, the researcher node is a relevant doctor who participates in the clinical test, and the clinical test management department node is a worker who is responsible for reviewing and supervising the clinical test process in government.
4. The method for storing and sharing clinical trial data according to claim 3, wherein in the recruitment phase of the clinical trial, a clinical trial administration department creates a public chain for storing the entry information of the enrollee, writes the clinical trial number, the enrollment standard, the rejection standard, the informed consent, the entry information table, the patient basic information public key, and the patient medical information public key of the clinical trial into the creation block, grants the patient medical information to the private key review node, allows all potential subjects with the enrollment desire to freely join the public chain network to view the information disclosed on the creation block, and determines whether the entry standard and the rejection standard provided by the clinical trial team meet the requirements of the clinical trial, if the enrollee meets the entry standard and voluntarily wants to join the clinical trial, then fills the basic information and the medical information of the enrollee according to the entry information table provided by the creation block, and clicks a submit button, and the information of the enrollee is encrypted according to an encryption contract deployed on the public chain.
5. The method of claim 4, wherein in the clinical trial phase, an application side submits a clinical trial application to the clinical trial administration department, and after the application is passed, the clinical trial administration department generates three public and private key pairs for the clinical trial, and the public keys are used as the trial number of the clinical trial, the basic information of the patient and the medical information of the patient, and the corresponding private keys are stored in the private server of the method.
6. The method of claim 5, wherein when the recruitment phase is over, the clinical trial team screens information of the registrants and transfers the data of the enrolled subjects from the public chain to the alliance chain.
7. The method as claimed in claim 6, wherein a screening contract is deployed on the public chain in the data screening stage for preliminary screening, the screened data of the enrollee is pushed to a review node in the system, the review node reviews the information of the enrollee, after the review is completed, the review node signs the data of the enrollee, the signature content is the public key + right/false of the enrollee, the signature is stored in the signature column of the enrollee data, and other review nodes review the data of the same enrollee again, so as to repeat the process.
8. The method for storing and sharing clinical trial data based on public and alliance chains as claimed in any one of claims 1-7, comprising the steps of:
step 1, an application is made to a clinical test management department by an application party, and a clinical test is initiated;
step 2, after the application of the application party is passed, the clinical trial management department creates three pairs of public and private key pairs for the clinical trial, wherein the public key of one pair is used as the clinical trial number of the clinical trial, the private key is stored in the private server, the other two pairs are respectively used as the authority public and private key pairs of the basic information and the medical information of the subject, and the private key is stored in the private server;
step 3, the clinical trial management department creates a public chain for storing the registration information of the registration person, writes the clinical trial number, the entry and exit standard, the rejection standard, the informed consent, the registration information table, the patient basic information public key and the patient medical information public key of the clinical trial into the creation block, and creates a alliance chain for storing the trial data of the subject in the trial stage;
step 4, staff of the clinical test project group creates an examination node on the public chain;
step 5, the registration person adds a public chain to check the entry and exit standards and the deselection standards in the created area, if the registration person agrees to add the clinical test, the registration person signs an informed consent and fills an entry form to complete entry;
step 6, the encryption contract encrypts the information of the registration person and stores the information in a chain way;
7, primarily screening the information of the registrant according to the ranking value standard by the screening contract;
step 8, the examination node carries out secondary confirmation on the information of the registration provider after the preliminary screening and attaches a signature, wherein the signature content is the public key of the registration provider + right/false;
step 9, the right label of the inspection contract monitoring entry information reaches the inspection threshold value n, and the information of the entry is informed to the data transfer contract;
step 10, the data transfer contract collects a sufficient number of the information of the registrars, hash calculation is carried out on all the information of the registrars which meet the conditions to obtain a data transfer hash, then the information of the registrars and the data transfer hash are encrypted by using clinical test numbers, and finally a data transfer request is sent to the alliance chain server, wherein the request content is a ciphertext obtained after encryption;
step 11, the data receiving contract receives a data transfer request initiated by the data transfer contract, a clinical test private key in a private server is called to decrypt a received ciphertext to obtain information of all the entry subscribers and corresponding data transfer hash, the data receiving contract calculates the hash of the entry subscriber data to obtain the data receiving hash, the data receiving hash is compared with the data transfer hash to judge whether the entry subscriber data is tampered, if the data is not tampered, the data receiving contract carries out uplink storage on the entry subscriber data on a alliance chain and returns data transfer completion to a public chain, if the data is tampered, the data transfer contract returns data transfer failure to the public chain, and the data transfer contract initiates the data transfer request again;
step 12, a subject, a sponsor, a researcher and a clinical trial management department create own nodes on the alliance chain, and the subject continues to use a public and private key pair on the public chain to create own nodes on the alliance chain;
step 13, the clinical trial management department grants the data authority private key to the node with the corresponding authority on the alliance chain;
step 14, during data encryption, the encryption contract respectively performs primary encryption processing on the data of the subject by using the corresponding data authority public key to obtain primary encryption ciphertexts, then performs secondary encryption processing on the primary encryption ciphertexts by using clinical test numbers to obtain secondary encryption ciphertexts, and finally uplink-stores the secondary encryption ciphertexts;
step 15, when the node requests the data of the subject, the decryption contract judges whether the data is requested by the subject;
step 16, if the subject requests data, the decryption contract calls a private key corresponding to the clinical test number in the private server to decrypt the secondary encrypted ciphertext of the subject for the first time to obtain a primary encrypted ciphertext, then calls a data authority private key in the private server to decrypt the primary encrypted ciphertext for the second time to obtain a subject data plaintext, and finally returns the plaintext data to the subject;
step 17, if the data is not requested by the subject himself, the decryption contract calls a private key corresponding to the clinical test number in the private server to decrypt the secondary encrypted ciphertext of the subject for the first time to obtain a primary encrypted ciphertext, and then the primary encrypted ciphertext is returned to the data request node;
and step 18, after the data request node receives the primary encrypted ciphertext, decrypting the primary encrypted ciphertext through a data authority private key granted by the system to obtain a data plaintext with authority.
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