be documented（It is vital that all meetings of this kind ______ and circulated to those concerned.）

本文目录

• It is vital that all meetings of this kind ______ and circulated to those concerned.
• 苹果简史 英文
• Correlation
• documented是什么意思
• ICH-GCP 7.2 The Research Protocol（2）
• 高分请高手帮忙翻译英文文献资料 (2)

It is vital that all meetings of this kind ______ and circulated to those concerned.

选择A。It is ...that 这种句型后接动词时，相当于省略了should，接动词必须接原型。

苹果简史 英文

Apple’s country of origin in central Europe, south-east, Central Asia and even China’s Xinjiang . Europe in the era before the three hundred years, MPCato apple varieties have been documented. Later, the Romans began to be cultivated and a grafting propagation. JB the eighteenth century, Mongolia and the TA’s have been using natural hybridization seedling breeding, and gradually promote the cultivation. When the discovery of America, European immigrants introduced the apple of America, in the Americas has trained many new varieties. Japan in the Meiji Restoration era, from Europe and the United States the introduction of Apple, is introduced in Asia. Since then, Australia, Africa also have the introduction of Apple’s. The past century, the world’s five continents, has had apple cultivation. The earliest Europeans have been eating apples, and carried out the improvement and breeding, some species found as early as 2,000 years ago, in pre-colonial to the Americas, Europe, up to hundreds of known varieties. Chung later times as the waves of migration in North America, around the seedling apple varieties have also spread to become a local legend of the roving ambassador, in the spread of Apple played a major role, most notably Chapman (John Chapman, nicknamed " Apple guys "〔〕 Johnny Appleseed), he was widely grown in Ohio and Indiana apples. Indians and trapping may also spread to Apple.
Apple in China for 2,000 years of cultivation history. According to legend, Yu’s eat "purple Nye" is red apple, see Apple already China has long had. Guoyi Gong Jin dynasty of "Guang-zhi," said: "Western cases of multi-nai, and everyone close to chest cut Bao dry, a few Shibai Gok to accumulate, that the frequency of po-food." Known at the time, "the first month in February, the turning axes of the mottled vertebra, then Rao." Peeling ring similar to the modern technology to promote more results. Can be seen planting apple Jin Dynasty of China have reached a very high technical level of live with it. Song Li Yuan tune of "the South China Sea 100 Wing-copy", there Wing Sterculia fruit poem goes: "Yu Fan Zhai years since autumn, Cuiye exquisite cut is not working, mistaken flowery vine-yan, I wonder if the child decorated scarlet pod. "Up to the Ming Dynasty, not only" summer-baked "," Su-naphthalene, Zhu Nai, green crab apple "and" Dong Nai has liangzhou winter cooked, Subband Bise "(Li’s" Compendium of Materia Medica "). However, China’s ancient culture of Prunus and Ringo, though, "smooth playable, incense smell a few steps," but "sweet song, those who eat, such as immature cotton, over-cooked food again sand bad bear" (see "beautiful and fragrant flowers spectrum"). Apple’s mid-19th century European citizenship to China, China’s cotton gradually replaced by apple. Apple’s first European settled in Yantai, Shandong Province, the late 19th century to the beginning of this century, Qingdao, Shandong and Liaoning south, but also have introduction, and began its economic cultivation. China is now the apple production area, in addition to the original Malus species, the apple varieties grown as the economy are mostly from Europe, the United States, Japan, the Soviet Union and other countries introduced, called the Western apples.

Correlation

The study area was situated in south of the Jiangnan Slope Belt，western Hunan（Peng 1990，1992）.It is well known as one of the most richly fossiliferous areas in China for the Middle and Late Cambrian trilobite faunas.As Cambrian trilobite faunas have been documented around the world，it has become evident that the faunas in western Hunan provide a correlative possibility for worldwide correlations（Text-figure 9）.As discussed above，18 trilobite zones were proposed for the Middle and Late Cambrian in South China（Peng，1999）.The interval with the Ptychagnostusatavus Zone（late Taijiangian Stage in South China）to the Proagnostus bulbus Zone is considered to be correlatable with the early Changhsian Stage（Middle Cambrian）in North China.The interval from the Liguagnostus reconditus Zone（early Waergangian Stage in South China）to the Leiostegium constrictum-Shenjiawania brevica Zone（late Taoyuanian Stage in South China）are considered equivalent with the Kushanian，Changshanian and Fengshanian Stage（Late Cambrian）in North China.In the study area，the topmost zone is the Eolotagnostus decorus-Kaolishaniella Zone，which is considered correlatable with the late Changshanian Stage（Late Cambrian）in North China（Peng，2000）.

As indicated above，the Aoxi Formation of the Middle Cambrian is largely unfossilifeous dolomite in northwest and western Hunan，but its stratigraphical position suggests that is correlated with the lower Changshanian Stage of North China.

Text-figure9 Correlation chart relation of the Middle and Upper Cambrian in studyarea，W.Zhejiang，N.YangtzePlatform，Xinjiang，Australia and S.Kazakhstan

3.2.1 Correlation between the study area and west Zhejiang

In the study area，Ptychagnostusatavus allows a direct correlation with the P.atavus Zone of the Yangliugang Formation of the Middle Cambrian in West Zhejiang（Text-figure 9）；the Ptagnostus punctuosus Zone in West Hunan includes Pseudophalacroma ovata［=Ps.triangularis］and Triplagnostus longitriangularis，the former（Ps.triangularis）also occurred in West Zhejiang as a zonal fossil.Many important elements of the Goniagnostus nathorsti and L.laevigata Zones of the Wangcunian Stage of West Hunan，such as：Lejopyge laevigata，L.armata，Goniagnostus（A.）spiniger，Hypagnostus parvifrons，Proceratopyge（P.）conifrons，and Fuchouia oratolimba，have also been reported from the L.armata Zone of the Upper Cambrian Yangliugang Formation in West Zhejiang.Both zones are comparable each other.As the Proagnostus bulbus Zone and the Linguagnostus reconditus Zone comprise Cyclagnostus yaogongbuensis，and Bergeronites hunanensis，these elements commonly appear in the L.sinonensis Zone of lower part of the Huayanshi Formation of West Zhejiang.These two zones are correlatable with the G.stolidotus and G.reticlatus zones，which are known as index zonal fossils for global correlation of the boundary between Middle and Upper Cambrian，and occurred in both areas.The first discovery of Erixanium in middle part of the Huaqiao Formation of the study area，suggests the subzone that bears its name in the Agnostus inexpectans-Proceratopyge protractaAssemblage Zone is correlatable with the Erixanium Zone in West Zhejiang.

As the Agnostotes clavata-Irvingella angustilimbata and Corynexochus plumula-Sinoproceratopyge cf.kiangshanensis Zone consists of Pseudaagnostus（P.）communis，Proceratopyge（S.）dubius and P.（S.）kiangshensis，Agnostotes clavata［=Pseudoglyptagnostus clavatus］，suggesting a correlation with the A.clavatus-Sinoprocertopyge kiangshanensis Zone in upper part of the Huayansi Formation in West Zhejiang.It is difficult to correlate with the L.punctatus-Hedinaspis Zone of the Xiyangshan Formation and the post A.clavata-Irvingellaangustilimbata Zone of the Bitiao Formation.The Rhaptagnostus ciliensis-Onchonotellus cf.kuruktagnostus and E.decorus-Kaolishaniella Zones may be generally compared with the lower part of the Lotagnostus punctagnostus Zone in West Zhejiang.The L.punctatus Zone-Hedinaspis regalis Zone of west Zhejiang bears L.punctatus and Ketyna zhejiangensis.These two species appeared also in the L.punctatus-H.regalis Zone in West Hunan.

3.2.2 Correlation between the study area and Northern margin of Yangtze Platform

The North Yangtze Platform region is situated around the borders between Sichuan，Hubei and Shanxi provinces.It was poorly known because of lacking fossils and lithofacies data.Since the early 1990’s，great improvement in the Cambrian biostratigrahy and lithofacies has been carried out by Yang etal.（1991）.According to analysis of lithofacies and biostratigraphy，there exist slope belts.Six trilobite zones were established by Yang et al.（1991）（Text-figure 9）.Peng（2000）revised some of the trilobite species names for these zones.Except for the Xystridura？jielingensis Zone that is non-agnostoid，all other zones are based on agnostoids and correlatable widely.

Notably，the Ptychagnostus atavus and Lejopyge laevigata-Clavagnostus（P.）variatus Zones occurred respectively in the base and top of the Baguamiao Formation of the late Middle Cambrian in North Yangtze Platform.These two zones indicate direct correlation with the P.atavus and L.laevigata Zones in Western Hunan，but the other zones bracketed between these two zones cannot be correlated with the study area on a one by one basis.The Gonignostus nathorsti Zone contains Hypagnostus parvifrons and H.brevifrons.Upward，the Fenghuangella and Shengia zones are difficult to correlate with those of West Hunan.Above the Shengia zone，there are hardly any fossils found in the North Yangtze slope belt probably because of an unsuitable，weakly reducing carbonate setting.

3.2.3 Correlation between the study area and Xinjiang（Kuruktag）

The trilobite faunas from the Kuruktag area of Xinjiang（Xiang et al.，1985）are similar to those of the study area（Text-figure 9），both belong to the Southeast-China Type（Lu et al.1974）.As a zonal fossil of the Middle Cambrian，Ptychagnostusatavus occurs in both areas，and therefore can make direct correlation each other.The Pt.punctusus Zone of the Wangcunian Stage may be compared with the Pt.punctuosus Zone of the Moheishan Group；while the Goniagnostus nothorsti Zone of the Wangcunian Stage contains Pseudophalacromaovale，suggesting a correlation with the Ps.ovale Zone of the Moheish Group in Kuruktag.The L.laevigata Zone bears two important elements（L.laevigataand L.sinensis），indicating a correlation with the top part of the Moheishan Group that contains L.laeviata and L.sinensis.Both the Proagnostus bulbus and Linguagnostus reconditus Zones contain Buttsia（Waergangia）globosa in West Hunan，a species also appeared in the bottom of the Buttsia-Acmarhachis Zone of the Torsuqtagh Group in Kuruktag.In Kururtag of Xingjing，due to the Liostracina Zone yielding G.stolidotus，Liostracina，Bergeronites，Shengia and Pseudagnostus，it can be approximately aligned with the G.stolidotus Zone of West Hunan.The interval from the G.reticulates Zone to E.decorus-Kaolishaniella Zone in the study area does not seem to have any equivalents in the Torsuqtngh Group of Kuruktag.Farther upward，the Lotagnostus hedini and L.astaticus-Hedinaspis regalis Zones in the Torsuqtagh Group may be correlated with the L.punctatus-H.regalis Zone and the P.nasailis-P.hunanensis Zone of the Taoyuanina Stage in West Hunan，interims of the existence of L.punctatus，Hedinaspis and Charchqia in both zones.

3.2.4 Correlation between the study area and Australia（Queensland）

The upper part of the Late Templetionian（Floran）Stage of Queensland in eastern Australia marked by Acidusus atavus（=Pt.atavus）and Euagnostus opimus is correlatable with the Ptychagnostus atavus Zone of west Hunan（Text-figure 9）.In addition，the Pt.punctuosus Zone occurs in both areas，suggesting direct correlation.The Doryagnostus notalibrae and the Goniagnostus nathorsti Zones of the Undillan Stage are correlative with the G.nathorsti Zone of West Hunan.

In Queensland，the L.laevigata Zone consists of Ptychagnostus cassis，Proampyx agra，Holteria arepo，Damesella torosa/Ascionepea janitrix.This zone and the succeeding Erediaspis eretes Zone can be correlated with the L.laevigata-Proagnostus bulbus Zone and the Linguagnostus reconditus Zone in west Hunan.The Cyclagnostus quasivespa Zone of the Mindayalian Stage is correlatable with the interval with the Proagnostus bulbus Zone and the Linguagnostus reconditus Zone of western Hunan.Glyptagnostus stolidotus is common to both Australia and west Hunan，suggesting a direct correlation with each other.The Idamean Stage of Queensland is correlative with lower three zones of the Waergangian in the study area because it is defined by the appearance of Glyptagnostus reticulates（s.s.）and is overlain by Irvingella tropica，a species closely resembling I.angustilimbata.Angnostus inexpectans in the upper part of the G.reticulates Zone in Queensland may indicate that the base of the Agnostus inexpectans-P.（P.）protractaZone correlates with a level within the G.reticculatus Zone of Queensland.The assemblage with Irvingella，Prochuangia，Stigmatoa，Eugonocare，Agnostotes and Protemnites from the I.tropicaZone in Queensland（Shergold，1982）is also known from the Agnostus clavata-I.angastilimbataZone to the E.decorus-Kaolishaniella Zone of the study area.In Queensland，the Wentsuia-Rh.apsis Zone（Shergold，1980）contains Rhptagnostus cf.impressus which is similar to R.ciliensis of the R.ciliensis-O.cf.kuruktagensis Zone in west Hunan，while Onchontellus and Maladiodellaare also known from the W.iota-R.aspsis Zone.Peichiashaniellus secunda-Prochuangia glabellamay be correlated with Eolotagnostus decorus Zone-Kaolishshania Zone in west Hunan.

3.2.5 Correlation between the study area and Kazakhstan（Malyi Karatau）

The Cambrian System in the Malyi Karatau region of Kazakhstan can be recognized as a part of westward extension from the Tianshan Mountains in northwest China，where the Cambrian strata are relatively well exposed（see above）.The Middle and Late Cambrian faunas of southern Kazakhstan are similar to those of western Hunan.Trilobites from the Kyrshabakty and Batyrbai sections in Malyi Karatau（Ergaliev，1980，1983a，1983b；Apollonov and Chugaeva，1983a，1983b）provide a basis for precise correlation of the Kazakh sequences with the study area（Text-figure 9）.

The lower part of the Amginian Stage is characterized by the Peronopsis？ultimus Zone，which is approximately correlated with the O.ovientalis Zone in the study area.Upward the Pt.atavus Zone indicates direct correlation with the Pt.atavus Zone in the upper part of the Amginian.Both the Pt.punctuosus and Goniagnostus nathorsti Zones of the Wangcuaian Stage are also found in the Mayanian Stage of Kazakhastan.In Kazakhastan，the L.armataZone contains Ptychagnostusaculeatus，Goniagnostus longispinus，Linguagnostus tricuspis，L.calvus，Homagnostus pater，Pseudophalacroma，Clavagnostus，Ammagnostus，Grandagnostus，Oidalagnostus，Dorypyge，Fuchouia，Lisania，Corynexochus，Prodamesella，Meringaspis，Buttsia，Damesella and Blackwelderia，among which many are common genera in the Goniagnostus nathorsti Zone of the study area.Upward，the L.laevigata Zone occurs in both areas.The Proagnostus bulus and Linguagnostus reconditus zones were below the G.stolidotus Zone in the study area，and can therefore be approximately correlated with the Kormagnostus simplex Zone of the Ajusockanian Stage based on their stratigraphic position.As both G.stolidotus and G.reconditus zones appear in both areas，they suggest a direct and accurate correlation.The Homagnostus hoiformis Zone can only be approximately equated with the Erixanium cf.E.sentum subzone of the study area due to this subzone bearing H.hoiformis.

An assemblage of A.clavatus with Irvingella has been recorded from the base of the Pseudagnostus curtare Zone in Malyi Karatau（Ergaliev，1980，1983a，1983b）.Additionally，the assemblage and the overlying Ivshinagnostus ivshini Zone in Kazkhstan also contains E.（Pseudeugnocare），Corynexochus plumula，Stigmatoa，Ivshinagnostus，Peratagnostus and Acutatagnostus，suggesting an alignment with the A.clavatus-I.angustilimbata Zone of the study area.The Ps.pseudagnostilobus Zone of the lower part of the Malykaratauian Stage may be compared with the Rh.cliensis-O.cf.kuruktagensis Zone to the E.decorus-Kaolishaniella Zone in the study area.

documented是什么意思

documented
备有证明文件的;

例句:
1.
Researchers documented the height, weight and body mass index of more than 3500 mexican undergraduate students.
调查人员记录了3500名墨西哥大学肄业生的身高、体重和体质指数。

2.
Although such team hunts are rarely seen, scientists believe they may be the most complex ever documented in the natural world.
虽然这样的团队狩猎非常罕见，科学家们相信这可能是在自然世界从未有过的最复杂记录

ICH-GCP 7.2 The Research Protocol（2）

Part 3: What is a Protocol Amendment?

Part 4: What is a Protocol Violation?

Part 5: Summary of Key Points
A protocol amendment is a written description of a change to some aspect(s) of the study as described in the research protocol.

方案修订是对研究方案中所述研究某些方面的变更的书面说明。

Protocol amendments must be submitted in writing to the designated Institutional Review Board (IRB) and must be approved by the IRB before they can be implemented, except when necessary to eliminate immediate hazards to the participants or when the change(s) involves only logistical or administrative aspects of the trial (e.g., change of monitor(s), telephone number(s)). If the study involves a product that is regulated by the U.S. Food and Drug Administration (FDA), the amendment must be submitted to FDA as well as to the IRB, prior to enacting the amendment (21 CFR 312.30).

方案修订案必须以书面形式提交给指定的机构审查委员会（IRB），并在实施前必须得到IRB的批准，除非有必要消除对参与者的直接危害，或者变更仅涉及试验的后勤或行政方面（例如，变更监查员，电话号码）。如果研究涉及的产品受美国食品和药物管理局（FDA）监管，则必须在颁布修正案之前将修订提交给FDA和IRB（21 CFR 312.30）。
Study participants must be informed of protocol amendments. Depending on the nature and extent of the amendment, the Informed Consent Form may be revised, and participants will need to complete and sign a new Informed Consent Form.

研究参与者必须被告知方案修订。根据修改的性质和范围，可能会修改知情同意书，参与者需要填写并签署新的知情同意书。

A protocol amendment is not to be confused with a “protocol clarification.” A protocol clarification aids in the implementation or conduct of the study and provides internal guidance. It does not change the protocol or alter the risk-benefit ratio of the study. A protocol clarification generally does not need to be submitted to the IRB. A clarification should be provided in writing to all investigators.

不得将议定书修正案与“议定书澄清”混淆。议定书澄清有助于研究的实施或进行，并提供内部指导。它不会改变研究方案或改变研究的风险效益比。议定书澄清通常不需要提交给IRB。应以书面形式提供澄清给所有调查人员。
A protocol violation occurs whenever a study staff person performs any action that does not adhere to the research protocol. Protocol violations are sometimes referred to as protocol "deviations." Although "deviations" may sound less serious than “violation,” the two terms are identical.

当研究人员执行任何不遵守研究方案的行为时，就会发生违反方案的情况。违反协议有时被称为协议“偏差”，虽然“偏差”听起来不如“违反”严重，但这两个词是相同的。
A protocol violation may be the result of a problem with study oversight, training of study personnel, or site study procedures.

违反方案可能是研究监督、研究人员培训或现场研究程序出现问题的结果。

A protocol violation may be:

Ⅰ、An omission (i.e., failure to do something required in the protocol)

Ⅱ、An addition (i.e., any action that is not required in the protocol).

Ⅲ、A change in any procedure described in the protocol.

违反协议可能是：

1、遗漏（即未按协议要求执行）

2、补充（即协议中不要求的任何行动）

3、协议中描述的任何程序的变更。

Protocol violations may occur due to human error. However, every attempt should be made to keep them at a minimum. Each violation and the action taken to correct the situation that led to the violation must be documented and submitted to the IRB.

由于人为错误，可能会发生违反协议的情况。然而，应尽一切努力将其控制在最低限度。必须记录每次违规行为以及为纠正导致违规的情况而采取的行动，并将其提交给IRB。

Repeated protocol violations may indicate the need for additional training of research staff or the need for a protocol amendment (e.g. to allow more flexibility in a follow-up plan that participants are having a difficult time adhering to).

反复违反方案可能表明需要对研究人员进行额外培训或需要修改方案（例如，在参与者难以遵守的后续计划中允许更大的灵活性）。
When a protocol violation occurs:

Ⅰ、Any concerns regarding participant safety must be addressed immediately by staff at the study site.

Ⅱ、The violation and a plan for corrective action must be documented.

Ⅲ、The violation must be reported to the principal investigator at the site, the study investigator, project management (if applicable), and the sponsor, and the FDA if the study is under an IND, in accordance with established procedures.

Ⅳ、The local IRB must be notified in a manner that conforms to the IRB’s documented procedures.

发生协议冲突时：

1、研究现场的工作人员必须立即解决与参与者安全有关的任何问题。

2、必须记录违规行为和纠正措施计划。

3、必须按照既定程序向现场主要研究者、研究研究者、项目管理人员（如适用）和申办方报告违规行为，如果研究处于IND中，则必须向FDA报告违规行为。

4、必须以符合IRB书面程序的方式通知当地IRB。

(For a more detailed discussion of the roles of the principal investigator and lead investigator, see the Roles and Responsibilities module.)

（有关首席研究员和首席研究员角色的更详细讨论，请参阅角色和责任模块）
Users are instructed as follows: Consider each of the five scenarios described below. Then, classify the occurrence as a protocol violation by choosing Violation or not by choosing No Violation。

对用户的指示如下: 分别考虑下述五种情景。然后，通过选择违反或不违反来将事件分类为违反协议。

The clinic is approaching the end of the day. The Research Coordinator has a patient there that is eligible for the study, and he wants to quickly get through screening procedures. He decides to streamline procedures and collect the screening urine specimen before the patient has an opportunity to discuss, review, and sign the Informed Consent.

诊所快结束了。研究协调员在那里有一名符合研究条件的患者，他希望能够快速通过筛查程序。他决定简化程序，在患者有机会讨论、审查和签署知情同意书之前收集筛查尿液样本。

Feedback: Is this a Violation or No Violation? This is a Violation. The informed consent process communicates all of the information that the individual needs to make an informed decision about taking part in the study, before any study procedures are performed.

反馈：这是违规还是不违规？这是违法行为。知情同意程序传达了在进行任何研究程序之前，个体需要就参与研究做出知情决定的所有信息。

The study protocol indicates that cash incentives are awarded based on a payment schedule, which will occur over the 12 months of the study. At each of the six study visits, the participant will receive 15 dollars in cash at the end of the visit. If the participant missed a visit or withdrew participation before the end of the study, they would not receive the reward for the missed visit(s).

The study staff at the ABC Research Clinic enrolled two participants at their site in the first week of study launch. At the first study visit, the PI determined that each participant and all future participants enrolled would receive the entire incentive ($90) at the last visit at the end of the study if the participants completed all six study visits. When the protocol monitor arrived weeks later for an interim monitoring visit, the site staff described these site procedures for applying incentives for the enrolled participants.

研究方案表明，现金奖励是根据付款计划授予的，付款计划将在研究的12个月内进行。在六次研究访问中，参与者将在访问结束时收到15美元现金。如果参与者在研究结束前错过了一次访问或退出了参与，他们将不会收到错过访问的奖励。

ABC研究诊所的研究人员在研究启动的第一周在他们的研究地点招募了两名参与者。在第一次研究访视时，PI确定，如果参与者完成了所有六次研究访视，则每位参与者和所有未来参与者在研究结束时的最后一次访视时将获得全部奖励（$90）。当方案监督员在几周后抵达进行临时监测访问时，现场工作人员描述了这些现场程序，以对登记的参与者实施激励。

Feedback: Is this a Violation or No Violation? This is a Violation. Site staff did not follow the incentive payment schedule outlined in the protocol. Also, incentive payments should not be conditional on the participant’s completion of the study.

反馈：这是违规还是不违规？这是违法行为。现场工作人员未遵守协议中概述的奖励付款计划。此外，奖励金不应以参与者完成研究为条件。

The protocol indicates that at the third and sixth study visits, the participant will have urine collected for drug testing. If the urine was not collected on the scheduled visit, study staff should collect at the following study visit.

At the Mercy Hospital, the clinician forgot to collect the urine specimen for drug testing on Visit 3. She collected the urine and performed the drug testing at Visit 4.

方案表明，在第三次和第六次研究访视时，参与者将收集尿液进行药物检测。如果计划访视时未收集尿液，研究人员应在下一次研究访视时收集。

在Mercy医院，临床医生在第3次就诊时忘记收集尿液样本进行药物检测。她在第4次就诊时收集尿液并进行药物测试。

Feedback: Is this a Violation or No Violation? This is No Violation. The site staff completed the urine drug testing according to the procedures outlined in the protocol.

反馈：这是违规还是不违规？这不是违反规定。现场工作人员根据方案中概述的程序完成尿液药物检测。

A participant receives the wrong dose of the study medication.

参与者服用了错误剂量的研究药物。

Feedback: Is this a Violation or No Violation? This is a Violation. Research that is not conducted in a standardized manner is unethical because it may put research participants at risk unnecessarily while yielding invalid data.

反馈：这是违规还是不违规？这是违法行为。未以标准化方式进行的研究是不道德的，因为它可能会使研究参与者处于不必要的风险中，同时产生无效数据。

Participants are enrolled in the study although they do not meet the inclusion or exclusion criteria.

参与者虽然不符合纳入或排除标准，但仍被纳入研究。

Feedback: Is this a Violation or No Violation? This is a Violation. Enrolling participants into a study that they are not eligible to participate in may put research participants at risk unnecessarily while yielding invalid data.

反馈：这是违规还是不违规？这是违法行为。将参与者纳入他们没有资格参与的研究可能会使研究参与者面临不必要的风险，同时产生无效数据。
Care should be taken when writing a protocol to avoid unnecessary rigidity in schedules and procedures and to allow for flexibility whenever it does not compromise the integrity of the study or the safety of participants. This is the first step in avoiding protocol violations.

在编写方案时应注意避免时间表和程序中不必要的僵化，并 在不损害研究完整性或参与者安全的情况下允许灵活性 。这是避免违反协议的第一步。

Then, every member of the research team must be familiar with the protocol and aware of the importance of following it at all times. The following steps can help to ensure that protocol violations are minimized.

然后，研究团队的每个成员都必须熟悉该协议，并意识到始终遵守该协议的重要性。以下步骤有助于确保协议冲突最小化。

Ⅰ、Provision of thorough protocol training as well as periodic refresher training for all members of the study team.

Ⅱ、Notification to all members of the study team of a protocol amendment.

Ⅲ、Updating research materials when changes occur such as the Informed Consent Form or Operations Manual reflecting the changes to the protocol or procedures.

Ⅳ、Reminders about protocol requirements during regular study team meetings.

1、为研究小组所有成员提供全面的 协议培训和定期进修培训 。

2、向研究小组所有成员发出 方案修订通知 。

Ⅲ、在发生变化时 更新研究材料 ，如反映方案或程序变化的知情同意书或操作手册。

Ⅳ、定期研究小组会议期间关于方案要求的提醒。

Again, protocol violations will occur in spite of the best intentions of research staff. Violations must be documented and corrective actions taken to prevent re-occurrences.

同样，尽管研究人员的意图是好的，但仍会发生违反协议的情况。必须记录违规行为，并采取纠正措施防止再次发生。
Ⅰ、Standardization of procedures is critical in a clinical research study. Research that is not conducted in a standardized manner is unethical because it may put research participants at risk while yielding invalid data.

1、 程序标准化 在临床研究中至关重要。不以标准化方式进行的研究是不道德的，因为它可能会使研究参与者处于风险之中，同时产生无效数据。

Ⅱ、All research staff involved in a clinical study must be familiar with, and must strictly adhere to, the procedures described in the research protocol.

2、参与临床研究的所有研究人员必须 熟悉并严格遵守研究方案中描述的程序 。

Ⅲ、The research protocol is one of the main documents that must be approved by a designated Institutional Review Board before a research study can begin. The research protocol provides a plan for the essential aspects of the proposed research.

3、 研究方案 是研究开始前必须由指定机构审查委员会批准的主要文件之一。研究方案为拟议研究的基本方面提供了计划。

Ⅳ、The Good Clinical Practice guidelines of the International Council for Harmonization require a research protocol for any study that involves human participants. In addition, Title 21 Part 312 of the Code of Federal Regulations requires a research protocol for studies conducted under an Investigational New Drug application.

4、国际协调理事会的《良好临床实践指南》要求对任何涉及人类参与者的研究制定研究方案。此外，《联邦法规》第21篇第312部分要求在试验性新药申请下进行研究的研究方案。

Ⅴ、A protocol amendment is a change to some aspect of the study. Amendments must be approved by the IRB before they can be implemented, unless there is an immediate safety concern for participants. If the study is to be submitted to the FDA, such as being under an IND, the amendment must be submitted to the FDA as well as to the IRB.

5、 方案修订 是对研究某些方面的改变。修正案在实施前必须得到IRB的批准，除非对参与者有直接的安全顾虑。如果该研究要提交给FDA，比如IND，则修订必须提交给FDA和IRB。

Ⅵ、A protocol violation occurs whenever any study staff member performs any action that does not adhere to the study description in the research protocol. Each violation must be documented and action must be taken to correct the situation that led to the violation. Repeated protocol violations may indicate the need for additional staff training or a protocol amendment.

6、当任何研究人员执行任何不符合研究方案中研究描述的行为时，就会发生 违反方案 的情况。必须记录每次违规行为，并采取措施纠正导致违规的情况。反复违反协议可能表明需要额外的员工培训或协议修订。

高分请高手帮忙翻译英文文献资料 (2)

A report from this project was issued in December 2002. 来自这一项目的一份报告在2002年12月发表。This report revealed some new areas that needed further research activities, and part 2 of the project was launched. 此报告揭示了某些需要进一步研究活动的新领域，而该项目的第二部分也开始了。Key issues here are heat transfer between materials, liquids and gas. 这里的关键问题是材料、液体和气体之间的热传导。A report from this project was issued in December 2003. 来自这一项目的一份报告在2003年12月发表。The objective of part 3 was to establish a link between the fire itself and the exposed process equipment. 第三部分的目标是建立火灾本身和暴露的工艺设备之间的联系。A complete model should be developed that could show the effect from a fire on the exposed component in an interactive process. 应该开发一个能反映火灾在相互作用过程中对暴露设备影响的完整模型。To perform further research work into this subject, a part 4 will most likely be launched in 2005. 为了对这一主题进行进一步的研究工作，第四部分很可能会在2005年开始。The objective is to integrate structural strength into the model.Control Philosophy.Performance based regulation. 其目标是根据规章将结构强度结合进“模型控制哲学性能”中。（说明，这里原文大些，又有句号，不太清楚，是否复制粘贴中出错了？）It is important to emphasize that the Norwegian HSE regulations for petroleum activities are performance based rather than being prescriptive . 重要的是要强调，挪威关于石油活动的HSE条例是以性能为依据的，而不是规定性的。The regulations are supported by guidelines, and the guidelines describe methods of achieving the functional requirements and goals. 这些规章由一些准则所支持，而这些准则描述了实现功能性要求和目标的方法。Normally the guidelines refer to international and national standards. 通常，这些准则指的是国际的和国家的标准。 It is therefore important for the regulator to know which standard is the most relevant, concerning for instance fire technical issues. 因此对管理者来说，了解哪一个标准是与比如火灾的技术问题最有关的是很重要的。 This is why the PSA in Norway is supporting this project. 这就是挪威的PSA支持这一项目的原因。
Requirements for protection of process equipment against fire.
工艺设备防火的要求
Requirements to fire protection of process equipment are stipulated in Regulation relating to design and outfitting of facilities etc. in the petroleum activities section 28. 工艺设备的防火要求在有关第28节中石油活动的设备等的设计和装备的规章中做了规定。（说明：前面讲section 8，这里是section28，有没有错？）This section say: ‘Where passive protection is used, it shall be designed so as to give relevant structures and equipment adequate fire resistance with regard to load bearing properties, integrity and insulation properties during a dimensioning fire.’ 这一节中说到：“在采用被动防护的情况下，应加以设计，以提供具有适当耐火性的相关结构和设备，所谓适当的耐火性关系到在一场定尺寸的（dimensioning）火灾过程中的承载性能、完整性和绝热性能In the guidelines it is further stated that: ‘for gas and liquid-filled vessels and pipe-sections, the passive fire protection should be sufficient to prevent rupture before depressurisation is carried out.’ 在准则中，它进一步说道：“对于充有气体和液体的容器和管线段来说，被动防火在进行减压前防止破裂应该是足够的。”The relevant standard referred to in this section is NORSOK S-001. This standard has the following heat flux values:在本节中参照的相关标准是NORSOK S－001。这一标准有以下的热通量值：
问题补充：New platform concepts – new challenges for safety management.
新的平台概念－安全管理的新挑战
During the last years we have been introduced to new concepts for developing oil and gas fields in Norway. 在近几年中，我们一直接受到有关开发挪威油气田的新概念。 This concerns mostly developments in deep-water areas, deeper than traditional developments (70-150m). 这大多数关系到深海区的开发，它们深于传统的开发（70－150m）。The petroleum activities are also moving further north on the Norwegian continental shelf. 石油活动也进一步的向挪威大陆架的北部移动。Northern areas imply more harsh weather conditions, and also environmental concerns. 北部区域意味着更恶劣的气候条件以及环境问题。It is therefore of importance to have good competence and knowledge in the HSE-area when developing new fields. 因此，在开发新油田时，在HSE区域有良好的胜任能力和了解是很重要的。The design must be based on well-proven and well-documented technology. 设计必须以得到充分证实，并有良好文献记载的技术为基础。But the performance-based regulations are also an opportunity for the operator to develop other technical solutions with the same safety level as those described in the guidelines, as long as compliance with the required safety level can be documented. 但是以性能为依据的规章对于经营者开发与准则中描述的安全水平相同的其他技术解决方案来说也是一个机遇，只要与所要求的安全水平的符合性有文献证明即可。