{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,24]],"date-time":"2026-03-24T17:34:31Z","timestamp":1774373671579,"version":"3.50.1"},"reference-count":11,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2015,3,23]],"date-time":"2015-03-23T00:00:00Z","timestamp":1427068800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2015,4]]},"abstract":"Aim<\/jats:title>The aim of this project was to perform an empirical evaluation of the impact of on site source data verification (SDV<\/jats:styled-content>) on the data quality in a clinical trial database to guide an informed decision on selection of the monitoring approach.<\/jats:p><\/jats:sec>Methods<\/jats:title>We used data from three randomized phase III<\/jats:styled-content> trials monitored with a combination of complete SDV<\/jats:styled-content> or partial SDV<\/jats:styled-content>. After database lock, individual subject data were extracted from the clinical database and subjected to post hoc<\/jats:italic> complete SDV. Error rates were calculated with focus on the degree of on study monitoring and relevance and analyzed for potential impact on end points.<\/jats:p><\/jats:sec>Results<\/jats:title>Data from a total of 2566 subjects including more than 3 million data fields were 100% source data verified post hoc<\/jats:italic>. An overall error rate of 0.45% was found. No sites had 0% errors. 100% SDV<\/jats:styled-content> yielded an error rate of 0.27% as compared with partial SDV<\/jats:styled-content> having an error rate of 0.53% (P<\/jats:italic> < 0.0001). Comparing partly and fully monitored subjects, minor differences were identified between variables of major importance to efficacy or safety.<\/jats:p><\/jats:sec>Conclusions<\/jats:title>The findings challenge the notion that a 0% error rate is obtainable with on site monitoring. Data indicate consistently low error rates across the three trials analyzed. The use of complete vs<\/jats:italic>. partial SDV<\/jats:styled-content> offers a marginal absolute error rate reduction of 0.26%, i.e. a need to perform complete SDV<\/jats:styled-content> of about 370 data points to avoid one unspecified error and does not support complete SDV<\/jats:styled-content> as a means of providing meaningful improvements in data accuracy.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.12531","type":"journal-article","created":{"date-parts":[[2014,10,20]],"date-time":"2014-10-20T04:09:21Z","timestamp":1413778161000},"page":"660-668","source":"Crossref","is-referenced-by-count":39,"title":["Impact of source data verification on data quality in clinical trials: an empirical post hoc<\/i> analysis of three phase 3 randomized clinical trials"],"prefix":"10.1111","volume":"79","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7215-5664","authenticated-orcid":false,"given":"Jeppe Ragnar","family":"Andersen","sequence":"first","affiliation":[{"name":"Nordic Bioscience A\/S Herlev Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Inger","family":"Byrjalsen","sequence":"additional","affiliation":[{"name":"Nordic Bioscience A\/S Herlev Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Asger","family":"Bihlet","sequence":"additional","affiliation":[{"name":"Nordic Bioscience A\/S Herlev Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Faidra","family":"Kalakou","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Sciences Faculty of Health and Medical Sciences University of Copenhagen Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hans Christian","family":"Hoeck","sequence":"additional","affiliation":[{"name":"CCBR A\/S Aalborg Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gitte","family":"Hansen","sequence":"additional","affiliation":[{"name":"Nordic Bioscience A\/S Herlev Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Henrik Bo","family":"Hansen","sequence":"additional","affiliation":[{"name":"Nordic Bioscience A\/S Herlev Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Morten Asser","family":"Karsdal","sequence":"additional","affiliation":[{"name":"Nordic Bioscience A\/S Herlev Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bente Juel","family":"Riis","sequence":"additional","affiliation":[{"name":"Nordic Bioscience A\/S Herlev Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2015,3,23]]},"reference":[{"key":"e_1_2_10_2_1","unstructured":"Food and Drug Administration.21 CFR part 312 subpart D and 21 CFR part 812 subpart C.2011. Ref Type: Bill\/Resolution."},{"key":"e_1_2_10_3_1","unstructured":"European Medicines Agency.ICH harmonised tripartite guideline E6: note for guidance on good clinical practice (PMP\/ICH\/135\/95). 1\u20106\u20102011. Ref Type: Bill\/Resolution."},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1177\/1740774511402703"},{"key":"e_1_2_10_5_1","unstructured":"Food and Drug Administration.Guidance for industry: guideline for monitoring of clinical investigations.1988. Ref Type: Generic."},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1177\/1740774511427325"},{"key":"e_1_2_10_7_1","unstructured":"FDA.Guidance for industry oversight of clinical investigations \u2013 a risk based approach to monitoring. 8\u20101\u20102014. Ref Type: Generic."},{"key":"e_1_2_10_8_1","unstructured":"EMA.Reflection paper on risk based quality management in clinical trials.2014. 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