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1. Title Title of document New EU regulation on clinical trials: the impact on ethics and safeguards for participants
 
2. Creator Author's name, affiliation, country Annelies Den Boer; Wemos Foundation, Ellermanstraat 15-O, PO Box 1693, 1000 BR Amsterdam; NL
 
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4. Description Abstract The European Commission has proposed a new regulation to replace the current clinical trials directive. The proposed regulation aims at accelerating the application procedure and simplifying and harmonising the administrative requirements for multi-centre trials across the European Union.
 
5. Publisher Organizing agency, location Forum for Medical Ethics Society
 
6. Contributor Sponsor(s)
 
7. Date (YYYY-MM-DD) 2016-11-30
 
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9. Format File format HTML , PDF
 
10. Identifier Uniform Resource Identifier https://ijme.in/articles/new-eu-regulation-on-clinical-trials-the-impact-on-ethics-and-safeguards-for-participants/
 
11. Source Title; vol., no. (year) Indian Journal of Medical Ethics;: Scrutiny is the key
 
12. Language English=en en
 
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14. Coverage Geo-spatial location, chronological period, research sample (gender, age, etc.)
 
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