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
We designed and applied the electronic data capture system (EDC) in order to strengthen the re-search quality and improve the efficiency of data collection of multi-center nursing research. According to the needs of research,we reasonably designed the EDC structure and functions,including data collection,verification, summary and export. Further improvement was performed after EDC was inputted into using. By using EDC,resear-chers from sub-centers completed the data collection smoothly,and the data quality met with research requirements. The design and application of EDC could effectively guarantee the data quality and improve the research efficiency.
ABSTRACT
Objective To establish a method for data quality control of clinical research data based on electronic data capture (EDC) system.Methods After analyzed the specific characteristics of EDC's workflow process,and also referred to international data management guideline,we established the data quality control strategy by summarizing actual data quality control experience of data management department in Peking University Clinical Research Institute.Results Application of EDC has changed traditional clinical research process,therefore EDC data quality control strategy should be built according to its own process flow,namely,selecting the appropriate EDC system,reasonable design and build electronic case report form (eCRF),standardization research center / user management processes,timely and accurate on line eCRF filling up,accurately capturing/docking ex ternal electronic data,planned data monitor and auditing,timely and efficient query management,strictly data locking and unlocking operation process,and strict electronic record life cycle monitoring.Conclusions At present time,clinical research in China is still in the earlier stage of the transition from traditional paper-based data collection (PDC) to EDC.Establishing and applying particular quality control strategy will optimize the process and results of data quality control.
ABSTRACT
OBJECTIVE: Personal Digital Assistants (PDAs) have the potential to improve clinical trial data collection; however, most current PDA-based clinical data collection systems typically collect and store data in the offline mode, and then transfer the data to an operational database. The purpose of this study was to explore the usefulness of a wireless clinical data collection system for an irritable bowel syndrome trial compared with the traditional paper based data collection. METHODS: We have developed a PDA-based data capture system for clinical trials, and tested it in a double-blind trial. Sixty four patients with irritable bowel syndrome were randomly selected and divided into a control group that used the standard paper report forms (CRF) and an intervention group that used the electronic report forms (e-CRF), daily for five weeks. There were 630 data sets consisting of six questions each, and thus 3,570 data points total were collected. RESULTS: The response rate of the control group was significantly higher than that of the intervention group. However, the completeness of the response in the intervention group was higher and the number of input errors per person for the PDA group was lower than in the paper group. CONCLUSION: A PDA based electronic diary improved the response rate and decreased input errors in an IBS trial. We conclude that mobile devices can be very useful, especially when the proposed design and connectivity aspects have been taken into account.