Publication

Good clinical practice: Historical background and key aspects

Otte, A., Maier-Lenz, H. & Dierckx, R. A., Jul-2005, In : Nuclear Medicine Communications. 26, 7, p. 563-574 12 p.

Research output: Contribution to journalArticleAcademicpeer-review

APA

Otte, A., Maier-Lenz, H., & Dierckx, R. A. (2005). Good clinical practice: Historical background and key aspects. Nuclear Medicine Communications, 26(7), 563-574.

Author

Otte, Andreas ; Maier-Lenz, Herbert ; Dierckx, Rudi A. / Good clinical practice : Historical background and key aspects. In: Nuclear Medicine Communications. 2005 ; Vol. 26, No. 7. pp. 563-574.

Harvard

Otte, A, Maier-Lenz, H & Dierckx, RA 2005, 'Good clinical practice: Historical background and key aspects', Nuclear Medicine Communications, vol. 26, no. 7, pp. 563-574.

Standard

Good clinical practice : Historical background and key aspects. / Otte, Andreas; Maier-Lenz, Herbert; Dierckx, Rudi A.

In: Nuclear Medicine Communications, Vol. 26, No. 7, 07.2005, p. 563-574.

Research output: Contribution to journalArticleAcademicpeer-review

Vancouver

Otte A, Maier-Lenz H, Dierckx RA. Good clinical practice: Historical background and key aspects. Nuclear Medicine Communications. 2005 Jul;26(7):563-574.


BibTeX

@article{35970eccc3e74ad9839fde3463e4bc0a,
title = "Good clinical practice: Historical background and key aspects",
abstract = "Clinical research trials (both academic and industry sponsored) are increasingly playing a role in various medical disciplines, including younger fields of clinical trial interest, such as nuclear medicine research. Knowledge for and compliance with good clinical practice (GCP) is essential for anyone involved. In this review article, key aspects of GCP and the responsibilities of investigators, monitors and sponsors are described. In addition, a comprehensive overview of the historical background on the development of GCP from the US Pure Food and Drugs Act of 1906 over the Nuremberg Code, the Kefauver-Harris Amendments and the Declaration of Helsinki until now is given. Knowledge of the historical background may help understand the developments in GCP.",
keywords = "good clinical practice (GCP), Food and Drug Administration (FDA), Declaration of Helsinki, Council for International Organizations of Medical Sciences (CIOMS), International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, (ICH), European Medicines Evaluation Agency (EMEA), EU Clinical Trial Directive",
author = "Andreas Otte and Herbert Maier-Lenz and Dierckx, {Rudi A.}",
year = "2005",
month = "7",
language = "English",
volume = "26",
pages = "563--574",
journal = "Nuclear Medicine Communications",
issn = "0143-3636",
publisher = "LIPPINCOTT WILLIAMS & WILKINS",
number = "7",

}

RIS

TY - JOUR

T1 - Good clinical practice

T2 - Historical background and key aspects

AU - Otte, Andreas

AU - Maier-Lenz, Herbert

AU - Dierckx, Rudi A.

PY - 2005/7

Y1 - 2005/7

N2 - Clinical research trials (both academic and industry sponsored) are increasingly playing a role in various medical disciplines, including younger fields of clinical trial interest, such as nuclear medicine research. Knowledge for and compliance with good clinical practice (GCP) is essential for anyone involved. In this review article, key aspects of GCP and the responsibilities of investigators, monitors and sponsors are described. In addition, a comprehensive overview of the historical background on the development of GCP from the US Pure Food and Drugs Act of 1906 over the Nuremberg Code, the Kefauver-Harris Amendments and the Declaration of Helsinki until now is given. Knowledge of the historical background may help understand the developments in GCP.

AB - Clinical research trials (both academic and industry sponsored) are increasingly playing a role in various medical disciplines, including younger fields of clinical trial interest, such as nuclear medicine research. Knowledge for and compliance with good clinical practice (GCP) is essential for anyone involved. In this review article, key aspects of GCP and the responsibilities of investigators, monitors and sponsors are described. In addition, a comprehensive overview of the historical background on the development of GCP from the US Pure Food and Drugs Act of 1906 over the Nuremberg Code, the Kefauver-Harris Amendments and the Declaration of Helsinki until now is given. Knowledge of the historical background may help understand the developments in GCP.

KW - good clinical practice (GCP)

KW - Food and Drug Administration (FDA)

KW - Declaration of Helsinki

KW - Council for International Organizations of Medical Sciences (CIOMS)

KW - International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

KW - (ICH)

KW - European Medicines Evaluation Agency (EMEA)

KW - EU Clinical Trial Directive

M3 - Article

VL - 26

SP - 563

EP - 574

JO - Nuclear Medicine Communications

JF - Nuclear Medicine Communications

SN - 0143-3636

IS - 7

ER -

ID: 4353225