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By simultaneously conducting this study in the U.S. and Kenya we have collected safety data in populations of varying characteristics, an important step in the clinical development of any vaginal microbicide.
First BEAT prospectively collected safety data from patients undergoing surgery and is the largest data set using a targeted agent in this setting.
Triangulating routinely collected safety data with staff and patient perceptions of safety will facilitate assessment of whether positively deviant wards have been correctly identified (concurrent validity).
7 This observational study addresses the first two stages of the positive deviance process 14 in order to (1) assess the concurrent validity of identifying positively deviant wards using routinely collected safety data and (2) generate hypotheses about how positively deviant wards deliver exceptionally safe patient care.
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Phase 4 studies focus on collecting safety data in large numbers of patients to look for rare but serious side effects.
"We intend to enhance the capabilities of the Otto truck, collect safety data to demonstrate its benefits, and bring this technology to every corner of the U.S. highway system," Levandowski and Lior wrote.
TSR can complement spontaneous reporting for collecting safety data on particular drugs and increase ADR reporting rates.
The methodology and use of modern technologies to collect safety data from large numbers of patients was successful and could be used again in similar safety studies.
We propose to collect safety data through various evaluations of CNTs using carbon black as a common reference, while paying attention to these facts.
Once medical products become available to the general population and for long-term use, postmarketing surveillance is required to collect safety data.
37 CONSIGN provides early access in countries where regorafenib has not yet been approved, and will collect safety data for regorafenib until market access.
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