Validating electronic source data clinical trials

To reduce the possibility of errors due to human entry, the systems employ various means to verify the data.Systems for clinical data management can be self-contained or part of the functionality of a CTMS.For example, RAVE can be connected to an IVRS (Interactive Voice Response System) facility to capture data through direct telephonic interviews of patients.Although IRT (Interactive Response Technology) systems (IVRS/IWRS) are most commonly associated to the enrollment of a patient in a study thus the system defining the arm of the treament that the patient will take and the treatment kit numbers allocated to this arm (if applicable).

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The data on forms is transferred to the CDMS tool through data entry.As an example, ASA (acetylsalicylic acid) could be mapped to aspirin, a common notation.Popular adverse event dictionaries are Med DRA and WHOART and popular Medication dictionaries are COSTART and WHO Drug Dictionary.A CTMS with clinical data management functionality can help with the validation of clinical data as well as helps the site employ for other important activities like building patient registries and assist in patient recruitment efforts.The CDMS can be broadly divided into paper-based and electronic data capturing systems.

Validating electronic source data clinical trials