{"id":"W4312468772","doi":"10.1007/978-3-031-10691-0_7","title":"Regulatory Documents for IND to Support FIH","year":2022,"lang":"en","type":"book-chapter","venue":"","topic":"Science, Research, and Medicine","field":"Medicine","cited_by":0,"is_retracted":false,"has_abstract":false,"ca_institutions":"University of British Columbia","funders":"","keywords":"Business","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":["insufficient_payload"],"consensus_categories":[],"category_scores_codex":[0.0007353231,0.0002381413,0.0004933613,0.0004671469,0.0001165198,0.0000130517,0.0002560193,0.0001600129,0.05288086],"category_scores_gemma":[0.0001304915,0.0001841596,0.0001772838,0.00006639046,0.0001302048,0.00005451784,0.0001962789,0.0003662464,0.000337341],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0002527736,"about_ca_system_score_gemma":0.0007265895,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00003779878,"about_ca_topic_score_gemma":0.00002147872,"domain_scores_codex":[0.9973718,0.000005845734,0.0003295529,0.0005496061,0.001305097,0.0004380863],"domain_scores_gemma":[0.998419,0.00008002684,0.00006924193,0.0006133937,0.0001678694,0.0006504602],"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":[0.0003830747,0.00003766682,0.0001965704,0.0002531039,0.0001350949,0.0002034091,0.0002974507,3.970557e-7,0.0002503193,0.0667635,0.8681134,0.06336603],"study_design_scores_gemma":[0.001306059,0.001992197,0.0003087647,0.0001065862,0.00009348856,0.0000566724,0.00007693857,0.000002541138,0.0001548768,0.001729528,0.9939871,0.0001852649],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"other","genre_gemma":"other","genre_scores_codex":[0.0004443125,0.000180246,0.00007177207,0.002937669,0.0006801404,0.001905669,0.00004811429,0.00006289343,0.9936692],"genre_scores_gemma":[0.001803467,0.0001434479,0.0005370149,0.005715339,0.0007160295,0.0000930172,0.000227025,0.00005682939,0.9907078],"genre_candidate":"other","genre_consensus":"other","teacher_disagreement_score":0.1258737,"threshold_uncertainty_score":0.9479849,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.06076803872569115,"score_gpt":0.3714282604093775,"score_spread":0.3106602216836864,"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."}}