Clinical Trials Administrator Archives – July 1, 2009
July 1, 2009
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Standard operating procedures: Don't wait until audit looms to develop SOPs
For many professionals in the clinical trial world, creating standard operating procedures (SOPs) is another box to check off. But if they look at it as a low priority duty, then they might be missing an opportunity to improve their organization's quality by using well prepared and regularly updated SOPs, experts say. -
SOP to you drop: Process inclusion and education
The first step to obtaining staff buy-in for your standard operating procedures (SOPs) is to include staff in the process of writing the SOPs and to make sure the final document is clear, concise, and useful. -
Compliance program supports IND and IDE research applications
With research institutions increasingly facing vigorous regulatory scrutiny, it is a good idea to provide investigators with support in areas where they might have issues. One such area involves applications for investigational new drugs (INDs) and investigational device exemptions (IDEs). -
Determining risk-benefit of clinical trial requires careful, statistical thinking
Investigators weighing the risks and benefits of a randomized clinical trial might try using a new statistical concept that offers consistency and clarity to their decision-making process. -
Compliance Corner: Audit program addresses systemic problems
Clinical trial audits typically lead to better research compliance, but the best strategy might be to look specifically for systemic problems. -
Educating parents about clinical trials with children
Community education and informed consent about an investigational treatment will be a more intense process when it involves parents of seriously ill children.