{"id":"W2995092269","doi":"10.2196/14379","title":"Expedited Safety Reporting to Sponsors Through the Implementation of an Alert System for Clinical Trial Management at an Academic Medical Center: Retrospective Design Study","year":2019,"lang":"en","type":"article","venue":"JMIR Medical Informatics","topic":"Pharmacovigilance and Adverse Drug Reactions","field":"Pharmacology, Toxicology and Pharmaceutics","cited_by":1,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"Korea Health Industry Development Institute","keywords":"Medicine; Timeline; Clinical trial; Adverse effect; Patient safety; Emergency department; Medical emergency; Emergency medicine; Health care; Internal medicine; Nursing","routes":{"ca_aff":false,"ca_fund":false,"ca_venue":true,"about_ca":false,"invisible_to_affiliation_only":true},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":["metaresearch"],"consensus_categories":[],"category_scores_codex":[0.06274427,0.000868842,0.001293799,0.005040378,0.001218924,0.002204862,0.001350646,0.001181488,0.002959568],"category_scores_gemma":[0.1276207,0.001224757,0.002505907,0.005380085,0.001391104,0.00208957,0.002107246,0.001505865,0.0008251321],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.002484418,"about_ca_system_score_gemma":0.00694867,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.002259832,"about_ca_topic_score_gemma":0.002079436,"domain_scores_codex":[0.8980637,0.05338724,0.02630639,0.008033751,0.01157612,0.002632857],"domain_scores_gemma":[0.7232415,0.07427062,0.1403234,0.02859061,0.02816686,0.005406965],"domain_codex":null,"domain_gemma":"reporting","domain_candidate":"reporting","domain_consensus":null,"study_design_codex":"observational","study_design_gemma":"observational","study_design_scores_codex":[0.01045655,0.001412958,0.953346,0.00108093,0.001090808,0.0001148912,0.001512381,0.0004138832,0.0004414074,0.0003092253,0.001320296,0.02850061],"study_design_scores_gemma":[0.003227936,0.03169553,0.9443508,0.0009679196,0.002515467,0.00062787,0.00216503,0.002968257,0.002179983,0.000358106,0.008765274,0.0001778507],"study_design_candidate":"observational","study_design_consensus":"observational","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9739376,0.00289028,0.0102263,0.0002145383,0.00010338,0.008555815,0.002250959,0.0001035808,0.001717648],"genre_scores_gemma":[0.9804874,0.0006557239,0.008608168,0.0004090174,0.0001343152,0.008149269,0.001170188,0.00003649491,0.000349504],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.9372557,"threshold_uncertainty_score":0.3318274,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.2478813146722327,"score_gpt":0.5794674934008301,"score_spread":0.3315861787285974,"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."}}