Method and System for Verification of Source Data in Pharmaceutical Studies and Other Applications

Abstract

A method and system are described for verifying database entries against corresponding source data collected at a plurality of geographically remote field locations. The invention provides an electronic means of verifying field data in a manner that is quicker, less labor-intensive and less error-prone as compared with existing methods. The invention is particularly useful in the conduct of adaptive clinical trials of pharmaceutical products.

1 . A method for performing source data verification as part of a clinical trial or other process that requires comparison of values in a database with source data at a plurality of geographically remote sites according to a set of procedures or parameters, said method comprising the steps of:
 (a) accessing a centralized database containing values representing the final product of source data that have been collected and/or recorded in the field;   (b) comparing a value in the database with the corresponding source data;   (c) determining whether the database value agrees with the corresponding source data; and   (d) determining whether any queries have been generated with respect to such value during the period since the source data were originally collected.   
   
   
       2 . The method of  claim 1 , wherein step (d) further comprises displaying the audit trail of any changes made to such value since the time it was first recorded. 
   
   
       3 . The method of  claim 2 , wherein the audit trail comprises a chronological list of queries generated with respect to such data. 
   
   
       4 . The method of  claim 1 , wherein the comparing in step (b) is conducted at the same clinical site where the source data were first recorded. 
   
   
       5 . The method of  claim 2 , further comprising:
 (e) if it is determined according to step (c) that the database value does not agree with the source data, generating a new query with respect to such data.   
   
   
       6 . The method of  claim 5 , further comprising:
 (f) if it is determined according to step (c) that the database value agrees with the source data, creating a record that such value has been verified.   
   
   
       7 . The method of  claim 6 , further comprising:
 (g) electronically reporting the audit trail of step (d) or the new query generated in step (e), along with the data corresponding to such audit trail or new query, to an entity capable of determining whether the data require correction or whether procedures or parameters utilized in conducting said clinical trial or other process require modification, and   (h) providing instructions, based on the reported data, to
 (1) correct the data, or 
 (2) follow or modify the procedures or parameters utilized in conducting said clinical trial or other process. 
   
   
   
       8 . The method of  claim 1  wherein database values in step (a) may have been changed during the period since the corresponding source data were originally collected, and wherein each database value represents the data point that is believed to be most accurate based on such audit or correction. 
   
   
       9 . The method of  claim 1 , further comprising:
 (i) prior to conducting step (b), ascertaining the number of values in the database with respect to which step (b) needs to be performed; and   (j) based on the number of values ascertained in step (i), determining when to conduct step (b).   
   
   
       10 . A system for performing source data verification as part of a clinical trial or other process that requires comparison of values in a database with source data at a plurality of geographically remote sites according to a set of procedures or parameters, said system comprising:
 (a) a centralized database containing values representing the final product of source data that have been collected and/or recorded in the field;   (b) means for comparing a value in the database with the corresponding source data;   (c) means for determining whether the database value agrees with the corresponding source data; and   (d) means for determining whether, during the period since the source data were originally collected, any queries have been generated with respect to a corresponding database value.   
   
   
       11 . The system of  claim 10 , wherein the means in paragraph (d) further comprises means for displaying the audit trail of any changes made to such value since the time it was first recorded. 
   
   
       12 . The system of  claim 11 , wherein the audit trail comprises a chronological list of queries generated with respect to such data. 
   
   
       13 . The system of  claim 10 , wherein the comparing in paragraph (b) is conducted at the same clinical site where the source data were first recorded. 
   
   
       14 . The system of  claim 11 , further comprising:
 (e) means for generating a new query with respect to a database value that does not agree with the corresponding source data.   
   
   
       15 . The system of  claim 14 , further comprising:
 (f) means for creating a record that a value has been verified with respect to any database value that agrees with the corresponding source data.   
   
   
       16 . The system of  claim 15 , further comprising:
 (g) means for electronically reporting the audit trail of paragraph (d) or the new query generated in paragraph (e), along with the data corresponding to such audit trail or new query, to an entity capable of determining whether the data require correction or whether procedures or parameters utilized in conducting said clinical trial or other process require modification; and   (h) means for providing instructions, based on the reported data, to
 (1) correct the data, or 
 (2) follow or modify the procedures or parameters utilized in conducting said clinical trial or other process. 
   
   
   
       17 . The system of  claim 10  wherein database values in paragraph (a) may have been subjected to prior audit or correction during the period since the corresponding source data were originally collected, and wherein each database value represents the data point that is believed to be most accurate based on such audit or correction. 
   
   
       18 . The system of  claim 10 , further comprising:
 (i) means for ascertaining the number of values in the database with respect to which the means in paragraph (b) need to be utilized; and   (j) means for determining when to utilize the means in paragraph (b), based on the number of values ascertained in paragraph (i).