{"id":"W4283072992","doi":"10.1016/j.jcrc.2022.154094","title":"Monitoring and auditing protocol adherence, data integrity and ethical conduct of a randomized clinical trial: A case study","year":2022,"lang":"en","type":"article","venue":"Journal of Critical Care","topic":"Ethics in Clinical Research","field":"Medicine","cited_by":4,"is_retracted":false,"has_abstract":true,"ca_institutions":"University of Calgary; Alberta Health Services; Agricultural Research Institute of Ontario; Sunnybrook Health Science Centre; Ontario Tobacco Research Unit; Université Laval; Public Health Ontario; CARE Canada; Humber River Regional Hospital; Hamilton Health Sciences; University of Toronto; Université de Sherbrooke; McMaster University; Impact","funders":"Canadian Institutes of Health Research","keywords":"Audit; Medicine; Documentation; Randomized controlled trial; Protocol (science); Data quality; Clinical trial; Missing data; Institutional review board; Medical emergency; Data integrity; Quality assurance; Emergency medicine; Family medicine; Computer security; Internal medicine; Alternative medicine; Pathology; Surgery; Accounting","routes":{"ca_aff":true,"ca_fund":true,"ca_venue":false,"about_ca":true,"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":["metaresearch"],"category_scores_codex":[0.3002118,0.0007355991,0.0009987958,0.004121635,0.00653589,0.005291361,0.00280802,0.005480239,0.001274052],"category_scores_gemma":[0.4841395,0.001002149,0.001423421,0.004078304,0.008232421,0.005399561,0.004031756,0.003726149,0.0002705823],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.01066017,"about_ca_system_score_gemma":0.02180726,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.003825614,"about_ca_topic_score_gemma":0.006357739,"domain_scores_codex":[0.4482855,0.4863113,0.02923766,0.006227992,0.02550793,0.004429599],"domain_scores_gemma":[0.2799845,0.5402616,0.1068699,0.04413648,0.02331876,0.005428737],"domain_codex":"methods","domain_gemma":"methods","domain_candidate":"methods","domain_consensus":"methods","study_design_codex":"observational","study_design_gemma":"qualitative","study_design_scores_codex":[0.006043634,0.004515648,0.3958591,0.008846299,0.0007970263,0.03346856,0.1735126,0.002343044,0.002468969,0.01756562,0.01081435,0.3437652],"study_design_scores_gemma":[0.003778753,0.02799668,0.267006,0.05356064,0.002423623,0.1647856,0.2515155,0.03194867,0.02430598,0.02862643,0.1427366,0.001315568],"study_design_candidate":"qualitative","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.8956285,0.01268455,0.04923478,0.02018359,0.0005380586,0.01292208,0.0002153547,0.0001463579,0.008446692],"genre_scores_gemma":[0.9284104,0.003083551,0.06085812,0.002242575,0.0002412959,0.004591506,0.00007705722,0.00003694743,0.0004586756],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.9945198,"threshold_uncertainty_score":0.8629634,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.8296728190256776,"score_gpt":0.7291766901287735,"score_spread":0.1004961288969041,"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."}}