Infrastructure and contents of clinical data management plan / 药学学报

Establishment of quality management system (QMS) plays a critical role in the clinical data management (CDM). The objectives of CDM are to ensure the quality and integrity of the trial data. Thus, every stage or element that may impact the quality outcomes of clinical studies should be in the controlled manner, which is referred to the full life cycle of CDM associated with the data collection, handling and statistical analysis of trial data. Based on the QMS, this paper provides consensus on how to develop a compliant clinical data management plan (CDMP). According to the essential requirements of the CDM, the CDMP should encompass each process of data collection, data capture and cleaning, medical coding, data verification and reconciliation, database monitoring and management, external data transmission and integration, data documentation and data quality assurance and so on. Creating and following up data management plan in each designed data management steps, dynamically record systems used, actions taken, parties involved will build and confirm regulated data management processes, standard operational procedures and effective quality metrics in all data management activities. CDMP is one of most important data management documents that is the solid foundation for clinical data quality.

Safety and immunogenicity on the formulation of trivalent split influenza vaccine among healthy people aged over 18 years / 中华流行病学杂志

Objective To evaluate the safety and immunogenicity of split influenza vaccine (Anflu(R) ). Methods An open-labeled clinical trial was carried out in adults aged 18-60 years and elders aged over 60 years from August to September, 2010 in Shenyang, Liaoning province. One dose of split influenza vaccine was administered and adverse events were observed. Serum samples were obtained prior to vaccination and 21 days post vaccination. A/H1N1, A/H3N2 and B antibodies against influenza virus were measured using micro-hemagglutination inhibition (HI) assay. Results A total of 130 subjects were recruited and 120 paired serum samples were obtained. The overall rate of adverse events was 2.3% (3/130) and all of them with systemic reaction. No single serious adverse event was reported. 21 days after the vaccination, the sero-conversion rates of A/H1N1, A/H3N2 and B antibodies against influenza virus among adults were 82.5%, 93.7% and 92.1%, respectively. The Geometric Mean Titer (GMT) ratios were 20.2, 32.0 and 11.4, while the sero-protection rates were 92.1%, 98.4% and 98.4%, respectively. The sero-conversion rates of antibodies among elders were 89.5%, 91.2% and 87.7%, with the GMT ratios as 23.9, 39.8 and 15.1, respectively. The seroprotection rates were 93.0%, 94.7% and 96.5%,respectively. Conclusion All indexes ofA/H1N1,A/H3N2 and B antibodies exceeded the licensure criteria established by the EU Committee for Medicinal Products for Human Use,proving the trial vaccine Anflu(R) with good safety and immunogenicity.