{"id":"W2128407187","doi":"10.1158/1078-0432.ccr-13-3206","title":"U.S. Food and Drug Administration Inspections of Clinical Investigators: Overview of Results from 1977 to 2009","year":2014,"lang":"en","type":"review","venue":"Clinical Cancer Research","topic":"Ethics in Clinical Research","field":"Medicine","cited_by":17,"is_retracted":false,"has_abstract":true,"ca_institutions":"University of Ottawa","funders":"","keywords":"Food and drug administration; Medicine; Drug; Administration (probate law); Drug administration; Clinical pharmacology; Pharmacology; Political science; Law","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":"metacan-v3-hybrid-931329e0061c","candidate_categories":["metaresearch","research_integrity"],"consensus_categories":[],"category_scores_codex":[0.02956379,0.0008630065,0.0007827672,0.02123379,0.001128658,0.002988061,0.001701549,0.001142676,0.004199742],"category_scores_gemma":[0.06060648,0.001012647,0.001433034,0.02371064,0.0008490243,0.001922111,0.001756425,0.001883715,0.002441953],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.008161921,"about_ca_system_score_gemma":0.01420767,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.08732139,"about_ca_topic_score_gemma":0.1141882,"domain_scores_codex":[0.9689994,0.005988817,0.006291794,0.002729432,0.01412109,0.001869434],"domain_scores_gemma":[0.8280436,0.03326495,0.04754324,0.003962945,0.08302501,0.004160275],"domain_codex":null,"domain_gemma":"evaluation","domain_candidate":"evaluation","domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"observational","study_design_scores_codex":[0.0005339002,0.0002835967,0.2917345,0.004879051,0.0003950515,0.0003579054,0.0009665189,0.0008632973,0.0007952779,0.001303265,0.2404741,0.4574136],"study_design_scores_gemma":[0.00006143685,0.0004064954,0.7511526,0.006203326,0.0003999677,0.001132391,0.001227495,0.0006789796,0.001527555,0.0002084279,0.236917,0.00008434906],"study_design_candidate":"observational","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.1743712,0.5693503,0.01045311,0.02528714,0.002269908,0.002094552,0.09696779,0.002571956,0.1166342],"genre_scores_gemma":[0.4620833,0.3748532,0.02306828,0.02151015,0.001673545,0.001307714,0.09019121,0.0008245946,0.02448808],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.9988573,"threshold_uncertainty_score":0.1736262,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.8812733416136131,"score_gpt":0.7414920111272241,"score_spread":0.1397813304863891,"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."}}