ABSTRACT
Data acquisition is one of the key links that influencing the quality of clinical research.Electronic data capture system (EDC) embodies the advantages of saving time,manpower and material resources and improving efficiency and reliability by data acquisition.CDISC has established worldwide industry standards to support the electronic acquisition,exchange,submission and archiving of clinical research data.The application of CDISC standards to EDC system is favorable in ensuring the validity and standardization of clinical data.This paper takes the Oracle's OC/ RDC (Oracle Clinical / Oracle Remote Data Capture) system as an example to discuss the application of CDISC standard to EDC system from the two aspects:direct application and indirect application.We suggest that data collection should be taken into account during the design phase of a clinical trial,and the CDISC standard be applied at the CRF design stage.A design for eCRF takes time and effort by the combination of EDC system and CDISC standard,while thoughtless design may collect the wrong data.Therefore,it is suggested that a specialized personnel should be put in charge of eCRF design and maintenance during the operation of EDC system,and a set of standardized eCRFs based on CDISC standard and standard operating procedures should be built in one organization.
ABSTRACT
In this article, a new TCM clinical trial of phaseⅢ was served as an example of application of Clinical Data Interchange Standards Consortium (CDISC). It briefly introduced seven data acquisition modules commonly used in clinical research of new traditional Chinese medicine, namely demographics, subject characteristic, clinical event, medical history, questionnaire, laboratory inspection and adverse event. It also introduced the process of transferring the above modules to Study Data Tabulation Models (STDM), and discussed the feasibility and some issues that required attention of CDISC application in clinical research of new traditional Chinese medicine.
ABSTRACT
While there is an advantage to be able to directly utilize some research database of medical information must solve several problems. It also includes support for international standardization, led by computerized system validation, and CDISC. We should countermeasures with epidemiological studies using SS-MIX standardized storage, in anticipation of its application to clinical trials in the near future in Japan. (Jpn J Pharmacoepidemiol 2013；18(1)：35-39)