ScholarGate
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Process / pipelinetrial-oversight

Usajili wa Majaribio ya Kliniki

Usajili wa majaribio ya kimatibabu ni uwekaji kumbukumbu wa awali wa taarifa muhimu za jaribio (dhahania, muundo, idadi ya watu, matokeo) katika rejista ya umma kabla ya kuanza kuandikisha washiriki au matokeo kujulikana. Mwaka 2005, Shirika la Afya Duniani lilianzisha hitaji kwamba majaribio yote ya kimatibabu yasajiliwe katika rejista inayotambulika kimataifa kabla ya kuandikisha washiriki. Kamati ya Kimataifa ya Wahariri wa Magazeti ya Kimatibabu (ICMJE) ilifanya usajili kuwa sharti la kuchapishwa katika magazeti makuu ya kimatibabu mwaka 2005, na kusahihishwa mwaka 2015. Rejista kuu ni pamoja na ClinicalTrials.gov (Marekani), ISRCTN (Uingereza), EudraCT (EU), na zingine zinazofanya kazi chini ya usimamizi wa WHO. Usajili unalenga kuzuia kuripoti matokeo kwa kuchagua, kupunguza upendeleo wa machapisho, na kuongeza uwazi wa utafiti.

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Vyanzo

  1. World Health Organization. (2005). Ensuring that Studies Are Prospectively Registered. International Clinical Trials Registry Platform (ICTRP) Statement. link
  2. International Committee of Medical Journal Editors. (2015). Recommendations for the Conduct, Reporting, Editorship, and Publication of Scholarly Work in Medical Journals. JAMA, 314(20), 2142-2150. link
  3. U.S. Food and Drug Administration. (2020). Expanded Access (Compassionate Use). Electronic Code of Federal Regulations Title 21, Section 312.300. link
  4. De Angelis, C., Drazen, J. M., Frizelle, F. A., Haivas, G., Hebert, P. C., Ioannidis, J. P., & Schroeder, T. V. (2004). Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors. N Engl J Med, 351(12), 1250-1251. DOI: 10.1056/NEJMe048225

Jinsi ya kunukuu ukurasa huu

ScholarGate. (2026, June 4). Prospective Registration of Clinical Trials and Observational Studies. ScholarGate. https://scholargate.app/sw/research-ethics/clinical-trial-registration

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Imerejelewa na

ScholarGateClinical Trial Registration (Prospective Registration of Clinical Trials and Observational Studies). Imepatikana 2026-06-17 kutoka https://scholargate.app/sw/research-ethics/clinical-trial-registration · Seti ya data: https://doi.org/10.5281/zenodo.20539026