220-Dictionary of Pharmaceutical Medicine, 2nd Edition-Gerhard Nahler Annette Mollet-3211898352-S

47data base is “frozen” or “closed” in order to follow development ofstored information, e.g. for statistical analysis, or every 6 monthsfor the first two years subsequently to the date of the first approvalby the first regulatory authority for a particular drug; → see alsoperiodic safety update report.data manager Responsible person for the data and administrativeactivities of a clinical research process from the very beginningtill the generation of the final report; she/he designs trial forms,ensures that randomization and data collection are conducted accordingto the protocol, ensures correct data entry, logic checks(e.g. blood pressures, heart rates, etc. checked for certain acceptablevalues) and editing, as well as documentation in a data masterfile within a data center, ready for use by the statistician; the d.m. isalso responsible for data base creation, its structure, and maintenance;together with the monitor she/he is responsible for resolvingdata queries; a data analyst may assist the d.m.data mining Process of sorting through large amounts of data andpicking out relevant information; statistical and logical analysis oflarge sets of data, looking for patterns that can aid decision making(useful: visual exploration of relationships with e.g., shift table/transition matrix, histograms, distribution curves, etc.); used forsignal detection in pharmacovigilance.data monitoring → see data editing.data protection act In most countries the storage of personal data inelectronically processed form is regulated by law; companies storinginformation must be registered in a national Data Registrar.data quality In order to be acceptable, data must be attributable,legible, contemporaneous, original and accurate (ALCOA). Thesequality and integrity criteria are applicable to all data, whetherthey are collected on paper or recorded electronically; → see alsoelectronic data, raw data, source data.data resolution form (DRF) syn. CRF correction log, data clarificationform, data edit form, notice-of-change form, query log, queryresolution form; form used by monitors or clinical researchassociates to collect missing or to correct illegible, wrong or implausibleentries in case record form (CRF); once collected, CRFnever go back to the investigator; → see data manager.data and safety monitoring board (DSMB) Group of independentresearchers who review data from blinded, controlled clinical trials;→ see also safety analysis, steering committee.data sheet → see summary of product characteristics.data trail syn. audit trail; integrity of the documentation recordwhich allows a monitor, auditor or inspector to follow the processof events from patient record to new drug application anddat