Indemnity clinical trials

Provision for indemnity or compensation in the event of injury or death attributable to the clinical trial... 

In order to promote a uniform approach to offering compensation to subjects and indemnity to investigators and institutions conducting clinical trials, Medicines Australia has published a Form of Indemnity for Clinical Trials and Guidelines for Compensation for Injury Resulting from Participation in a Company-Sponsored Chnical Trial. These documents are based on those published by the Association of the British Pharmaceutical Industry and are available from www.medicinesaustralia.com.au (the Medicines Australia website). 

NHS Trust by a Clinical Trial Subject, the Sponsor shall indemnify the NHS Trust, its servants, agents and employees in accordance with the terms of the indemnity set out at Appendix 4 hereto. 

For the purpose of this indemnity, the expression agents shall be deemed to include without limitation any nurse or other health professional providing services to the NHS Trust under a contract for services or otherwise and any person carrying out work for the NHS Trust under such a contract connected with such of the NHS Trust s facilities and equipment as are made available for the Clinical Trial. 

Insurance A copy of insurance certificates for clinical trials insurance and forms of mutual indemnity. 

Provision for indemnity or compensation in the event of injury or death of subjects attributable to the clinical trial, and for insurance or indemnity to cover liability of the investigator and sponsor must be described. The financial arrangements for rewarding or compensating investigators and trial subjects and relevant aspects between the sponsor and site and arrangements for recruiting subjects are to be documented. 

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