Application of Metadata Repository and Master Data Management in Clinical Trial and Drug Safety

2015 ◽  
pp. 33-46
Author(s):  
Chandrakant Ekkirala
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Data Management ◽  
Drug Safety ◽  
Detailed Explanation ◽  
Master Data ◽  
Master Data Management ◽  
Metadata Repository ◽  
Definition Of

This chapter talks about metadata repository, and master data management in clinical trial and drug safety. The chapter begins with the definition of metadata repository and gives an explanation around the same, It talks about a well designed metadata repository and the characteristics associated with the same. A brief around why we need metadata and the reasons for the using the same has also been mentioned. The benefits of a well structured metadata repository was also mentioned in detail. The chapter then gives a detailed explanation on master data management and the usage of MDM in clinical trials. MDM solutions for clinical trials management is also explained in detail.

Clinical Trial Data Management Software: A Review of the Technical Features

2019 ◽  
Vol 14 (3) ◽  
pp. 160-172 ◽  
Author(s):  
Aynaz Nourani ◽  
Haleh Ayatollahi ◽  
Masoud Solaymani Dodaran
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Data Management ◽  
Clinical Data ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Data Management System ◽  
Management Systems ◽  
Data Management Systems ◽  
Technical Features

Background:Data management is an important, complex and multidimensional process in clinical trials. The execution of this process is very difficult and expensive without the use of information technology. A clinical data management system is software that is vastly used for managing the data generated in clinical trials. The objective of this study was to review the technical features of clinical trial data management systems.Methods:Related articles were identified by searching databases, such as Web of Science, Scopus, Science Direct, ProQuest, Ovid and PubMed. All of the research papers related to clinical data management systems which were published between 2007 and 2017 (n=19) were included in the study.Results:Most of the clinical data management systems were web-based systems developed based on the needs of a specific clinical trial in the shortest possible time. The SQL Server and MySQL databases were used in the development of the systems. These systems did not fully support the process of clinical data management. In addition, most of the systems lacked flexibility and extensibility for system development.Conclusion:It seems that most of the systems used in the research centers were weak in terms of supporting the process of data management and managing clinical trial's workflow. Therefore, more attention should be paid to design a more complete, usable, and high quality data management system for clinical trials. More studies are suggested to identify the features of the successful systems used in clinical trials.

Experiences in Establishing Trustworthy Digital Repositories Within a Large Multi-National Pipeline Company

2012 ◽  
Author(s):  
David A. Weir ◽  
Stephen Murray ◽  
Pankaj Bhawnani ◽  
Douglas Rosenberg
Keyword(s):  
Data Management ◽  
Lessons Learned ◽  
Records Management ◽  
Digital Repositories ◽  
Geographically Dispersed ◽  
Local Business ◽  
Master Data ◽  
Business Area ◽  
Master Data Management ◽  
Trusted Data

Traditionally business areas within an organization individually manage data essential for their operation. This data may be incorporated into specialized software applications, MS Excel or MS Access etc., e-mail filing, and hardcopy documents. These applications and data stores support the local business area decision-making and add to its knowledge. There have been problems with this approach. Data, knowledge and decisions are only captured locally within the business area and in many cases this information is not easily identifiable or available for enterprise-wide sharing. Furthermore, individuals within the business areas often keep “shadow files” of data and information. The state of accuracy, completeness, and timeliness of the data contained within these files is often questionable. Information created and managed at a local business level can be lost when a staff member leaves his or her role. This is especially significant given ongoing changes in today’s workforce. Data must be properly managed and maintained to retain its value within the organization. The development and execution of “single version of the truth” or master data management requires a partnership between the business areas, records management, legal, and the information technology groups of an organization. Master data management is expected to yield significant gains in staff effectiveness, efficiency, and productivity. In 2011, Enbridge Pipelines applied the principles of master data management and trusted data digital repositories to a widely used, geographically dispersed small database (less than 10,000 records) that had noted data shortcomings such as incomplete or incorrect data, multiple shadow files, and inconsistent usage throughout the organization of the application that stewards the data. This paper provides an overview of best practices in developing an authoritative single source of data and Enbridge experience in applying these practices to a real-world example. Challenges of the approach used by Enbridge and lessons learned will be examined and discussed.

scholarly journals Practical and conceptual issues of clinical trial registration for Brazilian researchers

2015 ◽  
Vol 134 (1) ◽  
pp. 28-33 ◽  
Author(s):  
Carolina Gomes Freitas ◽  
Thomas Fernando Coelho Pesavento ◽  
Maurício Reis Pedrosa ◽  
Rachel Riera ◽  
Maria Regina Torloni
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
International Committee ◽  
New Drugs ◽  
Trial Registration ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Registration Process ◽  
Trial History ◽  
Definition Of

CONTEXT AND OBJECTIVE: Clinical trial registration is a prerequisite for publication in respected scientific journals. Recent Brazilian regulations also require registration of some clinical trials in the Brazilian Clinical Trials Registry (ReBEC) but there is little information available about practical issues involved in the registration process. This article discusses the importance of clinical trial registration and the practical issues involved in this process. DESIGN AND SETTING: Descriptive study conducted by researchers within a postgraduate program at a public university in São Paulo, Brazil. METHODS: Information was obtained from clinical trial registry platforms, article reference lists and websites (last search: September 2014) on the following topics: definition of a clinical trial, history, purpose and importance of registry platforms, the information that should be registered and the registration process. RESULTS: Clinical trial registration aims to avoid publication bias and is required by Brazilian journals indexed in LILACS and SciELO and by journals affiliated to the International Committee of Medical Journal Editors (ICMJE). Recent Brazilian regulations require that all clinical trials (phases I to IV) involving new drugs to be marketed in this country must be registered in ReBEC. The pros and cons of using different clinical trial registration platforms are discussed. CONCLUSIONS: Clinical trial registration is important and various mechanisms to enforce its implementation now exist. Researchers should take into account national regulations and publication requirements when choosing the platform on which they will register their trial.

Urban Master Data Management

2017 ◽  
pp. 441-465
Author(s):  
Adolphe Ayissi Eteme ◽  
Justin Moskolai Ngossaha
Keyword(s):  
Information Technology ◽  
Information Systems ◽  
Data Management ◽  
Data Repository ◽  
Distributed Data ◽  
Data Systems ◽  
Policy Makers ◽  
Master Data ◽  
Master Data Management

The use of information technology in council management has resulted in the generation of a large amount of data through various autonomous urban bodies. The relevant bodies barely or never reuse such locally-generated data. This may be due particularly to managers', policy makers' and users' lack of awareness of existing information. The Platform for the Integration and Interoperability of the Yaounde Urban Information Systems (YUSIIP) project seeks to reduce this deficit by establishing a federated operational platform of heterogeneous and distributed data systems based on a distributed data repository. The position developed in this paper is that Master Data Management (MDM) will contribute to achieving this objective in a context marked by the dispersion and duplication of data and diversity of information systems.

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