The DOI matches its Crossref record.
THE INTERNATIONAL CONFERENCE ON HARMONIZATION GOOD CLINICAL PRACTICE GUIDELINE
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.
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“The trial received ethics approval from the Monash Health Human Research Ethics Committee and was conducted under the Good Clinical Practice guidelines (Dixon, 1999).”
From Obsessive–compulsive disorder (OCD) is associated with increased engagement of frontal brain regions across multiple event-related potentials (2023) · cites this paper as Dixon, 1999
In the citing paper
“All data management procedures will be carried out according to the written SOPs, which ensure efficient implementation and compliance with Good Clinical Practice [49].”
From EFFects of Exposure and Cognitive behavioral Therapy for chronic BACK pain (“EFFECT-BACK”): study protocol for a randomized controlled trial (2024) · cites this paper as [49]
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Hassan, S. S., Romero, R., Vidyadhari, D., Fusey, S., Baxter, J. K., Khandelwal, M., Vijayaraghavan, J., Trivedi, Y., Soma‐Pillay, P., Sambarey, P., et al. (2011) · Ultrasound in Obstetrics & Gynecology · doi:10.1002/uog.9017 · Cited by 923
Guidelines for Controlled Trials of Drugs in Migraine: Second Edition
International Headache Society Clinical Trials Subcommittee, Tfelt-Hansen, P., Block, G., Dahlöf, C., Diener, H.-C., Ferrari, M., Goadsby, P., Guidetti, V, Jones, B., Lipton, R., et al. (2000) · Cephalalgia · doi:10.1046/j.1468-2982.2000.00117.x · Cited by 698
Fleisher, A. S., Pontecorvo, M. J., Devous, M. D., Lu, M., Arora, A. K., Truocchio, S. P., Aldea, P., Flitter, M., Locascio, T., Devine, M., et al. (2020) · JAMA Neurology · doi:10.1001/jamaneurol.2020.0528 · Cited by 448
Mendell, J. R., Sahenk, Z., Lehman, K., Nease, C., Lowes, L. P., Miller, N. F., Iammarino, M. A., Alfano, L. N., Nicholl, A., Al-Zaidy, S., et al. (2020) · JAMA Neurology · doi:10.1001/jamaneurol.2020.1484 · Cited by 405
Adaptive platform trials: definition, design, conduct and reporting considerations
Coalition, T. A. P. T., Angus, D. C., Alexander, B. M., Berry, S., Buxton, M., Lewis, R. J., Paoloni, M., Webb, S. A. R., Arnold, S. E., Barker, A., et al. (2019) · Nature Reviews Drug Discovery · doi:10.1038/s41573-019-0034-3 · Cited by 414
Metadata
- Authors
- Dixon, J. R.
- Affiliations
- Triangle Pharmaceuticals, Inc. (United States) (US)
- Corresponding author
- Dixon, James R
- Venue
- Quality Assurance
- Publisher
- Informa UK Limited
- Published
- 1999-02
- Volume
- 6
- Issue
- 2
- Pages
- 65-74
- ISSN
- 1052-9411 (ISSN-L)
- 1521-0677
- OpenAlex
- W1981066923
- Cited by
- 504
- References
- 0
- Citations by year
- 2026: 30 · 2025: 62 · 2024: 63 · 2023: 52 · 2022: 51 · 2021: 53 · 2020: 31 · 2019: 20 · 2018: 19 · 2017: 18 · 2016: 17 · 2015: 20 · 2014: 8 · 2013: 6 · 2012: 7
- FWCI
- 3.16
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Quality Assurance (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Nursing › Issues, ethics and legal aspects › Biomedical Ethics and Regulation
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- good clinical practice, clinical trial ethics, research participant protection, regulatory harmonization, drug development
- MeSH terms
- Clinical Trials as Topic, Europe, Forms and Records Control, Humans, Human Experimentation, Informed Consent, International Cooperation, Japan, Organizational Objectives, Professional Staff Committees, Quality Control, United States, Investigational New Drug Application, Guidelines as Topic
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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