中新社上海11月13日电 题：中国内地首批专职“研究护士”走马上任

China news agency Shanghai on November 13 (Reuters) problem:Mainland China the first full-time"The nurse"Took office

　　中新社记者 陈静

China news agency reporter reiter

　　做了约20年临床护士的赵彤芳，如今成为专职“研究护士”。她是上海首批13位进入药物试验专业科室的研究护士之一，也由此成为中国内地第一代专职研究护士。

Do about 20 years of clinical nurses ZhaoTongFang,Now become a full-time"The nurse".She is Shanghai the first 13 patients into drug test professional department research one of the nurses,And thus become the first generation of mainland China full-time study nurse.

　　研究护士全称“临床研究护士”，即临床研究协调员(CRC)，是指经主要研究者授权并受相关培训后，在临床试验中协助研究者进行非医学性判断的事务性工作人员。CRC最早起源于美国，如今在那些临床研究水平先进国家，没有CRC的临床研究机构不能实施药物临床试验。

The nurse full name"Clinical research nurse",Namely clinical research coordinator(CRC),Refers to the principal investigator and authorized by relevant training,In clinical trials to assist researchers for non-medical sex judgment routine work personnel.CRC originating in the United States,Now in those clinical research level advanced country,No CRC clinical research institutions cannot implement drug clinical trials.

　　刚刚走马任职的赵彤芳告诉中新社记者，她目前正在了解相关的药物临床试验方案，之后，将全程参与医院的一期药物试验。她的职责包括药品发放、采血、与受试者沟通，并与研究者(医生)保持联系等。

Just cook's office ZhaoTongFang told the China news agency reporter,She is currently understand relevant drug clinical trial scheme,after,Will participate in a hospital period drug test.Her duties include drug release/Draw blood/And subjects communication,And and the researchers(The doctor)Keep in touch, etc.

　　沪上首批13名研究护士新近在上海曙光医院上岗，引发各界关注。这些研究护士进入包括肝病科、肾病科等在内的13个药物试验专业科室，在药物临床试验中发挥协调作用。曙光医院国家药物临床试验机构办公室主任元唯安介绍说，被选拔担任全职研究护士者，其学历以本科为主，此前均参与过药物临床试验，不仅具有全面的护理知识，还有较强的沟通能力，且细致耐心。根据岗位设计，研究护士成为整个药物试验体系的沟通纽带。

Shanghai the first 13 research nurse recently in Shanghai shuguang hospital mount guard,Cause attention from all walks of life.These studies nurse into including liver ill division/ShenBingKe, 13 drug test professional departments,In drug clinical trials play a coordinating role.Dawn hospital national drug clinical trial institution office director yuan only AnJieShao said,Be selection as a full-time study the nurse,The record of formal schooling with undergraduate course is given priority to,After all participated in drug clinical trials,Not only has the comprehensive knowledge of nursing,And strong communication skills,And careful patient.According to job design,The nurse become the drug test system communication link.

　　赵彤芳认为，面对科研性工作，专业知识更显重要，包括解释说明、安抚在内的现场把控能力，也成为这些研究护士的“职业新挑战”。

ZhaoTongFang think,In the face of sex work of scientific research,Professional knowledge is more important,Including explanation/Comfort, the site control ability,Also become these research nurses"Professional new challenges".

　　近10年来，中国药物临床试验发展迅速，医疗机构每年承担的临床试验项目数量巨大，且增幅显著。据元唯安透露，两年前，上海曙光医院每年新增约20个新药临床试验项目，近两年增加至每年超过40项。目前在中国内地，临床试验绝大多数工作由研究者(医生)来完成，由于药物临床试验在细节上要求很高，繁忙的临床医生在试验过程中就有可能出现失误，或数据记录不准确、不规范，或与受试者沟通不足等。

Nearly 10 years,China's rapid development of drug clinical trials,Medical institutions for each year of clinical test project a huge number,And increase significantly.According to yuan and Ann has revealed,Two years ago,Shanghai shuguang hospital to an annual increase of about 20 new drug clinical trial project,Nearly two years increased to more than 40 items.At present in the Chinese mainland,Clinical trials most work by the researchers(The doctor)To complete,Because the drug clinical trial in detail demanding,Busy clinical doctors in the course of the experiments, it is possible to errors,Or data record is not accurate/Don't regulate,Or with subjects such as lack of communication.

　　据介绍，新上任的专职研究护士将在临床试验中发挥协调作用，重点是加强与研究者与受试者之间(医生与患者)之间的沟通，并承担试验过程中诸多繁琐细节事务，使医生得以将主要精力放在试验方案制订、数据分析研究上，以提升临床试验质量。

According to introducing,New incoming full-time study nurses in clinical trials will play a coordinating role,Key is to strengthen and between researchers and subjects(Doctors and patients)Communication between,And bear the test process many tedious details affairs,Make the doctor to put the main energy test scheme designing/Data analysis research,In order to improve the quality of clinical trials.

　　元唯安表示，借鉴国外经验设立CRC，是保证临床试验质量的重要举措，也是中国新药研究与国际接轨的必经途径。

Yuan and Ann said,The reference of foreign experience set up CRC,Is to guarantee the quality of the clinical trial is an important measure,Is China's new drug research and international standards the necessary way.

　　据上海曙光医院院方透露，在研究护士机制运作一段时期后，医院将对药物临床试验质量水平进行评估，以观研究护士岗位设立后的实效，并及时改进相关流程。元唯安称，与新药临床试验的需求相比，研究护士人数还远远不够，随着新药临床试验项目的增多，还将增加研究护士。

According to the Shanghai shuguang hospital, the hospital has revealed,In the research the nurse mechanism operation after a period,The hospital will be on drug clinical trials evaluate the quality level,With the view research nurse post set up after the actual effect,And prompt improvement related process.Yuan and Ann said,And new drug clinical trials compared to demand,The nurse toll was far from enough,With the increase of new drug clinical trial project,Will also increase the nurse.

　　研究护士这一新职的诞生，也引来此间医疗界聚焦，有业内人士预计，未来中国的药物临床试验将越来越多，相应的规范与标准也将升级，中国或将与国际先进国家一样，将研究护士岗位设置作为获得国家药物临床试验点资格的必要门槛。(完)

The nurse this new position of birth,Also draws supported here focus,The personage inside course of study is expected,China's future drug clinical trials will be more and more,The corresponding specification and standard will also upgrade,China or with international advanced countries,Will study the nurse post Settings as access to the national drug clinical test point qualifications necessary threshold.(finish)