Applied Clinical Trials-06-01-2003

Applied Clinical Trials

Developing and Validating Electronic Diaries

June 01, 2003

Feature Article

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

Les Nouveaux Clinical Trials Guidelines Sont Arrives

June 01, 2003

View from Brussels

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.

Technology Update: Electronic Diaries, Part 3--Developing and Validating Electronic Diaries

June 01, 2003

Feature Article

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.

Ensuring a HIPAA-Compliant Informed Consent Process

June 01, 2003

Media Review

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

Innovations at an Investigative Site

June 01, 2003

Feature Article

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

Genome Discoveries Shape Drug Development and Testing

June 01, 2003

View from Washington

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

Is Change Afoot? 21 CFR 11 in Transition

June 01, 2003

Technology Viewpoint

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

The UK Freelance Network

June 01, 2003

Feature Article

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

Principles and Practice of Clinical Research

June 01, 2003

Media Review

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

The HIPAA Privacy Rule, Research, and IRBs

June 01, 2003

Feature Article

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