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Page 396 Table 2 Advantages and Disadvantages of Using Local and Central Laboratories Local Laboratory Central Laboratory Perceived advantages to the investigator: Fully conversant with laboratory operation, fully conversant with reporting style No sample transportation delay No sample preparation Fast reporting time Perceived advantages to the investigator: ''Special test'' data available quickly Local laboratory audit not required Local archiving not required Laboratory operating to principles of GLP Perceived advantages to the sponsor: The investigator has confidence in his laboratory No transportation cost Fast local reporting time for safety data Perceived advantages to the sponsor: No "special test" data constraints Consistent methodology across multiple sites Consistent reporting Laboratory operating to principles of GLP Complete audit trial Single analytical charge Data validation at source Electronic data may be available Improved data integration and statistical analysis Single laboratory site audit Complete study overview Close monitoring of adverse events Perceived disadvantages to the investigator: "Special test" data availability constraints Local laboratory audit may be required Local archiving will be required for minimum of 15 years Perceived disadvantages to the investigator: Not confident with the system Not conversant with laboratory operation Unfamiliar with reporting style Unfamiliar with reporting units Sample preparation required before transportation Sample transportation procedures to be followed Delay in data reporting Perceived disadvantages to the sponsor: "Special test" data availability constraints Inconsistent methodology across multiple sites Inconsistent reporting style Integration of data very time consuming Perceived disadvantages to the sponsor: Investigator uncomfortable with the system Investigator training required Sample transportation cost Clinical Research Associate training required (Table continued on next page)
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