Applied Clinical Trials-06-01-2003

The study protocol and a set of specifications are the road map for developing the software and the support structures for an EPD study.

Just like London buses, you wait for one for ages, and then a whole bunch come along at once. That's what's happened with the European Union's guidelines on how the new clinical trials rules should be applied at national level.

The clinical and technical teams use the protocol and a set of specifications as a road map for developing the software and the support structures for an EPD study.

Kimberly Irvine and Eileen Hilton (CenterWatch, Boston, MA, 2003), 158 pages, paperback, ISBN: 1930624395, $39.99.

Planning and preparation, along with imaginative innovations, can put an investigative site on the road to best research practices.

FDA is exploring policies to incorporate genomic information into the regulatory process.

FDA surprises the pharmaceutical industry with its new interpretation of the Electronic Records, Electronic Signatures rule.

Economic realities are changing the way companies do business. One significant change is the growing numbers of freelancers in the clinical trials arena.

John I. Gallin, Ed. (Academic Press, San Diego, CA, 2002), 490 pages, hardcover, ISBN: 0122740653, $99.95.

HIPAA?s new Privacy Rule is in effect, and sponsors and clinical research professionals are learning how to apply it.