A practical guide to the EU Clinical Trials Directive : for investigators and study site staff, including research nurses, clinical researchers, monitors and CRAs, and anyone working on clinical trials / by Laura Brown.
Tipo de material:
TextoDetalles de publicación: London : Brookwood Booklets, 2005. Descripción: iii, 47 p. : ill. ; 20 cmISBN: 1904255078Tema(s): Clinical Trials -- legislation & jurisprudence | Clinical Trials -- standards | Drug Approval -- legislation & jurisprudence | European Union countries | Ensayos clínicos | Ensayos clínicos -- Normas
Contenidos:
Introduction -- What is the Clinical Trials Directive and what are the changes compared with ICH GCP? -- Planning and setting up CT Directive - compliant trials -- Running a trial to comply with the CT Directive -- End-of-trial activities -- Regulatory inspection -- Conclusion.
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Introduction -- What is the Clinical Trials Directive and what are the changes compared with ICH GCP? -- Planning and setting up CT Directive - compliant trials -- Running a trial to comply with the CT Directive -- End-of-trial activities -- Regulatory inspection -- Conclusion.
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