A Unique Data Validation Process By Internal And External Quality Assurance System Aimed To Combat Research Malpractice.

Research fabrication and data fraud are one of the major concerns worldwide which are rising and evident from increasing number of retractions in peer reviewed Journals. If not checked, this can impact the reputation of a research organisation as well as the costs of translation of research data. In basic research extremely publicized cases of falsification of data have been reported and it is possible, that there are many unreported or undetected cases. In order to improve the quality standards, the validation processes were implemented for data quality at Neuroscience research lab in India for verifying PhD thesis results. Good Laboratory practices could be implicated in every research institute so that data impostures were prevented. We aimed to establish superior data quality by randomly verifying raw data in multiple projects funded by national agencies before publication of results at Neuroscience Research Lab.

Exploration of the ethical review mechanism of serious adverse events in hospital clinical trials / 中华医学科研管理杂志

Objective To continuingly update the ethical review mechanism of Serious Adverse Events (SAE) in hospital clinical trials .Methods The definition of serious adverse events and the status quo of SAE review was analyzed ,considering the standard operating procedures of SAE review in our hospital ,as well as related measurements for improvement .Results At present ,there still exists some disadvantages in the report and ethical review of SAE ,which the ethical review committee should pay more attention .Conclusions It is important that the ethics committee review of SAE happened in clinical trial effec-tively and efficiently ,which helps to maximize the protection of the subject's health and rights .

Application of standard operating procedures in hospital logistics outsourcing projects / 中华医院管理杂志

This article introduced the application of the standard operating procedures(SOP) in the logistics outsourcing projects of a hospital. By means of enforcing SOPs and implementation, all aspects of hospital logistics outsourcing projects are managed by sections over the entire process. These SOPs constitute a task chain that is closely linked and efficient,enhancing working efficiency and reducing risk exposure of hospital logistics outsourcing projects.

Principles of necropsy and gross pathology examination for toxicologic pathology assessment / 药物评价研究

Toxicologic pathology plays an important role in the safety evaluation of drugs.The results of toxicologic pathology can answer the basic problems of pathological lesions such as location,severity grading,nature and prognosis,etc.Necropsy and gross pathology examination are important aspects of toxicologic pathology assessment.Procedures typically include preparation for the necropsy,euthanasia procedures,identification and recording all gross lesions,collection of tissues listed in the study protocol,determination of organ weight,as well as tissue fixation so as to be ready for the subsequent tissue processing and histopathology examination.All the procedures must be done in a consistent manner and in accordance with standard operating procedures (SOPs).The present paper briefly introduced the principles of necropsy and gross pathology examination for toxicologic pathology in order to standardize the procedures and to lay foundation for the improvement of the histopathology examination in the field of preclinical safety evaluation of drugs of China.

A quasi experimental study to assess the effectiveness of standard operating procedures on prevention and management of needle stick injury in a teaching hospital of Haryana, India.

Background: Nurses spend most of the time with patients and provide the most direct patient care; nurses are also the healthcare workers that are most susceptible to worksite-related medical problems the most common one being needle stick injuries. Adequate training will empower the nurses to protect themselves and effectively manage needle stick injuries. The aim of the study was to assess the effectiveness of standard operating procedures (SOP) in prevention and management of needle stick injuries. Methods: A quasi experimental study was conducted among nurses working in two teaching hospitals in Haryana A total of 150 nurses were included in the study. The tools included a knowledge questionnaire and a SOP on prevention and management of needle stick injuries. Results: There was a significant increase in the post test knowledge score of the experimental group -27.74 (day 9) and 24.13 (day 40) as compared to the pre-test knowledge score (21.00). However, there was no significant increase in the post test score on day 70 (22.26). Conclusions: Training of nurses is vital in prevention of needle stick injuries however continuous reinforcement is required for the sustainability of knowledge.

Avaliação dos conhecimentos e procedimentos em biossegurança de trabalhadores de laboratórios nível de biossegurança 3 / Knowledge of the procedures and evaluation in biosafety laboratory workers biosafety level 3

A Biossegurança constitui um campo do conhecimento com limites amplos e em constante construção. Entretanto, no Brasil, sua evolução teve fraco acompanhamento, especialmente em relação aos conhecimentos e procedimentos dos profissionais e infraestrutura dos laboratórios nível de Biossegurança 3, com poucos dados que possam indicar o grau de desenvolvimento e aplicabilidade de suas normas nas diversas instituições de saúde. Contudo, não bastam a adequação e funcionabilidade da infraestrutura predial, mas sim o conhecimento das necessidades dos usuários no sentido de propiciar aceitação das normas de Biossegurança por meio da conscientização dos riscos levando à mudança na conduta e no comportamento. Para isto, torna-se imprescindível a elaboração de treinamentos teóricos e práticos com atualizações constantes dos profissionais da área de saúde que deverão ser avaliados periodicamente para que haja melhorias nos programas de treinamentos oferecidos, uma vez que esses programas visam a garantir a qualidade e a segurança dos profissionais, dos ambientes internos e externos, à população em geral e a qualidade dos resultados pretendidos. Neste contexto, este trabalho teve, como objetivo principal, avaliar, a partir da pesquisa descritiva com abordagem qualitativa e exploratória, os dados coletados por questionários e entrevistas estruturadas, aplicadas aos 37 profissionais e nove gestores dos seis laboratórios NB3 participantes. A análise dos dados foi feita pela abordagem da multirreferencialidade, considerando os conhecimentos e procedimentos em Biossegurança e os possíveis impactos das estratégias dos últimos treinamentos oferecidos a esses profissionais, assim como as condições das instalações laboratoriais no país...

Biosafety is a field of knowledge with wide limits and constant construction. However, in Brazil, its evolution had weak monitoring, especially in relation to knowledge and professional procedures and infrastructure of Biosafety Level 3 laboratories, with little data that may indicate the degree of development and applicability of its norms in the various health institutions. However, it is not enough the adequacy and functionality of building infrastructure, but the knowledge of users' needs in order to provide accepted standards of biosafety through awareness of risks leading to change in the conduct and behavior. For this, it is essential the development of theoretical and practical trainings with constant updates of professionals in the health area who should be evaluated periodically with objectives of improvements in the training programs offered, since these programs aim to ensure the quality and safety of professionals, internal and external environments, the general population and the quality of intended results. In this context, this work has as main goal, to evaluate, from the descriptive and exploratory qualitative research approach, the data collected by questionnaires and structured interviews, applied to 37 professionals and nine managers of the six participating BSL3 laboratories. Data analysis was performed by the multi-referential approach, considering the knowledge and procedures on Biosafety and the possible impacts of the strategies of the last training offered to these professionals, as well as the conditions of laboratory facilities in the country...

Development of standard operating procedures of Habbe Shifa: A polyherbal Unani formulation.

Background: Unani medicines are being used since antiquity. However, in spite of their effi cacy, they have been widely criticized due to lack of standardization and poor quality presentation. For this reason, application of good manufacturing practices and development of standard operating procedures (SOPs) in the manufacture of herbal medicines became an essential tool to assure their quality. Objectives: Therefore, the objective of the study was to develop the SOP of Habbe Shifa (HS) regarding the particle size (PS), binder, temperature of drying, and duration of drying. Materials and Methods: In this study, 24 batches of HS were prepared according to the instructions given in formulary to develop SOP. Three particle sizes (i.e., 80, 100, and 120 No. Mesh sieve), were taken for preparation of pills. Water and Samaghe Arabi (Gum Acacia mucilage [GAM]) were used as binder for preparing the lubdi (mass) in different batches. Different temperature and duration of drying were used to dry the pills in hot air oven to get satisfactory results. All the batches were assessed three times for hardness, friability, and disintegration time and mean regarded as standard parameter value. Results and Conclusion: The batch with 150 m PS (100 mesh sieve), 5% w/w GAM used as a binder, dried at 90°C for 120 min showed hardness 3.50 ± 0.00 kg/cm, friability 0.02 ± 0.003%, and disintegration time 25.00 ± 0.57 min, which showed most appropriate result among all batches and considered as fi nal batch. Its SOP may be used for future reference which can help in setting up regulatory limit to assure the quality of Unani medicines.

Estrategia para la preparación de unidades de salud en buenas prácticas clínicas / Strategy for the preparation of health units for good clinical practices

Introducción: El entorno regulatorio mundial es cada vez más exigente para establecer, implementar y mantener el cumplimiento de las buenas prácticas clínicas (BPC). En Cuba, una respuesta necesaria derivada del desarrollo creciente de la industria farmacéutica y biotecnológica nacional fue la creación del Centro Nacional Coordinador de Ensayos Clínicos (CENCEC). Una de las misiones del CENCEC es preparar a las unidades-sitios clínicos seleccionados que realizan investigaciones clínicas, para su posterior certificación en BPC por la autoridad reguladora nacional, con la finalidad de avalar la calidad que corresponde al proceso de investigación clínica que redunda en una esmerada atención y protección al paciente objeto de estudio. Objetivo: Describir la estrategia del CENCEC para la preparación en BPC de los sitios clínicos seleccionados del Sistema Nacional de Salud (SNS) que participan en ensayos clínicos. Métodos: Se revisan más de 250 documentos normativos emitidos por Europa, Estados Unidos, Japón y los países nórdicos relacionados con aspectos prácticos y éticos para la implementación de las BPC...

Background: The global regulatory environment is increasingly demanding to establish, implement, and maintain the compliance with Good Clinical Practices (GCP). In Cuba, The National Coordinating Center for Clinical Trials (CENCEC) was created as a necessary response derived from the increasing development of the national pharmaceutical and biotechnological industry. One of the missions of the CENCEC is to prepare selected clinical units/sites that conduct clinical research for a further certification in GCP by the national regulatory authority in order to guarantee the quality that corresponds to the process of clinical research, resulting in a careful attention and protection of the patient under study. Objective: To describe the strategy of the CENCEC for the preparation of good clinical practices in the selected clinical sites of the National Health System (SNS) that participate in clinical trials. Methods: More than 250 regulatory documents issued by Europe, the United States, Japan and the Nordic countries, related to ethical and practical aspects for the implementation of good clinical practices, were reviewed...

XML schema for writing ISO 15189: 2007 - Compliant SOPs for clinical laboratory examinations.

Standard Operating Procedures are generally hard copy text documents at clinical laboratories. Due to wider access to computer based technology, Standard Operating Procedures are increasingly kept in electronic form allowing easier and wider access to its users. Such electronic form of Standard Operating Procedures are generally in plain text form or some form of word-processor document. Such presentation-centric documents are difficult to append and revise and access online. Development of Standard Operating Procedures based on eXtended Markup Language(XML) can rectify these difficulties by separating data from its presentation. This study analyses requirements of IS/ISO:15189 and NABL, India for writing examination Standard Operating Procedures and develops appropriate schema for validation of Standard Operating Procedures for clinical laboratory examinations.

Standard operating procedures of hard tissues such as femoral head, allografts obtained from living donors

Progress in medical science and cell biology has resulted in the transplantation of human cells and tissues from on human into another, facilitating reproduction and the restoration of form and function, as well as enhancing the quality of life. For more than 40 years, society has recognized the medical and humanitarian value of donation and transplanting organs and tissues. The standard operating procedures of hard tissues reflect the collective expertise and conscientious efforts of tissue bank professionals to provide a foundation for the guidance of tissue banking activities. Procurement of allograft tissues from surgical bone donors is a part of tissue banking. During the past decades the use of bone allografts has become widely accepted for the filling of skelectal defects in a variety of surgical procedures. In particular in the field of orthopaedic and oral and maxillofacial surgery the demand for allografts obtained from either living or post-mortem donors has increased. Hospital-based tissue banks mainly retrieve allografts from living donors undergoing primary total hip replacement for osteoarthritis or hemi arthroplasty for hip fractures and orthgnatic surgery such as angle reduction. Although bone banks have existed for many years, the elements of organized and maintaining a hospital bone bank have not been well documented. The experience with a tissue bank at Korea Tissue Bank(KTB) between 2001 and 2004 provides a model of procurement, storage, processing, sterilization and documentation associated with such a facility. The following report describes the standard operating procedures of hard tissues such as femoral head obtained from living donors.

Key activities involved in conduct of clinical trials / 中国临床药理学与治疗学

Key trial activities include: development of the trial protocol;development of standard operating procedures;development of support systems and tools;generation and approval of trial information documents;selection of trial sites and the selection of properly qualified,trained,and experienced investigators and study personnel;ethics committee review and approval of the protocol;review and approval by applicable regulatory authorities;enrollment of subjects into the study: recruitment,eligibility,and informed consent;the investigational product(s): quality,handling,and accounting;trial data acquisition: conducting the trial;trial data acquisition: conducting the trial; safety management and reporting;monitoring the trial;managing trial data;quality assurance of the trial performance and data;reporting the trial.