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| Dublin Core | PKP Metadata Items | Metadata for this Document | |
| 1. | Title | Title of document | The revision of the ICH Good Clinical Practice guidelines: a missed opportunity? |
| 2. | Creator | Author's name, affiliation, country | Raffaella Ravinetto; Institute of Tropical Medicine Antwerp, Nationalestraat, 155, 2000 Antwerp, BELGIUM |
| 3. | Subject | Discipline(s) | |
| 3. | Subject | Keyword(s) | |
| 4. | Description | Abstract | The Guideline for Good Clinical Practice (GCP) of the International Conference of Harmonisation (ICH) is an international standard for the ethical and scientific quality of the designing, conducting, recording and reporting of trials that involve the participation of human subjects. Today, most regulators and funding agencies follow the ICH guidelines. These were drawn up by a small number of regulatory agencies and drug companies from high-income countries and do not pay sufficient heed to the problematic aspects of clinical trials in the low- and middle-income countries. A recent process of revision of the ICH GCP, which focused mainly on improving the use of technology and quality systems in clinical trials, did not remedy the pre-existing divide between the guideline, ethics and the challenges of globalised clinical research. It is not clear whether another, newly announced "renovation" of the ICHGCP (a "reflection paper" was open for public comment until March 11, 2017) will succeed in addressing this divide. |
| 5. | Publisher | Organizing agency, location | Forum for Medical Ethics Society |
| 6. | Contributor | Sponsor(s) | |
| 7. | Date | (YYYY-MM-DD) | 2017-05-23 |
| 8. | Type | Status & genre | |
| 8. | Type | Type | |
| 9. | Format | File format | HTML , PDF |
| 10. | Identifier | Uniform Resource Identifier | https://ijme.in/articles/the-revision-of-the-ich-good-clinical-practice-guidelines-a-missed-opportunity/ |
| 11. | Source | Title; vol., no. (year) | Indian Journal of Medical Ethics;: The right to life |
| 12. | Language | English=en | en |
| 13. | Relation | Supp. Files | |
| 14. | Coverage | Geo-spatial location, chronological period, research sample (gender, age, etc.) | |
| 15. | Rights | Copyright and permissions | All articles published in IJME are available on its website free of charge. The copyright for published material belongs to IJME/FMES. IJME freely permits the reprint (or reproduction on a website) of articles from the journal, as long as this is for non-commercial use and appropriate credit is given to the author and the journal and publication details are mentioned. The commercial use of our content can be made only after obtaining permission from and on payment to IJME. This is intended to support production of the journal. |