{"id":"W1974360732","doi":"10.1097/chi.0b013e31802f5f54","title":"Data Safety Monitoring Boards and Other Study Methodologies That Address Subject Safety in “High-Risk” Therapeutic Trials in Youths","year":2007,"lang":"en","type":"letter","venue":"Journal of the American Academy of Child & Adolescent Psychiatry","topic":"Pharmaceutical studies and practices","field":"Medicine","cited_by":10,"is_retracted":false,"has_abstract":false,"ca_institutions":"Dalhousie University; University of Ottawa","funders":"","keywords":"Harm; Tolerability; Adverse effect; Medicine; Randomized controlled trial; Psychological intervention; Intensive care medicine; Audit; Intervention (counseling); Clinical trial; Psychology; Psychiatry; Pharmacology; Business; Surgery; Social psychology","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":["metaepi_narrow","research_integrity"],"consensus_categories":[],"category_scores_codex":[0.01803382,0.0006101651,0.003617221,0.0005621057,0.0001503691,0.00003773179,0.001538425,0.0004065014,0.00001807685],"category_scores_gemma":[0.001656484,0.0003623897,0.0005188833,0.0006729047,0.0005123999,0.0002263113,0.0006446022,0.01042634,6.939908e-7],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0001950349,"about_ca_system_score_gemma":0.000166662,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0002931301,"about_ca_topic_score_gemma":0.00003807709,"domain_scores_codex":[0.9885914,0.006011368,0.00280824,0.0006044583,0.001335726,0.000648844],"domain_scores_gemma":[0.9890403,0.003413159,0.006695032,0.0006624084,0.0000513792,0.0001377749],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"observational","study_design_gemma":"observational","study_design_scores_codex":[0.0103487,0.0006487981,0.9425717,0.0004190054,0.002047197,0.00003323726,0.0003454791,0.00002011677,0.00001372258,0.000002668628,0.0213685,0.02218088],"study_design_scores_gemma":[0.004837161,0.0004435695,0.8462481,0.003305221,0.002529605,0.0001408649,0.00261672,0.0000034249,0.00004706346,0.0000881339,0.1394263,0.0003138243],"study_design_candidate":"observational","study_design_consensus":"observational","genre_codex":"commentary","genre_gemma":"empirical","genre_scores_codex":[0.1705502,0.04563759,0.000126317,0.7785322,0.002515553,0.001985318,0.000440749,0.00002066564,0.0001914295],"genre_scores_gemma":[0.4918669,0.06343424,0.002580209,0.4316242,0.01030745,0.000006238265,0.000006705716,0.0001473788,0.00002666776],"genre_candidate":"commentary","genre_consensus":null,"teacher_disagreement_score":0.346908,"threshold_uncertainty_score":0.9998828,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.227153011850853,"score_gpt":0.4662287900123152,"score_spread":0.2390757781614621,"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."}}