{"id":"W7117541041","doi":"10.1186/s12910-025-01354-7","title":"Stakeholder perception of quality management of investigator-initiated clinical trials","year":2025,"lang":"en","type":"article","venue":"BMC Medical Ethics","topic":"Ethics in Clinical Research","field":"Medicine","cited_by":0,"is_retracted":false,"has_abstract":true,"ca_institutions":"Ministry of Education and Child Care","funders":"","keywords":"Clinical trial; Quality (philosophy); Perception; Stakeholder; Philosophy of medicine; Health informatics; Health care; Quality management","routes":{"ca_aff":true,"ca_fund":false,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"codex-gemma-dda1882f352a","candidate_categories":["metaresearch","sts","research_integrity","insufficient_payload"],"consensus_categories":["metaresearch","research_integrity"],"category_scores_codex":[0.2473923,0.0001726584,0.001533582,0.0001732441,0.00006241675,0.000008745266,0.000494285,0.003230441,0.001246618],"category_scores_gemma":[0.8552897,0.0001343514,0.000524636,0.000607733,0.003106258,0.00003515143,0.0004089591,0.007606087,0.00002629952],"about_ca_system_candidate":true,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00007147886,"about_ca_system_score_gemma":0.02178896,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.000183434,"about_ca_topic_score_gemma":0.000827123,"domain_scores_codex":[0.9723966,0.01379641,0.005817118,0.0006770063,0.006912229,0.0004006568],"domain_scores_gemma":[0.08671395,0.9016628,0.001794236,0.002683941,0.004916538,0.002228503],"domain_codex":null,"domain_gemma":"methods","domain_candidate":null,"domain_consensus":null,"study_design_codex":"theoretical_or_conceptual","study_design_gemma":"observational","study_design_scores_codex":[0.002192568,0.002241887,0.1695231,0.05712592,0.00100158,0.00005527926,0.000591184,0.000003162446,0.0005529081,0.7488382,0.004122849,0.01375132],"study_design_scores_gemma":[0.016815,0.001314281,0.649299,0.0387991,0.001175175,0.000005191871,0.005300556,0.000520053,0.001433673,0.2832614,0.001675231,0.0004014174],"study_design_candidate":"theoretical_or_conceptual","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.8212972,0.0008062402,0.04445168,0.0879631,0.002021781,0.002508221,0.00006999101,0.0001781985,0.04070362],"genre_scores_gemma":[0.9431211,0.0203156,0.01952713,0.01395647,0.0002604382,0.00004096658,0.00005619437,0.00002850264,0.002693536],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.8878664,"threshold_uncertainty_score":0.9996664,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.9455680964628158,"score_gpt":0.7362612458020918,"score_spread":0.209306850660724,"validation_status":"score_only:v0-immature-baseline","note":"Baseline scores from an immature model (maturity gate not passed). Scores rank; they never assert a category."}}