Ensure data integrity and subject safety in clinical research 

Electronic medical records and electronic handling of study data is increasingly common.
To involve computer systems in clinical research implies knowledge of 21 CFR Part 11(ELECTRONIC RECORDS; ELECTRONIC SIGNATURES) and all of the ramifications of this Part of the code is essential. Basically electronic records and electronic signatures must be trustworthy, reliable and generally equivalent to paper records and signatures executed on paper. The differences between the traditional paper system and an electronic system is significant. One must know and follow the Part 11 code. System validation has many items to follow but none more important than the who, what, and when aspect of the Data / Audit Trail. These trails must be secure, operator independent, computer generated, date & time stamped, and (most importantly) available for the FDA reviewer. SOPs and staff training is often what separates the good from the not good systems. This presentation is for the non-computer literate clinical research staff.
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