GLP机构档案室的建立和管理与科研档案管理之比较

档案的建立和管理在药物非临床安全性评价和科学研究中都起到非常重要的作用。我们通过查阅文献发现,关于GLP机构档案管理的文献综述极少,涉及到将它与科研档案管理作系统全面的比较的文章是没有的。现从资料档案保存机构的硬件设施、档案管理规范和应注意的问题3个方面详细介绍了资料档案管理的相关规定和经验,并将GLP档案管理规范与科研档案管理规范作比较,我们根据国家档案局发布的《科学技术研究档案管理暂行规定》和7年GLP档案管理经验以及多次国家食品药品监督管理局(SFDA)认证现场检查的经历,总结出两者在功能实现、硬件设施、温湿度要求、档案防护、制定SOP、档案管理人员资质、各方人员职责、归档范围、归档形式、资料档案的接收与审查、归档时间、保管期限、借阅返还规定、资料的书写规范性、进出记录和电子文件的保存这16个方面的异同之处,突出GLP档案管理规范的特点和重点。通过这一深入全面的比较分析,得出GLP档案管理更加明确、具体、细致和可操作。     

GLP认证对动物实验管理的要求

依据我国GLP法规和GLP检查办法,结合本单位申请GLP认证的实践,对GLP认证中与实验动物管理有关的人员、动物饲养设施设备、相关的标准操作规程（SOP）的制定和配备、动物实验的管理以及相关原始资料的归档保存等作了论述。     

浅谈军队基层科研单位科研档案的管理

科研档案记录着科学技术研究的真实过程,是科研活动的重要环节,也是科研诚信和过程溯源的重要依据,对保证研究机构的可持续发展具有重要意义。结合军队基层单位科学技术研究档案的基本情况、主要做法和管理经验,阐述了科研档案的重要性,并针对基层科研单位科研档案管理与利用的发展趋势提出建议。     

新时期医学科研档案管理的特点和问题

随着医学科学研究的迅速发展,医学科研档案管理实践中暴露出了一系列新的问题和矛盾,本文从医学科研档案的特点和现代医学研究发展的要求出发,对医学科研档案管理体制、管理模式、管理技术、全员档案意识、技术平台建设以及档案的开发利用等方面进行了深入的探讨。目的是增强档案意识,提高科研档案管理水平,更好地为医学科研活动服务。     

新时期医学科研档案管理的特点和问题

随着医学科学研究的迅速发展,医学科研档案管理实践中暴露出了一系列新的问题和矛盾,本文从医学科研档案的特点和现代医学研究发展的要求出发,对医学科研档案管理体制、管理模式、管理技术、全员档案意识、技术平台建设以及档案的开发利用等方面进行了深入的探讨。目的是增强档案意识,提高科研档案管理水平,更好地为医学科研活动服务。     

生物医学研究中的实验记录及其存档与管理

优良实验记录规范在生物医学工作者养成科学素养、提供科研首先发现权证据、开展数据分析、发表论文、科研协作、同行评议,乃至支持知识产权诉求和抗辩学术不端行为指控等方面均发挥重要的作用。多年来,我院一直极为重视实验记录的规范化管理工作,先后建立起一整套实验记录的职责、格式、内容、检查评比、归档和档案管理等规范性文件和要求,为科研成果申报、提高科研规范化水平和应对行政监管部门检查奠定了基础。     

浅论提高档案管理人员业务素质的途径

"档案事业是党和国家事业发展的一个不可缺少的方面",加强档案专业技术人才培养,提高档案人员专业技能,建设一支高素质和具有创新精神的档案管理人才队伍,是新形势下档案工作急待解决的问题。     

制定实验记录规范 提高科研工作质量

实验记录是科研工作中的一项基础性工作,也是一项非常严肃的工作。它的好坏直接影响到科研工作质量、科技档案质量和科研作风的养成,制定实验记录规范,对实验记录实行质量控制,是加强科研作风培养,保证科研工作效率,提高科技档案质量的重要环节。 1 制定实验记录规范的必要性 实验记录是在科研活动中形成的,是对科研活动的真实描述和记载,它包括各种载体的文字书写、图表、照片的保存等。随着科学技术     

红十字会档案网络安全管理存在的问题及对策研究

随着计算机水平的不断进步,档案管理出现了新的方式方法,为了提高档案信息管理的效率水平,红十字会也依托高新科技,不断加强档案管理的网络化。档案管理网络化让红十字会在档案管理上效率更高,查询更为便利快捷,在服务功能上远远高于传统的纸质档案。但受到网络威胁的制约,数字化档案在安全防护上存在着较大的缺陷,因此,如何提高数字化档案的安全管理、提供更为强大的防护体系,成为当前档案管理人员研究的热门课题。     

GLP原则在体外毒理学评价实验室的应用

在动物福利运动的推动下,以减少、优化和替代动物试验为核心内容的体外试验系统已成为安全评价不可或缺的组成部分,在药品、化学品、化妆品毒理学评价中起到重要作用。体外试验系统不同于体内动物实验,体外毒理学实验室GLP原则的建立和运行应充分考虑体外试验系统的特殊性。目前我国专业的体外安全评价实验室的建设刚刚起步,还没有可供借鉴的成熟经验。本文从实验室组织、试验系统维护、人员职责、质量管理和运行几个方面,介绍了GLP原则在化妆品体外毒理学检验和评价实验室的应用。     

Large numbers of mice established by in vitro fertilization with cryopreserved spermatozoa: implications and applications for genetic resource banks, mutagenesis screens, and mouse backcrosses

Recent advances in the methodologies for cryopreservation of mouse spermatozoa have opened up a number of opportunities for mouse geneticists. We have investigated various applications for this relatively new technology and have explored the potential of sperm freezing coupled with IVF for archiving, stock building, and the rapid establishment of backcrosses. Firstly, we investigated the use of sperm freezing for the archiving of (C3H/HeH × BALB/c)F₁ progeny from a large-scale mutagenesis program. We have demonstrated that it is possible to establish efficient, comprehensive, and deep archives and that potentially thousands of offspring can be derived from the frozen spermatozoa of a single mutant male mouse. Secondly, we examined the efficacy of sperm freezing for a number of other genotypes. For at least some genotypes, frozen spermatozoa can be utilized to rapidly build stock far more quickly than by conventional methods. Finally, we demonstrated that it is feasible to use frozen spermatozoa from the mouse mutant archive for the rapid generation of mutant backcross progeny. Received: 8 February 1999 / Accepted: 5 May 1999     

Archivierung von Genomdaten

In view of the increasing amount of data arising from genome research, efficient research data management is becoming increasingly important in this domain. The third, and last, article of the series on “Research data management for genome data” describes the general lifecycle of research data—from their planning via the selection and inclusion into storage facilities to preservation measures and final user access. Archives play an important role in nearly all phases of this life cycle, which renders them an important component of genome data processing. Three exemplary public archives for genome data are introduced: the European Molecular Biology Laboratory (EMBL) databank, the Sequence Read Archive, and the Trace Archive. Owing to the high level of specialization of these institutions, however, additional archives are required that allow more generic data storage or, alternatively, easy extension to other genome data types. A generic concept for such archives will be described and recommendations given for their practical implementation.     

Proteomics FASTA archive and reference resource

A FASTA file archive and reference resource has been added to ProteomeCommons.org. Motivation for this new functionality derives from two primary sources. The first is the recent FASTA standardization work done by the Human Proteome Organization's Proteomics Standards Initiative (HUPO-PSI). Second is the general lack of a uniform mechanism to properly cite FASTA files used in a study, and to publicly access such FASTA files post-publication. An extension to the Tranche data sharing network has been developed that includes web-pages, documentation, and tools for facilitating the use of FASTA files. These include conversion to the new HUPO-PSI format, and provisions for both citing and publicly archiving FASTA files. This new resource is available immediately, free of charge, and can be accessed at http://www.proteomecommons.org/data/fasta/. Source-code for related tools is also freely available under the BSD license.     

HydroServer Lite as an open source solution for archiving and sharing environmental data for independent university labs

Managing, archiving, and sharing large amounts of data are essential tasks in ecological laboratories, and detailed data management plans are now required by major funding agencies. Many independent research labs may lack the technical or financial resources needed to support some of the more comprehensive data management solutions that have become available. In this paper we describe an open-source solution to data management, archiving, and sharing that can be implemented and customized by someone with limited computer programming experience using free software and standardized web services. This software, HydroServer Lite, is a light-weight database and data management web-based application that integrates with and makes data available on a large data sharing network developed by the Consortium of Universities for the Advancement of Hydrologic Sciences, Inc. (CUAHSI). The CUAHSI Hydrologic Information System facilitates data sharing through a network of local HydroServers that are registered with the central registry. Each HydroServer may contain a variety of ecological and climate data, stored in a standardized relational database model. Someone searching for data that are registered in the central registry can query the network by source, location, variable type, and dates. These data can be downloaded from the local HydroServer to a computer in an office or lab where they can be manipulated and analyzed without compromising the data in the archives. We offer this HydroServer Lite case study as a possible solution for independent research laboratories looking for a data management system that requires little technical expertise or initial cost to set up.     

Protein Circular Dichroism Data Bank (PCDDB): data bank and website design

The Protein Circular Dichroism Data Bank (PCDDB) is a new deposition data bank for validated circular dichroism spectra of biomacromolecules. Its aim is to be a resource for the structural biology and bioinformatics communities, providing open access and archiving facilities for circular dichroism and synchrotron radiation circular dichroism spectra. It is named in parallel with the Protein Data Bank (PDB), a long-existing valuable reference data bank for protein crystal and NMR structures. In this article, we discuss the design of the data bank structure and the deposition website located at http://pcddb.cryst.bbk.ac.uk. Our aim is to produce a flexible and comprehensive archive, which enables user-friendly spectral deposition and searching. In the case of a protein whose crystal structure and sequence are known, the PCDDB entry will be linked to the appropriate PDB and sequence data bank files, respectively. It is anticipated that the PCDDB will provide a readily accessible biophysical catalogue of information on folded proteins that may be of value in structural genomics programs, for quality control and archiving in industrial and academic labs, as a resource for programs developing spectroscopic structural analysis methods, and in bioinformatics studies.     

Metrics for Success: Strategies for Enabling Core Facility Performance and Assessing Outcomes

Core Facilities are key elements in the research portfolio of academic and private research institutions. Administrators overseeing core facilities (core administrators) require assessment tools for evaluating the need and effectiveness of these facilities at their institutions. This article discusses ways to promote best practices in core facilities as well as ways to evaluate their performance across 8 of the following categories: general management, research and technical staff, financial management, customer base and satisfaction, resource management, communications, institutional impact, and strategic planning. For each category, we provide lessons learned that we believe contribute to the effective and efficient overall management of core facilities. If done well, we believe that encouraging best practices and evaluating performance in core facilities will demonstrate and reinforce the importance of core facilities in the research and educational mission of institutions. It will also increase job satisfaction of those working in core facilities and improve the likelihood of sustainability of both facilities and personnel.     

Best Practices for Core Facilities: Handling External Customers

This article addresses the growing interest among U.S. scientific organizations and federal funding agencies in strengthening research partnerships between American universities and the private sector. It outlines how core facilities at universities can contribute to this partnership by offering services and access to high-end instrumentation to both nonprofit organizations and commercial organizations. We describe institutional policies (best practices) and procedures (terms and conditions) that are essential for facilitating and enabling such partnerships. In addition, we provide an overview of the relevant federal regulations that apply to external use of academic core facilities and offer a set of guidelines for handling them. We conclude by encouraging directors and managers of core facilities to work with the relevant organizational offices to promote and nurture such partnerships. If handled appropriately, we believe such partnerships can be a win-win situation for both organizations that will support research and bolster the American economy.     

The Genome Sequence Archive Family: Toward Explosive Data Growth and Diverse Data Types

The Genome Sequence Archive (GSA) is a data repository for archiving raw sequence data, which provides data storage and sharing services for worldwide scientific communities. Considering explosive data growth with diverse data types, here we present the GSA family by expanding into a set of resources for raw data archive with different purposes, namely, GSA (https://ngdc.cncb.ac.cn/gsa/), GSA for Human (GSA-Human, https://ngdc.cncb.ac.cn/gsa-human/), and Open Archive for Miscellaneous Data (OMIX, https://ngdc.cncb.ac.cn/omix/). Compared with the 2017 version, GSA has been significantly updated in data model, online functionalities, and web interfaces. GSA-Human, as a new partner of GSA, is a data repository specialized in human genetics-related data with controlled access and security. OMIX, as a critical complement to the two resources mentioned above, is an open archive for miscellaneous data. Together, all these resources form a family of resources dedicated to archiving explosive data with diverse types, accepting data submissions from all over the world, and providing free open access to all publicly available data in support of worldwide research activities.