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Prior to commencement of this study, approvals to conduct the study were obtained from the appropriate independent ethics committee and/or institutional review boards governing the respective participating centres in each country/area (refer to full list under Appendix I).
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Time from study approval to first participant recruited took a median 124 days (min 53, max 290).
During CREW (ColoREctal Wellbeing) cohort study set up and recruitment, data were systematically collected on all centres that applied to participate, time from study approval to first participant recruited and the percentage of eligible patients recruited into the study.
Time taken to conduct the study from initial approvals to achieving target recruitment is shown in Figure 1.
In another Beckley Foundation study located in Europe, we are currently applying for approvals to study the effect of LSD on cerebral circulation and brain activity, This study will compliment both the research at Berkeley, and the psilocybin research at Imperial.
The Ethics Committee of Xi'an Jiaotong University Health Science Center approved this study (approval number 2014 204), which conformed to the ethics guidelines of the Declaration of Helsinki.
Medtronic further developed the TPV concept and conducted the necessary testing to complete the design/development process and clinical studies to obtain regulatory approvals to commercialize this technology.
Ethics committee approval was obtained prior to the study (Approval ID: 07/090/MIS) and the animal experiment was conducted in accordance with the Laboratory Animals Service Center's guidelines.
Prior to the study, approval by the Biomedical Research Ethics Board of the University of Saskatchewan was obtained.
CWY was responsible for the study design, seeking approval to perform the study, data collection and analysis.
The Progress Advisory Board was responsible for the oversight of the publication of results from this study, and provided approval to access and retrieve data from the study database.
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