Abstract: A method and system are described for centrally managing data in an adaptive clinical trial or other adaptive process that is conducted at a plurality of geographically remote sites. The invention includes (1) flexible means for collecting data from remote sites; (2) processing, tracking, and validating such data and meta-data at a processing location; (3) interacting between central and remote sites to manage and resolve data discrepancies (4) reporting data to managers and remote sites; and (5) facilitation of special services to clinical research such as flexible randomization of patients, patient participation eligibility verification and double-blind trials. The invention is of particular relevance to adaptive clinical trials and other applications that demand the ability to quickly collect, process, and respond to various forms of data in order to adjust actions such as randomization schedules, interim analyses, treatment arm pruning, editing subpopulations, and other adaptive measures.

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.

Abstract: A method for monitoring an individual's drug regimen and meal regimen to reduce the likelihood of a drug-to-food interaction. An ingredient group table is constructed that includes ingredient groups which are known to cause an adverse reaction when combined with a particular drug in an individual. Known drugs are linked to contraindicated ingredient groups listed in the ingredient group table to create a drug-ingredient group table, which includes the known drugs and the linked contraindicated ingredient groups. The drug regimen of an individual is determined from a Physicians' Orders database. The drug-ingredient group table is searched using the individual's drug regimen as the search criteria. Matching drugs along with the linked contraindicated ingredient groups are extracted from the drug-ingredient group table and placed in a personalized drug-ingredient group table.

Abstract: A printer for use with a data processor and a ribbon cartridge for use in the same are disclosed. The cartridge has at least two separate ribbon supplies which may differ in the type of ink on the ribbon (MICR vs. ordinary) and/or in color of ink or otherwise. A mechanism moves the cartridge along a straight line path to index selectively an active portion of each of the ribbons to a position aligned between a printhead and a platen for printing through the selected ribbon. A ribbon drive mechanism drives at least one of the ribbon supplies only when that ribbon supply has been selectively indexed to be printed through. In one embodiment a Magnetic Ink Character Recognition ribbon supply is driven between take-up and supply reels only when it is indexed for printing, while a multi-strike ribbon with ordinary ink is driven continuously. In another embodiment only one of two or more ribbon supplies is driven at one time.