Quality assurance review center: Role in multi-institutional breast cancer trials.

2011 ◽  
Vol 29 (27_suppl) ◽  
pp. 205-205
Author(s):  
J. Moni ◽  
H. T. Le-Petross ◽  
J. C. Boughey ◽  
F. Laurie ◽  
R. Hanusik ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Assurance ◽  
Data Acquisition ◽  
Data Management ◽  
Remote Access ◽  
Data Management System ◽  
Data Systems ◽  
Neoadjuvant Endocrine Therapy ◽  
Trial Management ◽  
Cancer Trials

205 Background: Central review is an important trial management and validation tool. Multisite trials require data systems to accommodate diverse image acquisition and review. Breast cancer is challenging as its imaging objects are not always easily shared across departments. Quality Assurance Review Center (QARC) has a diverse portfolio of facile data acquisition and powerful informatics support that meets these needs. We report on the role of QARC in three of the current breast cancer trials from the American College of Surgeons Oncology Group. Methods: QARC data management system includes secure network infrastructure and a validated relational operating database (MAX). QARC has data acquisition/imaging re-distribution expertise for real time response reviews, response measuring tools and corresponding data archive for secondary reviews. MAX includes query ability; records link to digital information. QARC underwent systematic information systems validation process for 21 CFR Part 11. DICOM/non-DICOM files are stored in the QARC PACS. On-site/remote reviewers use MAX to retrieve, view, annotate and save images. Data extracted is securely sent to partner statistical centers. Results: In Z1031, a neoadjuvant endocrine therapy trial, all of the mammographic exams are archived at QARC. For Z1071, a sentinel lymph node trial, pre- and post-treatment ultrasound (US) images of 321 patients were remotely reviewed. For Z1072, the cryoablation US, pre and post-cryoablation MRI for 40 of 47 cases were remotely archived, retrieved and transferred to investigator workstation for post-processing and review. The other 7 patients did not have evaluable imaging studies. In all three trials, the costs of shipping hardcopies of exams and travel to QARC for central review functions were eliminated. Conclusions: QARC data management systems provide diverse informatics supports for multi-institutional trials, ranging from archives of images, provide remote access and download of data, and central review. The vibrant informatics supports meet the growing needs of clinical trials. Future directions include radiation field review for breast cancer trials and the incorporation of pathology microarray analysis as DICOM objects.

scholarly journals Developing a modern data workflow for evolving data

2018 ◽  
Author(s):  
Glenda M. Yenni ◽  
Erica M. Christensen ◽  
Ellen K. Bledsoe ◽  
Sarah R. Supp ◽  
Renata M. Diaz ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Data Management ◽  
Research Process ◽  
Data Management System ◽  
Limited Attention ◽  
Data Pipeline ◽  
Evolving Data ◽  
Access To Data ◽  
And Control ◽  
Quality Assurance And Control

AbstractData management and publication are core components of the research process. An emerging challenge that has received limited attention in biology is managing, working with, and providing access to data under continual active collection. “Evolving data” present unique challenges in quality assurance and control, data publication, archiving, and reproducibility. We developed a evolving data workflow for a long-term ecological study that addresses many of the challenges associated with managing this type of data. We do this by leveraging existing tools to: 1) perform quality assurance and control; 2) import, restructure, version, and archive data; 3) rapidly publish new data in ways that ensure appropriate credit to all contributors; and 4) automate most steps in the data pipeline to reduce the time and effort required by researchers. The workflow uses two tools from software development, version control and continuous integration, to create a modern data management system that automates the pipeline.

scholarly journals Data Validation and Verification Using Blockchain in a Clinical Trial for Breast Cancer: Regulatory Sandbox (Preprint)

2020 ◽  
Author(s):  
Tomonobu Hirano ◽  
Tomomitsu Motohashi ◽  
Kosuke Okumura ◽  
Kentaro Takajo ◽  
Taiyo Kuroki ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Data Management ◽  
Clinical Data ◽  
Clinical Trial Data ◽  
Research Process ◽  
Current Data ◽  
Data Management System ◽  
Blockchain Technology

BACKGROUND The integrity of data in a clinical trial is essential, but the current data management process is too complex and highly labor-intensive. As a result, clinical trials are prone to consuming a lot of budget and time, and there is a risk for human-induced error and data falsification. Blockchain technology has the potential to address some of these challenges. OBJECTIVE The aim of the study was to validate a system that enables the security of medical data in a clinical trial using blockchain technology. METHODS We have developed a blockchain-based data management system for clinical trials and tested the system through a clinical trial for breast cancer. The project was conducted to demonstrate clinical data management using blockchain technology under the regulatory sandbox enabled by the Japanese Cabinet Office. RESULTS We verified and validated the data in the clinical trial using the validation protocol and tested its resilience to data tampering. The robustness of the system was also proven by survival with zero downtime for clinical data registration during a Amazon Web Services disruption event in the Tokyo region on August 23, 2019. CONCLUSIONS We show that our system can improve clinical trial data management, enhance trust in the clinical research process, and ease regulator burden. The system will contribute to the sustainability of health care services through the optimization of cost for clinical trials.

scholarly journals Data Validation and Verification Using Blockchain in a Clinical Trial for Breast Cancer: Regulatory Sandbox

10.2196/18938 ◽  
2020 ◽  
Vol 22 (6) ◽  
pp. e18938
Author(s):  
Tomonobu Hirano ◽  
Tomomitsu Motohashi ◽  
Kosuke Okumura ◽  
Kentaro Takajo ◽  
Taiyo Kuroki ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Data Management ◽  
Clinical Data ◽  
Clinical Trial Data ◽  
Research Process ◽  
Current Data ◽  
Data Management System ◽  
Blockchain Technology

Background The integrity of data in a clinical trial is essential, but the current data management process is too complex and highly labor-intensive. As a result, clinical trials are prone to consuming a lot of budget and time, and there is a risk for human-induced error and data falsification. Blockchain technology has the potential to address some of these challenges. Objective The aim of the study was to validate a system that enables the security of medical data in a clinical trial using blockchain technology. Methods We have developed a blockchain-based data management system for clinical trials and tested the system through a clinical trial for breast cancer. The project was conducted to demonstrate clinical data management using blockchain technology under the regulatory sandbox enabled by the Japanese Cabinet Office. Results We verified and validated the data in the clinical trial using the validation protocol and tested its resilience to data tampering. The robustness of the system was also proven by survival with zero downtime for clinical data registration during a Amazon Web Services disruption event in the Tokyo region on August 23, 2019. Conclusions We show that our system can improve clinical trial data management, enhance trust in the clinical research process, and ease regulator burden. The system will contribute to the sustainability of health care services through the optimization of cost for clinical trials.

scholarly journals AIDA – Seismic data acquisition, processing, storage and distribution at the National Earthquake Center, INGV

2012 ◽  
Vol 55 (4) ◽  
Author(s):  
Salvatore Mazza ◽  
Alberto Basili ◽  
Andrea Bono ◽  
Valentino Lauciani ◽  
Alfonso Giovanni Mandiello ◽  
...  
Keyword(s):  
Data Acquisition ◽  
Data Management ◽  
Seismic Data ◽  
Data Acquisition System ◽  
Northern Italy ◽  
Seismic Network ◽  
Data Management System ◽  
Seismic Data Acquisition ◽  
New System

On May 4, 2012, a new system, known as the AIDA (Advanced Information and Data Acquisition) system for seismology, became operational as the primary tool to monitor, analyze, store and distribute seismograms from the Italian National Seismic Network. Only 16 days later, on May 20, 2012, northern Italy was struck by a Ml 5.9 earthquake that caused seven casualties. This was followed by numerous small to moderate earthquakes, with some over Ml 5. Then, on May 29, 2012, a Ml 5.8 earthquake resulted in 17 more victims and left about 14,000 people homeless. This sequence produced more than 2,100 events over 40 days, and it was still active at the end of June 2012, with minor earthquakes at a rate of about 20 events per day. The new AIDA data management system was designed and implemented, among other things, to exploit the recent huge upgrade of the Italian Seismic Network (in terms of the number and quality of stations) and to overcome the limitations of the previous system.

Data management system development for on-line data acquisition and process control

1992 ◽  
Vol 23 (1-4) ◽  
pp. 341-344 ◽  
Author(s):  
O. Geoffrey Okogbaa ◽  
Jiansheng Huang ◽  
Chiwei Chen ◽  
Tom Borkes ◽  
James Moore
Keyword(s):  
Process Control ◽  
Data Acquisition ◽  
Data Management ◽  
Management System ◽  
System Development ◽  
Data Management System ◽  
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