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AIM：To establish a project management tool to measure the working ability of research coordinators and the workload of clinical trial projects, and optimize medical institutions or clinical trial site management organization (SMO) allocation basis of clinical trial items by collecting the work stress and personal ability values of clinical coordinators. METHODS: Different words in the five major databases were searched and information on the work capacity and workload in the Subei People' s Hospital was collected. In addition, the paper analyzes the characteristics of coordinators working pressure source by SPSS26.0 statistical software and stability coefficient method. RESULTS: The study established the clinical research coordinator's personal ability - assessment tool (CRCPA-AT) and clinical trial project workload - assessment tool (CTPW-AT) to assess the coordinator's working ability and clinical trial workload. The two tools in this study were tested retrospectively in 61 coordinators and 144 clinical trials, 39 (66.1%) coordinators' projects were reasonably allocated, 18 (30.5%) coordinators were in the state of theoretical pressure and 12 (20.3%) coordinators had high actual pressure, which matched with the theoretical pressure. CONCLUSION: In this study, two scoring scales were established to quantify the working ability of the coordinators and the workload of clinical trial projects. Through the verification of the 61 coordinators and its management projects, the Likert5 point scoring method was used to analyze, more than 86.4% of the actual pressure of coordinators was consistent with the theoretical pressure quantified by the tool.
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Objective:To introduce the construction and practice of the Clinical Research Coordinator(CRC) management system based on the whole process of the clinical trial project in Ninth People′s Hospital of Shanghai Jiao Tong University School of Medicine.Methods:Constructed CRC management system with hospital features, including the management of admission, examination, training, emergency, and evaluation.Results:CRC management system was put into practice, and investigators, sponsors, and drug clinical trial institutions were highly satisfied with clinical trials using this system.Conclusions:With the gradual formation of CRC industry norms and consensus, the standardized management of CRC can promote the development of China′s pharmaceutical industry.
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Objective:The Clinical Research Coordinator (CRC) is responsible for transcribing and verifying clinical trial data, and making recommendations to research institutions and sponsors on clinical trial data through analyzing and discussing data problems found in CRC work assessment, thereby improving the quality of clinical trials.Methods:Based on the ALOCA+ Principle, this study analyzed the data problems found in CRC assessment based on clinical trial quality conducted in a grade A tertiary hospital in Beijing from November 2018 to December 2021, and discussed improvement measures for clinical trial data problems.Results:Among the clinical trial data problems, data integrity is the most prominent, followed by accuracy.Conclusions:Research institutions and sponsors should improve the data management system and SOP, strengthen the training for clinical trial participants, optimize a trial plan and process design, strengthen supervision and inspection, and establish a risk-based quality control system, etc., so as to make clinical trial data conform to the international ALOCA+ principle and make clinical trial results accurate and reliable.
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OBJECTIVE To investigate the job mo bility of cl inical research coordinators （CRCs） and clinical research associates（CRAs）in Chongqing ，and to explore the feasible methods to improve the job stability of CRCs and CRAs. METHODS Questionnaire survey was conducted to investigate the job mobility of 200 CRCs and CRAs working in 22 drug clinical trial institutions of Chongqing. The contents included basic information ，job mobility ，and reasons for mobility. RESULTS & CONCLUSIONS Totally 178 valid questionnaires were recovered ，with an efficient recovery rate of 89.00％，of which 110 were recovered from CRCs and 68 were recovered from CRAs. Among the surveyed CRCs and CRAs ，the age distribution was mainly 20-30 years old ，accounting for 87.27％ and 82.35％ of the respective population respectively. The overall educational degree of CRAs were slightly higher than those of CRCs. The majors and previous work experience were mainly related to medicine ；the proportion of other non-medicine-related professions who switched to CRCs was higher than that of CRAs. Totally 88.18％ had CRC working experience within 3 years；after having 1-＜3 years of work experience ，50.00％ had worked in 2 or more work units. Totally 64.70％ had CRA working experience within 3 years；after having 1-＜3 years of work experience ，70.37％ had worked in 2 or more work units. CRCs handled 5.38 items of clinical trials and completed 1.22 items on average ；CRAs handled 7.47 items and completes 2.04 items on average. Main reasons of CRCs and CRAs for job-hopping included low salary below expectations，few promotion opportunities ，and too much workload ，accounting for 83.64％/80.88％，45.45％/39.71％，31.82％/ 26.47％，respectively. As an important part of clinical trials ，CRCs and CRAs had high job mobility. It is suggested to establish a unified industry standard ，standardize the management rights and responsibilities of CRCs and CRAs ，optimize the working mode of CRCs and CRAs ，and improve professional identity and sense of belonging ，so as to improve the job stability of relevant
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Objective:To analyze the problems existing in the management mode of clinical research coordinator (CRC) in the new context, propose improvement measures and analyze the effectiveness of improvement.Methods:Four types of stakeholders related to CRC, including investigators, clinical research associates(CRA), institutional managers and human subjects were investigated in regular monthly questionnaire survey on the basis of CRC management comparasionat home and abroad. The new CRC management countermeasures implemented by our institution in July 2020 were taken as the time node, and the data from January to June 2020 were taken as the pre-implementation group, and the data from July to December 2020 were taken as the post-implementation group. Compare the monthly scores of CRCs′ work effect for 30 projects in the institution before and after the implementation of such countermeasures.Results:The scores of CRCs′ working effectiveness were improved after the implementation of CRC management countermeasures, whcih including standardizing the entry of CRC, updating of the training and assessment mechanisms, conducting regular communication meetings and developing reward and punishment measures. The scores from investigators increased by 20.17%, scores from CRAs increased by 11.54%, scores from institutional managers increased by 14.26%, scores from subjects increased by 10.64%, and the total scores increased by 14.13%( P<0.01). Conclusions:Countermeasures to optimize CRC management taken by drug clinical trial institutions can significantly improve CRCs′ working effectiveness in multiple dimensions.
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Objective Sorting out work activity of China Clinical Research Coordinator(CRC),defining the core work activity of China CRC,and making comparison with foreign CRC's.Providing basic data to establish training system and occupational skill assessment system for China CRC.Methods This is a cross-section design survey.The method for sampling will be the convenient sampling combine the snowball sampling.A self-administered questionnaire was introduced.Data managed by Excel and analyzed by SPSS.The frequency,percentage,mean and SD will used for the description of the CRC's demographics information and vocation characteristics.The core work activities of CRCs were defined with the method which used to define core work activities of CRCs in foreign literatures.Results Totally 227 questionnaires were returned,223 effective questionnaires were used for analysis,the effective rate is 98％.Around 89％ of CRCs are female.The mean age is 27.5±3.8 years.Around 72％ of CRCs owned bachelor degree,24％ are junior college degree,4％ are master degree.Around 43％ CRCs are nurse background,34％ are pharmacy background,16％ are medical background.Around 55％ of CRCs owned 3 000-5 000RMB income.More than 50％ of the CRCs had worked in this position for less than 1.5 years.Totally 10 items of work activities are defined as the core work activity of China CRCs,mainly focus on clinical trial data collection and management.Comparing to foreign CRC,the involvement of China CRC on CRF completion,query solution,study document management,assisting Clinical Research Associate (CRA) on monitoring,AE and SAE reporting are lower than foreign CRC,and the involvement on assisting investigator on patient screening,lab-test report collection and management,sample delivery and management,assisting investigator on patient visit arrangement are higher than foreign CRC.Conclusions The CRC in China has now involved in all work activities of the whole process of clinical trials,their core work activities mainly in the phase of clinical trial conduct,they play an important role in clinical trial operation.Due to the immature training system and the unclear job description,there are differences Between Foreign CRC and China CRC on working activity.
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Background: Clinical research sites are hiring more non-licensed personnel to coordinate clinical trials and to replace licensed nurse counterparts. Revised regulatory documents heavily emphasize research staff training and research activity delegation of authority. The Scope and Standards of Practice for Clinical Research Nursing, published by the American Nurses’ Association and based on role delineation studies for nurses, is the guidance document for clinical research nurses participating in research activities. Policy making related to research activity delegation of authority would be informed by data that correlate protocol deviation rates with licensure and education of research staff. Protocol deviations can lead to invalid clinical trial results, adverse events, and ethical concerns related to participant risk exposure. Outcome data are lacking, which directly compare frequency of protocol deviations by licensed nurse study coordinators to deviation rates of non-licensed study coordinators.Methods: This pilot study reviewed 45 monitoring reports for 3 clinical research studies and associated research sites staffed with licensed RN study coordinators and research sites staffed with non-licensed, non-RN study coordinators to compare deviation rates related to informed consent, protocol endpoints, participant eligibility and adverse events.Results: We identified 101 deviations. Adverse event and endpoint deviations were the highest frequency. Differences were evident in overall deviation rates; however, specific deviation comparisons failed to show statistical significance due to low sample size. Conclusions: This study illustrates a useful method for planning future studies using monitoring reports for deviation tracking and comparison across staffing levels.
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According to the quality requirements of clinical trials and the work characteristics and the development trend of clinical research coordinators ( CRCs),we proposed that converting non-hospital CRCs to hospital CRCs or ‘hospital Staffs’ and arranging them to assist quality management in clinical trials are very important and significant for improving the quality of clinical trials. In present study, we also analyzed the methods about how to convert non-hospital clinical research coordinators to hospital CRC and briefly described their role in quality management.
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To explore the application of clinical research coordinator(CRC) in acupuncture and moxibustion study. The present application of CRC in many countries, such as America and Japan, was analyzed, and the critical actions of CRC were summarized. CRCs are crucial party of the clinical research coordinators group (CRCG).It aims to help regulate works among patients, sponsors and researchers with altruism. Now there are problems in clinical acupuncture and moxibustion research management, and the experience of CRC can enhance the efficiency and research level.
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OBJECTIVE:To provide reference of Clinical Research Coordinator(CRC)industry development in China. METH-ODS:By using the method of literature research combining with field survey research,the development status,training certifica-tion and working mode of CRC industry in Japan were summarized,and suggestions on the development of the CRC industry in China were proposed. RESULTS:Japanese CRC industry gradually matured,and staff tended to be stable,the standardized train-ing and certification system have been established,the services include the support on medical institutions,clinical trials,clinical researches and other multiple aspects. CRC industry in China should perfect the company system construction,carry out standard-ized training and certification examination, strengthen the hospitals' direct management of CRC, and expand the CRC services in clinical research. CONCLUSIONS:The experience of CRC industry development in Japan,including system construction,stan-dardized training and working mode,is a good example for China CRC industry to learn.
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BACKGROUND: This study was aimed to investigate the perception on working conditions and utilization of clinical research coordinators (CRCs) among investigators and sponsors. METHODS: The participants of this cross-section study were 114 investigators and 138 sponsors including clinical research associates (CRAs) who have worked with CRCs. Data was collected with paper or electronic form of self-administered questionnaires and analyzed with descriptive statistics and chi2 test or t test. RESULTS: Among investigators and sponsors, 56.1 % and 95.0 % perceived regular full-time positions as proper type of CRC employment, respectively. Those who perceived monthly salary with incentive as proper payment system were 67.5 % of investigators and 68.8 % of sponsors. The proper salary for 2-year CRCs and 5-year CRCs were significantly higher in sponsors than investigators. Investigators perceived CRCs could handle 3 studies as the same time and 5 studies per year. In regard to the difficulty in utilizing CRCs, 68.4 % of investigators perceived lack of experienced CRCs and 84.8 % of sponsors did frequent turnover. Those who responded pooling CRCs by hospital or clinical trial centers as a good solution to hire CRCs easily were 81.6 % of investigators and 58.0 % of sponsors. CONCLUSION: Almost all investigators and sponsors perceived CRCs were helpful for improving the quality of clinical trials. We recommend each institution or clinical trial centers could introduce the central CRCs' employment and management with proper salary and workload based on the results to maintain experienced CRCs and lessen the turnover of CRCs.
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Humans , Calcium Hydroxide , Electronics , Electrons , Employment , Motivation , Surveys and Questionnaires , Research Personnel , Salaries and Fringe Benefits , Zinc OxideABSTRACT
BACKGROUND: This study is intended to propose not only to introduce and evaluate the 2 years Clinical Research Coordinator (CRC) professional on-the-job training program that has been implemented in Samsung Medical Center on September of 2009, but also to develop the CRC future education program. METHODS: It is surveyed with self-report type for the 53 trainees, 18 non-trainees, and 17 investigators, the participants worked in Samsung Medical Center, and the major contents of the survey were general characteristics, training program evaluations, CRC qualification evaluation, and job satisfaction. The collected data was analyzed at the 0.05 level of significance by using SAS 9.1 version. RESULTS: The training program is conducted as 4 phases, each phase assessed separately. The Professional A course got the highest satisfaction, and it was deal with quality control (Mean=4.11 ~ 4.33). Most of the investigators answered that the trainees have high priority to be hired in the future (very much=82.45). The non-trainees answered that the training program would be helpful to improve the job competency and qualification (very much=22.2 %, somewhat=55.6 %) and 88.9 % of them answered that they have intention to participate in the training program. Finally, compared to non-trainees, the trainees have more job attachment (P=0.0036) and intention to continue CRC (P=0.0045). CONCLUSION: The CRC professional training program in Samsung Medical Center, as on the job training for 2 years, satisfies the investigators and trainees with positive effect on CRC job satisfaction and job stability. Based on this study, the education program with good quality should be developed considering the characteristics for each institution and close research field.
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Humans , Inservice Training , Intention , Job Satisfaction , Korea , Phenothiazines , Quality Control , Research PersonnelABSTRACT
BACKGROUND: In recent years, clinical trials have considerably increased and relevant education programs to clinical trials have been developed and implemented since 2008 in Korea. To enhance the quality as well as global competitiveness of clinical trial professionals (CTPs), a certification program of the human resource is needed. Accordingly, in Korea the first and the second certification examinations were implemented in February and October 2012, respectively. In this paper, introduction of the certification program of the human resource is described, and results of the certification examinations and questionnaire survey are presented. METHODS: Data including the examination results and questionnaire survey was collected by cooperative officials in Korea National Enterprise for Clinical Trials. Applicants who were selected eligible for examination by the steering committee were asked to complete questionnaires provided with the test papers on the day of the certification examination. RESULTS: In the first certification examination, a total of 221 eligible participants completed the examination. 99.5 % of the participants responded the questionnaire survey. In the second examination, a total of 223 applicants participated. The examination consisted of 50 multiple-choice questions with cut-off score of 70 per cent score.176 & 194 CTPs passed the first & second examinations respectively. CONCLUSION: This paper that described the results of the two certification tests and questionnaire surveys might be helpful in establishment and activation of the certification program in the future. Quality improvement of CTPs and international competitiveness of clinical trial in Korea can be anticipated by the certification program.
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Humans , Certification , Cytidine Triphosphate , Korea , Quality Improvement , Surveys and Questionnaires , SilanesABSTRACT
BACKGROUND: In recent years, clinical trials have considerably increased and relevant education programs to clinical trials have been developed and implemented since 2008 in Korea. To enhance the quality as well as global competitiveness of clinical trial professionals (CTPs), a certification program of the human resource is needed. Accordingly, in Korea the first and the second certification examinations were implemented in February and October 2012, respectively. In this paper, introduction of the certification program of the human resource is described, and results of the certification examinations and questionnaire survey are presented. METHODS: Data including the examination results and questionnaire survey was collected by cooperative officials in Korea National Enterprise for Clinical Trials. Applicants who were selected eligible for examination by the steering committee were asked to complete questionnaires provided with the test papers on the day of the certification examination. RESULTS: In the first certification examination, a total of 221 eligible participants completed the examination. 99.5 % of the participants responded the questionnaire survey. In the second examination, a total of 223 applicants participated. The examination consisted of 50 multiple-choice questions with cut-off score of 70 per cent score.176 & 194 CTPs passed the first & second examinations respectively. CONCLUSION: This paper that described the results of the two certification tests and questionnaire surveys might be helpful in establishment and activation of the certification program in the future. Quality improvement of CTPs and international competitiveness of clinical trial in Korea can be anticipated by the certification program.
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Humans , Certification , Cytidine Triphosphate , Korea , Quality Improvement , Surveys and Questionnaires , SilanesABSTRACT
BACKGROUND: This study was aimed to investigate recognition of clinical research coordinators (CRCs) among non-nursing major students. METHODS: The participants were 424 undergraduate or graduate students whose majors were related to life science, physical therapy or pharmaceutical engineering in three universities located in Busan. Data were collected with self administrated questionnaire including general characteristics (5 items), and recognition of CRCs (4 items). The collected data were coded and was analyzed using SPSS Version 18.0 for Windows for frequency and percentage, or mean and standard deviation. The Chi-squared test was used to assess the relationship between general characteristics and recognition of CRCs. All statistical tests were performed at the 0.05 level of significance for two-tailed tests. RESULTS: The percent of 'ever having heard of CRCs' was 28.3 % and 35.0 % of them showed the intention to work as CRCs. The 'ever having heard of CRCs' was related to major (p<0.001) and 'ever having heard of clinical trials' (p<0.001). The intention to work as CRCs was not related to gender, education, major, and 'ever having heard of clinical trials'. CONCLUSION: The level of 'ever having heard of CRCs' among non-nursing major students was lower than that of nurses. It is needed that more active introduction or promotion of CRCs to non-nursing major students through both regular curriculum or training programs. And it is also recommended to develop the job description for CRCs with nurse license or CRCs without nurse license.
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Humans , Biological Science Disciplines , Calcium Hydroxide , Curriculum , Intention , Job Description , Licensure , Surveys and Questionnaires , Zinc OxideABSTRACT
BACKGROUND: This study was aimed to investigate the current two years' clinical research coordinators (CRCs) employment and estimate total number of CRCs in Korea. METHODS: The participants were administrative officers or head CRCs in institutions designated by Korea Food & Drug Administration (KFDA). Data on the current status of CRCs' employment was collected with self-administered questionnaires or telephone interview. And total number of CRCs in Korea was estimated based on ratio between the number of the KFDA approved clinical trials and current number of CRCs. RESULTS: The number of CRCs was 1381 at 36 centers in 2009 and 1444 at 37 centers in 2010. About 79 percent of CRCs were employed by investigators. The estimated number of CRCs was from 1677 to 1763 at 135 centers in 2009 and from 1802 to 1890 at 142 centers in 2010 based on number of clinical trials approved by KFDA. Two third of regional clinical trial centers (RCTCs) had written employment policy, and 25 percent of RCTCs employed CRCs in a regular position. All RCTCs had educational programs for CRCs and supported CRCs for training outside. 75 percent of RCTCs provided ID card for CRCs belonging to investigators to access to hospital document. Half of RCTCs had CRC registration system in hospital-wide. CONCLUSION: The number of CRCs in Korea can be easily estimated with the number of KFDA approved clinical trials. Majority of RCTCs still employed CRCs in an irregular position, which should be switched to regular position to reduce the CRCs' unsatisfaction. It is also needed to develop centralized CRC management system for CRCs belonging to investigators.