Rapportering af bivirkninger og uønskede haendelser i randomiserede kliniske forsøg

Bianca Betina Hemmingsen; Lina Støy; Jørn Wetterslev; Lise Tarnow; Karin Ursula Friis Bach; Louise Lundby Christensen; Nader Salas; Christian Nyfeldt Gluud; Copenhagen Insulin Metformin Therapy Trial-Gruppen; Hans Jørgen Duckert Perrild; Thure Krarup; Louise Lundby Christensen; Henrik Vestergaard

Rapportering af bivirkninger og uønskede haendelser i randomiserede kliniske forsøg

Translated title of the contribution: Reporting adverse reactions and events in randomised clinical trials

Bianca Betina Hemmingsen, Lina Støy, Jørn Wetterslev, Lise Tarnow, Karin Ursula Friis Bach, Louise Lundby Christensen, Nader Salas, Christian Nyfeldt Gluud, Copenhagen Insulin Metformin Therapy Trial-Gruppen, Hans Jørgen Duckert Perrild, Thure Krarup, Louise Lundby Christensen, Henrik Vestergaard

Abstract

"Good clinical practice" (GCP) is an international guideline on how to conduct clinical trials on medical products involving human participants. Danish statute follows the EU trial directive (2001/20/EF) including the GCP guidelines. This article summarises the practical implementation of reporting adverse events and adverse reactions to the Danish Medicines Agency and the regional ethics committee based on the protocol of the ongoing Copenhagen Insulin and Metformin Therapy (CIMT) trial.

Translated title of the contribution	Reporting adverse reactions and events in randomised clinical trials
Original language	Danish
Journal	Ugeskrift for Laeger
Volume	172
Issue number	35
Pages (from-to)	2381-4
Number of pages	4
ISSN	0041-5782
Publication status	Published - 30 Aug 2010

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Hemmingsen, B. B., Støy, L., Wetterslev, J., Tarnow, L., Bach, K. U. F., Christensen, L. L., Salas, N., Gluud, C. N., Copenhagen Insulin Metformin Therapy Trial-Gruppen, Perrild, H. J. D., Krarup, T., Christensen, L. L., & Vestergaard, H. (2010). Rapportering af bivirkninger og uønskede haendelser i randomiserede kliniske forsøg. Ugeskrift for Laeger, 172(35), 2381-4.

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abstract = "{"}Good clinical practice{"} (GCP) is an international guideline on how to conduct clinical trials on medical products involving human participants. Danish statute follows the EU trial directive (2001/20/EF) including the GCP guidelines. This article summarises the practical implementation of reporting adverse events and adverse reactions to the Danish Medicines Agency and the regional ethics committee based on the protocol of the ongoing Copenhagen Insulin and Metformin Therapy (CIMT) trial.",

keywords = "Adverse Drug Reaction Reporting Systems, Denmark, European Union, Guideline Adherence, Guidelines as Topic, Humans, Hypoglycemic Agents, Insulin, Metformin, Randomized Controlled Trials as Topic",

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T1 - Rapportering af bivirkninger og uønskede haendelser i randomiserede kliniske forsøg

AU - Hemmingsen, Bianca Betina

AU - Støy, Lina

AU - Wetterslev, Jørn

AU - Tarnow, Lise

AU - Bach, Karin Ursula Friis

AU - Christensen, Louise Lundby

AU - Salas, Nader

AU - Gluud, Christian Nyfeldt

AU - Copenhagen Insulin Metformin Therapy Trial-Gruppen

AU - Perrild, Hans Jørgen Duckert

AU - Krarup, Thure

AU - Christensen, Louise Lundby

AU - Vestergaard, Henrik

PY - 2010/8/30

Y1 - 2010/8/30

N2 - "Good clinical practice" (GCP) is an international guideline on how to conduct clinical trials on medical products involving human participants. Danish statute follows the EU trial directive (2001/20/EF) including the GCP guidelines. This article summarises the practical implementation of reporting adverse events and adverse reactions to the Danish Medicines Agency and the regional ethics committee based on the protocol of the ongoing Copenhagen Insulin and Metformin Therapy (CIMT) trial.

AB - "Good clinical practice" (GCP) is an international guideline on how to conduct clinical trials on medical products involving human participants. Danish statute follows the EU trial directive (2001/20/EF) including the GCP guidelines. This article summarises the practical implementation of reporting adverse events and adverse reactions to the Danish Medicines Agency and the regional ethics committee based on the protocol of the ongoing Copenhagen Insulin and Metformin Therapy (CIMT) trial.

KW - Adverse Drug Reaction Reporting Systems

KW - Denmark

KW - European Union

KW - Guideline Adherence

KW - Guidelines as Topic

KW - Humans

KW - Hypoglycemic Agents

KW - Insulin

KW - Metformin

KW - Randomized Controlled Trials as Topic

M3 - Tidsskriftartikel

C2 - 20825743

SN - 0041-5782

VL - 172

SP - 2381

EP - 2384

JO - Ugeskrift for Laeger

JF - Ugeskrift for Laeger

IS - 35

ER -

Rapportering af bivirkninger og uønskede haendelser i randomiserede kliniske forsøg

Abstract

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