{"id":"https://openalex.org/W4415605138","doi":"https://doi.org/10.1093/jamia/ocaf174","title":"Compliance and factuality of large language models for clinical research document generation","display_name":"Compliance and factuality of large language models for clinical research document generation","publication_year":2025,"publication_date":"2025-09-26","ids":{"openalex":"https://openalex.org/W4415605138","doi":"https://doi.org/10.1093/jamia/ocaf174","pmid":"https://pubmed.ncbi.nlm.nih.gov/41144289"},"language":"en","primary_location":{"id":"doi:10.1093/jamia/ocaf174","is_oa":false,"landing_page_url":"https://doi.org/10.1093/jamia/ocaf174","pdf_url":null,"source":{"id":"https://openalex.org/S129839026","display_name":"Journal of the American Medical Informatics Association","issn_l":"1067-5027","issn":["1067-5027","1527-974X"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310311648","host_organization_name":"Oxford University Press","host_organization_lineage":["https://openalex.org/P4310311648","https://openalex.org/P4310311647"],"host_organization_lineage_names":["Oxford University Press","University of Oxford"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of the American Medical Informatics Association","raw_type":"journal-article"},"type":"article","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5067779271","display_name":"Zifeng Wang","orcid":"https://orcid.org/0000-0002-3026-9970"},"institutions":[{"id":"https://openalex.org/I4210136461","display_name":"Keiju Medical Center","ror":"https://ror.org/03t7c1217","country_code":"JP","type":"healthcare","lineage":["https://openalex.org/I4210136461"]}],"countries":["JP"],"is_corresponding":false,"raw_author_name":"Zifeng Wang","raw_affiliation_strings":["Keiji AI , Seattle, WA, 98115,","Keiji AI, Seattle, WA, 98115, United States"],"raw_orcid":"https://orcid.org/0000-0002-3026-9970","affiliations":[{"raw_affiliation_string":"Keiji AI , Seattle, WA, 98115,","institution_ids":["https://openalex.org/I4210136461"]},{"raw_affiliation_string":"Keiji AI, Seattle, WA, 98115, United States","institution_ids":["https://openalex.org/I4210136461"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5101813812","display_name":"Junyi Gao","orcid":"https://orcid.org/0000-0002-4951-8682"},"institutions":[{"id":"https://openalex.org/I4210164624","display_name":"The Queen's Medical Research Institute","ror":"https://ror.org/059zxg644","country_code":"GB","type":"government","lineage":["https://openalex.org/I4210164624","https://openalex.org/I98677209"]},{"id":"https://openalex.org/I98677209","display_name":"University of Edinburgh","ror":"https://ror.org/01nrxwf90","country_code":"GB","type":"education","lineage":["https://openalex.org/I98677209"]}],"countries":["GB"],"is_corresponding":false,"raw_author_name":"Junyi Gao","raw_affiliation_strings":["Centre for Medical Informatics, Usher Institute, University of Edinburgh , Edinburgh, EH3 9DR,","Centre for Medical Informatics, Usher Institute, University of Edinburgh, Edinburgh, EH3 9DR, United Kingdom"],"raw_orcid":"https://orcid.org/0000-0002-4951-8682","affiliations":[{"raw_affiliation_string":"Centre for Medical Informatics, Usher Institute, University of Edinburgh , Edinburgh, EH3 9DR,","institution_ids":["https://openalex.org/I4210164624","https://openalex.org/I98677209"]},{"raw_affiliation_string":"Centre for Medical Informatics, Usher Institute, University of Edinburgh, Edinburgh, EH3 9DR, United Kingdom","institution_ids":["https://openalex.org/I4210164624","https://openalex.org/I98677209"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5092595808","display_name":"Benjamin Danek","orcid":"https://orcid.org/0009-0002-8804-0826"},"institutions":[{"id":"https://openalex.org/I4210136461","display_name":"Keiju Medical Center","ror":"https://ror.org/03t7c1217","country_code":"JP","type":"healthcare","lineage":["https://openalex.org/I4210136461"]}],"countries":["JP"],"is_corresponding":false,"raw_author_name":"Benjamin Danek","raw_affiliation_strings":["Keiji AI , Seattle, WA, 98115,","Keiji AI, Seattle, WA, 98115, United States"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Keiji AI , Seattle, WA, 98115,","institution_ids":["https://openalex.org/I4210136461"]},{"raw_affiliation_string":"Keiji AI, Seattle, WA, 98115, United States","institution_ids":["https://openalex.org/I4210136461"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5018694879","display_name":"Brandon Theodorou","orcid":"https://orcid.org/0000-0002-8926-2378"},"institutions":[{"id":"https://openalex.org/I4210136461","display_name":"Keiju Medical Center","ror":"https://ror.org/03t7c1217","country_code":"JP","type":"healthcare","lineage":["https://openalex.org/I4210136461"]}],"countries":["JP"],"is_corresponding":false,"raw_author_name":"Brandon Theodorou","raw_affiliation_strings":["Keiji AI , Seattle, WA, 98115,","Keiji AI, Seattle, WA, 98115, United States"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Keiji AI , Seattle, WA, 98115,","institution_ids":["https://openalex.org/I4210136461"]},{"raw_affiliation_string":"Keiji AI, Seattle, WA, 98115, United States","institution_ids":["https://openalex.org/I4210136461"]}]},{"author_position":"middle","author":{"id":null,"display_name":"Ruba Shaik","orcid":null},"institutions":[{"id":"https://openalex.org/I157725225","display_name":"University of Illinois Urbana-Champaign","ror":"https://ror.org/047426m28","country_code":"US","type":"education","lineage":["https://openalex.org/I157725225"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Ruba Shaik","raw_affiliation_strings":["Carle Illinois College of Medicine, University of Illinois Urbana-Champaign , Urbana, IL, 61801,","Carle Illinois College of Medicine, University of Illinois Urbana-Champaign, Urbana, IL, 61801, United States"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Carle Illinois College of Medicine, University of Illinois Urbana-Champaign , Urbana, IL, 61801,","institution_ids":["https://openalex.org/I157725225"]},{"raw_affiliation_string":"Carle Illinois College of Medicine, University of Illinois Urbana-Champaign, Urbana, IL, 61801, United States","institution_ids":["https://openalex.org/I157725225"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5099241655","display_name":"Shivashankar Thati","orcid":null},"institutions":[{"id":"https://openalex.org/I157725225","display_name":"University of Illinois Urbana-Champaign","ror":"https://ror.org/047426m28","country_code":"US","type":"education","lineage":["https://openalex.org/I157725225"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Shivashankar Thati","raw_affiliation_strings":["Siebel School of Computing and Data Science, University of Illinois Urbana-Champaign , Urbana, IL, 61801,","Siebel School of Computing and Data Science, University of Illinois Urbana-Champaign, Urbana, IL, 61801, United States"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Siebel School of Computing and Data Science, University of Illinois Urbana-Champaign , Urbana, IL, 61801,","institution_ids":["https://openalex.org/I157725225"]},{"raw_affiliation_string":"Siebel School of Computing and Data Science, University of Illinois Urbana-Champaign, Urbana, IL, 61801, United States","institution_ids":["https://openalex.org/I157725225"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5075967459","display_name":"Seung Won","orcid":"https://orcid.org/0000-0003-1764-7890"},"institutions":[{"id":"https://openalex.org/I2803058125","display_name":"Seoul National University Bundang Hospital","ror":"https://ror.org/00cb3km46","country_code":"KR","type":"healthcare","lineage":["https://openalex.org/I139264467","https://openalex.org/I2802835388","https://openalex.org/I2803058125"]}],"countries":["KR"],"is_corresponding":false,"raw_author_name":"Seunghyun Won","raw_affiliation_strings":["Medical Research Collaborating Center, Seoul National University Bundang Hospital , Gyeonggi, 13620,","Medical Research Collaborating Center, Seoul National University Bundang Hospital, Gyeonggi, 13620, Republic of Korea"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Medical Research Collaborating Center, Seoul National University Bundang Hospital , Gyeonggi, 13620,","institution_ids":["https://openalex.org/I2803058125"]},{"raw_affiliation_string":"Medical Research Collaborating Center, Seoul National University Bundang Hospital, Gyeonggi, 13620, Republic of Korea","institution_ids":["https://openalex.org/I2803058125"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5084279065","display_name":"Jimeng Sun","orcid":"https://orcid.org/0000-0003-1512-6426"},"institutions":[{"id":"https://openalex.org/I157725225","display_name":"University of Illinois Urbana-Champaign","ror":"https://ror.org/047426m28","country_code":"US","type":"education","lineage":["https://openalex.org/I157725225"]},{"id":"https://openalex.org/I4210136461","display_name":"Keiju Medical Center","ror":"https://ror.org/03t7c1217","country_code":"JP","type":"healthcare","lineage":["https://openalex.org/I4210136461"]}],"countries":["JP","US"],"is_corresponding":false,"raw_author_name":"Jimeng Sun","raw_affiliation_strings":["Carle Illinois College of Medicine, University of Illinois Urbana-Champaign , Urbana, IL, 61801,","Keiji AI , Seattle, WA, 98115,","Siebel School of Computing and Data Science, University of Illinois Urbana-Champaign , Urbana, IL, 61801,","Keiji AI, Seattle, WA, 98115, United States","Siebel School of Computing and Data Science, University of Illinois Urbana-Champaign, Urbana, IL, 61801, United States","Carle Illinois College of Medicine, University of Illinois Urbana-Champaign, Urbana, IL, 61801, United States"],"raw_orcid":"https://orcid.org/0000-0003-1512-6426","affiliations":[{"raw_affiliation_string":"Carle Illinois College of Medicine, University of Illinois Urbana-Champaign , Urbana, IL, 61801,","institution_ids":["https://openalex.org/I157725225"]},{"raw_affiliation_string":"Keiji AI , Seattle, WA, 98115,","institution_ids":["https://openalex.org/I4210136461"]},{"raw_affiliation_string":"Siebel School of Computing and Data Science, University of Illinois Urbana-Champaign , Urbana, IL, 61801,","institution_ids":["https://openalex.org/I157725225"]},{"raw_affiliation_string":"Keiji AI, Seattle, WA, 98115, United States","institution_ids":["https://openalex.org/I4210136461"]},{"raw_affiliation_string":"Siebel School of Computing and Data Science, University of Illinois Urbana-Champaign, Urbana, IL, 61801, United States","institution_ids":["https://openalex.org/I157725225"]},{"raw_affiliation_string":"Carle Illinois College of Medicine, University of Illinois Urbana-Champaign, Urbana, IL, 61801, United States","institution_ids":["https://openalex.org/I157725225"]}]}],"institutions":[],"countries_distinct_count":4,"institutions_distinct_count":8,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":{"value":3967,"currency":"USD","value_usd":3967},"apc_paid":null,"fwci":1.3295,"has_fulltext":false,"cited_by_count":3,"citation_normalized_percentile":{"value":0.84888155,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":98,"max":99},"biblio":{"volume":"33","issue":"3","first_page":"563","last_page":"572"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11636","display_name":"Artificial Intelligence in Healthcare and Education","score":0.2614000141620636,"subfield":{"id":"https://openalex.org/subfields/2718","display_name":"Health Informatics"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T11636","display_name":"Artificial Intelligence in Healthcare and Education","score":0.2614000141620636,"subfield":{"id":"https://openalex.org/subfields/2718","display_name":"Health Informatics"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10028","display_name":"Topic Modeling","score":0.11969999969005585,"subfield":{"id":"https://openalex.org/subfields/1702","display_name":"Artificial Intelligence"},"field":{"id":"https://openalex.org/fields/17","display_name":"Computer Science"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T11710","display_name":"Biomedical Text Mining and Ontologies","score":0.0689999982714653,"subfield":{"id":"https://openalex.org/subfields/1312","display_name":"Molecular Biology"},"field":{"id":"https://openalex.org/fields/13","display_name":"Biochemistry, Genetics and Molecular Biology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/benchmark","display_name":"Benchmark (surveying)","score":0.6912999749183655},{"id":"https://openalex.org/keywords/compliance","display_name":"Compliance (psychology)","score":0.6696000099182129},{"id":"https://openalex.org/keywords/clinical-research","display_name":"Clinical research","score":0.4668999910354614},{"id":"https://openalex.org/keywords/foundation","display_name":"Foundation (evidence)","score":0.4410000145435333},{"id":"https://openalex.org/keywords/value","display_name":"Value (mathematics)","score":0.4142000079154968},{"id":"https://openalex.org/keywords/language-model","display_name":"Language model","score":0.34290000796318054}],"concepts":[{"id":"https://openalex.org/C185798385","wikidata":"https://www.wikidata.org/wiki/Q1161707","display_name":"Benchmark (surveying)","level":2,"score":0.6912999749183655},{"id":"https://openalex.org/C2781460075","wikidata":"https://www.wikidata.org/wiki/Q1399332","display_name":"Compliance (psychology)","level":2,"score":0.6696000099182129},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.5927000045776367},{"id":"https://openalex.org/C502991105","wikidata":"https://www.wikidata.org/wiki/Q5133849","display_name":"Clinical research","level":2,"score":0.4668999910354614},{"id":"https://openalex.org/C204321447","wikidata":"https://www.wikidata.org/wiki/Q30642","display_name":"Natural language processing","level":1,"score":0.46070000529289246},{"id":"https://openalex.org/C2780966255","wikidata":"https://www.wikidata.org/wiki/Q5474306","display_name":"Foundation (evidence)","level":2,"score":0.4410000145435333},{"id":"https://openalex.org/C2776291640","wikidata":"https://www.wikidata.org/wiki/Q2912517","display_name":"Value (mathematics)","level":2,"score":0.4142000079154968},{"id":"https://openalex.org/C509550671","wikidata":"https://www.wikidata.org/wiki/Q126945","display_name":"Medical education","level":1,"score":0.35899999737739563},{"id":"https://openalex.org/C154945302","wikidata":"https://www.wikidata.org/wiki/Q11660","display_name":"Artificial intelligence","level":1,"score":0.3573000133037567},{"id":"https://openalex.org/C137293760","wikidata":"https://www.wikidata.org/wiki/Q3621696","display_name":"Language model","level":2,"score":0.34290000796318054},{"id":"https://openalex.org/C19527891","wikidata":"https://www.wikidata.org/wiki/Q1120908","display_name":"Medical physics","level":1,"score":0.32829999923706055},{"id":"https://openalex.org/C2522767166","wikidata":"https://www.wikidata.org/wiki/Q2374463","display_name":"Data science","level":1,"score":0.31940001249313354},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.3012999892234802},{"id":"https://openalex.org/C3019869117","wikidata":"https://www.wikidata.org/wiki/Q42240","display_name":"Original research","level":2,"score":0.2962999939918518},{"id":"https://openalex.org/C2780454255","wikidata":"https://www.wikidata.org/wiki/Q7111916","display_name":"Outcomes research","level":3,"score":0.27720001339912415},{"id":"https://openalex.org/C3018127295","wikidata":"https://www.wikidata.org/wiki/Q5246046","display_name":"Research article","level":2,"score":0.26499998569488525},{"id":"https://openalex.org/C2986762682","wikidata":"https://www.wikidata.org/wiki/Q964754","display_name":"Basic research","level":2,"score":0.26409998536109924},{"id":"https://openalex.org/C2779473830","wikidata":"https://www.wikidata.org/wiki/Q1540899","display_name":"MEDLINE","level":2,"score":0.25769999623298645},{"id":"https://openalex.org/C23123220","wikidata":"https://www.wikidata.org/wiki/Q816826","display_name":"Information retrieval","level":1,"score":0.25130000710487366}],"mesh":[{"descriptor_ui":"D000098342","descriptor_name":"Large Language Models","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D000098342","descriptor_name":"Large Language Models","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D009323","descriptor_name":"Natural Language Processing","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D009323","descriptor_name":"Natural Language Processing","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D019983","descriptor_name":"Guideline Adherence","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D019983","descriptor_name":"Guideline Adherence","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D019985","descriptor_name":"Benchmarking","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D019985","descriptor_name":"Benchmarking","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D032962","descriptor_name":"Consent Forms","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":true},{"descriptor_ui":"D032962","descriptor_name":"Consent Forms","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":true},{"descriptor_ui":"D035843","descriptor_name":"Biomedical Research","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D035843","descriptor_name":"Biomedical Research","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true}],"locations_count":2,"locations":[{"id":"doi:10.1093/jamia/ocaf174","is_oa":false,"landing_page_url":"https://doi.org/10.1093/jamia/ocaf174","pdf_url":null,"source":{"id":"https://openalex.org/S129839026","display_name":"Journal of the American Medical Informatics Association","issn_l":"1067-5027","issn":["1067-5027","1527-974X"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310311648","host_organization_name":"Oxford University Press","host_organization_lineage":["https://openalex.org/P4310311648","https://openalex.org/P4310311647"],"host_organization_lineage_names":["Oxford University Press","University of Oxford"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of the American Medical Informatics Association","raw_type":"journal-article"},{"id":"pmid:41144289","is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/41144289","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of the American Medical Informatics Association : JAMIA","raw_type":null}],"best_oa_location":null,"sustainable_development_goals":[],"awards":[{"id":"https://openalex.org/G1896685704","display_name":null,"funder_award_id":"IIS-2034479","funder_id":"https://openalex.org/F4320306076","funder_display_name":"National Science Foundation"},{"id":"https://openalex.org/G3523148485","display_name":null,"funder_award_id":"SCH-2014438","funder_id":"https://openalex.org/F4320306076","funder_display_name":"National Science Foundation"},{"id":"https://openalex.org/G848389139","display_name":null,"funder_award_id":"SCH-2205289","funder_id":"https://openalex.org/F4320306076","funder_display_name":"National Science Foundation"}],"funders":[{"id":"https://openalex.org/F4320306076","display_name":"National Science Foundation","ror":"https://ror.org/021nxhr62"}],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":12,"referenced_works":["https://openalex.org/W2147388986","https://openalex.org/W2155265611","https://openalex.org/W4385498098","https://openalex.org/W4387440167","https://openalex.org/W4390704928","https://openalex.org/W4392193048","https://openalex.org/W4392598276","https://openalex.org/W4398776888","https://openalex.org/W4400657362","https://openalex.org/W4403846448","https://openalex.org/W4404486407","https://openalex.org/W4406055608"],"related_works":[],"abstract_inverted_index":{"OBJECTIVES:":[0],"Large":[1],"language":[2],"models'":[3],"(LLMs')":[4],"performance":[5,74],"in":[6,35,64,114,146,155,176,185,213],"high-stakes,":[7],"compliance-driven":[8],"settings":[9],"such":[10,103],"as":[11,104,134],"drafting":[12],"clinical":[13,42,55,150,178,186],"research":[14,151,179,187],"documents":[15],"remains":[16],"underexplored.":[17],"This":[18],"study":[19,142],"aims":[20],"to":[21,172],"build":[22],"a":[23,51,91,205],"benchmark":[24,52,201],"and":[25,33,58,67,110,129,158,169,194,202,209],"an":[26,60],"evaluation":[27,61],"framework":[28,62,203],"for":[29,149,166,197,207],"assessing":[30,210],"LLMs'":[31],"compliance":[32,109,128],"factuality":[34],"generating":[36],"informed":[37],"consent":[38,69],"forms":[39],"(ICFs)":[40],"from":[41],"trial":[43,56,77],"protocols.":[44],"MATERIALS":[45],"AND":[46],"METHODS:":[47],"We":[48,71],"introduce":[49],"InformBench,":[50],"comprising":[53],"900":[54],"documents,":[57],"propose":[59],"grounded":[63],"regulatory":[65,127,156],"guidelines":[66],"site-specific":[68],"templates.":[70],"assess":[72],"LLM":[73],"on":[75],"transforming":[76],"protocols,":[78],"often":[79],"hundreds":[80],"of":[81,116],"pages,":[82],"into":[83],"concise,":[84],"patient-facing":[85],"ICFs.":[86],"Additionally,":[87],"we":[88],"design":[89],"InformGen,":[90],"retrieval-augmented,":[92],"human-in-the-loop":[93],"pipeline":[94],"aimed":[95],"at":[96],"improving":[97,208],"generation":[98,189],"quality.":[99],"RESULTS:":[100],"Baseline":[101],"LLMs":[102,148,182],"GPT-4o":[105],"achieved":[106],"only":[107],"70%-80%":[108],"exhibited":[111],"factual":[112,132,159],"errors":[113],"18%-43%":[115],"cases.":[117],"In":[118],"contrast,":[119],"InformGen":[120],"substantially":[121],"improved":[122],"outputs,":[123],"achieving":[124],"nearly":[125],"100%":[126],"over":[130],"90%":[131],"accuracy,":[133],"validated":[135],"by":[136],"5":[137],"domain-expert":[138],"annotators.":[139],"DISCUSSION:":[140],"The":[141],"reveals":[143],"critical":[144],"limitations":[145],"current":[147],"document":[152,188],"drafting,":[153],"particularly":[154],"sensitivity":[157],"grounding.":[160],"Our":[161,200],"results":[162],"highlight":[163],"the":[164],"need":[165],"domain-specific":[167],"benchmarks":[168],"structured":[170],"evaluations":[171],"support":[173],"safe":[174],"deployment":[175],"real-world":[177],"workflows.":[180],"CONCLUSION:":[181],"offer":[183],"value":[184],"but":[190],"must":[191],"be":[192],"adapted":[193],"rigorously":[195],"evaluated":[196],"high-stakes":[198],"applications.":[199],"provide":[204],"foundation":[206],"LLM-generated":[211],"outputs":[212],"compliance-critical":[214],"domains.":[215]},"counts_by_year":[{"year":2026,"cited_by_count":3}],"updated_date":"2026-06-11T09:08:48.828518","created_date":"2025-10-28T00:00:00"}