>The regulation is an FDA regulation, so it only applies to records required >by another FDA regulation, which primarily applies to drug manufactures, >device manufacturers, etc. In reality, this does not limit the regulation very much at all. Most academic centers want very much to participate in clinical trials of new drugs, for example, an area where the reg clearly applies. I do not believe they would want to have *two* record keeping systems in place: one for regular use one for clinical trials. I think that the reality is WYSIWYG. John
