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.