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

The quality and integrity of clinical trials and associated data are not only derived from accuracy of trial data analyses, but also closely embodied to the authenticity and integrity of those data and data documents as well as the compliant procedures obtaining those data and relevant files in the life cycle of clinical trials. The compliances of good clinical practices and standards suggest the reliability, complete and accuracy of data and data documents, which is constructing the convincible foundation of drug efficacy and safety validated via clinical trials. Therefore, the monitoring and auditing on clinical trials and associated data quality keep eyes on not only verifications of reliability and correctness on the data analytic outcomes, but also validation of science and compliance of the trial management procedure and documentations in the process of data collections.
Clinical Trials as Topic ; standards ; Data Accuracy ; Reproducibility of Results

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

Objective To investigate the expression of sodium iodide symporter (NIS ) mRNA in differentiated thyroid Carcinoma (DTC)and further explore its value in clinical diagnosis and therapy of DTC. Methods The expression of NIS mRNA was detected and analyzed in 21 nodular goiter and 45 cases of DTC (including 35 cases of papillary thyroid carcinoma and 10 cases of follicular thyroid carcinoma)by using real-time fluorescent quantitative reverse transcription polymerase chain reaction (real-time RT-PCR).Results Compared with that in nodular goiter,the mRNA expression of NIS in DTC tissue was significantly decreased (P < 0.05 ). Moreover,the mRNA expression of NIS was significantly correlated with lymph node metastasis and AJCC stage, respectively.The expression of NIS mRNA in DTC with lymph node metastasis was significantly decreased compared with that in DTC without lymph node metastasis (P <0.05).In addition,the expression of NIS mRNA in Ⅱ-Ⅳstage DTC was significantly decreased compared with that in Ⅰ - Ⅱ stage DTC (P < 0.05 ).Conclusion Differential expression of NIS can provide evidence for individual 1 3 1 I therapy for DTC.