TY - JOUR
T1 - Rapportering af bivirkninger og uønskede haændelser i randomiserede kliniske forsøg
AU - Hemmingsen, Bianca
AU - Støy, Lina
AU - Wetterslev, Jørn
AU - Tarnow, Lise
AU - Bach, Karin Ursula Friis
AU - Christensen, Louise Lundby
AU - Salas, Nader
AU - Gluud, Christian
AU - Copenhagen Insulin Metformin Therapy Trial-Gruppen
AU - Perrild, Hans Jørgen Duckert
AU - Krarup, Thure
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.
M3 - Tidsskriftartikel
C2 - 20825743
SN - 1399-4174
VL - 172
SP - 2381
EP - 2384
JO - Ugeskrift for Laeger
JF - Ugeskrift for Laeger
IS - 35
ER -