[引用][C] Clinical Trial Data Integrity

JT Mitchel, J You, YJ Kim, R Nardi, L Cheng… - 2003 - Advanstar Communications Inc.

NIDDK data repository: a central collection of clinical trial data

AJ Cuticchia, PC Cooley, RD Hall, Y Qin - BMC medical informatics and …, 2006 - Springer
Abstract Background The National Institute of Diabetes and Digestive and Kidney Diseases
have established central repositories for the collection of DNA, biological samples, and …

[HTML][HTML] A simple versatile solution for collecting multidimensional clinical data based on the CakePHP web application framework

M Biermann - Computer methods and programs in biomedicine, 2014 - Elsevier
Clinical trials aiming for regulatory approval of a therapeutic agent must be conducted
according to Good Clinical Practice (GCP). Clinical Data Management Systems (CDMS) are …

Secondary use of routinely collected patient data in a clinical trial: an evaluation of the effects on patient recruitment and data acquisition

F Köpcke, S Kraus, A Scholler, C Nau… - International journal of …, 2013 - Elsevier
PURPOSE: Clinical trials are time-consuming and require constant focus on data quality.
Finding sufficient time for a trial is a challenging task for involved physicians, especially …

Could an open-source clinical trial data-management system be what we have all been looking for?

GW Fegan, TA Lang - PLoS medicine, 2008 - journals.plos.org
Could an Open-Source Clinical Trial Data-Management System Be What We Have All Been
Looking For? | PLOS Medicine Skip to main content Advertisement PLOS Medicine Browse …

[HTML][HTML] A pragmatic method for transforming clinical research data from the research electronic data capture “REDCap” to Clinical Data Interchange Standards …

K Yamamoto, K Ota, I Akiya, A Shintani - Journal of biomedical informatics, 2017 - Elsevier
Abstract The Clinical Data Interchange Standards Consortium (CDISC) Study Data
Tabulation Model (SDTM) can be used for new drug application studies as well as …

An eClinical trial system for cancer that integrates with clinical pathways and electronic medical records

K Yamamoto, K Yamanaka, E Hatano, E Sumi… - Clinical …, 2012 - journals.sagepub.com
Background Various information technologies currently are used to improve the efficiency of
clinical trials. However, electronic medical records (EMRs) are not yet linked to the electronic …

A European inventory of common electronic health record data elements for clinical trial feasibility

J Doods, F Botteri, M Dugas, F Fritz - Trials, 2014 - Springer
Background Clinical studies are a necessity for new medications and therapies. Many
studies, however, struggle to meet their recruitment numbers in time or have problems in …

Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting

P Bruland, M McGilchrist, E Zapletal, D Acosta… - BMC medical research …, 2016 - Springer
Background Data capture is one of the most expensive phases during the conduct of a
clinical trial and the increasing use of electronic health records (EHR) offers significant …

Designing, implementing, and testing a modern electronic clinical study management system–the HUBRO system

M Muzny, M Bradway, H Blixgård… - … Conference on Health …, 2022 - ecp.ep.liu.se
Clinical trials need to adapt to the rapid development of today's digital health technologies.
The fast phase these technologies are changing today, make the clinical study …