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Some terms have different meanings in various disciplines, but many have become standardized by ICH guidelines.

The consumer press has its spotlight on clinical research again, and some commentators are focusing on subject recruitment.

With 2003 fast approaching, all we know for sure about the EU?s legislative changes is that nothing is final yet.

The reviewer calls the second edition of Stephen Senn?s text ?well structured and easy to read.?

Wherever they live and whatever their area of interest, clinical trials professionals can probably join a group of professional peers.

Abbreviations don?t always mean the same thing to everyone everywhere, but these translations can help make sense of initials commonly used by clinical researchers.

A former White House advisor on health policy, Mark McClellan, is FDA's new commissioner.

Successful recruitment requires a good fit between the subjects, the sites, and the protocol. Here?s how to assess the necessary tailoring of procedures.

A health care attorney clarifies how amendments to the HIPAA Privacy Rule bear on the recruitment of clinical trials subjects.

The results of a Web-based survey of some subjects in recent clinical trials suggest ways to improve the consent process.

A survey of pharmaceutical manufacturers reveals that pediatric trials are widespread across Germany.

Our 10th annual guide to applications highlights software, Web-based solutions, and more.

Paul Bleicher examines the pros and cons of broadband Internet technology and explains how to build a home network and make it secure.

Putting staff training at the bottom of your list of important tasks is a self-defeating attitude in the business world.

Integrating IVRS with in-house clinical trial management solutions can provide a powerful project management tool.

Bert Spilker has been involved in clinical trials for 30 years. He?s written books, founded companies, and helped steer regulatory agencies. Now he wants to change how drugs are developed.

Some companies prefer live training for PIs; some are moving toward virtual training. Two Lilly authors advocate a combination of the two methods.

Careful attention to geography can help sites enlarge their catchment areas and increase subject accrual rates without negative consequences.

Modern radiological techniques and digital analysis technologies permit rapid evaluation of the efficacy of oncology drugs. Continual review of methods detects flaws promptly, creating the opportunity to take corrective steps.

A set of trials carried out by the Collaborative Ocular Melanoma Study Group at eye centers throughout the United States and Canada led to improvements in the care of patients with choroidal melanoma.

Experts discuss the use of subject diaries and the way researchers can comply with applicable regulations and guidelines.

The European Organisation for Research and Treatment of Cancer is dedicated to improving cancer treatment in Europe. Its Regulatory Affairs Unit provides important services to researchers.

Adaptive interim analysis may allow smaller sample sizes when a drug?s clinical effect is unknown.

Readers like Lynn Sadowski, a senior clinical research associate at Sention Inc., share their experiences.

After years of pilot trials, the pharmaceutical industry still sees EDC as something new. Here are two approaches toward making EDC into business as usual.

Support can be key to a successful EDC clinical trial. These suggestions may help your organization achieve a better experience with EDC.

Commitment, skill, leadership, a clear focus, performance metrics, and a proven process will keep your cross-functional team from dysfunction.

Readers write in with questions and comments about articles and editorials.