ABSTRACT
Perhaps even more interesting than the text of the actual regulations are the comments from the Food and Drug Administration (FDA) found in the introduction to 21 CFR Part 11. On pages 13450-13451 and 13464, the agency responds at length to comments sent in by the industry during the review phase of the rule. They use the responses to questions regarding training requirements to emphasize that the FDA believes training speci—c to the task is required, and they conclude by saying:
Because data managers use clinical data management systems, they are creating and maintaining electronic records that will be used in submissions. They will have to document their training and experience. This chapter discusses ways to satisfy these training requirements, identi—es some common problems in setting up training, and touches on approaches to address those problems.
