FDA’s main goal is to protect the rights, safety and welfare of the subjects enrolled in FDA regulated clinical trials. The next objective is to verify that the clinical trial completely and accurately captured all of the clinical trial data that will be used to support a research or marketing application. In addition, many times the FDA investigator is provided with tables and listings from the FDA center that is reviewing the clinical trial report prior to the inspection. The FDA investigator will then perform a comparison of the tables and listings supplied by the center, to the raw data in the sponsor’s clinical trial master file to assure that the clinical trial report is complete and accurate.
