Clinical Trials Administrator Archives – July 1, 2005
July 1, 2005
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Clinical trial drift can cause high PI turnover, low patient recruitment
The clinical trial industry continues to experience problems with investigator and patient recruitment, and experts say the cause is trial drift, defined as the gradual reduction in study knowledge as a clinical trial ages. -
Solving the problem of clinical trial drift
Finding solutions to trial drift begins at the top with the sponsor, but also requires clinical trial staff to become more committed to good clinical practices and knowledge testing, experts say. -
Don’t overlook budgeting, billing quality initiatives
One weak link for many research institutions in clinical research quality and best practices lies in the realm of financial affairs. Too often the clinical research team charged with negotiating budgets consists of research professionals who dont have training in finance or compliance, explained Harriett Singer, MS, FACMPE, an instructor in the department of pediatrics at Baylor College of Medicine in Houston. -
Compliance Corner: Deal with noncompliance before it reaches the FDA
The main causes of research noncompliance result from investigators, research staff, and industry sponsor staff misunderstanding or having difficulty interpreting regulations, says a former FDA investigator. -
Do you know what should be included in a CTD?
Clinical trial staff might have little knowledge or interest in the common technical document (CTD), although this document often is what drives some requests for additional information that come from sponsors and clinical research organizations (CROs). -
PHRP launches public education campaign
A new campaign aimed at improving public trust and knowledge of clinical trial research was launched in May by the Partnership for Human Research Protection Inc. (PHRP) based in Washington, DC.