Published online Oct 26, 2023. doi: 10.12998/wjcc.v11.i30.7363
Peer-review started: August 3, 2023
First decision: August 16, 2023
Revised: August 30, 2023
Accepted: September 28, 2023
Article in press: September 28, 2023
Published online: October 26, 2023
Processing time: 82 Days and 23.7 Hours
As one of the most important members in clinical trials, the number of clinical research nurses (CRN) can't keep up with the growth of experimental projects, so it is urgent to build clinical research training and strengthen the background knowledge of nurses.
To construct CRN training program based on position competence, accelerate the construction of CRN talent pool, and provide scientific guidance significance for CRN training.
Based on the position competence model, combined with literature research and qualitative interview results, the first draft was prepared of the CRN training program. Two rounds of correspondence with 16 experts were conducted using the Delphi method to determine the training program.
The effective recovery rate of the expert correspondence questionnaire was 100% and the authority coefficients of the 2 rounds of experts were 0.826 and 0.895. Finally, 4 first-level indicators and determine 15 s-level indicators of training objectives. The training program included 4 first-level indicators, training requirements, content, methods, assessment and evaluation, 15 s-level indicators, and 74 third-level indicators.
The CRN training program based on position competence is scientific and extendable, providing a basis for participation in CRN training.
Core Tip: With the development of clinical trials, there is a big gap in the number of clinical research nurses. Therefore, this study aims to build a nurse training program that meets the needs of clinical trials. Based on the results of literature research and interviews, this study compiled a training plan with the post competency model, and finally determined the training plan through two rounds of expert communication review. Multi-dimensional statistical results show that the training program is scientific.
- Citation: Sun J, Shan WC, Liu JM, Zhang QQ, Ye Y, Huang ST, Zhong K. Construction of clinical research nurse training program based on position competence. World J Clin Cases 2023; 11(30): 7363-7371
- URL: https://www.wjgnet.com/2307-8960/full/v11/i30/7363.htm
- DOI: https://dx.doi.org/10.12998/wjcc.v11.i30.7363
In recent years, clinical trials are in the stage of rapid development and the projects are increasing every year. However, the overall number of clinical trial registrations in China exceeded 3000 for the first time in 2021, an increase of 29.1% yearly[1]. The number of clinical research nurses (CRN) is far from keeping up with the growth of trial programs. As crucial and indispensable members of clinical trials[2], CRN work throughout the clinical trial process to ensure the quality and efficiency of implementation[3,4]. However, the training mode for clinical research nursing is still in the exploration stage with problems like that research nurses doing multiple jobs, inadequate training systems, and single training mode[5]. There is a demanding need to construct a set of training programs for CRN. Position competence refers to the sum of knowledge, skills, abilities, and characteristics that are competent for the job and capable of producing excellent work performance[6,7]. The National Nursing Career Development Plan (2021-2025)[8] proposed to improve the strengthen of nurse training and establish a training system oriented by job requirements and centered on position competence to strengthen the nurse workforce. Therefore, our study uses clinical research nurse (CRN) position competence as a guide to construct a training program by combining literature search and qualitative interview to provide a reference for CRN.
The research team consisted of 6 members, including a chief pharmacist, an associate chief nurse practitioner and four charge nurses (all CRN). The team members were mainly responsible for reviewing and analyzing literature, conducting qualitative interviews, preparing and distributing expert correspondence questionnaires, organizing and analyzing the expert’s opinions, and constructing the first draft of the research nurse training program.
Databases such as Web of Science, MEDLINE, EMBASE, CINAHL, EBM, PubMed, China Knowledge Network, Wan fang, and Wipu were searched with a search time frame until June 2022. Chinese search terms are research nurse, position competence, core competency, training model, and curriculum system. English search terms are clinical research nurse, post competency, core competency, and curriculum system. These were cross-checked by 2 researchers who independent
An interview outline was developed in conjunction with the literature study and 10 people were interviewed, including clinical research center managers and nursing department managers, research nurses, investigators, and clinical research centers. The outline of the interviews with the research nurse and researcher is as follows: (1) What does CRN actually do? (2) Which aspects of your work do you excel at? Which areas still need improvement? (3) What obstacles have you encountered in your work? How did you solve them? (4) What core competency do you think CRN should have? (5) Do you think training for CRN is necessary? (6) What training should be received? and (7) Why training should be done? The outline of the interview with the managers of the Clinical Research Center and the Nursing Department is as follows: (1) All questions in the previous interview outline; (2) What do you think are the key points that need quality control in the CRN work content of clinical trials? (3) Have you encountered any CRN jobs that you are very satisfied with? If so, could you please recall specific incidents or behaviors? and (4) What would you recommend for existing CRN? Interviews were conducted until data was reached and no new information emerged and the data were analyzed using the Colaizzi phenomenological data analysis[9,10]. The interviewees all agreed that CRN should have a competency system of professional practice, management skills, communication and coordination skills, critical thinking skills, and which training objectives should be based on and they proposed the content of training and training methods, etc. The assessment and evaluation should be multi-dimensional for a comprehensive assessment of the CRN competency system.
Analyze the current situation of the CRN position competence system with home and abroad training through literature research, understand the training needs and suggestions through qualitative interviews, and combine with Good clinical practice for clinical trial quality management[11]. After the research team deliberated, the preliminary draft of the CRN training program was prepared, including four parts: Training objectives, training content, training methods, and assessment and evaluation.
Preparation of expert correspondence questionnaire: It consists of 3 parts: (1) Research-related information and instructions for filling out the project; (2) Expert-related information, including general information questionnaires, expert familiarity questionnaires, and judgment basis questionnaires; and (3) The importance evaluation of the training program indicators (preliminary draft) is based on the Likert 5-point scale, with "very important" to "unimportant" being assigned a score of 5-1 in that order and experts can make comments in the revision column.
Selection of experts for correspondence: Inclusion Criteria: (1) Bachelor's degree or above, intermediate title or above, ≥ 10 working experience; (2) Participation as a key participant in clinical trials, clinical trials or care management and ≥ 10 years of teaching experience in their field; and (3) Active participation in research.
Implementation of expert correspondence: Email and on-site questionnaires were used and experts were asked to respond within 2 wk. After collecting the data, the research team analyzed and organized the data, adjusted the items according to the screening criteria (importance value > 3.5, coefficient of variation < 0.25, or expert agreement ≥ 75%), and expert opinions. Then they formed the next round of expert consultation questionnaires and distributed the questionnaires again until the experts' opinions were in agreement. Two rounds of correspondence were conducted in this study to make the results scientific and convergent.
Statistical methods: Excel 2019 and SPSS 25.0 software were used to analyze the data. The questionnaire return rate indicated the positivity of experts, the authority coefficient indicated the degree of authority of experts, the mean, standard deviation, and full score ratio of importance scores of indicators showed the degree of concentration of experts' opinions and the coefficient of variation and Kendall's coordination coefficient which indicated the degree of coordination of experts' opinions.
Sixteen experts from seven different hospitals with clinical trial qualifications completed the correspondence, involving clinical trials, clinical research centers, and professional fields of nursing management and nursing education. Age ranged from 38 to 55 (43.56 ± 5.34) and experience was 20 to 36 (26.72 ± 7.41). There were 2 bachelor's degrees, 12 master's degrees, and 2 doctoral degrees.
The effective recall rate was 100% after 2 rounds of expert indicating that experts were highly motivated to participate in this study[12]. The coefficients (Cr) for the corresponding experts were 0.854 and 0.887.
The indicators variation Cr were 0-0.1247 and 0-0.2290 after 2 rounds of correspondence. The Kendall coordination Cr of the 2 rounds were 0.212 and 0.332 (P < 0.001), as shown in Table 1.
Items | First round of consultation | Second round of consultation | ||||
Coordination factors | χ2 | P value | Coordination factors | χ2 | P value | |
Primary indicators | 0.250 | 13.230 | < 0.001 | 0.246 | 12.533 | < 0.001 |
Secondary indicators | 0.302 | 77.263 | < 0.001 | 0.341 | 96.354 | < 0.001 |
Tertiary indicators | 0.284 | 332.587 | < 0.001 | 0.286 | 335.624 | < 0.001 |
The first round of expert consultation added 3 training objectives, 3 sary indicators, 8 tertiary indicators, deleted 2 tertiary indicators and merged 5 tertiary indicators into 2 tertiary indicators, and the second round of expert correspondence modified 5 tertiary indicators. According to the opinions and suggestions of experts, finally formed a 4 primary indicators and 15 sary indicators of training objectives and 4 primary indicators, 15 sary indicators and 74 tertiary indicators of training programs, which are shown in Tables 2 and 3.
Items | Importance score (mean ± SD, score) | Variance coefficient | Full score ratio (%) |
Knowledge objectives | 4.538 ± 0.247 | 0.0544 | 90.76 |
Acquire specialist knowledge related to clinical research | 4.535 ± 0.264 | 0.0582 | 90.70 |
Acquire pharmacological knowledge related to drug testing | 4.535 ± 0.317 | 0.0699 | 90.70 |
Familiar with the fundamentals of medicine and nursing in clinical research specialties | 4.548 ± 0.244 | 0.0536 | 90.96 |
Familiar with laws and regulations related to clinical research | 4.875 ± 0.101 | 0.0207 | 97.50 |
Skill objectives | 4.868 ± 0.059 | 0.0121 | 97.36 |
Acquire basic nursing skills | 4.855 ± 0.082 | 0.0169 | 97.10 |
Acquire practical skills during the project implementation | 4.881 ± 0.032 | 0.0066 | 97.62 |
Acquire emergency handling skills for emergencies | 4.878 ± 0.043 | 0.0088 | 97.56 |
Competency objectives | 4.378 ± 0.049 | 0.0112 | 87.56 |
Ability to manage projects | 4.564 ± 0.505 | 0.1110 | 91.28 |
Ability to communicate and coordinate | 4.574 ± 0.204 | 0.0446 | 91.48 |
Ability to think critically | 4.591 ± 0.224 | 0.0488 | 91.82 |
Ability to research and innovate | 4.581 ± 0.210 | 0.0458 | 91.62 |
Ability to provide health education | 4.525 ± 0.206 | 0.0455 | 90.50 |
Professionalism objectives | 4.640 ± 0.579 | 0.1247 | 92.80 |
Comply with GCP regulations and safeguard the rights of subjects | 4.578 ± 0.549 | 0.1199 | 92.56 |
Discretion spirit | 4.564 ± 0.405 | 0.0887 | 93.28 |
Teamwork spirit | 5.574 ± 0.604 | 0.1083 | 92.48 |
Items | Importance score (mean ± SD, score) | Variance coefficient | Full score ratio (%) |
Ⅰ-1 Training requirements | 4.649 ± 0.292 | 0.0628 | 92.98 |
Ⅱ-1 Requirements for training teachers | 4.584 ± 0.359 | 0.0783 | 91.68 |
Ⅲ-1 Theoretical teaching experts: with a bachelor's degree or above, associate senior title or above, presiding over and participating in 20 clinical trials or above | 4.686 ± 0.195 | 0.0416 | 93.72 |
Ⅲ-2 Practice leading teachers: with bachelor degree or above, intermediate title or above, presiding over and participating in 20 clinical trials or above, participating in 10 clinical trials or above | 4.445 ± 0.340 | 0.0765 | 88.90 |
Ⅲ-3 Scientific research ability guidance experts: with a master's degree or above, associate senior title or above, strong scientific research ability, published ≥ 10 relevant articles in core journals as first author or correspondence author, or ≥ 2 SCI articles | 4.487 ± 0.305 | 0.0680 | 89.74 |
Ⅱ-2 CARGO REGISTRATION NOTE access conditions | 4.457 ± 0.374 | 0.0839 | 89.14 |
Ⅲ-4 Bachelor's degree or above in nursing | 4.615 ± 0.277 | 0.0600 | 92.30 |
Ⅲ-5 5 yr or more of clinical nursing experience | 4.701 ± 0.237 | 0.0504 | 94.02 |
Ⅰ-2 Training contents | 4.607 ± 0.192 | 0.0417 | 92.14 |
Ⅱ-3 Research nurses development status and prospects | 4.638 ± 0.273 | 0.0589 | 92.76 |
Ⅲ-6 Research nurse development and credentialing | 4.590 ± 0.238 | 0.0519 | 91.80 |
Ⅲ-7 Research nurse development prospects | 4.607 ± 0.136 | 0.0295 | 92.14 |
Ⅲ-8 Current status and prospects of research nurses at home and abroad | 4.732 ± 0.211 | 0.0445 | 94.64 |
Ⅲ-9 Research on nursing industry trends and career planning | 4.682 ± 0.070 | 0.0150 | 93.64 |
Ⅱ-4 Theoretical knowledge | 4.665 ± 0.544 | 0.1166 | 93.30 |
Ⅲ-10 ICH GCP thirteen basic principles | 4.719 ± 0.475 | 0.1007 | 94.38 |
Ⅲ-11 Interpretation of the new version of drug clinical trial quality management specification in 2020 | 4.677 ± 0.232 | 0.0496 | 93.54 |
Ⅲ-12 Basic pharmacological knowledge related to clinical trials | 4.534 ± 0.165 | 0.0364 | 90.68 |
Ⅲ-13 Fundamentals of medicine and nursing for clinical research specialties | 4.765 ± 0.116 | 0.0243 | 95.30 |
Ⅲ-14 Basic process of clinical trials | 4.565 ± 0.371 | 0.0813 | 91.30 |
Ⅲ-15 Clinical study design and methods in Biostatistics | 4.625 ± 0.169 | 0.0365 | 91.50 |
Ⅲ-16 Role responsibilities of the researcher and research team | 4.363 ± 0.449 | 0.1029 | 87.26 |
Ⅲ-17 Role responsibilities of the sponsor/CRO | 4.284 ± 0.428 | 0.0999 | 85.68 |
Ⅲ-18 Key points of ethical review in clinical trials | 4.646 ± 0.629 | 0.1353 | 78.92 |
Ⅲ-19 Interpretation of ethics and laws and regulations related to clinical research | 4.713 ± 0.158 | 0.0335 | 94.26 |
Ⅲ-20 Introduction to the main contents of the trial protocol and investigator's manual | 4.767 ± 0.748 | 0.1569 | 95.34 |
Ⅲ-21 Partner information protection | 4.755 ± 0.496 | 0.1043 | 95.10 |
Ⅲ-22 Subject rights protection | 4.625 ± 0.428 | 0.0925 | 96.50 |
Ⅲ-23 Clinical trial necessary documents interpretation | 4.757 ± 0.324 | 0.0681 | 95.14 |
Ⅲ-24 Key points of informed consent for subjects | 4.775 ± 0.340 | 0.0712 | 95.50 |
Ⅲ-25 Difference and treatment of AE, SAE, SUSAR | 4.445 ± 0.526 | 0.1183 | 88.90 |
Ⅲ-26 Common quality issues in clinical trials | 4.672 ± 0.207 | 0.0443 | 93.44 |
Ⅲ-27 Compliance in clinical research | 4.566 ± 0.165 | 0.0361 | 91.32 |
Ⅲ-28 Audit verification case sharing | 4.751 ± 0.341 | 0.0717 | 95.02 |
Ⅱ-5 Practical skills | 4.753 ± 0.216 | 0.0454 | 95.06 |
Ⅲ-28 Pre-launch preparation | 4.513 ± 0.345 | 0.0764 | 90.26 |
Ⅲ-29 Application and follow-up of various project reviews | 4.692 ± 0.199 | 0.0424 | 93.84 |
Ⅲ-30 Project launch | 4.701 ± 0.231 | 0.0491 | 94.02 |
Ⅲ-31 Subject recruitment | 4.636 ± 0.168 | 0.0362 | 92.72 |
Ⅲ-32 Subjects screening and enrollment | 4.642 ± 0.223 | 0.0362 | 92.84 |
Ⅲ-33 Informed consent of the subject | 4.638 ± 0.225 | 0.0485 | 92.76 |
Ⅲ-34 Subject entry visit | 4.607 ± 0.210 | 0.0455 | 92.14 |
Ⅲ-35 Subject visit management | 4.528 ± 0.177 | 0.0391 | 90.56 |
Ⅲ-36 CRF entry | 4.570 ± 0.182 | 0.0398 | 91.40 |
Ⅲ-37 Project closure management | 4.601 ± 0.169 | 0.0367 | 92.02 |
Ⅲ-38 Nursing skills related to clinical research | 4.788 ± 0.191 | 0.0399 | 95.76 |
Ⅲ-39 Emergency treatment of emergencies | 4.757 ± 0.178 | 0.0374 | 95.14 |
Ⅱ-6 Competency development | 4.765 ± 0.157 | 0.0329 | 95.30 |
Ⅲ-40 Planning and implementation | 4.676 ± 0.118 | 0.0252 | 93.52 |
Ⅲ-41 Equipment management | 4.661 ± 0.147 | 0.0315 | 93.22 |
Ⅲ-42 Subjects management | 4.507 ± 0.158 | 0.0351 | 90.14 |
Ⅲ-43 Trial drug administration | 4.528 ± 0.103 | 0.0227 | 90.56 |
Ⅲ-44 Test equipment and reagent management | 4.586 ± 0.202 | 0.0440 | 91.72 |
Ⅲ-45 Security management | 4.563 ± 0.684 | 0.1499 | 91.26 |
Ⅲ-46 Sample collection and management | 4.695 ± 0.572 | 0.1218 | 91.90 |
Ⅲ-47 Clinical study data management | 4.614 ± 0.412 | 0.0892 | 91.28 |
Ⅲ-48 Contract and funding management | 4.131 ± 0.441 | 0.1068 | 82.62 |
Ⅲ-49 File management | 4.351 ± 0.251 | 0.0577 | 87.02 |
Ⅲ-50 Material management | 4.621 ± 0.194 | 0.0420 | 92.42 |
Ⅱ-7 Professionalism | 4.131 ± 0.471 | 0.1140 | 82.62 |
Ⅲ-51 Clinical research nurse communication methods and techniques | 4.341 ± 0.256 | 0.0590 | 86.82 |
Ⅲ-52 Teamwork for clinical research nurses | 4.591 ± 0.155 | 0.0338 | 91.82 |
Ⅱ-8 Research capacity expansion | 4.695 ± 0.482 | 0.1026 | 92.90 |
Ⅲ-53 Method of selecting topics for scientific research | 4.622 ± 0.341 | 0.0727 | 88.44 |
Ⅲ-54 Knowledge of literature search | 4.112 ± 0.251 | 0.0610 | 82.24 |
Ⅲ-55 Statistical analysis methods | 4.242 ± 0.142 | 0.0335 | 84.84 |
Ⅲ-56 Research paper writing | 4.343 ± 0.351 | 0.0808 | 86.86 |
Ⅰ-3 Training methods | 4.156 ± 0.336 | 0.0808 | 83.12 |
Ⅱ-9 Training location | 4.691 ± 0.891 | 0.2290 | 77.82 |
Ⅲ-57 Clinical research center conference room | 4.012 ± 0.721 | 0.1797 | 80.24 |
Ⅲ-58 Phase I clinical trial ward | 4.336 ± 0.432 | 0.0996 | 86.72 |
Ⅲ-59 Clinical skills training center | 4.521 ± 0.234 | 0.0518 | 90.42 |
Ⅲ-60 Specialty group clinical trials office | 4.142 ± 0.312 | 0.0753 | 82.84 |
Ⅱ-10 Training format | 4.356 ± 0.366 | 0.0840 | 87.12 |
Ⅲ-61 Theoretical lectures (combination of online and offline) | 4.369 ± 0.459 | 0.1051 | 87.38 |
Ⅲ-62 Clinical practice leaders | 4.121 ± 0.462 | 0.1121 | 82.42 |
Ⅲ-63 Scenario-based teaching | 4.353 ± 0.228 | 0.0524 | 87.06 |
Ⅲ-64 Case study | 4.367 ± 0.234 | 0.0536 | 87.34 |
Ⅲ-65 Group study and discussion | 4.199 ± 0.785 | 0.1869 | 77.98 |
Ⅱ-11 Duration of training | 4.690 ± 0.679 | 0.1447 | 79.80 |
Ⅲ-66 Not less than 40 h of theoretical training | 4.593 ± 0.221 | 0.0481 | 91.86 |
Ⅲ-67 Not less than 160 h of Practical skills training | 4.644 ± 0.168 | 0.0362 | 92.88 |
Ⅱ-12 Training cycle | 4.352 ± 0.225 | 0.0517 | 87.04 |
Ⅲ-68 Organize a training once a year | 4.675 ± 0.122 | 0.0261 | 93.50 |
Ⅰ-4 Appraisal and evaluation | 4.675 ± 0.245 | 0.0524 | 93.50 |
Ⅱ-13 Theoretical examination (30%) | 4.567 ± 0.332 | 0.0727 | 91.34 |
Ⅲ-69 Closed-book written examination, ≥ 80 points to pass (percentage system) | 4.669 ± 0.156 | 0.0334 | 93.38 |
Ⅱ-14 Practical examination (50%) | 4.564 ± 0.268 | 0.0587 | 91.28 |
Ⅲ-70 First aid nursing skills assessment, ≥ 80 points to pass (percentage system) | 4.559 ± 0.156 | 0.0342 | 91.18 |
Ⅲ-71 Participate in project reporting in clinical trial projects and assessment of contingency plans | 4.342 ± 0.355 | 0.0818 | 86.84 |
Ⅲ-72 Participate in multicenter clinical research projects with a 90% compliance rate and less than 10% shedding rate | 4.352 ± 0.395 | 0.0908 | 87.04 |
Ⅱ-15 Research capability examination (20%) | 4.253 ± 0.423 | 0.0995 | 85.06 |
Ⅲ-73 Literature reporting in small groups, ≥ 40 points to pass (out of 50 points) | 4.012 ± 0.701 | 0.1747 | 80.24 |
Ⅲ-74 Each person formed a clinical trial-related scientific research paper, ≥ 40 points to pass (out of 50 points) | 4.553 ± 0.254 | 0.0558 | 91.06 |
There is a great demand for CRN across many nations due to the sharp rise in clinical trials, institutions implementing clinical trials on file, and the development of clinical trial wards in research hospitals[13]. The core competency of CRN, as key participants in clinical trials, is not only related to the quality of clinical trial projects, but also have a profound impact on the promotion and development of clinical trials. The oncology nursing society (ONS) emphasizes the training of research nurses and builds a 9-part core competency system[14]. The United Kingdom now has over 20000 CRN, with a more established system for the inclusion, training and job functions of research nurses[15]. However, research nurses in many national medical institutions are undertaken part-time by nurses in clinical positions, who lack specialized training and education[16]. There is also a large gap between countries and no unified training system. Position competenceserves as a crucial foundation for competence in all clinical trial processes and CRN training, as well as a crucial indicator of CRN's real capacity to take part in clinical trials[17]. Therefore, it is necessary to construct a training program for research nurses based on position competence.
The 2 rounds of expert consultation in strict accordance with the Delphi method played an important role in the study results[18]. In this study, the experts involved in the consultation were involved in several professional fields and experienced in clinical trial project management, including 7 with senior titles and 9 with associate titles, indicating that the experts had good representation and authority. The study reliability was reflected according to the positivity and expert authority. The return rate of the consultation questionnaires was all higher than the statistical requirement of 70%, indicating that the experts were highly motivated. Correspondence expert judgment coefficient, expert familiarity coefficient and authority coefficient are all greater than 0.80, indicating a high level of an expert authority. At the end of the second consultation round, the coefficient of variation of each indicator is less than 0.25, which indicates that the experts' opinions are more convergent and the importance and operability of the entries at all levels are recognized.
Based on extensive literature review and questionnaire survey, this program follows the principles of scientific, systematic and feasible, including all processes required for the successful implementation of the training program in clinical trials. The training program includes training objectives, training contents, training methods, and assessment and evaluation. Four primary indicators, 16 sary indicators, and 62 tertiary indicators, which comprehensively enumerates the elements of research nurse training and has good practicality. The content covers core courses such as project plan implementation and follow-up, ethical application, management of each process, document management, subject management, safety management, and drug management, etc. Flexible and diverse learning and teaching formats are used for different courses. As a key link in the education and training process, assessment and evaluation is an important means of testing the quality of education and training. This program determines the specific assessment methods, forms, evaluation criteria, and proposes specific passing standards, which have a certain reference value. After the training, follow up the implementation every year to supervise the continuous improvement of competency and complete clinical trial projects with high quality. However, this study also has certain limitations. The training system constructed in this study has basically covered the knowledge and skills of CRN, but there is still a lack of detailed training knowledge systems for different departments. Therefore, the training methods need to be further optimized and refined. In addition, this study aims to scientifically develop training methods for CRN, but there is a lack of empirical research, so corresponding validation experiments are needed in the future.
Based on the theoretical basis of position competence, this study constructed a training program for research nurses through literature study, qualitative interview, and Delphi method, which can provide a reference basis for research nurse training. The nurses training program should be scientifically customized to improve the clinical trials. This study found a 4 dimensional and 15 sary scientific and practical indicator for nurse training, which is essential to improve nurses’ clinical trial.
Based on the background of the rapid development of existing clinical trials, a scientific nurse training scheme is constructed to train professional clinical research nurses (CRN).
Based on the existing talent gap of CRN, the training scheme of nurses should be scientifically customized to promote the development of clinical trials.
To construct a scientific and systematic training scheme for CRN to serve the current construction of nurses.
Construct a scientific and effective training plan for CRN by combining literature research and expert targeted interviews.
Determine four dimensions (training requirements, training content, training methods; assessment and evaluation) as first level indicators, 15 s level indicators, and 74 third level indicators.
Based on the job competency model, a four dimensional and 15 sary indicator nurse training plan has been constructed, which is scientific and practical.
Formulate, construct and evaluate all processes of clinical nurse training program to serve the efficient development of clinical trial projects.
We would like to express our gratitude to all medical research institutes and patients who participated in this study, as well as to all reviewers for their review of this article.
Provenance and peer review: Unsolicited article; Externally peer reviewed.
Peer-review model: Single blind
Specialty type: Medicine, research and experimental
Country/Territory of origin: China
Peer-review report’s scientific quality classification
Grade A (Excellent): 0
Grade B (Very good): B
Grade C (Good): C
Grade D (Fair): 0
Grade E (Poor): 0
P-Reviewer: Lazaridis II, Switzerland; Mikami R, Japan S-Editor: Lin C L-Editor: A P-Editor: Xu ZH
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