{"id":"W2564790786","doi":"10.2196/cancer.6701","title":"Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project","year":2016,"lang":"en","type":"article","venue":"JMIR Cancer","topic":"Pharmacovigilance and Adverse Drug Reactions","field":"Pharmacology, Toxicology and Pharmaceutics","cited_by":11,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"U.S. Food and Drug Administration","keywords":"Investigational Drugs; Clinical trial; Medicine; Drug; Investigational device exemption; Pharmacology; Internal medicine","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":"codex-gemma-dda1882f352a","candidate_categories":["insufficient_payload"],"consensus_categories":[],"category_scores_codex":[0.01267467,0.000316091,0.0008524543,0.00007597842,0.0005831437,0.00002859899,0.0003126012,0.0003420153,0.0026014],"category_scores_gemma":[0.004675583,0.0001979945,0.0007243006,0.0002747684,0.0002638347,0.0006102229,0.00003984553,0.0009564409,0.00004578531],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0003745029,"about_ca_system_score_gemma":0.003004805,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.000058348,"about_ca_topic_score_gemma":0.0002457318,"domain_scores_codex":[0.9908174,0.00282053,0.004893096,0.0006061941,0.0002833117,0.0005794386],"domain_scores_gemma":[0.982956,0.01265733,0.003547834,0.0002949182,0.0002557161,0.000288197],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"not_applicable","study_design_gemma":"not_applicable","study_design_scores_codex":[0.05972967,0.0008717969,0.006907067,0.0000188913,0.001733771,0.000003186752,0.002016878,0.0001032106,0.001743971,0.003035129,0.4910883,0.4327481],"study_design_scores_gemma":[0.05182926,0.0001850026,0.002105412,0.00007984998,0.0004848574,0.000001840673,0.0003755561,0.0002700016,0.001736672,0.00210646,0.9405339,0.0002912314],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.4661405,0.002115239,0.04530225,0.3870664,0.0391055,0.03735335,0.0172207,0.0008131081,0.004882917],"genre_scores_gemma":[0.857559,0.03845558,0.001436995,0.04004839,0.03650217,0.01371743,0.005150761,0.0001621398,0.006967522],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.4494455,"threshold_uncertainty_score":0.9983104,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.6039039582388719,"score_gpt":0.6421311764728272,"score_spread":0.03822721823395536,"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."}}