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CIOMS

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CIOMSCouncil for International Organizations of Medical Sciences


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There were also important ethical challenges with regard to research in developing countries represented in the 1991 CIOMS Guidelines.
Some of the documents always requested in an EU pharmacoviglance inspection include: * CVs, job descriptions, training records; * Organization charts; * Procedural documents; * Individual ADE case files and CIOMS reports; * Contracts and agreements with third parties; * Risk management systems; * Meeting minutes; and * Line listings of ADR reports.
Some of the documents always requested in an EU pharmacoviglance inspection include: * CVs, job descriptions, training records; * Organization charts; * Procedural documents; * Individual ADE case files and CIOMS reports; * Contracts and agreements with third parties; * Risk management systems; * Meeting minutes; and * Line listings of ADR reports.
 
 
 
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