ABSTRACT
CDISC standard has become a set of global data standards that can be used in clinical study, covering the full life cycle of clinical researches. After nearly 20 years of development and continuous version upgrades, CDISC standard can improve the quality and efficiency of clinical research and drug review, and to facilitate all stakeholders involved in researches to exchange the study data and communicate the outcomes. CDISC standard has been or is to be adopted as standard format in data submission by multiple regulatory authorities, and more widely implemented by the global pharmaceutical community. CDISC standard is gradually adopted in China. The feasibility and roadmap of CDISC standard as the Chinese data submission format requirements are undergoing exploration and piloting further.
ABSTRACT
Objective To investigate the current status of the indoor air pollution in urban area in Beijing and find the influence factors for the concentrations of formaldehyde and nitrogen oxides (NOx) indoors. Methods 463 persons were chosen randomly from Xicheng district of Beijing to complete the questionnaires about their indoor environment condition. The levels of formaldehyde and NOx were monitored in the bedrooms and the kitchens of 91 households. And we used the multi-regression model to find out some influence factors that related to formaldehyde and NOx concentration. Results The average daily concentration of formaldehyde in the bedrooms was about 0.049 mg/m3 and the rate of excess standard was 13%. The formaldehyde pollution in the decorated rooms (0.058 mg/m3) was more serious than that in the control rooms (0.034 mg/m3) and there was statistically significant difference between them (P