Construction of clinical research nurse training program based on position competence

Table 3 Research nurse training program consulting results based on position competence

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

AE: Adverse event; CRF: Case report form; CRO: Contract research organization; GCP: Good clinical practice; ICH: International conference on harmonization; SAE: Serious adverse event; SUSAR: Suspected unexpected serious adverse reaction.