Standard requirements for GCP-compliant data management in multinational clinical trials

Christian Ohmann; Wolfgang Kuchinke; Steve Canham; Jens Lauritsen; Nader Salas; Carmen Schade-Brittinger; Michael Wittenberg; Gladys McPherson; John McCourt; Francois Gueyffier; Andrea Lorimer; Ferràn Torres; ECRIN Working Group on Data Centres

doi:10.1186/1745-6215-12-85

Standard requirements for GCP-compliant data management in multinational clinical trials

Christian Ohmann, Wolfgang Kuchinke, Steve Canham, Jens Lauritsen, Nader Salas, Carmen Schade-Brittinger, Michael Wittenberg, Gladys McPherson, John McCourt, Francois Gueyffier, Andrea Lorimer, Ferràn Torres, ECRIN Working Group on Data Centres

Copenhagen Trial Unit

56 Citations (Scopus)

Abstract

A recent survey has shown that data management in clinical trials performed by academic trial units still faces many difficulties (e.g. heterogeneity of software products, deficits in quality management, limited human and financial resources and the complexity of running a local computer centre). Unfortunately, no specific, practical and open standard for both GCP-compliant data management and the underlying IT-infrastructure is available to improve the situation. For that reason the "Working Group on Data Centres" of the European Clinical Research Infrastructures Network (ECRIN) has developed a standard specifying the requirements for high quality GCP-compliant data management in multinational clinical trials.

Original language	English
Journal	Trials
Volume	12
Pages (from-to)	85
ISSN	1745-6215
DOIs	https://doi.org/10.1186/1745-6215-12-85
Publication status	Published - 2011

Keywords

Certification
Clinical Trials as Topic
Data Collection
Guideline Adherence
Humans
Information Management
Information Storage and Retrieval
International Cooperation
Multicenter Studies as Topic
Quality Control
Research Design

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10.1186/1745-6215-12-85

Cite this

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title = "Standard requirements for GCP-compliant data management in multinational clinical trials",

abstract = "A recent survey has shown that data management in clinical trials performed by academic trial units still faces many difficulties (e.g. heterogeneity of software products, deficits in quality management, limited human and financial resources and the complexity of running a local computer centre). Unfortunately, no specific, practical and open standard for both GCP-compliant data management and the underlying IT-infrastructure is available to improve the situation. For that reason the {"}Working Group on Data Centres{"} of the European Clinical Research Infrastructures Network (ECRIN) has developed a standard specifying the requirements for high quality GCP-compliant data management in multinational clinical trials.",

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T1 - Standard requirements for GCP-compliant data management in multinational clinical trials

AU - Ohmann, Christian

AU - Kuchinke, Wolfgang

AU - Canham, Steve

AU - Lauritsen, Jens

AU - Salas, Nader

AU - Schade-Brittinger, Carmen

AU - Wittenberg, Michael

AU - McPherson, Gladys

AU - McCourt, John

AU - Gueyffier, Francois

AU - Lorimer, Andrea

AU - Torres, Ferràn

AU - ECRIN Working Group on Data Centres

PY - 2011

Y1 - 2011

N2 - A recent survey has shown that data management in clinical trials performed by academic trial units still faces many difficulties (e.g. heterogeneity of software products, deficits in quality management, limited human and financial resources and the complexity of running a local computer centre). Unfortunately, no specific, practical and open standard for both GCP-compliant data management and the underlying IT-infrastructure is available to improve the situation. For that reason the "Working Group on Data Centres" of the European Clinical Research Infrastructures Network (ECRIN) has developed a standard specifying the requirements for high quality GCP-compliant data management in multinational clinical trials.

AB - A recent survey has shown that data management in clinical trials performed by academic trial units still faces many difficulties (e.g. heterogeneity of software products, deficits in quality management, limited human and financial resources and the complexity of running a local computer centre). Unfortunately, no specific, practical and open standard for both GCP-compliant data management and the underlying IT-infrastructure is available to improve the situation. For that reason the "Working Group on Data Centres" of the European Clinical Research Infrastructures Network (ECRIN) has developed a standard specifying the requirements for high quality GCP-compliant data management in multinational clinical trials.

KW - Certification

KW - Clinical Trials as Topic

KW - Data Collection

KW - Guideline Adherence

KW - Humans

KW - Information Management

KW - Information Storage and Retrieval

KW - International Cooperation

KW - Multicenter Studies as Topic

KW - Quality Control

KW - Research Design

UR - https://www.scopus.com/pages/publications/79953067734

U2 - 10.1186/1745-6215-12-85

DO - 10.1186/1745-6215-12-85

M3 - Journal article

C2 - 21426576

SN - 1745-6215

VL - 12

SP - 85

JO - Trials

JF - Trials

ER -

Standard requirements for GCP-compliant data management in multinational clinical trials

Abstract

Keywords

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