Clinical Trials Administrator Archives – February 1, 2004
February 1, 2004
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Don’t be confused by the rules governing adverse event reporting
Reporting rules for adverse events in clinical trials only seem straightforward in the case of death or injury requiring hospitalization. Otherwise, those involved in clinical trials have to figure out how soon they need to report, what information needs to be included in the report, and who should get it. -
Grading the severity of adverse events (AEs)
All AEs will be assessed by the investigator using the protocol-defined grading system. If the protocol has no defined grading system, or if the AE is not described in the existing grading system, the following guidelines should be used to qualify severity. -
AE relationship to study product
The possible relationship of an adverse event to use of study product is assessed by the investigator. The terminology for these assessments can vary from one reporting system to the next. The DMID (S)AE reporting system uses the following terms to describe the relationship of an AE to the study product. -
Getting consent from non-English speakers
According to the U.S. Census Bureau, in 2000, just under 18% of the population thats more than 46 million people spoke a language other than English at home. For researchers doing work that can apply across populations, that has one big implication: Minority groups need to be actively recruited for clinical studies; and since many dont speak English, informed consent documents should be translated into a language they can read and understand. -
Parents often don’t understand research
Imagine you had a very sick child and were approached about him or her being in a study. In your worry for your son or daughter, how much of the informed consent process would you understand? Would you be clear on what the study entailed? According to several studies published in the last year, maybe not. -
Education vital in litigious clinical trial arena
Right now in Seattle, a lawsuit is pitting families of five research patients against the Fred Hutchinson Cancer Research Center. At issue is whether leukemia patients participating in a study on T-cell depletion fully understood the risks of the proposed treatment and gave informed consent. -
News Briefs
Better outcome not guaranteed for cancer research volunteers; FDA wants clinical trial database improvements; BRAAN gets smarter.