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Several times when I was the lead investigator on a study, I was frustrated with what seemed like endless nitpicking over the language in the informed consent or the request for further documentation of safety, but in each case I acceded, knowing that researchers can suffer a Pygmalion complex, falling so in love with their experiments that they become blind to their flaws.
"I know for a fact that many universities immediately reviewed their protocols for dealing with pyrophorics and many of them looked at their documentation of safety training," Phifer adds.
We found that patients placed on the care pathway had higher rates of neurological examination, documentation of safety and legal guidelines as regards driving, and lower rates of seizure readmission.
This chapter looks at the investigation and analysis of product radiation safety in terms of the analysis of possible risks, the possible technical methods that can be used to deal with them and the need for the documentation of safety aspects.
Only female patients' charts contained any documentation of safety planning.
†Only female patients' chart contained documentation of safety planning.
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Monday's bill could be a foil to that by ensuring "oil companies are not able to sidestep California's stringent pipeline safety laws," Jackson said, which include requirements for more frequent inspections, the use of the best available pipeline safety technology and more thorough documentation of pipeline safety test results.
Manufacturers would be required to register each year with the FDA and furnish documentation of ingredient safety through testing and expert analysis.
The potential routine clinical utility of 18F-labeled PET radiopharmaceuticals depends also on regulatory compliance in addition to documentation of potential safety and efficacy by various investigators.
Most requirements concerning documentation of the safety and efficacy of a non-radioactive drug must be also appled to radiopharmaceuticals. But, it must be recognised that radiopharmaceuticals do not have a measurable pharmacodynamic effect.
Documentation of drug safety is highly important, especially in pediatric drug trials.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com