A cross-sectional study of Phase I Clinical Trials authorized in Spain: An analysis of characteristics and times of execution based on experience-Reference-Cited by-同舟云学术

A cross-sectional study of Phase I Clinical Trials authorized in Spain: An analysis of characteristics and times of execution based on experience

Published:2024-07 Issue: Volume: Page:
ISSN:0025-7753
Container-title:Medicina Clínica
language:en
Short-container-title:Medicina Clínica

Author:

Filippi-Arriaga Francesca,Molina Pol,Delgado-Espinoza Claudia Erika,Antonijoan Rosa

Publisher

Elsevier BV

Reference28 articles.

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2. Official Journal of the European Union. Communication from the Commission regarding the guideline on the data fields contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC to be included in the database on medicinal products provided for in Article 57 of Regulation (EC) No 726/2004 2008; 2008. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX: 52008XC0703(02) [consulted 13.6.24].

3. National Institutes of Health, Department of Health and Human Services. Department of Health And Human Services 42 Cfr Part 11 [Docket Number Nih-2011-0003] Rin 0925-Aa55 Clinical Trials Registration And Results Information Submission; 2016. https://www.govinfo.gov/content/pkg/FR-2016-09-21/pdf/2016-22129.pdf [consulted 13.6.24].

4. Food and Drug Administration (FDA). Public Law 110-85—Sept. 27, 2007; 2007. https://www.govinfo.gov/content/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf#page=82 [consulted 13.6.24].

5. European Medicines Agency. Commission Guideline—Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006 and 2012/C 302/03; 2012. https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52008XC0703(02) [consulted 13.6.24].