{"id":"https://openalex.org/W119090810","doi":null,"title":"EU and US clinical investigation adverse event reporting.","display_name":"EU and US clinical investigation adverse event reporting.","publication_year":2004,"publication_date":"2004-06-01","ids":{"openalex":"https://openalex.org/W119090810","mag":"119090810","pmid":"https://pubmed.ncbi.nlm.nih.gov/15285486"},"language":"en","primary_location":{"id":"pmid:15285486","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/15285486","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,"listed_in":[],"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":"Medical device technology","raw_type":"Journal Article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["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/A5075122636","display_name":"Gordon Crowley","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":true,"raw_author_name":"Gordon Crowley","raw_affiliation_strings":["MedNova Ltd, Galway, Ireland. gcrowley@mednova.ie"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"MedNova Ltd, Galway, Ireland. gcrowley@mednova.ie","institution_ids":[]}]}],"institutions":[],"countries_distinct_count":0,"institutions_distinct_count":0,"corresponding_author_ids":["https://openalex.org/A5075122636"],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":false,"cited_by_count":2,"citation_normalized_percentile":{"value":0.02412941,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":88,"max":93},"biblio":{"volume":"15","issue":"5","first_page":"30","last_page":"2"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T14396","display_name":"Healthcare Regulation","score":0.7080000042915344,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"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/T14396","display_name":"Healthcare Regulation","score":0.7080000042915344,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"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/T11943","display_name":"Pharmacovigilance and Adverse Drug Reactions","score":0.24480000138282776,"subfield":{"id":"https://openalex.org/subfields/3005","display_name":"Toxicology"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T13690","display_name":"Quality and Safety in Healthcare","score":0.007499999832361937,"subfield":{"id":"https://openalex.org/subfields/3607","display_name":"Medical Laboratory Technology"},"field":{"id":"https://openalex.org/fields/36","display_name":"Health Professions"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/adverse-event-reporting","display_name":"adverse event reporting","score":0.9110000133514404},{"id":"https://openalex.org/keywords/clinical-research","display_name":"clinical research","score":0.6100000143051147},{"id":"https://openalex.org/keywords/medical-devices","display_name":"medical devices","score":0.7739999890327454},{"id":"https://openalex.org/keywords/regulatory-standards","display_name":"regulatory standards","score":0.5609999895095825},{"id":"https://openalex.org/keywords/eu-regulation","display_name":"European Union regulation","score":0.38600000739097595},{"id":"https://openalex.org/keywords/us-regulation","display_name":"US regulation","score":0.8169999718666077},{"id":"https://openalex.org/keywords/human-subjects-research","display_name":"human subjects research","score":0.5139999985694885},{"id":"https://openalex.org/keywords/medical-device-regulation","display_name":"medical device regulation","score":0.4000000059604645}],"concepts":[{"id":"https://openalex.org/C2779662365","wikidata":"https://www.wikidata.org/wiki/Q5416694","display_name":"Event (particle physics)","level":2,"score":0.4716191589832306},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.45192405581474304},{"id":"https://openalex.org/C3020535179","wikidata":"https://www.wikidata.org/wiki/Q6554101","display_name":"Medical device","level":2,"score":0.4400758445262909},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.42020249366760254},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.34853363037109375},{"id":"https://openalex.org/C19527891","wikidata":"https://www.wikidata.org/wiki/Q1120908","display_name":"Medical physics","level":1,"score":0.34240853786468506},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.324821799993515},{"id":"https://openalex.org/C136229726","wikidata":"https://www.wikidata.org/wiki/Q327092","display_name":"Biomedical engineering","level":1,"score":0.13246598839759827},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.0967700183391571},{"id":"https://openalex.org/C62520636","wikidata":"https://www.wikidata.org/wiki/Q944","display_name":"Quantum mechanics","level":1,"score":0.0},{"id":"https://openalex.org/C121332964","wikidata":"https://www.wikidata.org/wiki/Q413","display_name":"Physics","level":0,"score":0.0}],"mesh":[{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":true},{"descriptor_ui":"D003257","descriptor_name":"Consumer Product Safety","qualifier_ui":"Q000331","qualifier_name":"legislation & jurisprudence","is_major_topic":false},{"descriptor_ui":"D003257","descriptor_name":"Consumer Product Safety","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":true},{"descriptor_ui":"D004282","descriptor_name":"Documentation","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":false},{"descriptor_ui":"D004282","descriptor_name":"Documentation","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D004864","descriptor_name":"Equipment and Supplies","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":true},{"descriptor_ui":"D004864","descriptor_name":"Equipment and Supplies","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":true},{"descriptor_ui":"D004868","descriptor_name":"Equipment Failure","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D005060","descriptor_name":"Europe","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D011358","descriptor_name":"Product Surveillance, Postmarketing","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":false},{"descriptor_ui":"D011358","descriptor_name":"Product Surveillance, Postmarketing","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":true},{"descriptor_ui":"D014481","descriptor_name":"United States","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D019221","descriptor_name":"Mandatory Reporting","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D038622","descriptor_name":"Internationality","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false}],"locations_count":1,"locations":[{"id":"pmid:15285486","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/15285486","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,"listed_in":[],"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":"Medical device technology","raw_type":"Journal Article"}],"best_oa_location":null,"sustainable_development_goals":[{"display_name":"Good health and well-being","score":0.8048999905586243,"id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W2094199628","https://openalex.org/W6930129298","https://openalex.org/W2357126578","https://openalex.org/W7222326505","https://openalex.org/W2418518843","https://openalex.org/W7209497462","https://openalex.org/W2418424605","https://openalex.org/W7164628899","https://openalex.org/W2435140776","https://openalex.org/W7097875950"],"abstract_inverted_index":{"Revised":[0],"international":[1],"standards":[2],"on":[3],"clinical":[4],"investigations":[5],"were":[6],"recently":[7],"published.":[8],"ISO":[9],"14155":[10],"consists":[11],"of":[12,21,32],"two":[13],"parts":[14],"under":[15],"the":[16,30,33],"general":[17],"title":[18],"Clinical":[19],"Investigation":[20],"Medical":[22],"Devices":[23],"for":[24],"Human":[25],"Subjects.":[26],"This":[27],"article":[28],"outlines":[29],"requirements":[31],"revised":[34],"standard":[35],"and":[36],"contrasts":[37],"these":[38],"with":[39],"United":[40],"States":[41],"reporting":[42],"requirements.":[43]},"counts_by_year":[{"year":2013,"cited_by_count":1}],"updated_date":"2026-10-31T12:09:11.096373","created_date":"2016-06-24T00:00:00"}