{"doi":"10.1002/eahr.500066","title":"Ethical and Regulatory Concerns in Pragmatic Clinical Trial Monitoring and Oversight","abstract":"The implementation of pragmatic clinical trials (PCTs) can be accompanied by unique regulatory challenges. In this paper, we describe the experience and management of regulatory noncompliance during a 25-site acute care PCT. During the trial, the study team conducted a comprehensive audit of all enrollment forms (informed consent and Health Insurance Portability and Accountability Act authorization forms) and related study documentation. A review of 997 participants' enrollment forms identified 138 (13.8%) that required reporting to the institutional review board due to noncompliance. To prevent subsequent noncompliance, the study team developed and introduced a revised participant tracking system, reviewed all enrollment documentation, and retrained sites regarding study procedures. Based on these experiences, we developed a set of recommendations for future PCTs to ensure both operational success and regulatory compliance.","journal":"Ethics & Human Research","year":2020,"id":109776,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":8,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9603,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":523666,"name":"Dylan Fisher","orcid":"0000-0002-6879-0622","position":1,"is_corresponding":false},{"id":523667,"name":"Lea Parker","orcid":"0000-0001-5389-849X","position":2,"is_corresponding":false},{"id":523668,"name":"Doyanne Darnell","orcid":"0000-0002-0309-8774","position":3,"is_corresponding":false},{"id":323987,"name":"Jeremy Sugarman","orcid":"0000-0001-7022-8332","position":4,"is_corresponding":false},{"id":524449,"name":"Judith Carrithers","orcid":null,"position":5,"is_corresponding":false},{"id":443326,"name":"Kevin P. Weinfurt","orcid":"0000-0002-0624-7448","position":6,"is_corresponding":false},{"id":523669,"name":"Gregory J. Jurkovich","orcid":"0000-0003-0870-8583","position":7,"is_corresponding":false},{"id":413636,"name":"Douglas Zatzick","orcid":"0000-0001-7339-1020","position":8,"is_corresponding":false},{"id":467047,"name":"Michelle Roberts","orcid":"0000-0003-4908-704X","position":0,"is_corresponding":true}],"reference_count":15,"raw_metadata":null,"created_at":"2026-07-18T23:12:54.309019Z","pmid":"32937035","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}