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Applied Clinical Trials-06-01-2002
Applied Clinical Trials
Privacy Restrictions Alarm Clinical Researchers
June 01, 2002
View from Washington
Rules to ensure confidentiality of individual health information threaten to make clinical trials more complex and costly.
Clinical Research in Mexico: An Overview
June 01, 2002
Feature Article
The United States and Europe host most clinical trials?and receive the benefits of drugs even when such trials are carried out in developing countries. Eager to correct an imbalance, Mexico wants to participate more extensively. Is it ready?
Good Clinical Practice: 10 Steps for Improving FDA GCP Inspections
June 01, 2002
Feature Article
European inspectors are doing a better job of implementing ICH GCP guidelines than their American counterparts at FDA. Here are 10 ways U.S. inspectors could improve their inspection process.
Nobody Knows the Costs They?ve Seen
June 01, 2002
To judge the value of process improvement, companies need to understand the cost of doing business. The problem is: they don?t.
Filling in the EU Gaps on Clinical Trials Rules
June 01, 2002
View from Brussels
EU proposals are finally available for the pharmaceutical industry to begin commenting on, and you can bet the industry will take advantage of it.
Interpretation of Regulatory Requirements by Technology Providers: The Case for Electronic Source Data
June 01, 2002
Feature Article
The authors contrast two views on the regulations concerning electronic source data.
HIPAA Privacy Rule: Effect on Medical Research
June 01, 2002
Feature Article
An attorney who specializes in health law advises researchers and research organizations to study and put into practice the proposed changes in a rule that governs use and disclosure of protected health information.
Letters to the Editor
June 01, 2002
Letters to the Editor
Readers respond to articles and editorials.
Informed Consent
June 01, 2002
Media Review
Kenneth Getz and Deborah Borfitz, CenterWatch (Boston, MA, 2002) 306 pp., $16.95.
Ethical Review and the Globalization of Clinical Trials
June 01, 2002
Feature Article
As clinical trials become global affairs, more effort should be devoted to the protection of research subjects. However, the question of consistency among ethics committees looms.
Measuring Investigator Satisfaction
June 01, 2002
Feature Article
In a global survey, Roche asks investigators how to go about getting the best clinical trial sites.
European Guidelines for Auditing Independent Ethics Committees
June 01, 2002
Resources
The European Forum for Good Clinical Practice (EFGCP) put together these guidelines as a push toward quality and efficiency in ethical review practices.
Strategies for Placing CRO Offices in Europe
June 01, 2002
Feature Article
In Europe, U.S. CROs aren?t doing as well as they could. Where they locate their offices could make the difference.