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This project evaluated the completeness of manufacturer adverse drug experience (ADE) reports on computerized fields on the FDA-1639form for which completion is not required for data entry, (eg, age, sex, ADE onset date). The completion rate of such fields was determined for domestic, spontaneous, health professionalsubmitted ADE reports during 1986-1989. This project was limited to 20 manufac turers submitting the largest number of reports. Completion rates were computed for total reports and 15-day reports. A completion rate was defined for each field for each manufacturer as the number of times the field was filled in divided by the total number of reports. In general, the completion rate was higher for 15-day reports than total reports. Because there were manufacturers with >90% completion rates, other manufactur ers should concentrate on improving their completion rates. Consideration should be given to 15-day reports; they are used by FDA in the signaling of monitored adverse reactions.

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