Informed consent and assent guide for paediatric clinical trials in Europe

OBJECTIVE: Clinical trial sponsors spend considerable resources preparing informed consent (IC) and assent documentation for multinational paediatric clinical trial applications in Europe due to the limited and dispersed patient populations, the variation of national legal and ethical requirements,...

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Detalles Bibliográficos
Autores principales: Lepola, Pirkko, Kindred, Maxine, Giannuzzi, Viviana, Glosli, Heidi, Dehlinger-Kremer, Martine, Dalrymple, Harris, Neubauer, David, Boylan, Geraldine B, Conway, Jean, Dewhurst, Jo, Hoffman, Diane
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Original Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9125378/
https://www.ncbi.nlm.nih.gov/pubmed/34853000
http://dx.doi.org/10.1136/archdischild-2021-322798

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9125378/
https://www.ncbi.nlm.nih.gov/pubmed/34853000
http://dx.doi.org/10.1136/archdischild-2021-322798

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