International clinical trial

Other terms For example: NCT number, drug name, investigator name x. Yemen Zambia Zimbabwe x. City x. Distance 50 miles miles miles miles. Advanced Search. Researchers Search the database to stay up to date on developments in your field, find collaborators, and identify unmet needs.

Study Record Managers Learn about registering studies and about submitting their results after study completion. Registration and login are required to submit items online and to check the status of current submissions. If you find any difficulty in online submission of your manuscript, please contact editor at [email protected].

Fast track publication service is provided to shorten the time to decision and publication. Authors if they wish can have their article published as Online First Articles in Press within 2 weeks of manuscript submission Conditional to acceptance and author does prompt corrections.

Online First Articles in Press Articles are accepted, peer reviewed manuscripts, and are citable by the digital object identifier DOI assigned at the time of online publication. Int J Clin Trials. If you find any difficulty in online submission of your manuscript, please contact editor at [email protected] Abbreviation The correct abbreviation for abstracting and indexing purposes is Int J Clin Trials.

Advantages to publish in the International Journal of Clinical Trials Prompt review and rapid publication DOI Digital Object Identifiers for each article: The assignment of DOI names through the international registration agency CrossRef , recognizes published data as a first-class research output in the scientific world, Increase the acceptance of research data as legitimately citable contribution to the scientific record.

International Journal of Clinical Trials will apply to be indexed in other relevant databases and repositories in the future, where appropriate. Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C. Phase II Clinical Trials means those trials on sufficient numbers of patients that are designed to establish safety and assess the biological activity of a drug for its intended use, and to define warnings, precautions and adverse reactions that are associated with the drug in the to be prescribed dosage range.

Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.

Phase 1 Clinical Trial means a human clinical trial of a product in any country, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, that would satisfy the requirements of 21 C. Phase III Clinical Trial means a human clinical trial in any country, the results of which could be used to establish safety and efficacy of a Product as a basis for an NDA or would otherwise satisfy requirements of 21 CFR Phase II Clinical Trial means a human clinical trial in any country that is intended to initially evaluate the effectiveness of a Product for a particular indication or indications in patients with the disease or indication under study or would otherwise satisfy requirements of 21 CFR Phase IIb Clinical Trial means a relatively longer and larger Phase II Clinical Study designed to study the effectiveness of different doses of a particular Product against placebo or other positive controls for a particular Indication in patients with the disease or condition under study, which is determined by the PDC to be a Phase IIB Clinical Study.

Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

Clinical Trial means any human clinical trial of a Product.