Rapportering af bivirkninger og uønskede haendelser i randomiserede kliniske forsøg

Research output: Contribution to journal › Journal article › Research › peer-review

Standard

Rapportering af bivirkninger og uønskede haendelser i randomiserede kliniske forsøg. / Hemmingsen, Bianca Betina; Støy, Lina; Wetterslev, Jørn; Tarnow, Lise; Bach, Karin Ursula Friis; Christensen, Louise Lundby; Salas, Nader; Gluud, Christian Nyfeldt; Copenhagen Insulin Metformin Therapy Trial-Gruppen ; Perrild, Hans Jørgen Duckert; Krarup, Thure; Christensen, Louise Lundby; Vestergaard, Henrik.

In: Ugeskrift for Laeger, Vol. 172, No. 35, 30.08.2010, p. 2381-4.

Research output: Contribution to journal › Journal article › Research › peer-review

Harvard

Hemmingsen, BB, Støy, L, Wetterslev, J, Tarnow, L, Bach, KUF, Christensen, LL, Salas, N, Gluud, CN, Copenhagen Insulin Metformin Therapy Trial-Gruppen, Perrild, HJD, Krarup, T, Christensen, LL & Vestergaard, H 2010, 'Rapportering af bivirkninger og uønskede haendelser i randomiserede kliniske forsøg', Ugeskrift for Laeger, vol. 172, no. 35, pp. 2381-4.

APA

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.

Vancouver

Hemmingsen BB, Støy L, Wetterslev J, Tarnow L, Bach KUF, Christensen LL et al. Rapportering af bivirkninger og uønskede haendelser i randomiserede kliniske forsøg. Ugeskrift for Laeger. 2010 Aug 30;172(35):2381-4.

Author

Hemmingsen, Bianca Betina ; Støy, Lina ; Wetterslev, Jørn ; Tarnow, Lise ; Bach, Karin Ursula Friis ; Christensen, Louise Lundby ; Salas, Nader ; Gluud, Christian Nyfeldt ; Copenhagen Insulin Metformin Therapy Trial-Gruppen ; Perrild, Hans Jørgen Duckert ; Krarup, Thure ; Christensen, Louise Lundby ; Vestergaard, Henrik. / Rapportering af bivirkninger og uønskede haendelser i randomiserede kliniske forsøg. In: Ugeskrift for Laeger. 2010 ; Vol. 172, No. 35. pp. 2381-4.

Bibtex

@article{ce88c956a3f44ff6b8d37b951a958e02,
title = "Rapportering af bivirkninger og u{\o}nskede haendelser i randomiserede kliniske fors{\o}g",
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",
month = aug,
day = "30",
language = "Dansk",
volume = "172",
pages = "2381--4",
journal = "Ugeskrift for Laeger",
issn = "0041-5782",
publisher = "Almindelige Danske Laegeforening",
number = "35",

}

RIS

TY - JOUR

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

VL - 172

SP - 2381

EP - 2384

JO - Ugeskrift for Laeger

JF - Ugeskrift for Laeger

SN - 0041-5782

IS - 35

ER -

ID: 34162749