For pharmaceutical industries, clinical data is one of the most valuable deliverables. It is also the basis of analysis, submission, approval, labeling and marketing of a drug product. To ensure the integrity and reliability of clinical data, a scientific standardized quality control (QC) has to be established at each step of a clinical trial. Data validation is conducted to ensure the reasonability and compliance of clinical data by checking data quality before the data is statistically analyzed. This paper focuses on purpose of data validation, creation of data validation plan, rationale of data validation, types of data validation and performance of user acceptance testing on clinical database.
Clinical Trials as Topic ; standards ; Data Accuracy ; Data Collection ; standards ; Databases, Factual ; Quality Control ; Reproducibility of Results

Granulocyte Colony-Stimulating Factor ; immunology ; pharmacology ; therapeutic use ; Humans ; Liver Failure ; immunology ; therapy

ObjectiveTo investigate the effect of age and gender on the position of termination of the conus medullaris (CMT).MethodsOne thousand three hundred and thirty-nine patients aged 4-89 yr scheduled for lumbar magnetic resonance imaging examination were selected.The position of CMT was determined using Visart 1.5 T or Magnetom Trio 3.0 T magnetic resonance imaging instrument.Results Five hundred and ninety-four male patients and 745 female patients were enrolled in the study.There was no significant difference in the percentage of CMT located at the L2,3 intervertebral disc level between female (1.2％) and male (0.5％) patients (P＞0.05),and female patients had a lower mean CMT than male patients (P＜0.01).There was no correlation between age and mean CMT in patients aged ≤19 yr (P＞ 0.05).There was a positive correlation between age and mean CMT in female patients aged≤20 yr (r =0.076,P＜0.05),but there was no correlation between age and mean CMT in male patients aged ≤ 20 yr (P＞0.05 ).ConclusionFemale patients have a lower mean CMT than male patients,and there is still a risk when performing spinal anesthesia,although the probability that CMT located at the L2,3 intervertebral disc level is low in female and male patients.The position of CMT is lower with increased age in adult female patients,but it is not related to age in adult male patients.

Adult ; Humans ; Male ; Maxillary Sinus ; Xanthogranuloma, Juvenile

This study aims to perform a survey of genetic variation in neuraminidase (NA) gene of influenza A/H3N2 virus, as well as related resistance to NA inhibitors, in Qinghai Province of China, 2010 to 2012. Strains of influenza A/H3N2 isolated during an influenza survey from 2010 to 2012 in Qinghai were enrolled by random sampling. Viral RNA was extracted and amplified by RT-PCR. Purified PCR products were sequenced thereafter. Genetic analysis of nucleic acid and the derived amino acid sequences was performed by MEGA 4.0. Phylogenetic trees were also constructed. Strains isolated during 2010-2011 in this study clustered closely with World Health Organization (WHO) 2010-2012 reference vaccine strain A/Perth/16/2009 and 2008-2010 reference vaccine strain A/Brisbane/10/2007 on the phylogenetic tree, while the 2012 isolates were located on another branch. In analysis of derived amino acid sequences, the 2010 isolates mutated at K81T, the 2011 isolates mutated at I26V and D127N, while the 2012 isolates mutated at E41K, P46A, I58V, T71N, L81P, D93G, D127N, D151N, and I307M. The D151N mutation added a glycosylation site to the activity center of NA. No significant variation was discovered in H3N2 NA gene of 2010-2011 isolates in Qinghai, China. Isolates of 2012 were found with significant mutation, which has the potential of inducing minor resistance to NA inhibitors like zanamivir and oseltamivir.
Amino Acid Sequence ; China ; Humans ; Influenza A Virus, H3N2 Subtype ; classification ; enzymology ; genetics ; isolation & purification ; Influenza, Human ; virology ; Molecular Sequence Data ; Neuraminidase ; chemistry ; genetics ; Phylogeny ; Sequence Alignment ; Viral Proteins ; chemistry ; genetics

OBJECTIVE:To determine the contents of citric acid in fentanyl citrate raw materials and its injection by ion chro-matography. METHODS:The determination was performed on Thermo Dionex IonPacTM AS11-HC column with mobile phase con-sisted of potassium hydroxide (gradient elution) at the flow rate of 1.0 mL/min. The column temperature was 35 ℃,and sample size was 20 μL. The detector was suppressed conductivity detector. RESULTS:The linear range of citric acid were 0.1157-74.05 μg/mL(r=0.9995). The limit of quantitation was 0.1150 μg/mL,and the limit of detection was 0.0400 μg/mL;RSDs of preci-sion,stability and reproducibility tests were all lower than 2.0%;the average recoveries were 99.6%-101.5%(RSD=0.68%,n=9). CONCLUSIONS:The method is environmentally-friendly and simple with good accuracy and precision,and suitable for the contents determination of citric acid in fentanyl citrate raw materials and injection.

Conjunctiva ; surgery ; Diagnosis, Differential ; Eye Neoplasms ; metabolism ; pathology ; surgery ; Humans ; Infant ; Male ; Neoplasm Recurrence, Local ; Nerve Sheath Neoplasms ; metabolism ; pathology ; surgery ; Reoperation ; S100 Proteins ; metabolism

ObjectiveTo investigate the effect of cerebroprotein hydrolysate on diabetic peripheral neuropathy.Methods105 diabetic patients were randomly divided into the treatment group (34 cases, treated with intravenous injection of cerebroprotein hydrolysate), standard control group (38 cases, treated with intramuscular injection of Metrycobal combined with intravenous injection of Actovegin) and blank control group (33 cases, treated with oral vitamin B1, B6, B12). Curative effects of three groups were evaluated.ResultsIt was shown that intravenous injection of cerebropotein hydrolysate could improve patients' symptoms, raised speed of nerve conduction and its curative effect was as same as intramuscular injection of Metrycobal combined with intravenous injection of Actovegin.ConclusionIntravenous injection of cerebropotein hydrolysate has a curation effect on diabetic peripheral neuropathy.

Wound secretion from 20 patients with gaseous gangrene was collected for Gram staining,bacterial culture and drug sensitivity tests.The results indicated that gaseous gangrene was caused by the co-infection of both aerobic and anaerobic bacteria.Gram-negative bacilli were slishtly more common than other aerobic bacteria in gageous gangrene wound,which was different from the findings of ordinary gaseous gangrene.

China ; epidemiology ; Enterovirus A, Human ; genetics ; isolation & purification ; Enterovirus Infections ; diagnosis ; drug therapy ; epidemiology ; etiology ; Humans