JP3357039B2 - Anonymized clinical research support method and system - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

The present invention relates to a method and system for supporting anonymous clinical research, and more particularly to the collection and management of subject information, the anonymization of subject information and collected specimens, the management of experimental samples, and the basic genome. The present invention relates to a support method and system for smoothly performing a series of processes required for clinical research such as gene analysis such as data management and performing clinical research smoothly.

[0002]

2. Description of the Related Art At present, genome sequencing is progressing rapidly, and the whole genome sequences of multicellular nematodes and even Drosophila, following microorganisms such as Bacillus subtilis, Escherichia coli, cyanobacteria, and yeast, have already been developed. Were determined. A draft sequence has been published for the human genome sequence. Under these circumstances, the focus of genomic research has been to focus on analysis of genomic functions, including gene discovery, and analysis of polymorphisms between individuals, from sequencing to a large number of genes or the entire genome. Moving to post-genome research.

In particular, in recent years, single nucleotide polymorphism SNP (Single Nucleo) has received the most attention in the medical field such as elucidation of the cause of human diseases, diagnosis, treatment and prevention.
ide Polymorphism). SNP
Literally means a substitution or insertion of one base on the DNA sequence or a difference due to an arrowhead. The human gene sequence is
It is estimated that 99.9 percent (%) are the same, with a difference of 0.1%. Thus, approximately 1 to 3 million SNP sites, equivalent to 0.1% of the human genome of 3 billion base pairs, are expected.

[0004] Since the number of SNPs is very large,
It is considered to be optimal for individualizing the genetic background of each individual, and the "constitution" (difference in susceptibility to a certain disease or difference in drug responsiveness) can be fixed by an association study comparing with medical information etc. Is expected, and it will be possible to receive tailor-made treatment. Therefore, it is indispensable for future genetic analysis to provide medical information accumulated (or to be collected) at medical institutions to the genome research side.

[0005]

However, in a hospital, subject information such as consultation information and personal information obtained by examining a sample provider that provides a sample (sample) such as blood and cells, and The method of managing information, the method of anonymizing subject information and specimens and providing them to the research side, the method of managing specimens, and the method of managing basic genomic data obtained by gene analysis There has been a problem that a method of clinical research that integrates a series of operations in a unified manner and a system for such research have not been established because the method largely depends on judgment.

On the other hand, in clinical research such as genetic analysis, if specimens and patient information are provided directly to a research institution because of its simplicity, it is undeniable that individual privacy and human rights may be significantly violated. That is, the information of the individual who provided the specimen is linked to the genetic information analyzed from the specimen, and it is expected that disadvantages due to social discrimination will occur in employment, marriage, health insurance, life insurance, etc. . Furthermore, it is undeniable that various unforeseen social problems may occur at this time.

[0007] The present invention has been made in view of such a situation, and it is possible to protect the privacy and human rights of a sample provider without impairing the smoothness of clinical research such as gene analysis. The purpose is to establish an anonymized clinical research support method and system.

[0008]

The present invention includes the following invention as means for solving the above-mentioned problems. The invention is
Performing a medical examination for the subject, collecting a sample from the subject, an anonymized clinical research support system for performing clinical research on the sample collected from the patient, when inputting personal information about the subject, A personal identifier output unit configured with a required number of digits and composed of a symbol string capable of identifying each subject and outputting a personal identifier; and a first storing personal information relating to the subject in a searchable manner by the corresponding personal identifier. A storage means, a processing procedure information inputting means for receiving an informed consent regarding the specimen provision from the subject, and accepting an input of processing procedure information on the specimen collected from the corresponding subject, Second storage means for storing processing procedure information in a searchable manner based on the personal identifier, and at least a symbol string of the personal identifier Sample identification symbol string output means for outputting a sample identification symbol string capable of identifying each sample having a required number of digits and including the initialized processing stage identification information as a part thereof, and the output sample First instruction means for displaying an instruction to assign an identification symbol string to the sample; detecting the assigned sample identification symbol string; and a symbol string corresponding to a personal identifier and processing stage identification information in the sample identification symbol. First detecting means for detecting the diagnostic finding information, diagnostic finding information inputting means for receiving an input of diagnostic finding information corresponding to the personal identifier, and searching for diagnostic finding information for the subject based on the personal identifier for the subject. A third storage means for storing the character string of the personal identifier in a one-to-one correspondence with a part of a character string which cannot be inferred from the character string of the personal identifier. An anonymous personal identifier output means for outputting a differentiator, a fourth storage means for storing a correspondence between the personal identifier and the anonymous personal identifier, and a sample identification code corresponding to the sample identification symbol string one-to-one. The symbol string of the anonymous personal identifier corresponding to the symbol string of the personal identifier in the column is included in a part thereof, and the symbol string of the processing stage identification information capable of identifying that the anonymization processing has been completed is part thereof. An anonymous sample identification symbol string output means for outputting an anonymous sample identification symbol string; a fifth storage means for storing a correspondence between the sample identification symbol string and the anonymous sample identification symbol string; Alternatively, the first anonymizing means for displaying an instruction for giving the anonymous sample identification symbol string to the sample, and the first, second, and third storage means can be searched based on the personal identifier. Said stored in the The contents of the first storage means, the second storage means, and the third storage means are stored so that the personal information, the processing procedure information of the specimen, and the diagnostic finding information can be searched for by the corresponding anonymous personal identifier. Second anonymizing means for correcting, and a second detecting means for detecting an anonymous sample identification symbol string given to the sample and detecting a symbol string corresponding to an anonymous personal identifier and step identification information in the anonymous sample identification symbol string And reading the corresponding processing procedure information of the sample from the anonymized second storage means based on the anonymous identifier detected by the second detecting means and the step identification information, and is designated by the processing procedure information. For the transfer destination, the second instruction means for displaying an instruction of the transfer of the sample to which the anonymous sample identification symbol string is assigned, and diagnostic finding information and processing procedure information corresponding to the transferred sample, Based on the corresponding anonymous identifier and stage identification information, transmitting means for transmitting to the transfer destination specified in the read processing procedure information, diagnostic finding information and processing procedure information retrievable by the subject's anonymous identifier Receiving means for receiving the processing procedure information and the medical examination diagnosis information separately from the second storage means and the third storage means by the anonymous identifier so as to be searchable; Detecting the arrival of the sample to which the sample identification symbol string has been assigned, detecting the anonymous sample identification symbol string assigned to the sample, and corresponding to the anonymous identifier and step identification information in the anonymous sample symbol string. A third detecting means for detecting the symbol string of the portion, and a part corresponding to the anonymous identifier and the step identification information in the anonymous specimen identification symbol string detected by the third detecting means. A clinical research processing instruction means for reading out the corresponding processing procedure information from the processing procedure information stored in the sixth storage means based on the symbol sequence of Comprising, based on the anonymous identifier and the stage identification symbol string in the anonymous sample identification symbol string, while referring to the diagnostic finding information and processing procedure of the subject, for the sample,
An anonymized clinical research support system characterized by conducting necessary clinical research. Further, the present invention further includes a third anonymizing means for deleting the correspondence between the sample identification symbol string stored in the fifth storage means and the anonymous sample identification symbol string in the present invention. included. Further, the present invention also includes a configuration in which the anonymous personal identifier in the above invention is configured by a symbol string randomly generated independently of the personal identifier. Similarly, in the present invention, the instruction in the first instruction unit or the first anonymization instruction unit for giving the sample identification symbol string or the anonymous sample identification symbol string to the sample corresponds to the symbol string. A bar code to be printed on a label using a bar code printer, and an instruction for sticking the label printed with the bar code to the container of the sample, and these instruction means are display means related to the instruction. On the other hand, the first to third detection means is a bar code reader, which is attached to the container of the sample, and from the label on which the sample identification symbol string or the anonymous sample identification symbol string is printed,
Those detecting the sample identification symbol string to the anonymous sample identification symbol string are included.

[0009]

As shown in FIG. 1, the present invention comprises a hospital system having an anonymization system and a patient information management system, and a laboratory system having an experimental sample management system and a genome basic data management system. Both are organically connected by communication of physical distribution of specimens and the like and information on patients. As described in the problem to be solved by the invention, there is a risk of leakage of personal information when transferring information about the sample and the subject, and therefore, at least the identification symbol string for the information on the sample or the subject is anonymized. Processing becomes inevitable. However, simply (eg, random) anonymization processing results in a meaningless symbol string, which makes it difficult for the operator to determine individual samples or information, and may notice an operation error or the like. There was a problem that it became impossible.
As a further problem, once anonymized, it becomes impossible to know the relevance of samples and information at all. This condition is fatal in clinical studies such as genetic analysis. That is, in research such as gene analysis,
This is because it is not realistic to specify the sequence of the sample in a dark cloud, and it is necessary to narrow down in advance, for example, a site to be subjected to gene analysis based on medical information of the corresponding patient.

The present invention has been proposed in order to solve such a problem, and has improved the operability and discrimination of individual specimens and information even in a state in which anonymization is surely performed. , Operation mistakes, etc., and at the same time, grasp the mutual relationship,
That is, it is possible to distinguish samples and information relating to the same subject. Specifically, this is made possible by adopting an anonymization process using a symbol string for identifying the sample described in FIGS. 2 and 3. In FIG. 2, information on the project classification, the specimen classification, and the like is useful to the operator. Moreover, identification information such as date and serial number is simple and effective in operability. In some cases, it is preferable to employ a sample identification symbol string as shown in FIG. That is, it is useful to include a symbol string related to a personal identifier such as a subject ID in the symbol string. further,
If the symbol string includes the symbol string related to the processing stage identification information, the validity of the stage in which the sample exists can be checked, so that an operation error such as skipping the processing step can be detected. In addition, if the data can be sent together with the personal identifier and the additional information of the processing stage identification information at the same time as sending the sample or information, so-called data flow type physical distribution control becomes possible.

[0011] In the first place, the danger of information leakage is caused by the fact that the process of anonymization processing can be traced back in order to grasp the mutual relevance of samples and the like. After the anonymization process, if the subsequent operation can be performed without accessing the host having the anonymization system again, the danger of the individual who is involved in the sample or the information being identified is substantially eliminated. In other words, as long as access to the host including the anonymization system is permitted, the risk of reading out the anonymization correspondence table in the anonymization process cannot be completely eliminated. In particular, when samples and information are exchanged across multiple institutions such as hospitals and research laboratories, such as in clinical research such as genetic analysis, it is dangerous because outsiders can access the host. is there.

As a specific method for this purpose, complete anonymization can be realized by deleting the correspondence table itself for the anonymization process so that no one can access the anonymization correspondence table. Depending on how the specimens are collected, this method is a reliable anonymization method. This is the unlinkable anonymization process described later. However, with this method, it is not possible to refer to diagnostic findings, etc., and it is not possible to grasp the linkage between samples, such as when multiple samples related to the same subject are collected with a time difference. Etc. are often inconvenient in clinical studies.

Therefore, as a technique for ensuring anonymity without causing such inconveniences, identification information of specimens and information itself is transmitted with various additional information attached, and reference is expected. It is effective to perform so-called data flow type transmission control in which other information is subjected to the same anonymization process and transmitted separately. Accordingly, it is not necessary to access necessary information to the host, and it is possible to locally obtain information on the relevance of samples and the like and information on processing procedures and the like.

As described above, the present invention secures anonymity through such an anonymization system by local processing of the data flow type, and ensures a sample between two systems such as a hospital and a laboratory. And various types of information can be exchanged.

[0015] Further, such a secondary effect that the additional information can be attached to the identification information is that the sample itself is divided or derived by processing such as dispensing after being sent to the research institution. Even if data is generated in some cases, by integrating such information into the identification information as additional information, centralized management may be possible.

[0016]

FIG. 1 is a diagram showing an example of the overall configuration of an embodiment of an anonymized clinical research support system according to the present invention. The anonymized clinical research support system of the present invention includes a patient information management system that manages patient information, an anonymization process, an experiment sample management system that manages an anonymization system and an experiment sample, and a genome that manages genome basic data. It consists of a basic data management system. Details of the configuration of each system are shown in FIGS. 4 to 7, respectively. Hereinafter, with reference to FIGS. 1 and 4 to 7,
A series of processes for performing a genetic analysis study using a sample (specimen) collected from a patient using the gene analysis research system will be described. Note that the term “patient” here is not limited to a sick person, but is a term indicating the whole sample provider, and is the same as a so-called “subject”.

The patient information management system is constituted by a personal computer (not shown), a master information database 1 in which master information is registered, a research project information database 2 in which research project information is registered, and a patient in which patient information is registered. Information database 3, Sample information database 4 where sample information is registered
And a collection history information database 5 in which collection history information is registered.

First, in step S101,
The patient information CSV data is input to the patient information system from the hospital computer system (hospital system). Next, in step S102, field mapping is performed to register the input patient information CSV data in the patient information database 3 of the patient information management system. That is, the patient information CSV data is associated with the fields defined in the patient information database 3.

Next, in step S103, the field-mapped patient information is batch uploaded to the patient information database 3. On the other hand, the doctor (medical doctor) examines the patient in step S104. Next, in Step S105, Step S
At 103, the patient information uploaded collectively is registered in the patient information database 3. Next, step S1
At 06, the examination result is registered in the patient information database 3 as clinical information. Next, in step S107, the researcher on the hospital side obtains blood, serum, and buf from the patient.
Receive primary insights (samples) such as fy coats, tissues, cells, etc., and receive informed consent from patients for using them in gene analysis research.

When the hospital researcher receives informed consent from the patient, the doctor collects primary samples (samples) such as blood, serum, buffy coat, tissues, cells, etc. from the patient, and in step S108 , The collection history information in the collection history information database 5, for example,
The date when the sample was collected and the history information are registered in the collection history information database 5. Next, in step S109, sample information on the collected sample (for example, information on the patient from which the sample was collected, the sample number, etc.) is registered in the sample information database 4.

The master information database 1 contains:
Various information required to operate the gene analysis research system is registered. For example, the following information is registered. 1-1) Standard wound name master 1-2) Disease name master maintenance for classification 1-3) Inspection item master maintenance Analyte master, identification master, material master, measurement method master, result identification master, result identification master, inspection item example Master, examination item case group master 1-4) Research project information Project information, team information, researcher information, terminal management Login user management, patient list information management by project / team 1-5) Other information item names Other patient information item names , Other team information item names, other project information item names, other collection information item names, other medical examination information item names, other medical treatment information item name groups

Research project information is registered in the research project information database 2. For example, the following information is registered. 2-1) Project information 2-2) Team information 2-3) Researcher information 2-4) Terminal information 2-5) Login user information 2-6) Patient list information by project / team

The patient information database 3 includes, for example,
The following information is registered. 3-1) Basic patient information (name, address, age, gender, etc.) 3-2) Other patient information (family calendar, smoking, drinking, etc.) 3-3) Examination results 3-4) Disease history information

After the sample is collected, the following information is registered in the sample information database 4, for example. 4-1) Sample number 4-2) Sample classification 4-3) Collection amount 4-4) Consent form information

The following information is registered in the collection history information database 5, for example. 5-1) Date when the sample was collected 5-2) Sample number 5-3) Sample classification

Each database is an RDBMS (relational d
atabase management system)
Information registered in each database can be searched as needed.

When accessing these databases, user authentication is performed. For example, a project ID, a team ID, a user ID, and a password are input, and only when the user authentication succeeds, these databases can be accessed.

The sample information and patient information registered in step S109 are transferred to the anonymization system. Then, in the anonymization system, anonymization processing is performed on the sample information and the patient information. (S201
~)

The anonymization system comprises a personal computer (not shown), and a contactable anonymization code table database 21 in which a contactable anonymization code table is registered.
And a delivery information database 22 in which delivery information is registered
have.

First, in step S201,
Anonymization processing is performed on the sample information. In the patient information management system, a sample number is assigned to each sample in order to identify a sample collected from a patient. The sample number and the patient information are associated with each other, and the patient information can be specified from the sample number. Therefore, a new sample number (anonymous sample number) corresponding to this sample number (anonymous sample number) is generated, and a correspondence table (linkable anonymization code table) in which the anonymous sample number and the anonymous sample number are associated with each other The sample number is anonymized. The created correspondence table is registered in the linkable anonymized code table database 21.

Next, a barcode corresponding to the anonymous sample number is printed on a label using a barcode printer (not shown). Then, the label on which the barcode corresponding to the anonymous sample number is printed is attached to the container containing the corresponding sample. Thereafter, the anonymized sample attached with the label printed with the barcode corresponding to the anonymous sample number is provided to the research side in step S204.

On the other hand, in step S202, anonymization of the patient information is performed. Patient information, for example,
It consists of medical treatment information (information such as medical records), personal identification information for identifying patients individually, such as the patient's name, date of birth, gender, address, telephone number, fingerprint, medical record number, and disease history information. . Therefore, the patient information can be anonymized by deleting or processing a part of the information. For example, if the name, address, fingerprint, and the like are deleted, it becomes difficult to identify the patient. Further, if other information such as a telephone number and a date of birth is deleted, it becomes more difficult to specify a patient by the amount deleted.

Then, in step S203, the anonymized patient information is recorded on a recording medium such as a floppy (registered trademark) disk and then provided to the research side. The content recorded on the recording medium is encrypted. Or,
For example, after being encrypted by an encryption method such as DES (data encryption standard), it is provided to the research side via a network such as the Internet. At that time, the following information is registered in the delivery information database 22, for example. 22-1) Linkable anonymized sample number 22-2) Linkable anonymized sample number 22-3) Delivery date 22-4) Delivery history information

The experimental sample management system on the research side is constituted by a personal computer (not shown), and stores an anonymous patient information database 31 in which anonymous patient information is registered, a research project information database 32 in which research project information is registered, and a bar. A barcode issue history information database 33 in which code issue history information is registered;
Experimental sample information database 3 in which experimental sample information is registered
Four.

The experimental sample management system performs step S30.
In 1, the reception processing of the sample provided from the hospital is performed. That is, the anonymous sample number represented by the barcode attached to the sample provided by the hospital is read using a barcode reader (not shown), and the read anonymous sample number is stored in the research project information database 32 in step S302. register. Also, it registers and updates patient information, project information imported from the anonymization system, or new project information. The research project information management includes project information management, team information management, researcher information management, terminal management, login user management, and the like.

In the research project information database 32, project information, team information, researcher information, terminal information, login user information, patient list information for each project / team, and the like are registered.

The anonymized sample (the sample to which the label printed with the bar code corresponding to the anonymous sample number is affixed (anonymous sample)) for which the reception process has been completed is processed in step S30.
At 4, it is supplied to each analytical instrument. S step 30
At 7, cell separation is performed. For example, when the anonymized sample is blood, first, a cell fraction is separated by centrifugation, and then T cells, neutrophils, eosinophils, B cells, and the like are separated by a magnetic cell separation system.

Next, in step S309, mRNA is extracted. That is, among the separated cells (T cells, neutrophils, eosinophils, B cells, etc.), RNA (total RNA) is extracted from each of the T cells, neutrophils, and eosinophils,
MRNA of various genes present in cells at the time of collection
Check the amount. Before the mRNA extraction, step S30
In 8, there may be a case where stimulation by a drug is performed. That is,
In some cases, RNA is extracted after stimulating the cells by adding a special antibody or drug to the cells separated in step S307. It is mainly used for comparison before and after stimulation.

In some cases, immediately after step S309, mRNA is extracted from the anonymized specimen without performing cell separation in step S307.

After the mRNA is extracted in step S309, the process proceeds to step S310, where the cDNA (co
A mplementary DNA (complementary DNA) library is generated. That is, in order to perform sequence determination (analysis), expression analysis, SNP analysis, and the like in the genome basic data management system described later, the mR extracted in step S309
NA is changed to DNA. In practice, using the mRNA as a template, a DNA (complementary) corresponding to the mRNA is synthesized by a reverse transcriptase reaction. These synthesized DNAs
The set of cDNAs is called cDNA (complementary DNA).
)) The library.

If the anonymous sample accepted in step S301 is DNA, step S305
Is stored as it is in the archive. Also,
In step S306, the PCR (Polymerace Cha
in Roaction). This is because the synthesized DNA does not have a sufficient amount for analysis, and thus the DNA is usually amplified and analyzed in large quantities. PCR is an essential technology for gene analysis.

Anonymized patient information is registered in the anonymous patient information database 31. Information registered in the research project information database 32 of the patient information management system is copied to the research project information database 32 via a recording medium such as a floppy disk. That is, project information, team information, researcher information, terminal information, login user information, patient list information for each project / team, and the like are registered.

Barcode issuance history information database 3
For example, in the past, information such as a date when a barcode was printed on a label and issued in the past, an anonymous sample number corresponding to the issued barcode, and the like are registered. In the experimental sample information database 34, test categories, libraries, plate management, barcode information, and the like are registered.

The genome basic data management system comprises a UNIX (registered trademark) server (not shown), and a sequence information homology search information database 41 in which sequence information homology search information is registered, and expression information in which expression information is registered. It has a database 42 and a SNP information database 43 in which SNP information is registered, and is connected to various measuring devices required for gene analysis.

In step S401, the genome basic data management system receives the cDNA library generated by the experimental sample management system, and determines the sequence of the cDNA. In step S405, the DNA is provided from the experimental sample management system, and the sequence of the target region is determined. That is, an automatic sequencer to which polyacrylamide gel electrophoresis is applied (Applied Biosystems I
nc..377), and the amplified PCR product is sequenced.

In step S402, Stanford
Expression analysis is performed using a microarray. In step S403, expression analysis using GeneChip (Affymctrix) is performed. Microarray technology involves immobilizing probe DNA at high density on a non-porous carrier (often using a glass slide with a specially processed surface)
Fluorescent dye-labeled DNA, notably RNA, is hybridized thereto and quantitatively analyzed with a fluorescent scanner.
This is a method for detecting the expression level of mRNA. In a typical one,
There is a method proposed by the group of Brown et al. Of Stanford University mentioned above, and a method commercialized by Affymetrix in the United States.

In step S404, SN
P typing is performed. SNP (Singlec Nucleotide
Polymorphism) means a difference due to substitution / insertion or deletion of a base in a DNA sequence. What is typing?
Each individual (organization) is to check for base differences (or frequency of differences) against the standard.

Sequence information homology search information database 41
Information such as sequence management, automatic execution job management, sequence database management, and homology search (homology search) results is registered in. The expression information database 42 includes
Stanford type microarray or GeneChip (Affymetrix)
Thus, information such as the result of expression analysis (a numerical value representing the fluorescence intensity) is registered. Also, the SNP information database 43
, Information on the results obtained by the SNP analysis (SNP position information, Allelc number, genotype frequency, hetero frequency, etc.) is registered.

The program for executing the above-described processing is a CD-ROM (Compactdisc road only memo).
ry), a DVD (digital versatilc disc), a floppy disk, a memory card, and other various storage media. The program controls the operation of the computer, and the computer controlled by the program executes a predetermined process instructed by the program.

It should be noted that the configuration and operation of the above embodiment are examples, and it is needless to say that the configuration and operation can be appropriately changed without departing from the spirit of the present invention.

[0051]

As described above, according to the method and system for supporting anonymous clinical research such as gene analysis according to the present invention,
The hospital memorizes the subject's personal information, conducts a medical examination on the subject, memorizes the medical examination results obtained by the medical examination on the subject, receives informed consent from the subject regarding the provision of the sample, and A sample is collected, a sample number for identifying the collected sample is assigned to the sample, and an anonymous sample number obtained by anonymizing the sample number is assigned to the sample instead of the sample number, and the sample number and the anonymous The system stores data associated with the sample number, anonymizes the personal information and the examination result of the subject, and provides the sample to which the anonymous sample number is assigned and the anonymized personal information and the examination result to the research side. The research side accepts the sample provided with the anonymous sample number provided by the hospital, and stores the anonymized personal information and the examination result of the patient provided by the hospital in association with the anonymous sample number, Since clinical research such as genetic analysis is performed on samples to which anonymous sample numbers have been assigned, methods of clinical research such as genetic analysis that require anonymity have been established, protecting the privacy and human rights of subjects, Comprehensive analysis combining diagnosis information and genome information becomes possible.
In particular, by incorporating additional information such as personal information identifiers and processing stage identification information into the identification symbol strings of samples and information,
Local distribution control of a data flow type becomes possible, and an operability can be improved as well as anonymity.

[0052]

[Brief description of the drawings]

FIG. 1 is a diagram for explaining an overall configuration of a gene analysis research system and a processing procedure when the anonymized clinical research method of the present invention is applied to gene analysis research.

FIG. 2 is a diagram for explaining a configuration of a symbol string for specimen identification according to the present invention.

FIG. 3 is a diagram for explaining a configuration when additional information is incorporated into a symbol string for specimen identification according to the present invention.

FIG. 4 is a diagram for explaining a configuration of an anonymization system and a processing procedure thereof according to the present invention;

FIG. 5 is a diagram for explaining a configuration of a patient information management system of the present invention and a processing procedure thereof.

FIG. 6 is a diagram for explaining a configuration of an experimental sample management system of the present invention and a processing procedure thereof.

FIG. 7 is a diagram for explaining a configuration of a genome basic data management system of the present invention and a processing procedure thereof.

[0053]

[Explanation of symbols]

 1 Master Information Database 2 Research Project Information Database 3 Patient Information Database 4 Specimen Information Database 5 Collection History Information Database 21 Connectable Anonymization Code Table 22 Delivery Information Database 31 Anonymous Patient Information Database 32 Research Project Information Database 33 Barcode Issue History Information Database 34 Experimental sample information database 41 Sequence information homology search information database 42 Expression information database 43 SNP information database

──────────────────────────────────────────────────続 き Continuing on the front page (72) Inventor Tetsuya Takeda 2-7-14 Higashinakano, Nakano-ku, Tokyo Inside Mitsui Information and Development Co., Ltd. (72) Inventor Nobutaka Mitsuhashi 2-7-14 Higashinakano, Nakano-ku, Tokyo Mitsui Information Development Co., Ltd. (72) Hideya Kuwahara, Inventor 2-7-14 Higashinakano, Nakano-ku, Tokyo Mitsui Information Development Co., Ltd. (72) Koji Yanagisawa 2-chome, Higashinakano, Nakano-ku, Tokyo No. 14 Mitsui Information Development Co., Ltd. (72) Inventor Toshihide Kauchi 2-7-1 Higashinakano, Nakano-ku, Tokyo Mitsui Information Development Co., Ltd. (72) Inventor Izumi Fukuda 2-7-1, Higashinakano, Nakano-ku, Tokyo No. 14 Mitsui Information Development Co., Ltd. (72) Inventor Yuko 2-7-14 Higashinakano, Nakano-ku, Tokyo Mitsui Information Development Co., Ltd. (56) References JP-A-8-26357 JP-A-11-154185 (JP, A) JP-A-9-179923 (JP, A) JP-A-11-295318 (JP, A) JP-A-6-59937 (JP, U) Tokuhyo Hei 11-505352 (JP, A) Hitoshi Takei, Labor saving of inspection processing by using barcode labels, Medical care and computer, Japan, Limited Company Network, July 25, 1994, Volume 6, No. 6. No.4, pp.31-37 Shigeyoshi Tani, Utilization of Two-Dimensional Barcode in Hospital, Medical and Computer, Japan, Limited Network, July 25, 1994, Volume 6, No.4, pp.2-8 Hasegawa References, registration system: Problems of patient privacy protection in the registration system for cardiovascular diseases, Nikkei Cooperative Journal, Japan, April 1990, Vol. 25, No. 1, pp. 60-63 (58) (Int.Cl. ⁷ , DB name) G06F 17/60 G06F 17/30 C12N 15/09 JICST file (JOIS)

Claims (4)

(57) [Claims] An anonymized clinical research support system for performing an examination on a subject, collecting a sample from the subject, and performing a clinical study on the sample collected from the patient, the system comprising: At the time of inputting information, a personal identifier output means for outputting a personal identifier, which is composed of a required number of digits and is composed of a symbol string capable of identifying each subject, and personal information relating to the subject can be searched by the corresponding personal identifier A first storage means for storing in the memory, a processing procedure information input means for receiving an informed consent regarding the provision of the sample from the subject, and receiving an input of processing procedure information on the sample collected from the corresponding subject; A second storage means for storing processing procedure information for the sample in a searchable manner based on the personal identifier; Sample identification symbol string output means for outputting a sample identification symbol string capable of identifying each sample having a required number of digits, including a symbol string of an identifier and initialized processing stage identification information as a part thereof, First instruction means for displaying an instruction to assign the outputted sample identification symbol string to the sample, detecting the assigned sample identification symbol string, and converting the sample identifier into a personal identifier and processing step identification information. First detection means for detecting a corresponding symbol string; diagnostic finding information input means for accepting input of diagnostic finding information corresponding to the personal identifier; and diagnostic finding information for the subject, the personal identifier for the subject. A third storage unit that stores the symbol string of the personal identifier in a one-to-one correspondence with the symbol string of the personal identifier, and the symbol string of which the analog string of the personal identifier cannot be inferred. An anonymous personal identifier output means for outputting an anonymous personal identifier, a fourth storage means for storing a correspondence between the personal identifier and the anonymous personal identifier, a one-to-one correspondence with the specimen identification symbol string, and The symbol string of the anonymous personal identifier corresponding to the symbol string of the personal identifier in the specimen identification symbol string is included in a part thereof, and the symbol string of the processing stage identification information capable of identifying that the anonymization processing has been completed is performed. An anonymous sample identification symbol string output means for outputting an anonymous sample identification symbol string, a fifth storage means for storing a correspondence between the sample identification symbol string and the anonymous sample identification symbol string, A first anonymizing unit that displays an instruction to assign the anonymous sample identification symbol string to the sample instead of an identification symbol string; and the first storage unit, the second storage unit, and the third storage unit.
The first storage unit, the first storage unit, the second storage unit, and the second storage unit, so that the personal information stored in a searchable manner based on the personal identifier, the processing procedure information of the sample, and the diagnostic finding information can be searched by the corresponding anonymous personal identifier. A second anonymizing means for re-storing the contents of the second storage means and the third storage means, detecting an anonymous sample identification symbol string given to the sample, and identifying an anonymous individual identifier and a stage identification in the anonymous sample identification symbol string Second detecting means for detecting a symbol string corresponding to information;
Based on the anonymous identifier and the stage identification information detected by the detection means, read the corresponding processing procedure information of the sample from the anonymized second storage means, and for the transfer destination specified by the processing procedure information, Second instruction means for displaying an instruction to transfer the sample to which the anonymous sample identification symbol string has been assigned; and diagnostic finding information and processing procedure information corresponding to the sample to be transferred to the corresponding anonymous identifier and step identification information. Transmitting means for transmitting to the transfer destination specified in the read processing procedure information, based on the received processing procedure information, receiving means for receiving diagnostic finding information and processing procedure information that can be searched for by the anonymous identifier of the subject, and The processing procedure information and consultation diagnosis information,
A sixth storage unit, which is separate from the second storage unit and the third storage unit, so as to be searchable by the anonymous identifier, and detects arrival of the sample to which the anonymous sample identification symbol string has been added; A third method of detecting the assigned anonymous sample identification symbol string and detecting a symbol string corresponding to the anonymous identifier and the stage identification information in the anonymous sample symbol string.
Detecting means, based on the anonymous identifier in the anonymous specimen identification symbol string detected by the third detection means and the symbol string corresponding to the step identification information, from the processing procedure information stored in the sixth storage means. Reading out the processing procedure information to be performed, and displaying the designated clinical research processing instruction for the sample, based on the anonymous identifier and the stage identification symbol string in the anonymous sample identification symbol string. An anonymized clinical research support system characterized in that necessary clinical research is performed on the sample while referring to the diagnostic finding information and processing procedure of the subject. 2. The apparatus according to claim 1, further comprising third anonymizing means for deleting a correspondence between the sample identification symbol string and the anonymous sample identification symbol string stored in the fifth storage means. Anonymized clinical research support system as described. 3. The anonymous sample identification symbol string output means, wherein the anonymous personal identifier is constituted by a symbol string randomly generated independently of the personal identifier. An anonymized clinical research support system according to any one of the preceding claims. 4. The instruction for giving the sample identification symbol string or the anonymous sample identification symbol string to a sample in the first instruction means or the first anonymization instruction means is a bar code corresponding to the symbol string. It is an instruction for printing on a label using a printer and attaching the label printed with the barcode to the container of the sample, and these instruction means are display means for the instruction, while the The first to third detection means are bar code readers, which are attached to the container of the sample, and the sample identification symbol string or the anonymous sample identification symbol string is printed on the sample identification symbol string or the label. The anonymized clinical research support system according to any one of claims 1 to 3, wherein the system detects anonymous sample identification symbol strings.