THE INTERNATIONAL CONFERENCE ON HARMONIZATION GOOD CLINICAL PRACTICE GUIDELINE

Dixon, James R

doi:10.1080/105294199277860

Cited by 504Ethics in Clinical ResearchBiomedical Ethics and RegulationStatistical Methods in Clinical Trials

THE INTERNATIONAL CONFERENCE ON HARMONIZATION GOOD CLINICAL PRACTICE GUIDELINE

Dixon, James R·1999·Quality Assurance

DOI 10.1080/105294199277860

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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 study received ethics approval from Monash Health Human Research Ethics Committee and was conducted under Good Clinical Practice guidelines.
“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
All data management procedures are carried out according to written SOPs, which ensure efficient implementation and compliance with Good Clinical Practice.
“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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Humphrey, L., Willgoss, T. G., Trigg, A., Meysner, S., Kane, M., Dickinson, S., & Kitchen, H. (2017) · Journal of Patient-Reported Outcomes · doi:10.1186/s41687-017-0013-6 · Cited by 44 · see citing works
“However, guidance for Good Clinical Practice to protect human research subjects was followed, including the requirement for written informed consent and ensuring anonymity and confidentiality of data [14].”
Background
Untreated Hypertension and Subsequent Incidence of Colorectal Cancer: Analysis of a Nationwide Epidemiological Database
Kaneko, H., Yano, Y., Itoh, H., Morita, K., Kiriyama, H., Kamon, T., Fujiu, K., Michihata, N., Jo, T., Takeda, N., et al. (2021) · Journal of the American Heart Association · doi:10.1161/jaha.121.022479 · Cited by 44 · see citing works
A Phase 1/2 Single-arm Clinical Trial of Recombinant Bacillus Calmette-Guérin (BCG) VPM1002BC Immunotherapy in Non–muscle-invasive Bladder Cancer Recurrence After Conventional BCG Therapy: SAKK 06/14
Rentsch, C. A., Thalmann, G. N., Lucca, I., et al. (2022) · European Urology Oncology · doi:10.1016/j.euo.2021.12.006 · Cited by 42 · see citing works
Camlipixant in Refractory Chronic Cough: A Phase 2b, Randomized, Placebo-controlled Trial (SOOTHE)
Smith, J. A., Birring, S. S., Blaiss, M. S., et al. (2025) · American Journal of Respiratory and Critical Care Medicine · doi:10.1164/rccm.202409-1752oc · Cited by 42 · see citing works
A randomized trial comparing concise and standard consent forms in the START trial
Grady, C., Touloumi, G., Walker, A. S., et al. (2017) · PLoS ONE · doi:10.1371/journal.pone.0172607 · Cited by 42 · see citing works
Fasting plasma glucose and subsequent cardiovascular disease among young adults: Analysis of a nationwide epidemiological database
Kaneko, H., Itoh, H., Kiriyama, H., Kamon, T., Fujiu, K., Morita, K., Michihata, N., Jo, T., Takeda, N., Morita, H., et al. (2021) · Atherosclerosis · doi:10.1016/j.atherosclerosis.2020.12.024 · Cited by 44 · see citing works
Evaluation of Nomacopan for Treatment of Bullous Pemphigoid
Sadik, C. D., Rashid, H., Hammers, C. M., et al. (2022) · JAMA Dermatology · doi:10.1001/jamadermatol.2022.1156 · Cited by 42 · see citing works
The ethics of reusing archived tissue for research
Ashcroft, R. E. (2000) · Neuropathology and Applied Neurobiology · doi:10.1046/j.1365-2990.2000.00276.x · Cited by 42 · see citing works
IFNL3 polymorphisms predict response to therapy in chronic hepatitis C genotype 2/3 infection
Eslam, M., Leung, R. C., Romero‐Gómez, M., et al. (2014) · Journal of Hepatology · doi:10.1016/j.jhep.2014.03.039 · Cited by 41 · see citing works
Hemodynamic Management Guided by the Hypotension Prediction Index in Abdominal Surgery: A Multicenter Randomized Clinical Trial
Ripollés‐Melchor, J., Tomé-Roca, J. L., Vaca, A. Z., Aldecoa, C., Colomina, M. J., Parga, E. B., Lorente, J. V., Ruiz-Escobar, A., Carrasco-Sánchez, L., Sadurni-Sarda, M., et al. (2025) · Anesthesiology · doi:10.1097/aln.0000000000005355 · Cited by 43 · see citing works
Additional evidence for a therapeutic effect of dextromethorphan/quinidine on bulbar motor function in patients with amyotrophic lateral sclerosis: A quantitative speech analysis
Green, J. R., Allison, K. M., Cordella, C., Richburg, B. D., Pattee, G. L., Berry, J. D., Macklin, E. A., Pioro, E. P., & Smith, R. A. (2018) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.13745 · Cited by 39 · see citing works
Inhomogeneity and temporal effects in AutoPulse Assisted Prehospital International Resuscitation—an exception from consent trial terminated early
Paradis, N. A., Young, G. S., Lemeshow, S. A., et al. (2010) · The American Journal of Emergency Medicine · doi:10.1016/j.ajem.2010.02.002 · Cited by 39 · see citing works
“In evaluating the trial, we compared its design and execution to recognized Good Clinical Practice as described by the International Conference on Harmonization [8].”
Method
CD19+ B-Cells, a New Biomarker of Mortality in Hemodialysis Patients
Molina, M., Allende, L. M., Ramos, L., et al. (2018) · Frontiers in Immunology · doi:10.3389/fimmu.2018.01221 · Cited by 38 · see citing works
“All procedures were performed according to good clinical practice guidelines and all patients gave their written informed consent for study participation (38).”
Method
Participants’ responsibilities in clinical research
Resnik, D. B., & Ness, E. A. (2012) · Journal of Medical Ethics · doi:10.1136/medethics-2011-100319 · Cited by 38 · see citing works
Prevalence and risk factors of preconception anemia: A community based cross sectional study of rural women of reproductive age in northeastern Tanzania
Msemo, O. A., Bygbjerg, I. C., Møller, S. L., Nielsen, B. B., Ødum, L., Perslev, K., Lusingu, J., Kavishe, R. A., Minja, D. T. R., & Schmiegelow, C. (2018) · PLoS ONE · doi:10.1371/journal.pone.0208413 · Cited by 37 · see citing works
Matched-pair comparison of three different approaches for thymectomy in myasthenia gravis
Sobel, H. K., G�hring, S., Einh�upl, K. M., et al. (2003) · Surgical Endoscopy · doi:10.1007/s00464-002-9162-6 · Cited by 37 · see citing works
Risk-based, 6-monthly and 24-monthly dental check-ups for adults: the INTERVAL three-arm RCT
Clarkson, J. E., Pitts, N. B., Goulao, B., Boyers, D., Ramsay, C. R., Floate, R., Braid, H. J., Fee, P. A., Ord, F. S., Worthington, H. V., et al. (2020) · Health Technology Assessment · doi:10.3310/hta24600 · Cited by 35 · see citing works
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Yu, J., Gao, Y., Chen, L., et al. (2022) · JAMA Network Open · doi:10.1001/jamanetworkopen.2022.0426 · Cited by 35 · see citing works
Effect of cooking methods and intestinal conditions on lipolysis, proteolysis and xanthophylls bioaccessibility of eggs
Asensio‐Grau, A., Peinado, I., Heredia, A. B., & Andrés, A. (2018) · Journal of Functional Foods · doi:10.1016/j.jff.2018.05.025 · Cited by 35 · see citing works
“LOD and LOQ were defined as the signal-to-noise ratio equal to 3 and 10 respectively, according 215 to the International Conference on Harmonization (ICH) Guideline (Dixon, 1999).”
Method
The 5-year Tysabri global observational program in safety (TYGRIS) study confirms the long-term safety profile of natalizumab treatment in multiple sclerosis
Foley, J. F., Carrillo-Infante, C., Smith, J. J., et al. (2019) · Multiple Sclerosis and Related Disorders · doi:10.1016/j.msard.2019.101863 · Cited by 35 · see citing works
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Chowdhury, D., Bansal, L., Duggal, A. K., Datta, D., Mundra, A., Krishnan, A., Koul, A., & Gupta, A. (2021) · Cephalalgia · doi:10.1177/03331024211047454 · Cited by 35 · see citing works
“This study was conducted in accordance with the International Council for Harmonisation Good Clinical Practice regulations and guidelines (15).”
Method
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Mills, A., Richmond, G. J., Newman, C. L., Osiyemi, O. O., Cade, J. L., Brinson, C. C., Vente, J. D., Margolis, D. A., Sutton, K., Wilches, V., et al. (2021) · AIDS · doi:10.1097/qad.0000000000003085 · Cited by 36 · see citing works
“The International Conference on Harmonization Good Clinical Practice guideline.”
Method
Individualized Thresholds of Hypoxemia and Hyperoxemia and their Effect on Outcome in Acute Brain Injured Patients: A Secondary Analysis of the ENIO Study
Robba, C., Battaglini, D., Cinotti, R., Asehnoune, K., Stevens, R. D., Taccone, F. S., Badenes, R., Pelosi, P. P., Collaborators, T. E., Abback, P.-S., et al. (2023) · Neurocritical Care · doi:10.1007/s12028-023-01761-x · Cited by 36 · see citing works
“Data management, monitoring, and reporting of the study were performed in accordance with the International Conference on Harmonization Good Clinical Practice Guidelines [42, 43].”
High‐resolution separation of monoclonal antibodies mixtures and their charge variants by an alternative and generic CZE method
Goyon, A., François, Y., Colas, O., Beck, A., Veuthey, J., & Guillarme, D. (2018) · Electrophoresis · doi:10.1002/elps.201800131 · Cited by 34 · see citing works
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Hancock, H. C., Maier, R. H., Kasim, A., Mason, J. M., Murphy, G. J., Goodwin, A. T., Owens, W. A., & Akowuah, E. (2021) · BMJ Open · doi:10.1136/bmjopen-2020-041398 · Cited by 34 · see citing works
Amiodarone or Implantable Cardioverter-Defibrillator in Chagas Cardiomyopathy
Filho, M. M., Marin‐Neto, J. A., Scanavacca, M., de Paola, Â. A. V., Medeiros, P. D. T. J., Owen, R., Pocock, S., de Siqueira, S. F., CHAGASICS investigators, Penteado, J. O. P., et al. (2024) · JAMA Cardiology · doi:10.1001/jamacardio.2024.3169 · Cited by 33 · see citing works
Berberine Ursodeoxycholate for the Treatment of Type 2 Diabetes
Ji, L., Ma, J., Ma, Y., Cheng, Z., Gan, S., Yuan, G., Liu, D., Li, S., Liu, Y., Xue, X., et al. (2025) · JAMA Network Open · doi:10.1001/jamanetworkopen.2024.62185 · Cited by 34 · see citing works
Efficacy, safety and pharmacokinetics of a new high‐purity factor X concentrate in subjects with hereditary factor X deficiency
Austin, S. K., Kavaklı, K., Norton, M., et al. (2016) · Haemophilia · doi:10.1111/hae.12893 · Cited by 33 · see citing works
Influence of deep neuromuscular block on the surgeonś assessment of surgical conditions during laparotomy: a randomized controlled double blinded trial with rocuronium and sugammadex
Madsen, M. V., Scheppan, S., Mørk, E., et al. (2017) · British Journal of Anaesthesia · doi:10.1093/bja/aex241 · Cited by 32 · see citing works
Clinical evidence for silver diamine fluoride to reduce dentine hypersensitivity: A systematic review
Chan, A. K. Y., Tsang, Y. C., Yu, O. Y., Lo, E. C. M., Leung, K., & Chu, C. H. (2024) · Journal of Dentistry · doi:10.1016/j.jdent.2024.104868 · Cited by 31 · see citing works
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Lee, E. Y., Hwang, S., Lee, S., Lee, Y.-H., Choi, R. A., Lee, Y., Lee, B.-W., Kang, E., Ahn, C., Cha, B., et al. (2014) · Journal of Diabetes Investigation · doi:10.1111/jdi.12187 · Cited by 33 · see citing works
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Amaechi, B. T., Alshareif, D. O., Azees, P. A. A., Shehata, M. A., Lima, P. P. D. C. S., Abdollahi, A., Kalkhorani, P. S., Evans, V., Bagheri, A., & Okoye, L. O. (2021) · Journal of Dentistry · doi:10.1016/j.jdent.2021.103863 · Cited by 31 · see citing works
Quality of Life in High Myopia
Ieong, A., Rubin, G. S., & Allan, B. D. (2008) · Ophthalmology · doi:10.1016/j.ophtha.2008.09.020 · Cited by 31 · see citing works
Non-transferrin-bound iron is associated with biomarkers of oxidative stress, inflammation and endothelial dysfunction in type 2 diabetes
Aljwaid, H., White, D., Collard, K. J., Moody, A. J., & Pinkney, J. H. (2015) · Journal of Diabetes and its Complications · doi:10.1016/j.jdiacomp.2015.05.017 · Cited by 31 · see citing works
High-dose and low-dose varenicline for smoking cessation in adolescents: a randomised, placebo-controlled trial
Gray, K. M., Rubinstein, M. L., Prochaska, J. J., Dubrava, S., Holstein, A. R., Samuels, L., & McRae, T. D. (2020) · The Lancet Child & Adolescent Health · doi:10.1016/s2352-4642(20)30243-1 · Cited by 32 · see citing works
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Ueno, K., Kaneko, H., Suzuki, Y., Okada, A., Matsuoka, S., Fujiu, K., Michihata, N., Jo, T., Takeda, N., Morita, H., et al. (2024) · Journal of Cachexia Sarcopenia and Muscle · doi:10.1002/jcsm.13443 · Cited by 30 · see citing works
Experience of a new high‐purity factor X concentrate in subjects with hereditary factor X deficiency undergoing surgery
Escobar, M. A., Auerswald, G., Austin, S. K., et al. (2016) · Haemophilia · doi:10.1111/hae.12954 · Cited by 30 · see citing works
Risk Factors Associated with Cisplatin-Induced Nephrotoxicity in Patients with Advanced Lung Cancer
Miyoshi, T., Misumi, N., Hiraike, M., et al. (2016) · Biological and Pharmaceutical Bulletin · doi:10.1248/bpb.b16-00473 · Cited by 30 · see citing works
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Eng, C., Fakih, M., Amin, M. A., et al. (2020) · Oncotarget · doi:10.18632/oncotarget.27536 · Cited by 30 · see citing works
“The study was compliant with International Conference on Harmonization Good Clinical Practice guidelines for conducting, recording and reporting clinical studies [39].”
Method
Possible association between eating behaviors and cardiovascular disease in the general population: Analysis of a nationwide epidemiological database
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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
DOI: 10.1080/105294199277860
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 › Medicine › Physiology › 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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