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

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.

Bidragets oversatte titel	Reporting adverse reactions and events in randomised clinical trials
Originalsprog	Dansk
Tidsskrift	Ugeskrift for Laeger
Vol/bind	172
Udgave nummer	35
Sider (fra-til)	2381-4
Antal sider	4
ISSN	0041-5782
Status	Udgivet - 30 aug. 2010

Emneord

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

FN’s Verdensmål

Dette resultat bidrager til følgende verdensmål

Citationsformater

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",

author = "Hemmingsen, {Bianca Betina} and Lina St{\o}y and J{\o}rn Wetterslev and Lise Tarnow and Bach, {Karin Ursula Friis} and Christensen, {Louise Lundby} and Nader Salas and Gluud, {Christian Nyfeldt} and Hans Perrild and Perrild, {Hans J{\o}rgen Duckert} and Thure Krarup and Christensen, {Louise Lundby} and Henrik Vestergaard",

year = "2010",

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day = "30",

language = "Dansk",

volume = "172",

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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

Emneord

FN’s Verdensmål

Fingeraftryk

Citationsformater