Cargando…

Sponsors’ and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials

BACKGROUND/AIMS: The Food and Drug Administration’s final rule on investigational new drug application safety reporting, effective from 28 March 2011, clarified the reporting requirements for serious and unexpected suspected adverse reactions occurring in clinical trials. The Clinical Trials Transfo...

Descripción completa

Detalles Bibliográficos
Autores principales:	Perez, Raymond, Archdeacon, Patrick, Roach, Nancy, Goodwin, Robert, Jarow, Jonathan, Stuccio, Nina, Forrest, Annemarie
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	SAGE Publications 2017
Materias:	Articles
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5560478/ https://www.ncbi.nlm.nih.gov/pubmed/28345368 http://dx.doi.org/10.1177/1740774517700640

Ejemplares similares

Industry-sponsored economic studies in oncology vs studies sponsored by nonprofit organisations
por: Hartmann, M, et al.
Publicado: (2003)

Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project
por: Perez, Raymond P, et al.
Publicado: (2016)

Optimizing Expedited Safety Reporting for Drugs and Biologics Subject to an Investigational New Drug Application
por: Archdeacon, Patrick, et al.
Publicado: (2013)

Regulatory Framework for Academic Investigator-Sponsored Investigational New Drug Development of Cell and Gene Therapies in the USA
por: Dasgupta, Anindya, et al.
Publicado: (2021)

ASCO-Sponsored Oncology Student Interest Groups in the World
por: Anampa-Guzmán, Andrea, et al.
Publicado: (2021)

American Society of Clinical Oncology–Sponsored Oncology Student Interest Groups in Latin America
por: Anampa-Guzmán, Andrea, et al.
Publicado: (2020)

The Value of Pharmaceutical Industry-Sponsored Patient Registries in Oncology Clinical Research
por: Flick, E Dawn, et al.
Publicado: (2023)

Current aspects in biobanking for personalized oncology investigations and treatments
por: Policiuc, Liliana, et al.
Publicado: (2023)

Position paper on current aspects of sponsoring in accredited CME
por: Stolz, Daiana, et al.
Publicado: (2017)

Sponsor Acknowledgement
Publicado: (2015)

Sponsor's Foreword
por: Shurtleff, David, et al.
Publicado: (2007)

Sponsor Acknowledgement
Publicado: (2018)

Sponsor Acknowledgement
Publicado: (2019)

Impact of investigator initiated trials and industry sponsored trials on medical practice (IMPACT): rationale and study design
por: Nury, E., et al.
Publicado: (2020)

Photovoltaic Safety Conference Sponsored By The Solar Energy Research Institute
por: Luft, Werner
Publicado: (1988)

Investigating the Current Status of SARS-CoV-2 Antibodies in Hospital Staff
por: Liu, Keh-Sen, et al.
Publicado: (2023)

More than a box to check: Research sponsor and clinical investigator perspectives on making GCP training relevant
por: Swezey, Teresa, et al.
Publicado: (2020)

A comparative study to evaluate quality of data documentation between investigator-initiated and pharmaceutical industry-sponsored studies
por: Figer, Brinal H., et al.
Publicado: (2020)

Investigator initiated trials versus industry sponsored trials - translation of randomized controlled trials into clinical practice (IMPACT)
por: Blümle, Anette, et al.
Publicado: (2021)

Ethics of sponsored research
por: Mandal, Jharna, et al.
Publicado: (2014)

"Sponsors" for Out-Patients
Publicado: (1887)

The oncology nurse coordinator: role perceptions of staff members and nurse coordinators
por: Monas, Liza, et al.
Publicado: (2017)

Safety climate perception for staff nurses in an ICU
por: Rivera-Romero, RL, et al.
Publicado: (2013)

Perinatal staff perceptions of safety and quality in their service
por: Sinni, Suzanne V, et al.
Publicado: (2014)

Investigation on cognition of COVID-19 and safety during the pandemic among hospital pharmacy staff
por: He, Yan, et al.
Publicado: (2020)

Illuminating for Safety: Investigating the Role of Lighting Appraisals on the Perception of Safety in the Urban Environment
por: van Rijswijk, Leon, et al.
Publicado: (2017)

Industry - from sponsor to provider?
por: Griebenow, Reinhard
Publicado: (2017)

Error in Role of the Funder/Sponsor
Publicado: (2022)

Building an Evidence Base on the Place of Industry-Sponsored Programs in Drug Safety Surveillance
por: Arlett, Peter
Publicado: (2019)

Perception of Patient Safety Culture among Hospital Staff
por: Stoyanova, Rumyana, et al.
Publicado: (2021)

Investigation of the value of a photographic tool to measure self-perception of enamel opacities
por: Davies, Gill M, et al.
Publicado: (2012)

Data-driven strategies for increasing patient diversity in Bristol Myers Squibb–sponsored US oncology clinical trials
por: Kuri, Lorena, et al.
Publicado: (2023)

Genetic testing and employer‐sponsored wellness programs: An overview of current vendors, products, and practices
por: McDonald, Whitney S., et al.
Publicado: (2020)

Studying both patient and staff experience to investigate their perceptions and to target key interactions to improve: a scoping review
por: Crubezy, Marion, et al.
Publicado: (2022)

‘A life in a day’ simulation experience: perceptions of oncology nurses and pharmacy staff
por: Ehibhatiomhan, Rachel, et al.
Publicado: (2022)

Industry-Sponsored Research: Author's Reply
por: Sotelo, Julio
Publicado: (2006)

Understanding the Reporting Practices of CAHPS(®) Sponsors
por: Teleki, Stephanie S., et al.
Publicado: (2007)

Sponsoring gesunder Lebensmittel ändert Einkaufsverhalten
por: Müssig, Karsten
Publicado: (2021)

Error in the Role of the Funder/Sponsor Section
Publicado: (2023)

“Time is of the essence”: relationship between hospital staff perceptions of time, safety attitudes and staff wellbeing
por: Ellis, Louise A., et al.
Publicado: (2021)

Cannot write session to /tmp/vufind_sessions/sess_13qkrl5hcj2h6ui6kt7o6f7ssp