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Writing and Managing SOPs for GCP is the first book to discuss managing Standard Operating Procedures (SOPs) for Good Clinical Practice (GCP) from conception to retirement. It recommends approaches that have a direct impact on improving SOP and regulatory compliance. Throughout the text, the book provides a user's point of view to keep topics focused on the practical aspects of SOPs and SOP management.The idea of specifically calling out approaches to SOP creation and maintenance in an effort to make it easier for users to stay in compliance is a theme found throughout all book chapters. Examp

Background: There is a significant lack of research regarding the knowledge, perception and attitude of health care professionals towards compliance with Good Clinical Practice (GCP) within the entire Arabic world. The present study intends to assess health care professionals' knowledge, perception, and attitude towards compliance with the International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines. Methods: A cross-sectional study was conducted at King Abdullah International Medical Research Center (KAIMRC) and King Abdulaziz Medical City (KAMC) in Riyadh. A self-administered questionnaire was used to assess the knowledge, perception, and attitude towards ICH-GCP in a sample of 78 health care professionals. Results: The vast majority of the respondents 55(71%) were principal or co-investigators and 23(29%) were research coordinators. Almost all, 66(85%), of the respondents had received GCP training. Of 78 health care professionals, 98% reported that the research subjects provide voluntary consent and the study protocols give a clear and adequate description of the study procedures. 97% reported that GCP principles are followed in clinical trial studies and GCP compliant activities improve the quality of clinical research. Only 57% of the health care professionals reported that clinical research is a part of routine activities done in the clinic. 72% reported that they suffer from delay in the approval by the national IRB to start their research and 59% reported negative attitude towards the IRB approval process or monitoring and audit of the clinical trials. Conclusion: The present study suggests that the level of knowledge and perception towards compliance with ICH-GCP are generally satisfactory among health care professionals who involved in clinical trials in Saudi Arabia.

Currently one of the structural mandates for the effective protection of rights is the fundamental right to the evidence, not only because of the new phenomenon of constitutionalization process but by the experience of individual cases, which have driven it serious reforms. Before the General Code of Procedure its reality reveals a citizen who comes to the administration of justice and sees defined the validity and effectiveness of its claim or exception through three systems: i) the ability or directed intention of his or her counterpart in providing or no evidence of the fact, which is another way to understand the classical notion of who has to show the evidence; ii) in the search for truth by the judge, through his functions; and iii) the surprise of looking for evidence, which the person is assigned to take the evidence get know in the judgment that he had to do it. Nowadays with the GCP and the Status of National and International Arbitration, the functions of the judge will increase, to be allowed to assign the burden of proving on the part of the procedural relationship which is in a better position to do so and enact measures evidentiary precautionary, which means to define and to study what we call the "input" or "bags" to which the judge can go intending to make an effective protection of the right to evidence the proposition stage and requirement of the test, which under this new legislation actually affects the substantive law of this fundamental right, on one hand, and the structure of this new institution towards some aspects that defined the GCP, which can be approached from its critical aspects in what is considered eminently procedural. ; Actualmente, uno de los mandatos estructurales para la tutela efectiva de los derechos es el derecho fundamental a la prueba, no solo por el novedoso fenómeno de constitucionalización del proceso, sino por casos concretos que han impulsado serias reformas. Con anterioridad al Código General del Proceso, el ciudadano que acudía a la administración de justicia veía definida la vigencia y eficacia de su pretensión o excepción por medio de tres hipótesis de la actividad probatoria: i) la habilidad o dirigida intención de su contraparte de aportar o no la prueba del hecho, que es otra manera de entender la noción clásica de carga de la prueba; ii) la búsqueda de la verdad por parte del juez, mediante sus poderes oficiosos; y iii) la sorpresa de una inversión de la carga de la prueba por el juez, de la cual la persona a quien se le asignaba la carga de probar se enteraba en la sentencia de segunda instancia, o en sede de casación o en la eventual revisión. En la actualidad, con el CGP y el Estatuto de Arbitraje Nacional e Internacional, se le aumentan los poderes de instrucción al juez, al permitírsele i) asignar la carga de probar a la parte de la relación procesal que se encuentra en mejor posición de hacerlo y ii) decretar medidas cautelares probatorias; esta nueva realidad implica redefinir y examinar lo que denominaremos los "insumos" a los cuales puede acudir el juez que pretenda hacer una protección efectiva del derecho a la prueba, en la etapa de proposición y requerimiento de la prueba. Como consecuencia, se plantea la disertación frente a la afectación del derecho sustancial de este derecho fundamental, de una parte, y en torno a los serios desafíos frente a la estructura y el trámite creado para la carga dinámica desde el CGP, abordados desde sus aspectos críticos en lo que se considera eminentemente procesal.

A partir del principio general de inembargabilidad de bienes del Estado, el contenido de este documento incursiona en el tema de las excepciones al mismo legalmente contempladas, a efectos de verificar la aplicabilidad de la medida cautelar de embargo sobre tales bienes en los casos procedentes, cuando los particulares adelantan procesos ejecutivos ante la jurisdicción contenciosoadministrativa, en procura de defender sus intereses y del pago de dineros a cargo del Estado como consecuencia de contratos, sentencias, acreencias laborales, laudos arbitrales u otro tipo de documento eficaz. El propósito fue establecer claramente la normatividad aplicable en este tipo de eventos, aportando de este modo respuesta objetiva y confiable frente a la problemática generada tanto por las distintas posiciones en torno al tema adoptadas por el legislador, como igualmente por dificultades para clasificar los bienes y rentas estatales en orden a determinar su carácter y la posibilidad real de su embargo. Todo ello, además, con el referente de pronunciamientos jurisprudenciales adoptados como soporte conceptual básico puesto que desde esta perspectiva dan cuenta de una línea coincidente de pensamiento por parte de los altos organismos pertinentes. ; From the general principle of immunity from seizure of State property, this paper move into the topic of the exceptions thereto legally referred to, in order to verify the applicability of the precautionary measure of garnishee on such in appropriate cases, when individuals advance business processes before the contentiousadministrative courts in an attempt to defend their interests and the payment of money by the State as a result of contracts, judgments, labor claims, arbitration awards or other effective document. The purpose was clearly to establish the applicable rules in such events, thus providing objective and reliable response to the problems caused both by the different positions on the issue adopted by the legislature, as also by difficulties in classifying State assets and income in order to determine its nature and the real possibility of garnishee. All this, along with the reference to judicial rulings adopted as a basic conceptual support since from this perspective realize a matching line of thinking on the part of senior relevant agencies.

The Good Clinical Practices (GCP) codes of the WHO and the International Conference of Harmonization set international standards for clinical research. But critics argue that they were written without consideration for the challenges faced in low and middle income countries (LMICs). Based on our field experience in LMICs, we developed a non-exhaustive set of recommendations for the improvement of GCP. These cover 3 domains: ethical, legal and operational, and 8 specific issues: the double ethical review of 'externally sponsored' trials; the informed consent procedure in minors and in illiterate people; post-trial access to newly-developed products for the trial communities; the role of communities as key research actors; the definition of sponsor; and the guidance for contractual agreements, laboratory quality management systems, and quality assurance of investigational medicinal products. Issues not covered in our analysis include among others biobanking, standard of care, and study designs. The international GCP codes de facto guide national legislators and funding agencies, so the current shortcomings may weaken the regulatory oversight of international research. In addition, activities neglected by GCP are less likely to be implemented or funded. If GCP are meant to serve the interests of global society, a comprehensive revision is needed. The revised guidelines should be strongly rooted in ethics, sensitive to different sociocultural perspectives, and allow consideration for trial-specific and context-specific challenges. This can be only achieved if all stakeholders, including researchers, sponsors, regulators, ethical reviewers and patients' representatives from LMICs, as well as non-commercial researchers and sponsors from affluent countries, are transparently involved in the revision process. We hope that our limited analysis would foster advocacy for a broad and inclusive revision of the international GCP codes, to make them at the same time 'global', 'context centred' and 'patient centred'.

Background: Institutional review boards (IRBs) face delays in reviewing research proposals, underscoring the need for optimized standard operating procedures (SOPs). This study assesses the abilities of three artificial intelligence (AI) platforms to address IRB challenges and draft essential SOPs. Methods: An observational study was conducted using three AI platforms in 10 case studies reflecting IRB functions, focusing on creating SOPs. The accuracy of the AI outputs was assessed against good clinical practice (GCP) guidelines. Results: The AI tools identified GCP issues, offered guidance on GCP violations, detected conflicts of interest and SOP deficiencies, recognized vulnerable populations, and suggested expedited review criteria. They also drafted SOPs with some differences. Conclusion: AI platforms could aid IRB decision-making and improve review efficiency. However, human oversight remains critical for ensuring the accuracy of AI-generated solutions.

BACKGROUND: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is undertaking a major revision of ICH E6 Good Clinical Practice (GCP) decided to involve external stakeholders in ICH-GCP renovation. Activities such as surveys and public conferences have taken place in the United States, European Union, and Japan. For stakeholder engagement in Japan, a designated research group conducted a survey of academic stakeholders. METHODS: A total of 105 academic stakeholders from 18 institutions responded to the survey. The research group developed recommendations reflecting the survey results and the opinions from patients and the public. RESULTS: The survey showed the top four principles needing renovation were (i) informed consent (Chapter 2.9, 12.4% of respondents believed it needed renovation), (ii) systems for quality assurance (Chapter 2.13, 9.5%), (iii) information on an investigational product (Chapter 2.4, 5.7%), and (iv) procedures on clinical trial information (Chapter 2.10, 5.7%). The top three sections identified as needing renovation were: (i) informed consent (Chapter 4.8, 27.6%), (ii) monitoring (Chapter 5.18, 22.9%), and (iii) composition, functions, and operations of the ethics committee (Chapter 3.2, 14.3%). Recommendations included clarification of ICH-GCP's scope, proportionality in various aspects of clinical trials, diversity and liquidity of ethics committee members, modernization of informed consent procedures, variations in monitoring, and regulatory grade when using real-world data. CONCLUSION: The recommendations from Japanese investigators and patients have been submitted to the ICH E6 Expert Working Group, which will strengthen the robustness of the GCP renovation.

RESUMENLa presente investigación evalúa la calidad y precisión del levantamiento de fotografíaaérea con nuevas herramientas tecnológicas. Para ello se realizó el levantamiento defotografía a escala 1:1.000 de un aérea de 30 hectáreas por medio de un Vehículo Aéreono Tripulado (UAV por sus siglas en ingles), más conocido como Drone; esto en la ciudadde Paute, provincia de Azuay (sierra sur del Ecuador). Para ello se estableció una red geodésica de cuarto orden o GCP (Ground Control Point) para corregir los errores de posicionamiento del drone, con programas especializados. Con esta información se procesaronlos datos del levantamiento de fotografía aérea y se compararon con las especificacionestécnicas generales para realización de cartografía topográfica a cualquier escala, y conlas Especificaciones Técnicas para Ortofotos Digitales, para dadas por el Instituto Geográfico Militar del Ecuador (IGM). Se pudo comprobar que el ortofotomosaico realizadocon el drone cumple son las especificaciones técnicas mencionadas tanto en su precisiónhorizontal como vertical.Palabras clave: UAV (Unmanned Aerial Vehicle), drone, IGM (Instituto Geográfico Militar), REGME (Red GNSS de Monitoreo Continuo del Ecuador), GCP (Ground Control Point) ABSTRACTThis research carried out in the city of Paute, Azuay province (southern Ecuador, mountain region), evaluates the quality and precision of aerial photography with new technological tools. In order to achieve this, a picture at a 1: 1.000 scale of a 30 hectare are wastaken through an Unmanned Aerial Vehicle (UAV) better known as Drone, which requiredestablishing a fourth order geodetic network or GCP (Ground Control Point) to correct dronepositioning errors through specialized programs. With this information, the data of aerialphotography survey were processed and compared with the technical specifications for implementing topographic maps of any scale, as well as with the Technical Specifications forDigital Orthophotography provided by the Military Geographic Institute of Ecuador (IGM,as per its Spanish acronym). It was found that the orthophotomosaic made with the dronemeets the technical specifications both in horizontal and vertical accuracy.Keywords: UAV (Unmanned Aerial Vehicle), Drone, IGM (Military Geographic Institute),REGME (GNSS Continuous Monitoring Network of Ecuador), GCP (Ground Control Point)

The Eurasian Economic Union (EAEU) is an international economic integration organisation consisting of 5 member states: Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia. It was created with the aim of ensuring comprehensive modernisation, cooperation and competitiveness of national economies and creating conditions for stable development in order to improve the living standards of the population of the member states. Regarding the creation of a common pharmaceutical market in the EAEU, common principles and rules for the authorisation and circulation of medicinal products are introduced in accordance with the Eurasian Economic Union Agreement of 29 May 2014. The Agreement on Common Principles and Rules for the Circulation of Medicines in the Eurasian Economic Union of 23 December 2014 is a fundamental document for the establishment of a common market for human medicines. Common rules for expertise of medicinal products, common rules of GMP, GCP, GCP, GLP, common rules for inspection, pharmacopoeia, common requirements for labelling of medicinal products and many other legislative acts have been approved. Marketing authorisation for medicinal products under the common EU rules will be mandatory from January 2021. At the same time, all medicines authorised under national procedures will have to be brought into line with the EAEU requirements by the end of 2025, the so-called re-attestation procedure. This procedure for re-attestation of a medicine within the EAEU will be explained through an applied case. ; L'Union économique eurasienne (UEEA) est une organisation internationale d'intégration économique composée de 5 États membres : l'Arménie, le Belarus, le Kazakhstan, le Kirghizstan et la Russie. Elle a été créée dans le but d'assurer la modernisation globale, la coopération et la compétitivité des économies nationales et de créer les conditions d'un développement stable afin d'améliorer le niveau de vie de la population des États membres. Concernant la création d'un marché commun pharmaceutique dans l'UEEA, des principes et des règles communes pour l'autorisation et la circulation des médicaments sont introduits conformément à l'Accord de l'Union économique eurasienne du 29 mai 2014. L'accord sur les principes et les règles communs pour la circulation des médicaments au sein de l'Union économique eurasienne du 23 décembre 2014 est un document fondamental pour l'établissement d'un marché commun des médicaments humains. Des règles communes pour l'expertise des médicaments, des règles communes de BPF, BPPV, BPC, BPL, des règles communes pour l'inspection, la pharmacopée, des exigences communes pour l'étiquetage des médicaments et de nombreux autres actes législatifs ont été approuvés. L'Autorisation de mise sur le marché des médicaments en vertu des règles communes de l'Union sera obligatoire à partir de janvier 2021. Dans le même temps, tous les médicaments autorisés selon les procédures nationales devront être mis en conformité avec les exigences de l'EAEU d'ici la fin 2025, c'est la procédure de ré-attestation. Cette procédure de ré-attestation d'un médicament au sein de l'UEEA sera explicitée à travers un cas appliqué.

La siguiente investigación resuelve una problemática que viven las IES (Instituciones de Educación Superior) del sector defensa en Colombia, las cuales presentan dificultades en cuanto al manejo adecuado de la información, esto se evidencia en la gran cantidad de errores causados por procesos manuales que se llevan a cabo en las áreas administrativas y educativas, lo cual genera inconformidades por parte deestudiantes, docentes y directivos; resulta indispensable que por medio del uso de las tecnologías de la información y comunicación, se evalúen los principales requerimientos y se determine como pueden ser suplidos al diseñar una metodología para la implementación de Google Apps for Education (GAFE). Ahora conocido como G Suite For Education desde 2016 y Google Cloud Platform (GCP); por medio de la caracterización de las entidades del sector defensa, este trabajo aporta a la comunidad una metodología para la implementación de GAFE y GCP en IES del sector defensa, la cual ha sido implementada en el Centro de Educación Militar del Ejército de Colombia, generando como resultados la apropiación de diferentes herramientas tecnológicas en la cultura de la organización, además de una mejora significativa en la trazabilidad de los procesos administrativos. Para así evolucionar esta metodología de un escenario Colombiano a un escenario global, con el fin de que sea aplicada a cualquier IES del sector defensa alrededor del mundo. ; Resumen 6 Abstract 7 Tabla de Contenido 8 Lista de tablas 10 Lista de Figuras 11 Lista de Abreviaturas 12 Lista de Anexos 13 Capítulo 1. Introducción 14 1.1. Justificación del Proyecto 14 1.2. Objetivos 16 1.2.1. General 16 1.2.2. Específicos. 16 Capítulo 2. Antecedentes y Estado de Arte 18 2.1. Antecedentes. 18 2.2. Estado del Arte. 21 Capítulo 3. Marco Teórico 35 Capítulo 4. Metodología 44 Capítulo 5. Desarrollo y Resultados 45 5.1. Caracterización De Las Entidades De Educación Superior Defensa 45 5.2. Implementación metodología, Análisis y Resultados 48 5.2.1 Análisis de requerimientos. 49 5.2.2 Identificar las necesidades. 52 5.2.3 Priorizar. 56 5.2.4 Definir fases de desarrollo. 58 5.2.5 Definir equipo de trabajo. 61 5.2.6 Aprobación del proyecto y presupuesto. 63 5.2.7 Comenzar desarrollos. 66 5.2.8 Pilotear, estandarizar y divulgar. 68 Capítulo 6. Conclusiones/Recomendaciones 73 6.1. Conclusiones 73 6.2. Recomendaciones 74 Bibliografía 75 Anexos 79 ; This project involves the problem that HEI (Higher Education Institutions), from the defense sector in Colombia, have with the proper Information Management. This is evidenced in the huge amount of errors caused by the manual processes carried out in administrative and educational areas, which in turn generates discontent in students, teachers and senior management. It is essential to evaluate the main requirements and determine how them can be substituted through the use of information and communication technologies (ICTs), designing a methodology for implementing Google Apps for Education (GAFE) which is known as G Suite for Education since 2016 and Google Cloud Platform (GCP); this research aims to propose a methodology for the implementation of GAFE and GCP in HEI belonging to the defense sector as a contribution to the community. This methodology has already been implemented in the Military Education Center of the Colombian Army resulting in a change in the organization's culture which has appropriated different technological tools in addition to a significant improvement in the traceability of the administrative processes, to evolve this methodology from a Colombian scenario to a global scenario, in order to be suitable to any IES in the defense sector around the world.

A major requirement both of national and international ethical codes for human experimentation, and of national legislation in many cases, is that new substances or devices should not be used for the first time on human beings unless previous tests on animals have provided a reasonable presumption of their safety. That is so called: Good Clinical Praxis (GCP). There are two international ethical codes intended principally for the guidance of countries or institutions that have not yet formulated their own ethical requirements for human experimentation:The Declaration of Helsinkiof the World Medical Association andThe Proposed International Guidelines for Biomedical Research Involving Human Subjectsof the Council for International Organizations of Medical Sciences and the World Health Organization[1]. Animal experimentation is fundamental to the biomedical sciences, not only for the advancement of specific vital processes, but also for the improvement of methods of prevention, diagnosis, and treatment of disease both in man and in animals. The use of animals is also indispensable for testing the potency and safety of biological substances used in human and veterinary medicine, as well as for determining the toxicity of the rapidly growing number of molecules that never existed before in nature and which may represent a hazard to health. This extensive exploitation by man of animals implies philosophical and moral problems that are not peculiar to their use for scientific purposes, and there are no objective ethical criteria by which to judge claims and counterclaims in such matters[2]. However, there is a consensus that "deliberate cruelty is repugnant". While many countries have general laws or regulations imposing penalties for ill-treatment of animals, relatively few make specific provision for their use for scientific purposes. Because of differing legal systems and cultural backgrounds there are varying approaches to the use of animals for research, testing, or training in different countries. In the few that have done so, the measures adopted vary widely: on the one hand, legally enforceable detailed regulations with licensing of experimenters and their premises together with an official inspectorate; on the other, entirely voluntary self-regulation by the biomedical community, with lay participation. Many variations are possible between these extremes, one intermediate situation being a legal requirement that experiments or other procedures involving the use of animals should be subject to the approval of ethical committees of specified composition. The International Guiding Principles are the product of the collaboration of a representative sample of the international biomedical community, including experts of the World Health Organization, and of consultations with responsible animal welfare groups. The International Guiding Principles have already gained a considerable measure of acceptance internationally. European Medical Research Councils (EMRC), an international association that includes all the West European medical research councils, fully endorsed the Guiding Principles in 1984. Here we bring the basic bioethical principles for using animals in biomedical research[3]: Methods such as mathematical models, computer simulation andin vitrobiological systems should be used wherever appropriate, Animal experiments should be undertaken only after due consideration of their relevance for human or animal health and the advancement of biological knowledge, The animals selected for an experiment should be of an appropriate species and quality, and the minimum number required to obtain scientifically valid results, Investigators and other personnel should never fail to treat animals as sentient, and should regard their proper care and use and the avoidance or minimization of discomfort, distress, or pain as ethical imperatives, Procedures with animals that may cause more than momentary or minimal pain or distress should be performed with appropriate sedation, analgesia, or anesthesia in accordance with accepted veterinary practice. Surgical or other painful procedures should not be performed on unanesthetized animals paralyzed by chemical agents, Where waivers are required in relation to the provisions of article V, the decisions should not rest solely with the investigators directly concerned but should be made, with due regard to the provisions of articles IV, and V, by a suitably constituted review body. Such waivers should not be made solely for the purposes of teaching or demonstration, At the end of, or, when appropriate, during an experiment, animals that would otherwise suffer severe or chronic pain, distress, discomfort, or disablement that cannot be relieved should be painlessly killed, The best possible living conditions should be maintained for animals kept for biomedical purposes. Normally the care of animals should be under the supervision of veterinarians having experience in laboratory animal science. In any case, veterinary care should be available as required, It is the responsibility of the director of an institute or department using animals to ensure that investigators and personnel have appropriate qualifications or experience for conducting procedures on animals. Adequate opportunities shall be provided for in-service training, including the proper and humane concern for the animals under their care. Also seeDraft CIOMS Guiding Principles 2011to be used by the international scientific community to guide the responsible use of vertebrate animals in scientific and/or educational activities[4]. Go to: Alternatives for animal in biomedical research There remain many areas in biomedical research which, at least for the foreseeable future, will require animal experimentation. An intact live animal is more than the sum of the responses of isolated cells, tissues or organs; there are complex interactions in the whole animal that cannot be reproduced by biological or non-biological "alternative" methods. The term "alternative" has come to be used by some to refer to a replacement of the use of living animals by other procedures, as well as methods which lead to a reduction in the numbers of animals required or to the refinement of experimental procedures. The experimental procedures that are considered to be "alternatives" include biological and non-biological methods. The biological methods include the use of micro-organisms,in vitropreparations (subcellular fractions, short-term cellular systems, whole organ perfusion, and cell and organ culture) and under some circumstances, invertebrates and vertebrate embryos. The non-biological methods include mathematical modeling of structure-activity relationships based on the physico-chemical properties of drugs and other chemicals, and computer modeling of other biological processes. In addition to experimental procedures, retrospective and prospective epidemiological investigations on human and animal populations represent other approaches of major importance. There no need specialy underline that the adoption of "alternative" approaches is viewed as being complementary to the use of intact animals and their development and use should be actively encouraged for both scientific and humane reasons.

Trypanosoma brucei gambiense causes human African trypanosomiasis (HAT). Between 1990 and 2015, almost 440000 cases were reported. Large-scale screening of populations at risk, drug donations, and efforts by national and international stakeholders have brought the epidemic under control with <2200 cases in 2016. The World Health Organization (WHO) has set the goals of gambiense-HAT elimination as a public health problem for 2020, and of interruption of transmission to humans for 2030. Latent human infections and possible animal reservoirs may challenge these goals. It remains largely unknown whether, and to what extend, they have an impact on gambiense-HAT transmission. We argue that a better understanding of the contribution of human and putative animal reservoirs to gambiense-HAT epidemiology is mandatory to inform elimination strategies. ; This work was supported by a grant from the Bill & Melinda Gates Foundation ( OPP1150674 ). KSR gratefully acknowledges funding of the NTD Modelling Consortium by the Bill & Melinda Gates Foundation in partnership with the Task Force for Global Health under grant number OPP1053230 . AML, BB, EM, GS, HI, MK, VJ, and VL are supported by TrypanoGen funded by the Wellcome Trust (grant number 099310/Z/12/Z ). NC acknowledges funding from the Bill & Melinda Gates Foundation under grant OPP1156227 . LMF is funded by Fundacao para a Ciencia e Tecnologia ( IF/01050/2014 ). FAO contribution to this study was provided in the framework of the Programme against African Trypanosomosis (PAAT), and supported by the Government of Italy (FAO Project 'Improving food security in sub-Saharan Africa by supporting the progressive reduction of tsetse-transmitted trypanosomosis in the framework of the NEPAD', codes GTFS/RAF/474/ITA and GCP/RAF/502/ITA). The funders had no role in design, decision to publish, or preparation of the manuscript. The views, opinions, assumptions or any other information set out in this article are solely those of the authors. ; Sí

INTRODUCTION: Lassa fever (LF) is a severe and often fatal systemic disease in humans and affects a large number of countries in West Africa. Treatment options are limited to supportive care and the broad-spectrum antiviral agent ribavirin. However, evidence for ribavirin efficacy in patients with LF is poor and pharmacokinetic (PK) data are not available. Irrua Specialist Teaching Hospital (ISTH) developed an intravenous ribavirin regimen different to the WHO recommendation. Apart from a lower total daily dose the drug is usually administered once per day which reduces the exposure of personnel to patients with LF. The aim of this study is to characterise the PK of the Irrua ribavirin regimen. METHODS AND ANALYSIS: This prospective, observational clinical study will assess PK properties of the Irrua ribavirin regimen on routinely ribavirin-treated patients with LF at ISTH, a referral hospital serving 19 local governmental areas in a LF endemic zone in Nigeria. Participants will be adults with PCR-confirmed LF. The primary objective is to describe classical PK parameters for ribavirin (maximum plasma drug concentration, time to maximum plasma drug concentration, area under the plasma drug concentration vs time curve, half-life time T1/2, volume of distribution). Blood samples will be collected at 0.5, 1, 3, 5, 8, 12 and 24 hours after doses on day 1, day 4 and day 10 of ribavirin treatment. Ribavirin plasma concentrations will be determined using liquid chromatography coupled to tandem mass spectrometry. ETHICS AND DISSEMINATION: The study will be conducted in compliance with the protocol, the Declaration of Helsinki, Good Clinical Practice (GCP) and the Nigerian National Code for Health Research Ethics. The protocol has received approval by the Health Research Ethics Committee of ISTH. Results will be made available to LF survivors, their caregivers, the funders, LF research society and other researchers. REGISTRATION DETAILS: ISRCTN11104750