Abstract:
A method for the tracking of biological samples and information obtained from those samples during clinical studies is provided. In particular, the present invention provides a method that facilitates the tracking, analysis, and reporting of genotype information derived from biological samples taken from individuals during clinical studies. The method includes recording predetermined characteristics of biological samples in a database, determining procedures to be performed on those samples, determining sample attributes to be recorded, preparing a checklist that includes the procedures and attributes, storing the checklist in the database, performing the procedures and recording the results in the database. The present invention provides an automated system for tracking clinical study protocols, and allows access to information regarding a clinical study to be obtained from a central database. Accordingly, reports regarding the location, chain of custody, test results, and other information concerning samples in a study can be obtained in a highly automated fashion.