{"doi":"10.4103/2229-3485.184817","title":"Assessment and classification of protocol deviations","abstract":null,"journal":"Perspectives in Clinical Research","year":2016,"id":649603,"datarank":0.5375278407684165,"base_score":3.58351893845611,"endowment":3.58351893845611,"self_citation_contribution":0.5375278407684165,"citation_network_contribution":0.0,"self_endowment_contribution":0.5375278407684165,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":35,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":4,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1693508,"name":"Neelambari Bhosale","orcid":null,"position":1,"is_corresponding":false},{"id":1693510,"name":"Reena Wadhwani","orcid":null,"position":2,"is_corresponding":false},{"id":1693512,"name":"Pathik Divate","orcid":null,"position":3,"is_corresponding":false},{"id":1693513,"name":"Uma Divate","orcid":null,"position":4,"is_corresponding":false},{"id":1693506,"name":"RavindraBhaskar Ghooi","orcid":null,"position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"Assessment and classification of protocol deviations","abstract":"INTRODUCTION: Deviations from the approved trial protocol are common during clinical trials. They have been conventionally classified as deviations or violations, depending on their impact on the trial. METHODS: A new method has been proposed by which deviations are classified in five grades from 1 to 5. A deviation of Grade 1 has no impact on the subjects' well-being or on the quality of data. At the maximum, a deviation Grade 5 leads to the death of the subject. This method of classification was applied to deviations noted in the center over the last 3 years. RESULTS: It was observed that most deviations were of Grades 1 and 2, with fewer falling in Grades 3 and 4. There were no deviations that led to the death of the subject (Grade 5). DISCUSSION: This method of classification would help trial managers decide on the action to be taken on the occurrence of deviations, which would be based on their impact.","is_dataset_classified":null,"base_score":3.58351893845611,"endowment":3.58351893845611,"datacite_reuse_total":4,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"27453830","pmcid":"PMC4936072","openalex_id":"https://openalex.org/W2460924545","authors":[],"funders":[],"total_grants":0,"fwci":1.0341,"citation_percentile":0.81460127,"influential_citations":2,"citation_trend":[{"year":2017,"count":1},{"year":2018,"count":2},{"year":2019,"count":1},{"year":2020,"count":4},{"year":2021,"count":3},{"year":2022,"count":5},{"year":2023,"count":5},{"year":2024,"count":4},{"year":2025,"count":8},{"year":2026,"count":2}],"oa_status":"gold","license":"cc-by-nc-sa","oa_locations":[{"url":"https://doi.org/10.4103/2229-3485.184817","host_type":"journal"},{"url":"https://doi.org/10.4103/2229-3485.184817","host_type":"GOLD"},{"url":"https://doi.org/10.4103/2229-3485.184817","host_type":"publisher"},{"url":"https://pubmed.ncbi.nlm.nih.gov/27453830","host_type":"repository"},{"url":"https://doaj.org/article/3c2d67be6ffa41f0bed5ac8d90e23902","host_type":"repository"},{"url":"https://www.ncbi.nlm.nih.gov/pmc/articles/4936072","host_type":"repository"},{"url":"https://europepmc.org/articles/PMC4936072","host_type":"Europe_PMC"}],"fields_of_study":["Meta-analysis and systematic reviews","Statistical Methods in Clinical Trials","Dermatoglyphics and Human Traits","Computer Science","Medicine"],"mesh_terms":[],"keywords":["Protocol (science)","Computer science","Data science","Statistics","Information retrieval","Medicine","Mathematics","Alternative medicine","Pathology","Data Quality","Noncompliance","Subject Protection","Deviations"],"sdg_mappings":[{"sdg_number":0,"sdg_label":"Peace, Justice and strong institutions"}],"linked_datasets":[{"doi":"10.6084/m9.figshare.20294494.v1","title":"Additional file 1 of A review of reproducible and transparent research practices in urology publications from 2014 to2018","publisher":"figshare","resource_type":"JournalArticle"},{"doi":"10.6084/m9.figshare.20294494","title":"Additional file 1 of A review of reproducible and transparent research practices in urology publications from 2014 to2018","publisher":"figshare","resource_type":"JournalArticle"},{"doi":"10.6084/m9.figshare.20294497.v1","title":"Additional file 2 of A review of reproducible and transparent research practices in urology publications from 2014 to2018","publisher":"figshare","resource_type":"JournalArticle"},{"doi":"10.6084/m9.figshare.20294497","title":"Additional file 2 of A review of reproducible and transparent research practices in urology publications from 2014 to2018","publisher":"figshare","resource_type":"JournalArticle"}],"clinical_trials":[],"software_tools":[],"database_accessions":[],"source":"live","citation_network_status":"fetched"},"created_at":"2026-08-10T04:00:25.407587Z","pmid":null,"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":[]}