Realize The Semi-automation Of SAE Reconciliation

Objectives:The semi-automation of SAE reconciliation is realized. The semi-automatic method and the manual method are compared. Finally the semi-automatic mode of SAE reconciliation is established. The safety data of the new drug will be managed efficiently. The consistency of the safety data will be ensured. The SAEs data will comply with the requirements of the safety report and be submitted to the authorities. It is favorable to the entire smooth drug development.Methods:(1) Realize the semi-automation of SAE Reconciliation by SAS programming.(2) Survey:Get the mean time of the reconciliation of one SAE and the wash-out time of the cross-over experiment; calculate the sample size of the cross-over experiment.(3)Cross-over Experiment:Compare the efficiency and the accuracy of the manual method and the semi-automatic method.(4) Test:Test the semi-automatic mode with Access system. It will emphasize on the collection of SAE data, the storage of SAE data and the reconciliation between the safety database and the clinical database.Results:The discrepancies can be identified by different colors in the semi-automatic process, which helps data managers to distinguish various kinds of data. The work time is reduced significantly (P<0.05). The efficiency of work is improved. The semi-automatic mode is established with CDASH and ICH E2B guidelines. It is favorable to the extensive application of the semi-automatic method in the whole pharmaceutical industry, which is worth referenced.