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What should we report? Lessons learnt from the development and implementation of serious adverse event reporting procedures in non-pharmacological trials in palliative care

BACKGROUND/AIMS: Serious adverse event reporting guidelines have largely been developed for pharmaceutical trials. There is evidence that serious adverse events, such as psychological distress, can also occur in non-pharmaceutical trials. Managing serious adverse event reporting and monitoring in pa...

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Detalles Bibliográficos
Autores principales: Dunleavy, Lesley, Collingridge Moore, Danni, Korfage, Ida, Payne, Sheila, Walshe, Catherine, Preston, Nancy
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7819235/
https://www.ncbi.nlm.nih.gov/pubmed/33472621
http://dx.doi.org/10.1186/s12904-021-00714-5