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Education and instruction of personnel at the study sites; |
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Providing consistency checks between sites; |
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Organizing and managing sample transportation; |
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Specimen management: analyzed in house, by another facility, saved in a repository; and |
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Study management by providing monthly updates on |
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numbers of patients screened and enrolled into a study, |
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patient progressnumber of patients that have reached a particular visit number, |
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trend analyses that follow the results from screening and periodic laboratory tests, |
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a broad glimpse of the data 23 months in advance of final database output, |
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the resolution of demographic inconsistencies between visits and preventing such data problems from accumulating, |
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manually entering trial data generated from local laboratories to allow sponsor to have timely access to the data, and |
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data archiving. |
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A. Added Value Associated with Efficient Data Processing |
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It is important that an efficient electronic communication link is established early between the sponsor and the central laboratory. The key events in the stages of data processing are listed below and it is in both parties' interest to ensure that the principles are adhered to. |
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Laboratory data should be transferred electronically once patients are randomized and other details from the CRF have been validated and entered onto the medical database. |
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2. Query Turnround Timings |
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In a multicenter study, it is not unusual for laboratory data queries to comprise the majority of the total queries on the data collected. Take the case of a multicenter study consisting of 60 sites, each of which has a designated laboratory. Each laboratory has patients unique to it and the units and reference ranges often differ from laboratory to laboratory, according to their own methodology of measurement and sample patient population. Each laboratory has at least 2 sets of lab ranges (one for each sex), and some laboratories may change one or two of their ranges during a trial of several month's duration or |
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