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

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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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Method
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Method
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Method
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Ramakrishnan, M., Saiprasad, S. M., & Savaiano, D. A. (2024) · Nutrients · doi:10.3390/nu16121963 · Cited by 8
“The study (NCT05669274) was approved by the Purdue Institutional Review Board (IRB-2021-1407) and adhered to the Helsinki Declaration of 1975 as revised in 2008 [23] and the International Conference on Harmonization Good Clinical Practice guidelines [24].”
Method
Effect of joint transition visits on quality of life in adolescents with inflammatory bowel diseases: a protocol for a prospective, randomised, multicentre, controlled trial (TRANS-IBD)
Erös, A., Dohos, D., Veres, G., Tárnok, A., Vincze, Á., Tészás, A., Zádori, N., Gede, N., Hegyi, P., & Sarlós, P. (2020) · BMJ Open · doi:10.1136/bmjopen-2020-038410 · Cited by 8
Association between proteinuria and incident colorectal cancer: analysis of a nationwide population-based database
Matsuoka, S., Kaneko, H., Okada, A., Fukui, A., Yano, Y., Itoh, H., Morita, K., Fujiu, K., Michihata, N., Jo, T., et al. (2022) · BMJ Open · doi:10.1136/bmjopen-2021-056250 · Cited by 8
Overcoming burdens in the regulation of clinical research in children. Proceedings of a consensus conference, in historical context
Levine, R. J., Genel, M., Cuttler, L., Becker, D. J., Nieman, L. K., & Rosenfield, R. L. (2011) · International Journal of Pediatric Endocrinology · doi:10.1186/1687-9856-2011-19 · Cited by 8
“The leading international documents on the ethics of medical research endorse the concept that “low risk” research is permissible in children under these circumstances, though variations in defining the permissible burden of risk reflect the underlying complex ethical issues [29-32].”
Background
A Role of ICH- GCP in Clinical Trial Conduct
Wandile, P. M., & Ghooi, R. B. (2017) · Journal of Clinical Research & Bioethics · doi:10.4172/2155-9627.1000297 · Cited by 8
Antiplatelet Effect of Different Loading Doses of Ticagrelor in Patients With Non–ST-Elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: The APELOT Trial
Liu, H., Wei, Y., Ding, P., Zhang, J., Li, T., Wang, B., Wang, M.-S., Li, Y., Zhang, J.-J., Ren, Y., et al. (2017) · Canadian Journal of Cardiology · doi:10.1016/j.cjca.2017.09.002 · Cited by 8
Informed Consent Form Challenges for Genetic Research in Jordan
Alkaraki, A. K., Khabour, O. F., Alzoubi, K. H., Al-Ebbini, L. M. K., & Altaany, Z. (2020) · Journal of Multidisciplinary Healthcare · doi:10.2147/jmdh.s243669 · Cited by 8
Prehospital continuous positive airway pressure for acute respiratory failure: the ACUTE feasibility RCT
Fuller, G. W., Keating, S., Goodacre, S. W., Herbert, E., Perkins, G. D., Rosser, A., Gunson, I. M., Miller, J., Ward, M., Bradburn, M. J., et al. (2021) · Health Technology Assessment · doi:10.3310/hta25070 · Cited by 9
Efficacy and safety of Shenyankangfu tablets for primary glomerulonephritis: study protocol for a randomized controlled trial
Kou, J., Wu, J., Yang, H., et al. (2014) · Trials · doi:10.1186/1745-6215-15-479 · Cited by 8
“The study will be conducted according to the established study protocol, the principles of the current version of the Declaration of Helsinki [32], the International Conference on Harmonization guidelines for Good Clinical Practice, and the Good Clinical Practice guidelines of the China Food and Drug Administration [3…”
Method
Development and validation of a machine learning-based risk model for metastatic disease in nmCRPC patients: a tumor marker prognostic study
Ni, X., Wang, Z., Li, X., Sui, J., Ma, W., Pan, J., Ye, D., & Zhu, Y. (2025) · International Journal of Surgery · doi:10.1097/js9.0000000000002321 · Cited by 7
Associations of positive end-expiratory pressure (PEEP) with extubation failure and clinical outcomes in invasively ventilated patients with acute brain injury: A secondary analysis of the ENIO study
Battaglini, D., Cinotti, R., Asehnoune, K., et al. (2025) · Journal of Critical Care · doi:10.1016/j.jcrc.2025.155274 · Cited by 7
Occurrence and determinants of selective reporting of clinical drug trials: design of an inception cohort study
van den Bogert, C. A., Souverein, P. C., Brekelmans, C. T. M., Janssen, S. W. J., van Hunnik, M., Koëter, G. H., Leufkens, H. G. M., & Bouter, L. M. (2015) · BMJ Open · doi:10.1136/bmjopen-2015-007827 · Cited by 7
Multi-omics integrative modelling for stereotactic body radiotherapy in early-stage non-small cell lung cancer: clinical trial protocol of the MONDRIAN study
Volpe, S., Zaffaroni, M., Piperno, G., Vincini, M. G., Zerella, M. A., Mastroleo, F., Cattani, F., Fodor, C. I., Bellerba, F., Bonaldi, T., et al. (2023) · BMC Cancer · doi:10.1186/s12885-023-11701-9 · Cited by 8
Effect of pentoxifylline on endothelial dysfunction, oxidative stress and inflammatory markers in STEMI patients
Saeed, A., Farouk, M. M., Sabri, N. A., et al. (2024) · Future Science OA · doi:10.2144/fsoa-2023-0266 · Cited by 7
“…the Research Ethics Committee for Experimental and Clinical Studies at Faculty of Pharmacy, Ain Shams University (ENREC – ASU no. 289) and was performed in accordance with the declaration of Helsinki and the International Conference on Harmonization Guidelines for Good Clinical Practice [24 , 25] .”
Method
Assessment of arterial stiffness in paediatric patients with type 1 diabetes mellitus
Georeli, E., Stamati, A., Dimitriadou, M., Chainoglou, A., Galli‐Τsinopoulou, A., Stabouli, S., & Christoforidis, A. (2024) · Journal of Diabetes and its Complications · doi:10.1016/j.jdiacomp.2024.108782 · Cited by 8
KLC3 activates PI3K/AKT signaling and promotes ovarian cancer cell proliferation and migration through COL3A1
Yang, J., He, R., Zhang, X., et al. (2025) · Oncology Reports · doi:10.3892/or.2025.8900 · Cited by 7
“The current study was conducted in compliance with the International Conference on Harmonization guidelines for Good Clinical Practice (20) and the 2013 Declaration of Helsinki.”
Physical activity and cognitive changes in younger women after breast cancer treatment
Arneil, M., Anderson, D. J., Alexander, K. E., et al. (2019) · BMJ Supportive & Palliative Care · doi:10.1136/bmjspcare-2019-001876 · Cited by 7
Co-ordinated multidisciplinary intervention to reduce time to successful extubation for children on mechanical ventilation: the SANDWICH cluster stepped-wedge RCT
Blackwood, B., Morris, K. P., Jordan, J., McIlmurray, L., Agus, A., Boyle, R., Clarke, M. J., Easter, C., Feltbower, R. G., Hemming, K., et al. (2022) · Health Technology Assessment · doi:10.3310/tcfx3817 · Cited by 8
Randomized controlled trial to compare safety and efficacy of mycophenolate vs. cyclosporine after rituximab in children with steroid‐resistant nephrotic syndrome
Assadi, F. K., Mazaheri, M., & Sadeghi‐Bodj, S. (2022) · Pharmacotherapy The Journal of Human Pharmacology and Drug Therapy · doi:10.1002/phar.2721 · Cited by 7
Jusvinza, an anti-inflammatory drug derived from the human heat-shock protein 60, for critically ill COVID-19 patients. An observational study
Venegas-Rodriguez, R., Díaz, A. S., Peña-Ruiz, R., Santana-Sanchez, R., Hernández-Cedeño, M., Navarro, A. R., Cruz, I. G., Aguilera, L. M. P., Segura-Fernández, A., del Rosario-Cruz, L., et al. (2023) · PLoS ONE · doi:10.1371/journal.pone.0281111 · Cited by 7
Comparison of the anesthetic effect of alkalized lidocaine versus non-alkalized lidocaine administered at a slow rate in mandibular primary molars
Torres-Rojas, K., Chumpitaz-Cerrate, V., Rimache, L. C., et al. (2023) · Journal of Dental Research Dental Clinics Dental Prospects · doi:10.34172/joddd.2023.37014 · Cited by 7
Fracture discrimination capability of ulnar flexural rigidity measured via Cortical Bone Mechanics Technology: study protocol for The STRONGER Study
Warden, S. J., Dick, A., Simon, J. E., Manini, T. M., Russ, D. W., Lyssikatos, C., Clark, L. A., & Clark, B. C. (2024) · JBMR Plus · doi:10.1093/jbmrpl/ziad002 · Cited by 6
“…or disease, temporally associated with the subject’s participation in the study, whether or not considered related to the subject’s participation (modified from the definition of adverse events in the 1998 International Conference on Harmonization E-6 Guidelines for Good Clinical Practice 54 ).”
Background
Can the trail making test black and white predict white matter hyperintensity on MRI?
Han, S., Chung, M. S., Kim, S., & Youn, Y. C. (2019) · Journal of Clinical Neuroscience · doi:10.1016/j.jocn.2019.03.014 · Cited by 7
The Symptom Checklist: Frequency and Severity Scale – translation and psychometric properties of the Swedish version
Carnlöf, C., Malinowsky, C. W., Insulander, P., Gadler, F., Jensen‐Urstad, M., & Iwarzon, M. (2020) · Nordic journal of nursing research · doi:10.1177/2057158519898383 · Cited by 7
Impact of hyperoxia and phenylephrine on cerebral oxygenation: An experimental clinical study
Pedersen, S. S., Meyhoff, C. S., Olsen, M. H., Stisen, Z. R., Lund, A., Møller, K., Skjøth‐Rasmussen, J., Moltke, F. B., & Sørensen, M. K. (2022) · Acta Anaesthesiologica Scandinavica · doi:10.1111/aas.14149 · Cited by 7
“Written informed consent was obtained from all subjects, and external monitoring of consent, study documents and data was performed according to the ICH-GCP.17 Patients were recruited from September 2018 to October 2020, at the Department of Neuroanaesthesiology, Rigshospitalet, Copenhagen University Hospital, Denmark.”
Method
Establishing a Health Qigong protocol for rehabilitation of patients with COPD
Ng, B. H., & Tsang, H. W. H. (2009) · International Journal of Therapy and Rehabilitation · doi:10.12968/ijtr.2009.16.1.37937 · Cited by 7
Combination therapy of Epidermal Growth Factor and Growth Hormone-Releasing Hexapeptide in acute ischemic stroke: a phase I/II non-blinded, randomized clinical trial
Hernández‐Bernal, F., Estenoz-García, D., Gutiérrez-Ronquillo, J. H., et al. (2024) · Frontiers in Neurology · doi:10.3389/fneur.2024.1303402 · Cited by 6
Biologics and oral systemic treatment preferences in patients and physicians for moderate-to-severe atopic dermatitis: a discrete choice experiment in the United Kingdom and Germany
Durno, N. S., Prieto, P. A., Pantiri, K., Heisen, M., Boeri, M., Paris, J., Jack, K., Chambenoit, O., Subramanian, R., Puelles, J., et al. (2024) · Journal of Dermatological Treatment · doi:10.1080/09546634.2024.2417966 · Cited by 6
“All procedures followed the guidelines outlined in the Declaration of Helsinki and good clinical practice of the International Conference on Harmonization [27].”
Impact of Country Income Level on Outcomes in Patients with Acute Brain Injury Requiring Invasive Mechanical Ventilation: A Secondary Analysis of the ENIO Study
Feng, S. N., Diaz‐Cruz, C., Cinotti, R., et al. (2025) · Neurocritical Care · doi:10.1007/s12028-024-02198-6 · Cited by 6
“Data management, monitoring, and reporting of the study were performed according to International Conference on Harmonization Good Clinical Practice Guidelines [16, 17].”
Efficacy, Safety, and Patient Reported Outcomes of Rhenium-Skin Cancer Therapy for Non-Melanoma Skin Cancer: 1-Year Results from the EPIC-Skin Study
CARDACI, G. T., Baxi, S., Vohra, S., Allison, C., Hong, A., Mulholland, N. J. R., Sathekge, M. M., Mokoala, K. M. G., Heuschkel, M., Tietze, J. K., et al. (2025) · Advances in Radiation Oncology · doi:10.1016/j.adro.2025.101802 · Cited by 7
Continuous Glucose Monitoring Metrics and Continuous Glucose Monitoring–Based Hypoglycemia, Including Duration, in Individuals with Type 1 Diabetes Switching to Once-Weekly Insulin Icodec: A Post Hoc Evaluation of ONWARDS 6
Danne, T., Engberg, S., Irace, C., Kjaersgaard, M. I. S., Klonoff, D. C., Mathieu, C., Watt, S. K., & Russell-Jones, D. L. (2025) · Diabetes Technology & Therapeutics · doi:10.1177/15209156251359319 · Cited by 8
“%]) and the degludec arm ( n = 292; 60 [10] mmol/mol; 7.63% [0.93%]).”
Influential
Does physical activity level have an impact on long-term treatment response in temporomandibular disorders: protocol for a prospective study
Chun, Y., Jo, J. H., & Park, J. W. (2022) · BMC Oral Health · doi:10.1186/s12903-022-02428-3 · Cited by 7
Association of cardiovascular health metrics with annual incidence of prediabetes or diabetes: Analysis of a nationwide real‐world database
Okada, A., Kaneko, H., Matsuoka, S., Itoh, H., Suzuki, Y., Fujiu, K., Michihata, N., Jo, T., Takeda, N., Morita, H., et al. (2022) · Journal of Diabetes Investigation · doi:10.1111/jdi.13958 · Cited by 6
Clinical Outcomes of a Non-Compliant Balloon Dilatation Catheter: MOZEC™ NC Study
Pradhan, A. K., Vishwakarma, P., Bhandari, M., et al. (2022) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph192316231 · Cited by 6
“The study design and procedures conformed to the principles of the Declaration of Helsinki [11] and the ICH-GCP guidelines [12].”
Method
A multi-modal intervention for managing the fatigue–sleep disturbance–depressed mood symptom cluster in breast cancer patients undergoing chemotherapy: A pilot study
Wong, W. M., Chan, D. N. S., Choi, K. C., Choy, Y. P., & So, W. K. W. (2023) · Asia-Pacific Journal of Oncology Nursing · doi:10.1016/j.apjon.2023.100269 · Cited by 6

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 › 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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