Article: The International Conference on Harmonization Good Clinical Practice guideline.
Quality assurance (San Diego, Calif.)
1998 Volume 6, Issue 2, Page(s) 65–74
Abstract: The purposes of the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline are to protect the rights of human subjects participating in clinical trials and to ensure the scientific validity and credibility of the data ... ...
| Abstract | The purposes of the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline are to protect the rights of human subjects participating in clinical trials and to ensure the scientific validity and credibility of the data collected in human clinical studies. The guiding principle in the guideline is that the rights, safety, and well-being of the trial subject are the most important considerations and should prevail over the interests of science and society. The guideline will have an important and beneficial impact on the clinical trials conducted in the three participating regions (the United States, Europe, and Japan) as well as many other regions throughout the world. In the years to come, it should fulfill its intended purpose of providing for a more economical use of human, animal, and material resources and the elimination of unnecessary delays in the global development and availability of new medicines, and at the same time maintaining safeguards on quality, safety, and efficacy and regulatory obligations to protect public health. |
|---|---|
| MeSH term(s) | Clinical Trials as Topic/legislation & jurisprudence ; Clinical Trials as Topic/standards ; Europe ; Forms and Records Control ; Guidelines as Topic ; Human Experimentation/legislation & jurisprudence ; Humans ; Informed Consent ; International Cooperation ; Investigational New Drug Application ; Japan ; Organizational Objectives ; Professional Staff Committees ; Quality Control ; United States |
| Language | English |
| Publishing date | 1998-04 |
| Publishing country | United States |
| Document type | Journal Article |
| ZDB-ID | 1097078-2 |
| ISSN | 1521-0677 ; 1052-9411 |
| ISSN (online) | 1521-0677 |
| ISSN | 1052-9411 |
| DOI | 10.1080/105294199277860 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
More links
Kategorien
In stock of ZB MED Cologne/Königswinter
| Zs.A 4960: Show issues | Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG) |
Order via subito
This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.