| 主权项 |
1. A method operational in a computer system, comprising:
(a) receiving personal identifying information from a subject proposed for inclusion in the first clinical trial, the personal identifying information comprising:
(i) initials of the subject, wherein the initials comprise the first letter of a first name of the subject, the first letter of a middle name of the subject, and the first letter of a last name of the subject;(ii) day, month, and year of birth of the subject;(iii) 4 consecutive characters of a verified identification; and(iv) height and gender of a study participant; (b) comparing the height and gender of the proposed subject to height and gender information in a database, the database comprising the personal identifying information of a plurality of clinical trial subjects participating in one or more other clinical trials; (c) if the height and gender of the proposed subject matches the height and gender of one or more enrolled clinical trial subjects, then the following personal identifying information of the proposed subject are compared with corresponding personal identifying information of the enrolled clinical trial subjects:
(i) first initial;(ii) second initial;(iii) last initial;(iv) day and month of birth;(v) year of birth; and(vi) four consecutive digits of an alphanumeric identifier of a verified identification; (d) if all the items of personal identifying information listed in step (c) of the proposed subject match the same items of personal identifying information of an enrolled clinical trial subject, then identifying the subject pursuant to step (g); (e) if some of the items of personal identifying information listed in step (c) of the proposed subject do not match the same items of personal identifying information of an individual enrolled clinical trial subject, then obtaining frequency information for each of the items of personal identifying information listed in step (c) of the proposed subject which do match the same items of personal identifying information of an enrolled clinical trial subject, wherein the frequency information is derived from a predetermined data set and comprises the following:
(i) frequency of first initial of a subject as either the first initial or second initial of an enrolled clinical trial subject;(ii) frequency of middle initial of a subject as either the first initial or second initial of an enrolled clinical trial subject;(iii) frequency of last initial of a subject as last initial of an enrolled clinical trial subject;(iv) frequency of day and month of birth of a subject;(v) frequency of year of birth of a subject;(vi) frequency of gender; and(vii) frequency of four consecutive alphanumeric digits used in an alphanumeric identifier of a verified identification; (f) multiplying the frequency information for each of the items of personal identifying information listed in step (c) of the proposed subject which match the same items of personal identifying information of an enrolled clinical trial subject, thereby obtaining a product of the frequencies, wherein if the product is <0.00001, then identifying the subject pursuant to step (g); (g) identifying the subject as possibly matching a clinical trial subject participating in one or more other clinical trials. |
