Clinical Trials Administrator Archives – July 1, 2004
July 1, 2004
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Two trials prove that recruiting women isn’t as difficult as it sometimes seems
Although progress is being made, advocates say, women still have a lot of catching up to do after decades of historical, cultural, and legal barriers that excluded them from both the benefits and risks of participation in medical research. -
In-process QA soon may be standard for research
In a never-ending quest to make clinical trials safe for participants and learn from unfortunate incidents that may have occurred during a clinical trial, the Food and Drug Administration is not only scrutinizing corrective and preventive action plans (CAPA), but also looking outside of health care for effective quality assurance processes. -
Think of 21 CFR Part 11 as a business issue
An expert advises how to best comply. Slipping away are the days of pen-and-paper record keeping. Here to stay are electronic records and electronic signatures. -
An oversight process can improve quality
Investigators and physicians may be experts on research and medicine, but its up to the research compliance staff and the clinical trial managers to be experts in the interpretation and application of regulations governing clinical research. -
News Briefs
Petition for stem cell policy change circulated; Stem cell research moving forward; FDA initiative seeks to speed up approvals.