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AIM: To investigate the design significance, method and content of the oncology clinical trial case report form (CRF) based on the clinical data acquisition standards harmonization (CDASH). METHODS: Compared with CDASH v 2.2, the characteristics of oncology clinical trial data were analyzed, and a standardized CRF was designed to meet the actual needs of oncology clinical trials. RESULTS: The CDASH was applied to the design of the CRF of the oncology clinical trial, and the data collection of the oncology clinical trial was standardized, so that the CRF design of the oncology clinical trial was relatively standardized and the data quality was improved. CONCLUSION: The implementation of oncology CRF design based on CDASH can promote the exchange and sharing of oncology clinical research data, which is conducive to improving the reliability of oncology clinical research results.
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With the enormous resources having been invested in oncology drugs development in China in recent years, the Center for Drug Evaluation (CDE) of National Medical Products Administration has been issuing a number of technical guidelines to further standardize the requirements on implementation and registration of domestic oncology clinical trials. As data is the cornerstone of clinical trials, data integrity and quality will directly decide the outcome of clinical studies. Given the specific characteristics of oncology therapeutic clinical trials, and combined with the clinical data standards established by the Clinical Data Interchange Standards Consortium (CDISC) and the issued industrial guidelines, this article introduces the general considerations of clinical data management for oncology clinical trials, with the aim of emphasizing normative data collection and timely data monitoring to ensure the data quality and reliability of results of the study. This article discusses the impact of complex study design on CRF, design CRF according to CDASH, develop DVP scientifically, rolling submissions and data cut-off.
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Optimum research on famous TCM doctors’ experienced prescriptions can optimize the composition of prescriptions which originated from experienced prescriptions, clarify the functions of indications and efficacy features of experienced prescriptions. Case report forms which are normally adapted to clinical new medicine study cannot meet the demand of observational study to optimize experienced prescriptions. This article expounded design features, structure elements and collection timing and proposed requirements for information collection through practice of case report forms in the optimum research on famous TCM doctors’ experienced prescriptions, with a purpose to realize the optimization of experienced prescriptions through observational study on famous TCM doctors’ experienced prescriptions and provide evidence for further clinical research on experienced prescriptions.
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OBJECTIVE: This study aims to develop the web-interface creator, which automatically changes the Case Report Form(CRF) web page when the protocol developer in any clinical study revises the ontology of CRF. METHODS: This study established the conceptual model of CRF on oriental and western medicine, and developed ontologies. A program was developed to produce online-based a input form through the parser that generates automatically HTML script from OWL. RESULTS: The CRF applied in this study is a draft through consensus of experts for stroke research at the Korea Institute of Oriental Medicine. The ontology of CRF consisted of Label, ControlType and Value classes and hasControl, hasValue and hasSymptoms properties. The Label is the class of question items groups, so it could have CRF questionnaire instances. The ControlType is the class that expresses controls such as checkbox, text, etc in the HTML script. The Value class represents selections for each items. Finally, the HTML script was created by XSL transformation from the OWL script. CONCLUSION: Online-based automatic interface creation, which enables immediate coping with the continuous change in the medical knowledge system, assures reduced time requirement.
Subject(s)
Consensus , Korea , Medicine, East Asian Traditional , Strigiformes , StrokeABSTRACT
OBJECTIVE: Clinical trials are the most time-consuming and expensive part of the drug development process. Clinical Trial Management Systems (CTMSs) help sponsors of clinical trials manage all aspects of planning, performance, and reporting. Most conventional systems provide data processing functions using database management system (DBMS) procedures, which cause DBMS dependency problems. Thus, it is hard to handle the system by researchers who are unfamiliar with database. It is also difficult to share Electronic Case Report Forms (eCRFs) between institutions because conventional systems rely on specific software. METHODS: PhactaManager was developed for solving these problems by introducing an XML Layer in the application tier using an Entity-Attribute-Value model in the database tier. RESULTS: PhactaManager is a three-tier clinical trial management system that has an XML layer. The XML Layer provides a common DBMS independent eCRF document processing platform. Also we developed XML based eCRF Grammar to describe eCRF documents. The XML data elements described by eCRF grammar was constitute to eCRF by PhactaDesigner which an eCRF document design program. CONCLUSION: We achieved DBMS independency by implementing the XML Layer in PhactaManager. The Development of the eCRF Grammar enables the standardization of eCRF design, data correction and data sharing in multicenter clinical trial.