Clinical Trials Administrator Archives – March 1, 2006
March 1, 2006
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Sites, sponsors need to reduce time spent on clinical trial agreements
Clinical trial contract and budget negotiations were cited most often in 2005 as the reason trials were delayed, and this was a change from 2003, according to Thomson CenterWatch in Boston. -
3 steps to prepare for contract negotiations
Clinical trial sites often are concerned about their ability to negotiate meaningfully with large companies, an expert says. -
Enrollment doubles with electronic reminder tool
A new study suggests that clinical trial sites could significantly improve their subject recruitment with the use of an electronic medical record tools physician reminder. -
Competency tool not excessively burdensome
Investigators who used a competence assessment tool as part of a large clinical study of antipsychotic drugs and a schizophrenia population have found that the tools use during the studys informed consent process was not considered burdensome by most clinical trial staff and investigators. -
Write a comprehensive data safety monitoring plan
Developing a data safety monitoring plan is good practice for all research protocols, an expert says. Data and safety monitoring plans may be developed as a general plan for a research institution or center; a global plan for a protocol or as the specific plan for a protocol conducted at a local research site. -
Russian research expert discusses training
In this Q&A interview, Anatoly Gorkoun, MD, PhD, project manager of clinical operations of PSI Pharma Support International in Saint Petersburg, Russia, discusses some of the differences and similarities of clinical trial research in Russia and how U.S. investigators might prepare to collaborate on these projects. In this issue, Gorkoun discusses investigator training and best practices.