The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Stud

1.2 A new paradigmOstromThere are two opposing form of organization –bureaucracy and markets. The key difference between the two form of organization is that between choice and compulsion ;allowing the market to find an agreed result or having it imposed by a bureaucratic hierarchy.The public management paradigm has the very different underlying theoretical bases of economics and private management. As an OECD paper argues, ‗this new management paradigm emphasises results in terms of ―value for money‖, to be achieved through management by objectives, the use of markets and market-type mechanisms, competition and choice , and devolution to staff through a better matching of authority, responsibility and accountability‘(1998).1.3 The emergence of a new approachreformThe new approach:Emphasize resultsFocus on clients, outputs and outcomesManagement by objectives and performance measurementThe use of markets and market-type mechanisms in place of centralized command-and-control-style regulationCompetition and choiceDevolution with a better matching of authority, responsibility and accountabilitySome views.Rhodes saw managerialism in Britain as a ‗determined effort to implement the ―3Es‖ of economy, efficiency and effectiveness at all levels of Br itish government‘(1991).Horton would argue ‗during the 1980s and 1990s the civil service moved form an administered to a managed bureaucracy and from a system of public administration to one of new public management (NPM)‗ (1999).The Gore Report which was clearly influenced by Osborne and Gaebler set out to change the culture of American federal government through four key principles: (i) cutting red tape ‗shifting from systems in which people are accountable for following rules to systems in which they are accountable for achieving results‘; (ii) putting customers first; (iii) empowering employees to get results; (iv) cutting back to basics and ‗producing better government for less (1993).1.4 Public administration andpublic managementAdministration essentially involves following instructions and service;Management involves: first, the achievement of results, and secondly, personal responsibility by the manager for results being achieved.Management does include administration.Public administration andpublic managementPublic administrationBeside being an activity and a profession, it referred to the study of the public sector.Public administration is the use of managerial, political, and legal theories and processes to fulfil legislative, executive and judicial governmental mandates for the provision of regulatory and service functions for the society as a whole or for some segments of it.Public managementPublic management as a branch of the larger field of public administration or public affairs. Overviews the art and science of applied methodologies for public administrative program design and organisational restructuring, policy and management planning, resource allocations through budgeting systems, financial management, human resources management, and programme evaluation and audit.They was regarded as competing paradigms.1.5 Imperatives of changeThe changes in the public sector have occurred as a response to several interrelated imperatives:(1) The attack on the public sector;(2) Changes in economic theory;(3) The impact of change in the private sector ,particularly globalization as an economic force;(4)Changes in technology.(1)The attack on the public sector(i) The scale of the public sector was simply too large: consuming too many scarce resources. (ii) There were governmental responses to argument about the scope of government.(iii) There was a sustained attack on the methods of government, with bureaucracy in particular becoming highly unpopular.(2)Economic theory(i) Public choice theory.Public choice is a sub-branch of economic thought concerned with the application of microeconomics to political and areas (Mueller,1989). Public choice theorists generally conclude that the ‗best‘ outcome will involve a maximum role for market forces and a minimal role for government. Even if this view is often ideological, and not an axiom of the theory itself, they argue there is a substantial body of evidence that private markets are better than government or political markets. If the role of government in supplying goods and services could be reduced, the economy as a whole would benefit. Markets are also argued to have better mechanisms for accountability as opposed to a bureaucracy accountable to no one.(ii) Principal/agent theory.The economic theory of principal and agent has also been applied to the public sector, especially concerning its accountability. The theory was developed for the private sector to explain the divergence often found between the goals of managers (agents) in private firms and shareholders (principals).(iii) Transaction cost theory.As set out by Williamson (1986), this challenges the notion that transaction are without cost and specifies the circumstances where a firm many prefer market-testing or contracting to in-house provision. The same applies to the public sector; there are some transactions which would be less costly if contracted out to reduce administrative cost and provide some competition.(3)Private sector changeA further imperative for public sector change has been the rapid change in the private sector and the realization that the management and efficiency of the public sector affects the private economy and national competitiveness. A concern with national competitiveness leads fairly naturally to a need for reform of the public sector.(4)Technological changeTechnological change affects management, including the management of government. This should be regarded as one of the main driving forces both towards new forms of public management and away from traditional bureaucracy.Chapter 2.The Traditional Model of Public Administration2.1 Early administrationAdministrative systems existed in ancient Egypt to administer irrigation from the annual flood of Nile and to build the pyramids.China in the Han dynasty adopted the Confucian precept that government should be handled by men chosen, not by birth, but by virtue and ability.In Europe the various Empires controlled form the centre by rules and procedures. Characteristic :(1) ‗personal‘, based on loyalty to a particular individual such as a king or a minister.(2) ‗impersonal‘ ,based on legality and loyalty to the organization and the state.2.2 The reforms of the nineteenth century(1) ‗The Northcote -Trevelyan Report ‘, 1854.Appointment by merit through examinations, and non-partisan, neutral administration.It signals the start of merit- based appointments to the public service and the gradual decline of patronage.2.3 Weber‘s theory of bureaucracyWeber argued there were three types of authority:The charismatic – the appeal of an extraordinary leaderThe traditional - such as the authority of a tribal chief;Rational/legal authority.(1)Six principles for modern systems of bureaucracy set out by Weber.(i) Authority derives from the law , and from rules made according to law.(ii) The hierarchy.(iii) The organization is something with an existence separate from the private lives of its employees; it is impersonal.(iv) Administration is a specialist occupation .(v) Working for the bureaucracy was a fulltime occupation .(vi) Office management was an activity that could be learned as it followed general rules.(2)The position of the officialThe official is to be part of an elite with status higher than that of ordinary citizens.Web er‘s theory required recruitment by merit, not by election or by patronage, into a position normally held for life in exchange for impartial service. Part of the lifetime and full-time career of the public servant is the principle of fixed salary and the prospect of advancement through the hierarchical structure.The two principles – the model of bureaucracy and position of the official - had specific purposes.A formal, impersonal system offers ‗ the optimum possibility for carrying through the principle o f specialising functions according to purely objective considerations‘.The hierarchy of authority and the system of rules make for certainty in decision; and the impersonality of the system implies that the same decision can be repeated in the same circumstances; decisions are not made arbitrarily.2.4 Wilson and political controlWilson believed that the evils of the spoils system resulted from the linking of administrative question with political ones.The politics/ administration dichotomy.The worlds of the politician and the public official were to be separate.Political officesMake the rule.Be filled competitively in the political arena.Be selected on the basis of their political competence.Be judged by the electorate or their political peers.Be of limited tenure and subject to frequent elections.Bureaucratic officesDo their bidding.Be filled competitively in the bureaucratic arena.Be selected on the basis of their bureaucratic competence.Be judged by their political overseers or their bureaucratic peers.Be of unlimited tenure, subject to good behaviour.2.5 Taylor and managementScientific management-Frederick Taylor(i) Time-and-motion studies to decide a standard for working;(ii) A wage-incentive system that was a modification of the piecework method already in existence;(iii) Changing the functional organization.(2) Human relationThe theory‘s founder was Elton Mayo.(i) The social context of the work group was the most important factor in management.(ii) Conflict was pathological and to be avoided, and there was no necessary antagonism between management and workers.(iii) Productivity increased most by taking an interest in the workers.(3) A continuing debateSome people regard the theories of Taylor and Mayo as mutually exclusive-at one time theory is pre-eminent while at other times the other is-but this would be misleading.The same pointThey both did not favour unions orindustrial democracy.The goal of both-increased productivity-was the same.Both continue to influence managementin the public sector.(4)The Golden Age of public administrationThe Golden Age of public administration was from around 1920 to the early 1970s.One variation was the ‗POSDCORB‘ set of functions set out by Gulick and Urwick (1937).POSDCORBPlanning: goal setting techniques/methods applied by executives as a means of preparing future courses of organizational action;Organizing: arranging the organizational structure and processes in an appropriate manner essential to achieving these ends;Staffing: recruiting and hiring personal to carry out the essential agency work;Directing: supervising the actual processes of doing the assignments;Coordinating: integrating the various detailed elements of the work within the organization; Reporting: tracking and communicating the progress of the work within the organization; Budgeting: fiscal and financial activities necessary to economically support the completion of these programmes, services, or activities.2.6 Problems with the traditional modelThe problem of political controlThe problem of one best wayThe problem of bureaucracyThe public choice critique(1) The problem of political controlA strict separation between politicians and administrators, between policy and administration ,was never realistic in its original home.Peters(1989)Administration and policy, instead of being discrete phenomena, are actually interrelated. In both an objective and subjective manner, the nature of the administrative system can influence the policy outputs of the political system. Administration does make policy, although these policies are not always written and promulgated in the same manner as the rules made by legislatures and executives. Moreover, the operational rules developed by administrators can be more telling for the actual outcomes for individuals than are the formally promulgated rules.(2) The problem of one best wayTedious , trivial, copious, inflexible.Gulick‘s POSDCORBTaylor‘s scientificManagement(3) The problem of bureaucracyThe problems with the theory of bureaucracy.The problematic relationship between bureaucracy and democracy;Formal bureaucracy could not longer be considered as a particularly efficient form of organization.The problematic relationship between bureaucracy and democracyWith its formal rationality, secrecy, rigidity and hierarchy, it seems inevitable that there would be some conflict between bureaucracy and democracy.It did not make sense for a democracy to have a distinct elite acting secretively.There was and is some conflict between bureaucracy and democracy.Formal bureaucracy could not longer be considered as a particularly efficient form of organization There were always some extreme interpretations of Weberian principles, particularly in the personnel system, which was made more rigid, more formal and less elitist than Weber imagined, and this tended to reduce its efficiency.New theories of organizational behaviour argue that formal bureaucratic models are no longer particularly efficient or effective in any sense, when compared to more flexible forms of management .(4)The public choice critiqueThe confrontation of bureaucracy theory andpublic choice theory.The bureaucracyThe theory of publicChoice.Two main claims:Government bureaucracy greatly restricted the freedom of the individual and its power needed to be reduces in the name of ‗choice.Market economists argued that the traditional bureaucracy model did not provide an equivalent structure of incentives and rewards to those of the market. It was less efficient than market processes.Chapter 3. Public Management3.1 IntroductionThe 1980s and 1990s saw the emergence of a new managerial approach in the public sector, in response to what many regarded as the inadequacies of the traditional model of administration.Public management(1) It paid more attention to the achievement of results and the personal responsibility of managers.(2) There is an expressed intention to move away from classic bureaucracy .(3) Organizational and personal objectives are to be set clearly.(4) Senior staff are more likely to be politically committed to the government of the day.(5) Government functions are more likely to face market tests; in separating the purchaser of government services from the provider.(6) There is also a trend towards reducing government functions.3.2 The meaning of managementAdministration means following instructions .Management means the achievement of results and taking personal responsibility for doing so. 3.3 Functions of general management‗Functions of general management ‘—Allison(1982)STRA TEGY(1) Establishing objectives and priorities for the organization.(2) Devising operational plans to achieve these objectives.MANAGING INTERNAL COMPONENTS(3) Organizing and staffing.(4) Directing personnel and the personnel management system.(5) Controlling performance.MANAGING EXTERNAL CONSTITUENCIES(6) Dealing with ‗external units‘ of the organization.(7) Dealing with independent organization.(8) Dealing with the press and public.(1)Public management is management of the external environment of the organization;Public administration is within the context of the organization.(2) Traditional public administration tended to consider short-term goals within the organization. Public management aim at the longer term and at the relationship between the organization and the external environment.(3) Traditional public administration‘s some functions was not carried out to its fulles t.(4) Under the traditional model, the concepts of public service anonymity and neutrality. New public management focus on external environment, and public service anonymity has declined.3.4 The beginnings of management approachBetween 1950s to 1980s, one starting point is the 1968 Fulton Report in the United Kingdom. This report noted concerns with the management capability of the public service.Four aspects made up the total management task of the Civil Service:(1) Formulation of policy under political direction.(2) Creating the ‗machinery‘ for implementation of policy(3) Operation of the administrative machine.(4) Accountability to Parliament and the Public.3.5 The public management reformsInstead of there being reforms to the public sector, new public management represents a transformation of the public sector and its relationship with government and society.3.6 The managerial programmeThere are various ideas of what is involved in the public management of reforms.(1)Most countries are fol lowing ‗two broad avenues‘ to improve production and delivery of publicly provided goods and services(OECD,1991).① Raise the production performance of public organization.②Make greater use of the private sector.(2) ‗New public management‘ is comprised of seven main points:① Hands-on professional management in the public sector.② Explicit standards and measures of performance .③ Greater emphasis on output controls.④ A shift to disaggregation of units in the public sector.⑤ A shift to greater competition in the public sector.⑥ A stress on private sector styles of management practice.⑦ A stress on greater discipline and parsimony in resource use.--Hood 1991.(3)Holmes and Shand ,1995‗Good managerial approach‘:① A more strategic or results-oriented approach to decision-making.②The replacement of highly centralized hierarchical hierarchical organizational structures with decentralized management environment.③Flexibility to explore alternatives to direct public provision which might provide more cost-effective policy outcomes.④ Focusing attention on the matching of authority and responsibility.⑤ The creation of competitive environments within and between public sector organizations.⑥ The strengthening of strategic capacities at the centre to ‗steer‘ government.⑦ Greater accountability and transparency through requirement.⑧ Service-wide budgeting and management systems to support and encourage these changes.(4) Pollitt argued there were a number of general elements of the new model accepted by most commentators(2001).① A shift in the focus of management systems and management systems and management effort from inputs and processes to outputs and outcomes.② A shift towards more measurement.③ A performance for more specialized, ‗lean‘, ‗flat‘ and autonomous organization forms.④ A widespread substitution of contract or contract-like relationships for hierarchical relationships.⑤ A much wider than hitherto use of market or market-like mechanisms for the delivery of public services.⑥ A broad ening and blurring of the ‗frontier‘ between the public and private sectors.⑦ A shift in value priorities away from universalism, equity, security and resilience and towards efficiency and individualism.The main points involved in the public management reforms including those emerging from the various formulations.A strategic approach. Government have aimed to develop better methods for long-term planning and strategic management.Management not administration. Public management now requires professional management where administration did not.A focus on results. The organization must focus on outcomes or outputs, instead of inputs.Managerial reforms have stressed performance by individuals and by agencies.Improved financial management. The most important change in this area has been performance and programme budgeting systems to replace the older line-item budget and accounting systems. Flexibility in staffing. There has been a consistent trend away from position classification towards flexibility in arrangements for filing senior positions.Flexibility in organization. One aspect of organizational flexibility is disaggregation, which means splitting large departments into different parts by setting up agencies to deliver services for a small policy department.A shift to greater competition. Competition for provision through contracting, is seen as reducing costs compared to bureaucratic provision.The new contractualism. Under what has been called ‗contractualism‘ , any conceivable government service can be provided by contract.A stress on private sector styles of management practice. This includes staffing changes designed to better fit staff for their positions, to appraise their performance and to reward them accordingly with merit pay.Relationships with politicians. In the traditional, model the relationship with the political leadership was narrow and technical, of master and servant, of those giving the orders and those carrying them out. Under the public management model the relationship between politician and manager is more fluid and is closer than before.Relationships with the public. There is recognition of the need for direct accountability between managers and the public, as the result of demands for a ‗client focus‘ and for greater responsiveness to outside groups and individuals.Separation of purchaser and provider. Even if government is involved in an activity it does not need to be the final provider.Re-examining what government does. One important part of the public management reform process has been to examine and reexamine government programmes to ascertain if they are meeting their goals. (Six tests, public interest test, role of government test, federalism test, partnership test, efficiency test, affordability test.)Traditional public administration was based on two theories, the theory of bureaucracy and the theory of separation between politicians and administrators. There are also two main theoretical bases to new public management. These are economics and private management.There are two key assumptions in economics.First, there is the assumption of individual rationality, that individuals can be assumed to prefer more of something rather than less.Secondly, the individual rationality assumption allows the elaboration of models that can extend to high levels of abstraction. The second theoretical basis for public management can be found in private management. There are several managerial changes with antecedents in the private sector.3.8 Criticisms of managerialism(1) The economic basis of managerialismThere are two main criticisms of the economic basis of managerialism.① Economics is a flawed social science and its application to government is similarly flawed.②Economics has some validity as the basis for the economic system and private sector, its application to government is ill-conceived.(2) The basis in private management.The derivation of managerialism from a private business model is a source of criticism. The public sector might be so different that generic or private sector models of management become irrelevant to its operations.(3) ‗Neo- Taylorism‘.With its emphasis on the control of government spending and decentralizing management responsibilities with targets and performance measurement systems, Pollitt sees a management philosophy in the new model that he describes as ‗neo- Taylorian‘ (1993).(4) Politicization.There are two sides to the question of politicization.① It could be said that those making arguments about ‗politicization‘ ignore th e fact that the public service is fundamentally a political instrument.②Politicization could lead to problems of the kind that Woodrow Wilson and the reform movement in the 1880s tried to repair. Wilson argued that separation between politics and administration would reform the spoils system and reduce the corruption that system engendered.(5) Reduced accountabilityConflicts may occur between the concepts of public management and public accountability.(6) Difficulties with contracting-out.While it is easy to argue private markets are superior and efficiencies will result from privatizing government activities, implementation is not simple.(7) Ethical issues(8) Implementation and morale problemsChapter.5The Role of Government5.1 IntroductionWhat government should or should not doneeds to be of fundamental concern to publicManagers.The debate is now whether governmentsshould have no role, but what that role shouldBe.Public sector and private sector.IntroductionIn mixed economies there must be somedemarcation between those activities that fall ineither the public sector or the private sector.Since the mid-1970s, most OECD nations haveundertaken a reassessment of the role of theirpublic sectors.IntroductionThe current debate on the role of governmentmainly concern its economic aspects: should itprovide the goods and services it does, orshould some be handed to the private sectors?Should it subsidize or regulate to the extent itdoes? Such questions also raise the very politicalmatter of how various members of the communityperceive and value the things government does.5.2 The need for a public sectorBy convention, the economy is divided between the private and public sector.Governments are command-based.Markets are voluntary.Setting up a strict dichotomy between the private and public sectors is rather misleading.The private sector relies on government for infrastructure and the system of laws, without which markets could not operate.Government relies on the private sector for the production and supply of goods and services, and for tax revenue.Private and public managementThere are several reasons why the two sectors are not the same, and cannot be the same.(1) In a way not characteristic of the private sector, public sector decisions may be coercive.(2) The public sector has different forms ofaccountability from the private sector.(3) The public service manager must cope with an outside agenda largely set by the political leadership.(4) The public sector has inherent difficulties in measuring output or efficiency in production.(5) The public sector‘s sheer size and diversity make any control of coordination difficult.‗Government‘ and ‗governance‘Government is the institution itself, is the subset that acts with authority and creates formal obligations.Governance is a broader concept describing forms of governing which are not necessarily in the hands of the formal government. It mean the processes and institution, both formal and informal. It also argue that, with globalization, government is becoming more diffuse and that instead of governments having a monopoly over issues of governance there are many players.5.3 Market failure as the basis for public policyThe market mech anism alone cannot perform all economic functions; public policy is needed ‗to guide, correct, and supplement it in certain respects‘.The key kinds of market failure .Public goods.Externalities.Market transactions often have effects on third parties, or on the environment, that only government action can alleviate.Natural monopolyGovernment involvement need not mean direct government provision, and there is now a worldwide trend to privatization of such services but with some form of government regulation attached.The key kinds of market failure .Imperfect information.Market theory does assume perfect information for buyers and sellers. To the extent that information is not gained, especially by the buyer, markets can be less than optimal.Limitation of market failureSome people think market failure may result in too much government. Other people agree it may artificially reduce the scope of government action.5.4 Instruments of governmentGovernment provision Subsidy Production RegulationGovernment provisionDirect provision by government through the budget forms the major part of its operations.SubsidySubsidies vary widely but could include subsidies to farmers or industry, or to private bus companies or private schools.ProductionUnlike provision, production takes place away from the government budget, and users are charged in the same way as if the items were provided by the private sector.。

第一章导论—是否存在国际税收体系？它是否是国际法的组成部分？Introduction: is there an international tax regime?Is it part of international law?本书的观点是存在连贯一致的国际税收体系，它体现在税收条约网络和国内法中，是国际法（包括条约及习惯法）的重要组成部分。

其实际意义在于，各国不能随意采纳国际税收规则，而只能在这个体系的范围内运作。

当国际法随时间的迁移发生变化时，这个体系也会同样发生变化。

因此，单边行动虽然不是没有可能，但是也会受到限制，各国通常都不愿采取违反这个体系基本准则的单边行动。

这些基本准则是单次征税原则（即，所得只能被征一次税——既不能多次征税，也不能不征税）和利益原则（即，积极所得主要在来源地被征税；消极所得主要在居民国被征税）。

This book has a thesis: that a coherent international tax regime exists, embodied in both the tax treaty and in domestic laws, and that it forms a significant part of international law (both treaty-based and customary). The practical implication is that countries are not free to adopt any international tax ru1es they please, but rather operate in the context of the regime, which changes in the same ways international law changes over time. Thus, unilateral action is possib1e, but is also restricted, and countries are generally reluctant to take unilateral actions that violate the basic norms that underlie the regime. Those norms are the single tax principle (i.e., that income should be taxcd once - not rnore and not less) and the benefits principle (i.e., that active business income should be taxed primarily at source, and passive investment income primarily at residence).这个观点存在很大争议。

UnclassifiedENV/JM/MONO(2002)9Organisation de Coopération et de Développement EconomiquesOrganisation for Economic Co-operation and Development 25-Jun-2002___________________________________________________________________________________________English - Or. EnglishENVIRONMENT DIRECTORATEJOINT MEETING OF THE CHEMICALS COMMITTEE ANDTHE WORKING PARTY ON CHEMICALS, PESTICIDES AND BIOTECHNOLOGY OECD SERIES ON PRINCIPLES OF GOOD LABORATORY PRACTICE AND COMPLIANCE MONITORING Number 13Consensus Document of the Working Group on Good Laboratory Practice The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Studies JT00128856ENV/JM/MONO(2002)9Unclassified English - Or. EnglishCancels & replaces the same document of 11 March 2002ENV/JM/MONO(2002)9ENV/JM/MONO(2002)9 OECD Environment, Health and Safety PublicationsSeries on Principles of Good Laboratory Practiceand Compliance MonitoringNo. 13Consensus Document of the Working Group on Good Laboratory Practice The Application of the OECD Principles of GLP to theOrganisation and Management of Multi-Site StudiesEnvironment DirectorateORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENTParis 2002ENV/JM/MONO(2002)9Also published in the Series on Principles of GoodLaboratory Practice and Compliance MonitoringNo. 1, OECD Principles of Good Laboratory Practice (asrevised in 1997)No. 2, Revised Guides for Compliance MonitoringProcedures for Good Laboratory Practice (1995)No. 3, Revised Guidance for the Conduct of LaboratoryInspections and Study Audits (1995)No. 4, Quality Assurance and GLP (as revised in 1999)No. 5, Compliance of Laboratory Suppliers with GLPPrinciples (as revised in 1999)No. 6, The Application of the GLP Principles to Field Studies(as revised in 1999)No. 7, The Application of the GLP Principles to Short-termStudies (as revised in 1999)No. 8, The Role and Responsibilities of the Study Director inGLP Studies (as revised in 1999)No. 9, Guidance for the Preparation of GLP InspectionReports (1995)No. 10, The Application of the Principles of GLP toComputerised Systems (1995)No. 11, The Role and Responsibilities of the Sponsor in theApplication of the Principles of GLP (1998)No. 12, Requesting and Carrying Out Inspections and StudyAudits in Another Country (2000)© OECD 2002Applications for permission to reproduce or translate all or part of this material should be made to: Head of Publications Service, OECD, 2 rue André-Pascal, 75775 Paris Cedex 16, France.ENV/JM/MONO(2002)9About the OECDThe Organisation for Economic Co-operation and Development (OECD) is an intergovernmental organisation in which representatives of 30 industrialised countries in North America, Europe and the Pacific, as well as the European Commission, meet to co-ordinate and harmonize policies, discuss issues of mutual concern, and work together to respond to international problems. Most of the OECD’s work is carried out by more than 200 specialised Committees and subsidiary groups composed of Member country delegates. Observers from several countries with special status at the OECD, and from interested international organisations, attend many of the OECD’s Workshops and other meetings. Committees and subsidiary groups are served by the OECD Secretariat, located in Paris, France, which is organised into Directorates and Divisions.The work of the OECD related to chemical safety is carried out in the Environment, Health and Safety Division. The Environment, Health and Safety Division publishes free-of-charge documents in eight different series: Testing and Assessment; Principles on Good Laboratory Practice and Compliance Monitoring; Pesticides; PRTRs; Risk Management; Chemical Accidents; Emission Scenario and Harmonisation of Regulatory Oversight in Biotechnology. More information about the Environment, Health and Safety Programme and EHS publications is available on OECD’s World Wide Web site (see next page).This publication was produced within the framework of the Inter-Organization Programme for the Sound Management of Chemicals (IOMC).The Inter-Organization Programme for the Sound Management of Chemicals (IOMC) was established in 1995 by UNEP, ILO, FAO, WHO, UNIDO and the OECD (the Participating Organizations), following recommendations made by the 1992 UN Conference on Environment and Development to strengthen co-operation and increase international co-ordination in the field of chemical safety. UNITAR joined the IOMC in 1997 to become the seventh Participating Organization. The purpose of the IOMC is to promote co-ordination of the policies and activities pursued by the Participating Organizations, jointly or separately, to achieve the sound management of chemicals in relation to human health and the environment.ENV/JM/MONO(2002)9This publication is available electronically, at no charge.For the complete text of this and many other Environment, Health and Safety publications, consult the OECD’sWorld Wide Web site (/ehs/)or contact:OECD Environment Directorate,Environment, Health and Safety Division2 rue André-Pascal75775 Paris Cedex 16FranceFax: (33-1) 45 24 16 75E-mail: ehscont@ENV/JM/MONO(2002)9FOREWORDIt is becoming increasingly common for non-clinical health and environmental safety studies to be conducted at more than one site. For example, companies may use facilities which specialise in different activities located at sites in various countries; or field trials on agrochemicals may have to be conducted on different crops or soil types located in different regions or countries. Toxicology studies may also have phases of the study conducted by different departments of the same organisation or different companies.In the framework of the second OECD Consensus Workshop on Good Laboratory Practice, held 21st– 23rd May 1991, in Vail, Colorado, experts discussed and reached consensus on the application of the GLP Principles to field studies. An OECD Consensus Document on “The Application of the GLP Principles to Field Studies” was subsequently published in 1992 and revised in 1999 [ENV/JM/MONO(99)23]. Among other aspects, this document introduced the concept of a “Principal Investigator” who could assume delegated responsibility for a phase of a field study being conducted at a test site that was remote from the Study Director. Although the concept of a Principal Investigator had originally been developed to assist in the conduct of field studies that included trials being conducted at several different locations, the concept is equally applicable to any other type of multi-site study.The revised OECD Principles of Good Laboratory Practice published in 1997 now refer to the role of the Principal Investigator in the conduct of any multi-site study.A study can be a “multi-site” study for a variety of reasons. A single site that undertakes a study may not have the technical expertise or capability to perform a particular task that is needed, so this work is performed at another site. A sponsor who has placed a study at a contract research organisation may request that certain study activities, such as bioanalysis, be contracted out to a specified laboratory or the sponsor may request that specimens be returned to them for analysis.The purpose of this document is to provide guidance on the issues that are involved in the planning, performance, monitoring, recording, reporting and archiving of multi-site studies. It was developed by the Fourth OECD Consensus Workshop in Horley, United Kingdom in June 2001. It was endorsed by the Working Group on GLP in December 2001 and, subsequently, by the Joint Meeting of the Chemicals Committee and Working Party on Chemicals, Pesticides and Biotechnology in February 2002. It was declassified under the authority of the Secretary-General.This guidance is complementary to that given in other documents in the OECD Series on GLP and Compliance Monitoring.ENV/JM/MONO(2002)9CONTENTSINTRODUCTION (9)MANAGEMENT AND CONTROL OF MULTI-SITE STUDIES (9)QUALITY ASSURANCE (13)MASTER SCHEDULES (14)STUDY PLAN (14)PERFORMANCE OF THE STUDY (14)REPORTING OF STUDY RESULTS (15)STANDARD OPERATING PROCEDURES (16)STORAGE AND RETENTION OF RECORDS AND MATERIALS (17)ENV/JM/MONO(2002)9INTRODUCTIONThe planning, performance, monitoring, recording, reporting and archiving of a multi-site study present a number of potential problems that should be addressed to ensure that the GLP compliance of the study is not compromised. The fact that different study activities are being conducted at different sites means that the planning, communication and control of the study are of vital importance.Although a multi-site study will consist of work being conducted at more than one site (which includes the test facility and all test sites), it is still a single study that should be conducted in accordance with the OECD Principles of GLP. This means that there should be a single study plan, a single Study Director, and ultimately, a single final report. It is therefore essential that, when the study is first planned, personnel and management at the contributing sites are made aware that the work they will perform is part of a study under the control of the Study Director and is not to be carried out as a separate study.It is imperative that the work to be carried out by the various sites is clearly identified at an early stage of planning, so that the necessary control measures can be agreed upon by the parties concerned before the study plan is finalised.Many of the problems associated with the conduct of multi-site studies can be prevented by clear allocation of responsibilities and effective communication among all parties involved in the conduct of the study. This will include the sponsor, the Study Director, and the management, the Principal Investigator(s), Quality Assurance and study personnel at each site.All of these parties should be aware that when a multi-site study is conducted in more than one country there might be additional issues due to differences in national culture, language and GLP compliance monitoring programmes. In these situations it may be necessary to seek the advice of the national GLP compliance monitoring authority where the site is located.The guidance contained within this document should be considered during the planning, performance, monitoring, recording, reporting and archiving of any study that will be conducted at more than one site. The guidance applies to all types of non-clinical health and environmental safety studies. MANAGEMENT AND CONTROL OF MULTI-SITE STUDIESA multi-site study means any study that has phases conducted at more than one site. Multi-site studies become necessary if there is a need to use sites that are geographically remote, organisationally distinct or otherwise separated. This could include a department of an organisation acting as a test site when another department of the same organisation acts as the test facility.A phase is a defined activity or set of activities in the conduct of a study.The decision to conduct a multi-site study should be carefully considered by the sponsor in consultation with test facility management assigned by the sponsor before study initiation. The use of multiple test sites increases the complexity of study design and management tasks, resulting in additional risks to study integrity. It is therefore important that all of the potential threats to study integrity presented by a multi-site configuration are evaluated, that responsibilities are clear and that risks are minimised. FullENV/JM/MONO(2002)9consideration should be given to the technical/scientific expertise, GLP compliance status, resources and commercial viability of all of the test sites that may be used.CommunicationFor a multi-site study to be conducted successfully it is imperative that all parties involved are aware of their responsibilities. In order to discharge these responsibilities, and to deal with any events that may need to be addressed during the conduct of the study, the flow of information and effective communication among the sponsor, management at sites, the Study Director, Principal Investigator(s), Quality Assurance and study personnel is of paramount importance.The mechanism for communication of study-related information among these parties should be agreed in advance and documented.The Study Director should be kept informed of the progress of the study at all sites.Study managementThe sponsor will assign a study to a test facility. Test facility management will appoint the Study Director who need not necessarily be located at the site where the majority of the experimental work is done. The decision to conduct study activities at other sites will usually be made by test facility management in consultation with the Study Director and the sponsor, where necessary.When the Study Director is unable to perform his/her duties at a test site because of geographical or organisational separation, the need to appoint a Principal Investigator(s) at a test site(s) arises. The performance of duties may be impracticable, for example, because of travel time, time zones, or delays in language interpretation. Geographical separation may relate to distance or to the need for simultaneous attention at more than one location.Test facility management should facilitate good working relationships with test site management to ensure study integrity. The preferences of the different groups involved, or commercial and confidentiality agreements, should not preclude the exchange of information necessary to ensure proper study conduct.Roles and ResponsibilitiesSponsorThe decision to conduct a multi-site study should be carefully considered by the sponsor in consultation with test facility management before study initiation. The sponsor should specify whether compliance with the OECD Principles of GLP and applicable national legislation is required. The sponsor should understand that a multi-site study must result in one final report.The sponsor should be aware that, if its site acts as a test site undertaking a phase(s) of a multi-site study, its operations and staff involved in the study are subject to control of the Study Director. According to the specific situation, this may include visits from test facility management, the Study Director and/or inspections by the lead Quality Assurance. The Study Director has to indicate the extent to which the study complies with GLP, including any work conducted by the sponsor.Test Facility ManagementTest facility management should approve the selection of test sites. Issues to consider will include, but are not limited to, practicality of communication, adequacy of Quality Assurance arrangements, and the availability of appropriate equipment and expertise. Test facility management should designate a lead Quality Assurance that has the overall responsibility for quality assurance of the entire study. Test facility management should inform all test site quality assurance units of the location of the lead Quality Assurance. If it is necessary to use a test site that is not included in a national GLP compliance monitoring programme, the rationale for selection of this test site should be documented. Test facility management should make test site management aware that it may be subject to inspection by the national GLP compliance monitoring authority of the country in which the test site is located. If there is no national GLP compliance monitoring authority in that country, the test site may be subject to inspection by the GLP compliance monitoring authority from the country to which the study has been submitted.Test Site ManagementTest site management is responsible for the provision of adequate site resources and for selection of appropriately skilled Principal Investigator(s). If it becomes necessary to replace a Principal Investigator, test site management will appoint a replacement Principal Investigator in consultation with the sponsor, the Study Director and test facility management where necessary. Details should be provided to the Study Director in a timely manner so that a study plan amendment can be issued. The replacement Principal Investigator should assess the GLP compliance status of the work conducted up to the time of replacement.Study DirectorThe Study Director should ensure that the test sites selected are acceptable. This may involve visits to test sites and meetings with test site personnel.If the Study Director considers that the work to be done at one of the test sites can be adequately controlled directly by him(her)self without the need for a Principal Investigator to be appointed, he/she should advise test facility management of this possibility. Test facility management should ensure that appropriate quality assurance monitoring of that site is arranged. This could be by the test site’s own Quality Assurance or by the lead Quality Assurance.The Study Director is responsible for the approval of the study plan, including the incorporation of contributions from Principal Investigators. The Study Director will approve and issue amendments to and acknowledge deviations from the study plan, including those relating to work undertaken at sites. The Study Director is responsible for ensuring that all staff are clearly aware of the requirements of the study and should ensure that the study plan and amendments are available to all relevant personnel.The Study Director should set up, test and maintain appropriate communication systems between him(her)self and each Principal Investigator. For example, it is prudent to verify telephone numbers and electronic mail addresses by test transmissions, to consider signal strength at rural field stations, etc. Differences in time zones may need to be taken into account. The Study Director should liase directly with each Principal Investigator and not via an intermediary except where this is unavoidable (e.g., the need for language interpreters).Throughout the conduct of the study, the Study Director should be readily available to the Principal Investigators. The Study Director should facilitate the co-ordination and timing of events andmovement of samples, specimens or data between sites, and ensure that Principal Investigators understand chain of custody procedures.The Study Director should liase with Principal Investigators about test site quality assurance findings as necessary. All communication between the Study Director and Principal Investigators or test site quality assurance in relation to these findings should be documented.The Study Director should ensure that the final report is prepared, incorporating any contributions from Principal Investigators. The Study Director should ensure that the final report is submitted to the lead Quality Assurance for inspection. The Study Director will sign and date the final report to indicate the acceptance of responsibility for the validity of the data and to indicate the extent to which the study complies with the OECD Principles of Good Laboratory Practice. This may be based partly on written assurances provided by the Principal Investigator(s).At sites where no Principal Investigator has been appointed, the Study Director should liase directly with the personnel conducting the work at those sites. These personnel should be identified in the study plan.Principal InvestigatorThe Principal Investigator acts on behalf of the Study Director for the delegated phase and is responsible for ensuring compliance with the Principles of GLP for that phase. A fully co-operative, open working relationship between the Principal Investigator and the Study Director is essential.There should be documented agreement that the Principal Investigator will conduct the delegated phase in accordance with the study plan and the Principles of GLP. Signature of the study plan by the Principal Investigator would constitute acceptable documentation.Deviations from the study plan or Standard Operating Procedures (SOPs) related to the study should be documented at the test site, be acknowledged by the Principal Investigator and reported to and acknowledged by the Study Director in a timely manner.The Principal Investigator should provide the Study Director with contributions which enable the preparation of the final report. These contributions should include written assurance from the Principal Investigator confirming the GLP compliance of the work for which he/she is responsible.The Principal Investigator should ensure that all data and specimens for which he/she is responsible are transferred to the Study Director or archived as described in the study plan. If these are not transferred to the Study Director, the Principal Investigator should notify the Study Director when and where they have been archived. During the study, the Principal Investigator should not dispose of any specimens without the prior written permission of the Study Director.Study PersonnelThe GLP Principles require that all professional and technical personnel involved in the conduct of a study have a job description and a record of the training, qualifications and experience which support their ability to undertake the tasks assigned to them. Where study personnel are required to follow approved SOPs from another test site, any additional training required should be documented.There may be some sites where temporarily employed personnel carry out aspects of study conduct. Where these persons have generated or entered raw data, or have performed activities relevant to the conduct of the study, records of their qualifications, training and experience should be maintained. Where these individuals have carried out routine operations such as livestock handling subject to supervision by more highly qualified staff, no such personnel records need be maintained.QUALITY ASSURANCEThe quality assurance of multi-site studies needs to be carefully planned and organised to ensure that the overall GLP compliance of the study is assured. Because there is more than one site, issues may arise with multiple management organisations and Quality Assurance programmes.Responsibilities of Lead Quality AssuranceThe lead Quality Assurance should liase with test site quality assurance to ensure adequate quality assurance inspection coverage throughout the study.Particular attention should be paid to the operation and documentation relating to communication among sites. Responsibilities for quality assurance activities at the various sites should be established before experimental work commences at those sites.The lead Quality Assurance will ensure that the study plan is verified and that the final report is inspected for compliance with the Principles of GLP. Quality assurance inspections of the final report should include verification that the Principal Investigator contributions (including evidence of quality assurance at the test site) have been properly incorporated. The lead Quality Assurance will ensure that a Quality Assurance Statement is prepared relating to the work undertaken by the test facility including or referencing quality assurance statements from all test sites.Responsibilities of Test Site Quality AssuranceEach test site management is usually responsible for ensuring that there is appropriate quality assurance for the part of the study conducted at their site. Quality assurance at each test site should review sections of the study plan relating to operations to be conducted at their site. They should maintain a copy of the approved study plan and study plan amendments.Quality assurance at the test site should inspect study-related work at their site according to their own SOPs, unless required to do otherwise by the lead Quality Assurance, reporting any inspection results promptly in writing to the Principal Investigator, test site management, Study Director, test facility management and lead Quality Assurance.Quality assurance at the test site should inspect the Principal Investigator’s contribution to the study according to their own test site SOPs and provide a statement relating to the quality assurance activities at the test site.MASTER SCHEDULESA multi-site study in which one or more Principal Investigators have been appointed should feature on the master schedule of all sites concerned. It is the responsibility of test facility management and test site management to ensure that this is done.The unique identification of the study must appear on the master schedule in each site, cross-referenced as necessary to test site identifiers. The Study Director should be identified on the master schedule(s), and the relevant Principal Investigator shown on each site master schedule.At all sites, the start and completion dates of the study phase(s) for which they are responsible should appear on their master schedule.STUDY PLANFor each multi-site study, a single study plan should be issued. The study plan should clearly identify the names and addresses of all sites involved.The study plan should include the name and address of any Principal Investigators and the phase of the study delegated to them. It is recommended that sufficient information is included to permit direct contact by the Study Director, e.g. telephone number.The study plan should identify how data generated at sites will be provided to the Study Director for inclusion in the final report.It is useful, if known, to describe in the study plan the location(s) at which the data, samples of test and reference items and specimens generated at the different sites are to be retained.It is recommended that the draft study plan should be made available to Principal Investigators for consideration and acknowledgement of their capability to undertake the work assigned to them, and to enable them to make any specialised technical contribution to the study plan if required.The study plan is normally written in a single language, usually that of the Study Director. For multi-national studies it may be necessary for the study plan to be issued in more than one language; this intention should be indicated in the original study plan, the translated study plan(s) and the original language should be identified in all versions. There will need to be a mechanism to verify the accuracy and completeness of the translated study plan. The responsibility for the accuracy of the translation can be delegated by the Study Director to a language expert and should be documented.PERFORMANCE OF THE STUDYThis section repeats the most important requirements from the Principles of GLP and recommendations from the Consensus Document on the Application of the GLP Principles to Field Studies in order to provide useful guidance for organisation of multi-site studies. These documents should be consulted for further details.FacilitiesSites may not have a full time staff presence during the working day. In this situation it may be necessary to take additional measures to maintain the physical security of the test item, specimens and data.When it is necessary to transfer data or any materials among sites, mechanisms to maintain their integrity need to be established. Special care needs to be taken when transferring data electronically (e-mail, internet, etc.).EquipmentEquipment being used in a study should be fit for its intended purpose. This is also applicable to large mechanical vehicles or highly specialised equipment that may be used at some sites.There should be maintenance and calibration records for such equipment that serve to indicate their “fitness for intended purpose” at the time of use. Some apparatus (e.g., leased or rented equipment such as large animal scales and analytical equipment) may not have records of periodic inspection, cleaning, maintenance and calibration. In such cases, information should be recorded in the study-specific raw data to demonstrate “fitness for intended purpose” of the equipment.Control and accountability of study materialsProcedures should be in place that will ensure timely delivery of study related materials to sites. Maintaining integrity/stability during transport is essential, so the use of reliable means of transportation and chain of custody documentation is critical. Clearly defined procedures for transportation, and responsibilities for who does what, are essential.Adequate documentation should accompany each shipment of study material to satisfy any applicable legal requirements, e.g., customs, health and safety legislation. This documentation should also provide relevant information sufficient to ensure that it is suitable for its intended purpose on arrival at any site. These aspects should be resolved prior to shipment.When study materials are transported between sites in the same consignment it is essential that there is adequate separation and identification to avoid mix-ups or cross contamination. This is of particular importance if materials from more than one study are transported together.If the materials being transported might be adversely affected by environmental conditions encountered during transportation, procedures should be established to preserve their integrity. It may be appropriate for monitoring to be carried out to confirm that required conditions were maintained.Attention should be given to the storage, return or disposal of excess test and reference items being used at sitesREPORTING OF STUDY RESULTSA single final report should be issued for each multi-site study. The final report should include data from all phases of the study. It may be useful for the Principal Investigators to produce a signed and dated report of the phase delegated to them, for incorporation into the final report. If prepared, such reports。

/oeguide.htmOECD GUIDELINES FOR CRYPTOGRAPHY POLICY:OECD GUIDELINES FOR CRYPTOGRAPHY POLICYI.AIMSII.SCOPEIII.DEFINITIONSIV.INTEGRATIONV.PRINCIPLESI. AIMSThe Guidelines are intended:∙to promote the use of cryptography;∙to foster confidence in information and communications infrastructures, networks and systems and the manner in which theyare used;∙to help ensure the security of data, and to protect privacy, in national and global information and communications infrastructures, networks and systems;∙to promote this use of cryptography without unduly jeopardising public safety, law enforcement, and national security;∙to raise awareness of the need for compatible cryptography policies and laws, as well as the need for interoperable, portable and mobilecryptographic methods in national and global information andcommunications networks;∙to assist decision-makers in the public and private sectors in developing and implementing coherent national and internationalpolicies, methods, measures, practices and procedures for theeffective use of cryptography;∙to promote co-operation between the public and private sectors in the development and implementation of national and internationalcryptography policies, methods, measures, practices andprocedures;∙to facilitate international trade by promoting cost-effective, interoperable, portable and mobile cryptographic systems;∙to promote international co-operation among governments, business and research communities, and standards-making bodies in achieving co-ordinated use of cryptographic methods.II. SCOPEThe Guidelines are primarily aimed at governments, in terms of the policy recommendations herein, but with anticipation that they will be widely read and followed by both the private and public sectors.It is recognised that governments have separable and distinct responsibilities for the protection of information which requires security in the national interest; the Guidelines are not intended for application in these matters.III. DEFINITIONSFor the purposes of the Guidelines:∙"Authentication" means a function for establishing the validity ofa claimed identity of a user, device or another entity in aninformation or communications system.∙"Availability" means the property that data, information, and information and communications systems are accessible and usable on a timely basis in the required manner.∙"Confidentiality" means the property that data or information is not made available or disclosed to unauthorised individuals,entities, or processes.∙"Cryptography" means the discipline which embodies principles, means, and methods for the transformation of data in order to hide its information content, establish its authenticity, prevent its undetected modification, prevent its repudiation, and/or prevent its unauthorised use.∙"Cryptographic key" means a parameter used with a cryptographic algorithm to transform, validate, authenticate, encrypt or decrypt data.∙"Cryptographic methods" means cryptographic techniques, services, systems, products and key management systems.∙"Data" means the representation of information in a manner suitable for communication, interpretation, storage, or processing.∙"Decryption" means the inverse function of encryption.∙"Encryption" means the transformation of data by the use of cryptography to produce unintelligible data (encrypted data) to ensure its confidentiality.∙"Integrity" means the property that data or information has not been modified or altered in an unauthorised manner.∙"Interoperability" of cryptographic methods means the technical ability of multiple cryptographic methods to function together.∙"Key management system" means a system for generation, storage, distribution, revocation, deletion, archiving, certification orapplication of cryptographic keys.∙"Keyholder" means an individual or entity in possession or control of cryptographic keys. A keyholder is not necessarily a user of the key.∙"Law enforcement" or "enforcement of laws" refers to the enforcement of all laws, without regard to subject matter.∙"Lawful access" means access by third party individuals or entities, including governments, to plaintext, or cryptographic keys, ofencrypted data, in accordance with law.∙"Mobility" of cryptographic methods only means the technical ability to function in multiple countries or information andcommunications infrastructures.∙"Non-repudiation" means a property achieved through cryptographic methods, which prevents an individual or entity from denying having performed a particular action related to data (such as mechanisms for non-rejection of authority (origin); for proof of obligation, intent, or commitment; or for proof of ownership).∙"Personal data" means any information relating to an identified or identifiable individual.∙"Plaintext" means intelligible data.∙"Portability" of cryptographic methods means the technical ability to be adapted and function in multiple systems.IV. INTEGRATIONThe principles in Section V of this Annex, each of which addresses an important policy concern, are interdependent and should be implemented as a whole so as to balance the various interests at stake. No principle should be implemented in isolation from the rest.V. PRINCIPLES1. TRUST IN CRYPTOGRAPHIC METHODSCryptographic methods should be trustworthy in order to generate confidence in the use of information and communications systems.Market forces should serve to build trust in reliable systems, and government regulation, licensing, and use of cryptographic methods mayalso encourage user trust. Evaluation of cryptographic methods, especially against market-accepted criteria, could also generate user trust.In the interests of user trust, a contract dealing with the use of a key management system should indicate the jurisdiction whose laws apply to that system.2. CHOICE OF CRYPTOGRAPHIC METHODSUsers should have a right to choose any cryptographic method, subject to applicable law.Users should have access to cryptography that meets their needs, so that they can trust in the security of information and communications systems, and the confidentiality and integrity of data on those systems. Individuals or entities who own, control, access, use or store data may have a responsibility to protect the confidentiality and integrity of such data, and may therefore be responsible for using appropriate cryptographic methods. It is expected that a variety of cryptographic methods may be needed to fulfil different data security requirements. Users of cryptography should be free, subject to applicable law, to determine the type and level of data security needed, and to select and implement appropriate cryptographic methods, including a key management system that suits their needs.In order to protect an identified public interest, such as the protection of personal data or electronic commerce, governments may implement policies requiring cryptographic methods to achieve a sufficient level of protection.Government controls on cryptographic methods should be no more than are essential to the discharge of government responsibilities and should respect user choice to the greatest extent possible. This principle should not be interpreted as implying that governments should initiate legislation which limits user choice.3. MARKET DRIVEN DEVELOPMENT OF CRYPTOGRAPHIC METHODSCryptographic methods should be developed in response to the needs, demands and responsibilities of individuals, businesses and governments.The development and provision of cryptographic methods should be determined by the market in an open and competitive environment. Such an approach would best ensure that solutions keep pace with changingtechnology, the demands of users and evolving threats to information and communications systems security. The development of international technical standards, criteria and protocols related to cryptographic methods should also be market driven. Governments should encourage and co-operate with business and the research community in the development of cryptographic methods.4. STANDARDS FOR CRYPTOGRAPHIC METHODSTechnical standards, criteria and protocols for cryptographic methods should be developed and promulgated at the national and international level.In response to the needs of the market, internationally-recognised standards-making bodies, governments, business and other relevant experts should share information and collaborate to develop and promulgate interoperable technical standards, criteria and protocols for cryptographic methods. National standards for cryptographic methods, if any, should be consistent with international standards to facilitate global interoperability, portability and mobility. Mechanisms to evaluate conformity to such technicalstandards, criteria and protocols for interoperability, portability and mobility of cryptographic methods should be developed. To the extent that testing of conformity to, or evaluation of, standards may occur, the broad acceptance of such results should be encouraged.5. PROTECTION OF PRIVACY AND PERSONAL DATAThe fundamental rights of individuals to privacy, including secrecy of communications and protection of personal data, should be respected in national cryptography policies and in the implementation and use of cryptographic methods.Cryptographic methods can be a valuable tool for the protection of privacy, including both the confidentiality of data and communications and the protection of the identity of individuals. Cryptographic methods also offer new opportunities to minimise the collection of personal data, by enabling secure but anonymous payments, transactions and interactions. At the same time, cryptographic methods to ensure the integrity of data in electronic transactions raise privacy implications. These implications, which include the collection of personal data and the creation of systems for personal identification, should be considered and explained, and, where appropriate, privacy safeguards should be established.The OECD Guidelines for the Protection of Privacy and Transborder Flows of Personal Data provide general guidance concerning the collection and management of personal information, and should be applied in concert with relevant national law when implementing cryptographic methods.6. LAWFUL ACCESSNational cryptography policies may allow lawful access to plaintext, or cryptographic keys, of encrypted data. These policies must respect the other principles contained in the guidelines to the greatest extent possible.If considering policies on cryptographic methods that provide for lawful access, governments should carefully weigh the benefits, including the benefits for public safety, law enforcement and national security, as well as the risks of misuse, the additional expense of any supporting infrastructure, the prospects of technical failure, and other costs. This principle should not be interpreted as implying that governments should, or should not, initiate legislation that would allow lawful access.Where access to the plaintext, or cryptographic keys, of encrypted data is requested under lawful process, the individual or entity requesting access must have a legal right to possession of the plaintext, and once obtained the data must only be used for lawful purposes. The process through which lawful access is obtained should be recorded, so that the disclosure of the cryptographic keys or the data can be audited or reviewed in accordance with national law. Where lawful access is requested and obtained, such access should be granted within designated time limits appropriate to the circumstances. The conditions of lawful access should be stated clearly and published in a way that they are easily available to users, keyholders and providers of cryptographic methods.Key management systems could provide a basis for a possible solution which could balance the interest of users and law enforcement authorities; these techniques could also be used to recover data, when keys are lost. Processes for lawful access to cryptographic keys must recognise the distinction between keys which are used to protect confidentiality and keys which are used for other purposes only. A cryptographic key that provides for identity or integrity only (as distinct from a cryptographic key that verifies identity or integrity only) should not be made available without the consent of the individual or entity in lawful possession of that key.7. LIABILITYWhether established by contract or legislation, the liability of individuals and entities that offer cryptographic services or hold or access cryptographic keys should be clearly stated.The liability of any individual or entity, including a government entity, that offers cryptographic services or holds or has access to cryptographic keys, should be made clear by contract or where appropriate by national legislation or international agreement.The liability of users for misuse of their own keys should also be made clear. A keyholder should not be held liable for providing cryptographic keys or plaintext of encrypted data in accordance with lawful access. The party that obtains lawful access should be liable for misuse of cryptographic keys or plaintext that it has obtained.8. INTERNATIONAL CO-OPERATIONGovernments should co-operate to co-ordinate cryptography policies. As part of this effort, governments should remove, or avoid creating in the name of cryptography policy, unjustified obstacles to trade.In order to promote the broad international acceptance of cryptography and enable the full potential of the national and global information and communications networks, cryptography policies adopted by a country should be co-ordinated as much as possible with similar policies of other countries. To that end, the Guidelines should be used for national policy formulation.If developed, national key management systems must, where appropriate, allow for international use of cryptography.Lawful access across national borders may be achieved through bilateral and multilateral co-operation and agreement.No government should impede the free flow of encrypted data passing through its jurisdiction merely on the basis of cryptography policy.In order to promote international trade, governments should avoid developing cryptography policies and practices which create unjustified obstacles to global electronic commerce. Governments should avoid creating unjustified obstacles to international availability of cryptographic methods.。

oecd principles of good laboratorypractice -回复关于O E C D（经济合作与发展组织）良好实验室实践原则（G o o d L a b o r a t o r y P r a c t i c e，以下简称G L P）的文章。

第一步：引言（I n t r o d u c t i o n）O E C D G L P原则是一套旨在增强实验室研究质量和可靠性的全球性标准。

本文将分析G L P的重要性、其原则以及实施G L P的步骤。

第二步：G L P的重要性（T h e I m p o r t a n c e o f G L P）清晰的实验室标准和规范对于确保数据质量、结果再现性和可靠性至关重要。

不遵守这些标准可能导致不准确的结果，严重时可能会对公共安全产生风险。

G L P的实施可以确保实验过程的透明性、数据的准确性和结果的可靠性。

第三步：G L P原则（G L P P r i n c i p l e s）O E C D G L P原则包括实验室组织和人员、设备和测量仪器、实验室操作、质量保证、记录和报告等方面的要求。

这些原则旨在确保实验室研究的可靠性和结果再现性。

第四步：实施G L P的步骤（S t e p s t o I m p l e m e n tG L P）1.建立实验室基础a.确定实验室的目标和范围b.成立一个G L P团队，负责实施和监督G L P实践c.确定实验室设备和技术要求2.制定标准操作规程(S O P s)a.制定清晰的实验操作流程，包括样品收集、配制试剂、分析和数据记录等步骤b.S O P需要详细描述实验操作流程，确保操作的一致性和质量3.培训实验室人员a.为实验室人员提供相关G L P培训，以确保其了解并遵守G L P原则b.定期组织培训课程和研讨会，确保人员的知识和技能处于最佳状态4.管理质量控制a.确保实验室设备和测量仪器的准确性和可靠性，进行校准和维护b.建立质量控制机制，确保实验室操作和数据的合规性和可靠性5.记录和报告数据a.准确记录实验操作和数据，包括数据来源、实验条件和所采用的方法等细节b.撰写详细的实验报告，确保结果的可重复性和再现性6.质量保证和审核a.进行间期和临时审核，确保实验室操作符合G L P的要求b.参与定期的内部和外部质量保证审查，以评估实验室的G L P实践水平第五步：G L P的实际应用（P r a c t i c a lA p p l i c a t i o n o f G L P）G L P的应用不仅在科学研究领域具有重要意义，也适用于医药、化妆品、农产品和环境领域的实验室研究。

General Questions and Answers Concerning OECD Principles of Good Laboratory Practice (GLP)andMutual Acceptance of Data (MAD)(6 November, 2015)I. OECD Good Laboratory Practice (GLP)1) What are the OECD Principlesof Good Laboratory Practice (GLP)?a)The Principles of Good Laboratory Practice (GLP) are a managerialquality control system covering the organisational process and the conditions under which non-clinical health and environmental studies are planned, performed, monitored, recorded and reported. The OECD Principles of GLP are followed by test facilities carrying out studies to be submitted to national authorities for the purposes of assessing the health and environmental safety of chemicals and chemical products which may also be of natural or biological origin and, in some circumstances, may be living organisms. Depending on the jurisdiction, the Principles of GLP can also be applied to non-clinical safety testing of other regulated products, such as medical devices.b) The Principles of GLP define the responsibilities of test facility management, study personnel and quality assurance personnel that are operating within a GLP system, and minimum standards concerning the suitability of facilities and equipment to perform studies, the need for standard operating procedures, documentation of raw data, study reports, the archiving of records, etc.2) What is a test facility? A test facility includes the persons, premises (e.g. a testing laboratory) and operational unit(s) that are necessary for conducting a non-clinical health and environmental safety study (see below). For multisite studies, those which are conducted at more than one site, the test facility comprises the site at which the Study Director is located and all individual test sites, which individually or collectively can be considered to be test facilities.3) What types of tests are carried out at such facilities under GLP? a) The OECD Principles of GLP concern “non-clinical” testing of a chemical or chemical product, examined under laboratory conditions or in the environment, including work conducted in greenhouses and in the field. They do not include studies which use human subjects.b) Examples of studies carriedout under GLP include, inter alia:i) physical-chemical testing;ii) toxicity studies;iii) mutagenicity studies;iv) environmental toxicity studies onaquatic and terrestrial organisms;v) studies on behaviour in water, soiland air; bioaccumulation;vi) studies to determine pesticideresidues in food or animal feedstuffs;vii) studies on effects on mesocosmsand natural ecosystems; andviii) analytical and clinical chemistrytesting.4) What types ofchemicals /chemicalproducts arecovered underthe OECDPrinciples of GLP?a) The OECD Principles of GLPapply to the non-clinical safety testing of test items contained in: i) pharmaceutical products; ii) pesticide products (including biocides);iii) cosmetic products;iv) veterinary drugs;v) food additives;vi) feed additives; andvii) industrial chemicals.Depending on the jurisdiction, the Principles of GLP may also be applied tonon-clinical safety testing of other regulated products, such as medical devices.b) Under GLP, a“test item” is the article that is the subject of a study, andis frequently a synthetic chemical, but may be of natural or biological originand, in some circumstances, may be living organisms. While the test item is the subject of a study, other testing associated with the test item and part of thetest study (e.g., biological samples which are taken and analysed for the contentof a test item and/or its metabolites) still need to be conducted under GLP.(Note: The term “test chemical” has been applied in new and updated OECDTest Guidelines since 2013 to designate what is being tested. However, it is important to note that previously adopted OECD Test Guidelines still use theterms “test item”, “test compound”, “test substance” or other similar terms to describe what is being tested. The term “test chemical” is without prejudice onthe applicability of the Test Guideline to individual chemical substance or mixtures; in case of restrictions, the Guideline will clarify what these are in the Limitations section.”)5) How do governments know that a study conducted at a test facility was carried out according to the OECD Principles of GLP?OECD countries in which non-clinical health and environmental safety testing is carried out according to the OECD Principles of GLP have established national GLP Compliance Monitoring Programmes (CMP) with responsibilities for monitoring GLP compliance of test facilities within their territories (see Guidance for GLP Monitoring Authorities; Revised Guides for Compliance Monitoring Procedures for Good Laboratory Practice.) GLP compliance is verified by CMPs through inspections of GLP test facilities, and audits of GLP studies. A test facility which has been subject to periodic inspections by a CMP, and found to be operating in compliance with the Principles of GLP, is recognised as a GLP compliant facility.6) How can test facilities become recognised as GLP-compliant?Any test facility that conducts non-clinical health and safety studies (e.g., a university, research institute, private enterprise, government, etc.) can become OECD GLP-compliant or recognised. (This includes facilities in OECD member countries as well as non-OECD economies who become full adherents to the Mutual Acceptance of Data (MAD) system –see Section II below.) In most countries, facilities that wish to become recognised as GLP compliant can apply to the government CMP. The CMP then conducts an inspection to determine if the facility complies with the OECD Principles of GLP. In other countries, CMPs can inspect any test facility claiming to conduct studies according to GLP.7) Why are the OECD Principles of GLP needed?a) In the 1970’s, prior to the introduction of GLP, some governments discovered fraudulent studies had been submitted by testing laboratories to regulatory authorities. As a result, OECD governments decided that there would be value in developing a set of principles– applied across all OECD countries –concerning the generation of quality test data. This would ensure that before making regulatory decisions concerning the safety of chemicals that will enter the market (or are already on the market), governments would have confidence that the data upon which they make their decisions is valid and of high quality.b) Through standards built into the OECD Principles of GLP which allow the “traceability” of studies, CMP inspectors who visit test facilities can audit the results of a study long after it has been completed. This provides another level of confidence to regulators about the validity and integrity of data they are reviewing.c) Further, as the application of GLP is harmonised across OECD countries, governments can accept data from other countries with the assurance that it will be valid and of high quality. (See discussion of the Mutual Acceptance ofData (MAD) system below.)8) Areauthoritiesactuallyinspecting testfacilities?Yes. Government CMPs conduct periodic inspections of test facilities withintheir country and perform random study audits.9) Are the OECD Principles of GLP - established in 1997 - still relevant today given advances in testing methods?Yes. The OECD Principles of GLP make up a general framework concerned with the process a test facility uses to conduct a test, not the specific substance being tested, nor the scientific approach followed when carrying out a test. Thus, the OECD Principles of GLP do cover all types of tests, including those not envisioned when the Principles were first established. However, OECD does periodically publish advisory documents which provide additional guidance or clarity concerning the application of GLP to new testing approaches (e.g., guidance for in vitro test methods).II. OECD System of Mutual Acceptance of Data (MAD)1Cutting Costs in Chemicals Management (OECD, 2010).10) What is OECD’s Mutual Acceptance of Data (MAD) system?The OECD Mutual Acceptance of Data (MAD) system is a multilateral agreement which allows participating countries (including non-member economies) to share the results of various non-clinical tests done on chemicals. Under MAD, a non-clinical chemical safety study developed using OECD Test Guidelines and OECD Principles of Good Laboratory Practice (GLP) in one Member country or non-Member full adherent, must be accepted for assessment purposes in all member and adhering countries. This is the concept of “tested once, accepted for assessment everywhere.”11) What is the legal framework for the MAD system?The multilateral agreement is composed of three OECD Council Acts (adopted by OECD ambassadors): i) The 1981 Council Decision on the Mutual Acceptance of Data in the Assessment of Chemicals (revised in 1997) that states that test data generated in any member country in accordance with OECD Test Guidelines and OECD Principles of Good Laboratory Practice (GLP) shall be accepted in other member countries for assessment purposes and other uses relating to the protection of human health and the environment.ii) The 1989 Council Decision-Recommendation on Compliance with Principles of Good Laboratory Practices which establishes procedures for monitoring GLP compliance through government inspections and study audits as well as a framework for international liaison among monitoring and data-receiving authorities.iii) The 1997 Council Decision on the Adherence of Non-Member countries to the Council Acts related to the Mutual Acceptance of Data in the Assessment of Chemicals that sets out a step-wise procedure fornon-OECD economies to take part as full members in this system.12) Why was theMAD system established?a) As many of the same chemicals are produced in more than one country (or are traded across countries), different national chemical control policies can lead to duplication in testing and government assessment, thereby wasting the resources of industry and governments alike. Furthermore, differences inregulations and test standards discourage research, innovation and growth and they increase the time it takes to introduce a new product onto the market. They can also lead to inefficiencies for governments, because authorities cannot take full advantage of the work of others which would help reduce theresources needed for chemicals control. It is for these reasons, that OECD has developed and is implementing the Mutual Acceptance of Data (MAD) system. b) By reducing duplication, and creating a framework for the sharing of work, the MAD system saves governments and industry around €150,000,000 each year 1.13) Is the primary aim of the MAD system to save money for industry?No. The primary aim of the MAD system is to help governments protect human health and the environment. But, there are many other benefits: fewer duplicative tests means there is a reduction in both costs and the number of laboratory animals needed. In addition, as a result of the harmonisation of test methods and GLP, governments are able to collaborate on assessments of the same chemicals and “share the burden” of assessing the thousands of chemicals which are on the market. As a result, governments can assess chemicals faster and more cost effectively. For example, as a result of MAD, governments have been able to work together to assess chemicals through OECD’s Hazard Assessment Programme, which uses data generated according to OECD Test Guidelinesand GLP, [/chemicalsafety/risk-assessment/oecdcooperativechemicalsassessmentprogramme.htm]. Underthis Programme, more than a 1,000 high production volume chemicals wereassessed, and countries have used these assessments for their nationalchemicals management activities (e.g. for classification and labeling).14) How does onegovernmentparticipating inthe MAD systemhave confidencein the quality andintegrity of datagenerated inanother countryin the system?a) To enhance mutual confidence in GLP Compliance MonitoringProgrammes among participating OECD member countries and non-member economies, the OECD Working Group on GLP has established aprogramme of On-Site Evaluations of each country in the MAD system.Every national GLP Compliance Monitoring Programme is subject to aregular on-site evaluation visit, normally every ten years. The evaluationincludes a review of the documentation of the GLP monitoring programmethat is being examined, and an on-site evaluation visit to that programmeto observe a full GLP inspection from start to finish, including associatedstudy audits. A team of two or three representatives from other GLPCompliance Monitoring Programmes participate in the site visit.b) The report of the on-site evaluation team, reviewed by theWorking Group, has two primary aims: (i) to inform the members of theWorking Group on GLP about the organisation, practices and procedures ofthe Monitoring Programme evaluated; and (ii) to describe the degree towhich they are adhering to the 1989 Council Act.15) How do non-membereconomies jointhe MADsystem?There is a step-wise procedure for non-OECD economies to become fulladherents to MAD.i) First, the non-member economy’s government confirms that itwill provisionally adhere to MAD. That is, it agrees to accept, forassessment purposes, non-clinical data generated in the testing ofchemicals with OECD Test Guidelines and OECD Principles of GoodLaboratory Practice from countries adhering to the OECD Council Actson MAD. However, OECD countries and full adherents are notobligated to accept data for assessment purposes from the provisionaladherent. This is because the provisional adherent’s GLP ComplianceMonitoring Programme (CMP) has not yet been evaluated by OECD.ii) Second, as the provisional adherent is setting up a GLP CMP, it is invited to attend OECD Working Group on GLP meetings and training courses, and to serve as an observer in on-site evaluations of other countries.iii) Third, once the provisional adherent has fully developed its GLP CMP according to OECD guidance, an On-Site Evaluation visit is carried out. Based on the outcome of this visit, if the OECD concludes that the provisional adherent’s GLP Compliance Monitoring Programmeis in accord with the OECD Council Acts on MAD, the country becomesa “full” adherent to MAD. As a full adherent, all non-clinical study data conducted in that country according OECD Test Guidelines and OECD Principles of Good Laboratory Practice must be accepted for assessment purposes in all 34 OECD member countries and adhering non-member economies.16) What is a full adherent to MAD?A full adherent is a non-member economy whose GLP Compliance Monitoring Programme has been evaluated by OECD and complies with the OECD Council Acts on MAD (see question 11). As a result, non-clinical health and environmental safety testing of chemicals and chemical products conducted in a full adherent in accordance with OECD Test Guidelines and OECD Principles of Good Laboratory Practice, shall be accepted for assessment purposes in OECD Member countries, provisional adherents and other full adherents.17) Which non-OECD countries are full adherents to MAD?As of November, 2015, Argentina, Brazil, India, Malaysia, Singapore and South Africa are full adherents. (More information on full and provisional adherents can be found here.)18) What is meant by “acceptance” of data generated within the MAD system?a) Once a country receives study data for assessment purposes from a MAD adherent country it cannot ask that the study be repeated. That is the concept of “test once, accepted for assessment purposes everywhere”. However, how the receiving country interprets study results is its own prerogative.b) Further, if a country does not require or need data on a particular hazard endpoint (e.g., acute inhalation toxicity) to conduct its chemical assessments, but it receives a MAD compliant study on that endpoint, it is up to that government to decide how, if at all, it uses the study in its assessment.19) Is a government restricted to using only MAD compliant studies when assessing the safety of a chemical for regulatory purposes? No. All governments should ensure they have the best scientific evidence concerning the safety of a chemical before drawing any conclusions about the chemical. They are free to set their own quality requirements for non-clinical data and to accept the results of a studythat was not conducted according to an OECD Test Guideline andaccording to OECD GLP if they believe it is scientifically valid. While theMAD system promotes the sharing of quality (and verifiable) data ontest results, governments can always require more tests if they needadditional information upon which to base a decision or if there areconfounding results. Finally, governments also use a weight-of-evidence approach when assessing the safety of a chemical, and, thus,may take into consideration older studies that were conducted beforean OECD Test Guideline for that endpoint was developed or studies thatare based on novel methods for which a Test Guideline has yet to bedeveloped.20) If a provisionaladherent only has aComplianceMonitoringProgramme for oneproduct type (e.g.,industrial chemicals),must it accept data onall product types fromother MAD countries?Yes, with the exception stated in 18b).21) If a full adherentor OECD country onlyhas a ComplianceMonitoringProgramme for oneproduct type (e.g.,industrial chemicals),must OECD membersand adherents toMAD accept data onother product typestested in the fulladherent (e.g.,pesticides)?No. Countries that are part of the MAD system are only required toaccept test data on a particular product type from another country inthe system, if that country has a Compliance Monitoring Programme forthe product type being tested.22) Must governments who are part of theMAD system acceptproducts that have been tested according to the OECD Principles of GLP?No. MAD only applies to non-clinical health and safety studies. Each government can reach its own conclusion as to the risk posed by a chemical based on those studies, and, from that, make a decision as to whether the product that was tested can be placed on (or imported into) the market.23) If a test facility is in a country that is not an adherent to MAD, but has been inspected by a country that is an adherent, must other MAD countries accept data from this facility?No. Countries which adhere to MAD are only required to accept GLP data that has been generated in other countries that are full adherents.。

oecd转让定价指南中英文对照1.1.本指南的目的是为了提供一个国际一致的转让定价框架，以解决相关当事方之间涉及转让定价的问题。

The purpose of these Guidelines is to provide an internationally agreed framework for transfer pricing which will assist tax administrations and multinational enterprises in the application of the arm’s length principle.1.2. 当地监管机构应该考虑本指南的原则和方法，以及它们如何在特定情况下解决转让定价问题。

Local regulatory authorities should consider the principles and methodologies set out in these Guidelines, and how they can be applied to resolve transfer pricing issues in specific cases.2. Scope of the Guidelines 适用范围2.1. 本指南适用于所有相关当事方之间的转让定价问题。

These Guidelines apply to all transfer pricing issues between associated enterprises.2.2. 相关当事方是指相互具有直接或间接控制、管理或资本关系的两个或多个企业。

Associated enterprises are enterprises that are under the direct or indirect control of the same person(s) or enterprise(s).2.3. 本指南涉及的转让定价问题包括跨国企业内部的物品、服务、资产或权利的转让、使用或授权。