{"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":"metacan-v3-hybrid-931329e0061c","candidate_categories":["metaresearch"],"consensus_categories":["metaresearch"],"category_scores_codex":[0.316631,0.00297106,0.002672132,0.006910282,0.005338362,0.02239476,0.01307994,0.02335498,0.01352395],"category_scores_gemma":[0.3245043,0.002889731,0.00499234,0.007580595,0.007347631,0.02076824,0.01726572,0.02824682,0.0132768],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.007512586,"about_ca_system_score_gemma":0.1329346,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.01023872,"about_ca_topic_score_gemma":0.01586468,"domain_scores_codex":[0.7283342,0.1813316,0.03143921,0.004759626,0.04552053,0.008614772],"domain_scores_gemma":[0.498169,0.2166105,0.0455103,0.0296729,0.1454418,0.06459557],"domain_codex":null,"domain_gemma":"reporting","domain_candidate":"reporting","domain_consensus":null,"study_design_codex":"not_applicable","study_design_gemma":"theoretical_or_conceptual","study_design_scores_codex":[0.000466808,0.002815135,0.009025078,0.00608043,0.0001563811,0.0008916574,0.003910752,0.001827184,0.001237425,0.02073846,0.6442212,0.3086295],"study_design_scores_gemma":[0.001986328,0.001803088,0.01546862,0.0265227,0.0004393652,0.001246928,0.008403336,0.004882934,0.002033158,0.02359,0.9131693,0.0004542415],"study_design_candidate":"theoretical_or_conceptual","study_design_consensus":null,"genre_codex":"commentary","genre_gemma":"methods","genre_scores_codex":[0.004230417,0.007514216,0.06670871,0.8526637,0.0041582,0.01882915,0.00165668,0.005365334,0.03887356],"genre_scores_gemma":[0.02248305,0.02039457,0.7428662,0.1569425,0.00257896,0.03419982,0.004214796,0.001312435,0.01500779],"genre_candidate":"methods","genre_consensus":null,"teacher_disagreement_score":0.683369,"threshold_uncertainty_score":0.8427156,"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."}}