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Table 1 Overview of the definition of sponsor

From: Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines

Guideline/regulation

Year

Sponsor’s definition

WHO GCP

1995

An individual, a company, an institution or an organization which takes responsibility for the initiation, management and/or financing of a clinical trial.

ICH GCP

1996

An individual, a company, an institution or an organization which takes responsibility for the initiation, management and/or financing of a clinical trial.

EU Directive

2002

An individual, company, institution or organization which takes responsibility for the initiation, management and/or financing of a clinical trial

Belgian Law

2004

An individual, company, institution or organization which takes responsibility for the initiation, management and/or financing of a clinical trial

UK Regulation

2004

Takes responsibility for the initiation, management and financing (or arranging the financing) of that trial.

South Africa GCP

2006

An individual, company, institution, or organisation which takes responsibility for the initiation, management, and/or financing of a clinical trial

Uganda Guidelines

2007

The sponsor is responsible for providing all the necessary financial support for initiation and completion of the research project

Uganda Guidelines

2014

The sponsor as such is not defined

Ghana GCP

2013

An individual, company, institution or organization which takes responsibility for the initiation, management and/or financing of a trial. This excludes an individual company, institution or organization which has been requested to provide money for a trial and does not benefit in any way from the results of the trial

EU Regulation

2014

An individual, company, institution or organisation which takes responsibility for the initiation, the management and for setting up the financing of the clinical trial

Ethiopia GCP

Not dated

An individual, a company, an institution or an organization which takes responsibility for the initiation, management and/or financing of a clinical trial.