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Data Integrity in Global Clinical Trials: Discussions From Joint US Food and Drug Administration and UK Medicines and Healthcare Products Regulatory Agency Good Clinical Practice Workshop.
Khin, Ni A; Francis, Gail; Mulinde, Jean; Grandinetti, Cheryl; Skeete, Rachel; Yu, Bei; Ayalew, Kassa; Cho, Seongeun-Julia; Fisher, Andrew; Kleppinger, Cynthia; Ayala, Ruben; Bonapace, Charles; Dasgupta, Arindam; Kronstein, Phillip D; Vinter, Stephen.
Afiliação
  • Khin NA; Division of Clinical Compliance Evaluation, Office of Scientific Investigations (OSI), Office of Compliance, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Francis G; Inspection, Enforcement and Standards Division, Medicines and Healthcare Products Regulatory Agency (MHRA), London, UK.
  • Mulinde J; Division of Clinical Compliance Evaluation, Office of Scientific Investigations (OSI), Office of Compliance, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Grandinetti C; Division of Clinical Compliance Evaluation, Office of Scientific Investigations (OSI), Office of Compliance, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Skeete R; Division of Clinical Compliance Evaluation, Office of Scientific Investigations (OSI), Office of Compliance, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Yu B; Division of Clinical Compliance Evaluation, Office of Scientific Investigations (OSI), Office of Compliance, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Ayalew K; Division of Clinical Compliance Evaluation, Office of Scientific Investigations (OSI), Office of Compliance, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Cho SJ; Division of Generic Drug Bioequivalence Evaluation, Office of Study Integrity and Surveillance (OSIS), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Fisher A; Inspection, Enforcement and Standards Division, Medicines and Healthcare Products Regulatory Agency (MHRA), London, UK.
  • Kleppinger C; Division of Clinical Compliance Evaluation, Office of Scientific Investigations (OSI), Office of Compliance, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Ayala R; Division of New Drug Bioequivalence Evaluation, Office of Study Integrity and Surveillance (OSIS), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Bonapace C; Division of New Drug Bioequivalence Evaluation, Office of Study Integrity and Surveillance (OSIS), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Dasgupta A; Division of New Drug Bioequivalence Evaluation, Office of Study Integrity and Surveillance (OSIS), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Kronstein PD; Division of Clinical Compliance Evaluation, Office of Scientific Investigations (OSI), Office of Compliance, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Vinter S; Inspection, Enforcement and Standards Division, Medicines and Healthcare Products Regulatory Agency (MHRA), London, UK.
Clin Pharmacol Ther ; 108(5): 949-963, 2020 11.
Article em En | MEDLINE | ID: mdl-31958142
ABSTRACT
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. Regulatory agencies conduct GCP inspections to verify the integrity of data generated in clinical trials and to assure the protection of human research subjects, in addition to ensuring that clinical trials are conducted according to the applicable regulations. The first joint GCP workshop of the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) and the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA-UK) was held in October 2018 and provided the agencies' perspectives on the importance of data quality management practices on data integrity. Regulatory perspectives on data blinding to minimize introduction of bias, and the role of audit trails in assessing data integrity in global clinical trials were discussed. This paper summarizes considerations of both agencies on these topics, along with case examples.
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Texto completo: 1 Eixos temáticos: Pesquisa_clinica Base de dados: MEDLINE Assunto principal: Projetos de Pesquisa / United States Food and Drug Administration / Ensaios Clínicos como Assunto / Aprovação de Drogas / Gerenciamento de Dados Tipo de estudo: Clinical_trials Limite: Humans País como assunto: America do norte / Europa Idioma: En Ano de publicação: 2020 Tipo de documento: Article
Texto completo
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Texto completo: 1 Eixos temáticos: Pesquisa_clinica Base de dados: MEDLINE Assunto principal: Projetos de Pesquisa / United States Food and Drug Administration / Ensaios Clínicos como Assunto / Aprovação de Drogas / Gerenciamento de Dados Tipo de estudo: Clinical_trials Limite: Humans País como assunto: America do norte / Europa Idioma: En Ano de publicação: 2020 Tipo de documento: Article