Impact of source data verification on data quality in clinical trials: an empiricalpost hocanalysis of three phase 3 randomized clinical trials
Author:
Affiliation:
1. Nordic Bioscience A/S; Herlev Denmark
2. School of Pharmaceutical Sciences; Faculty of Health and Medical Sciences; University of Copenhagen; Copenhagen Denmark
3. CCBR A/S; Aalborg Denmark
Publisher
Wiley
Subject
Pharmacology (medical),Pharmacology
Link
http://onlinelibrary.wiley.com/wol1/doi/10.1111/bcp.12531/fullpdf
Reference11 articles.
1. Food and Drug Administration 21 CFR part 312, subpart D and 21 CFR part 812, subpart C 2011
2. European Medicines Agency ICH harmonised tripartite guideline E6: note for guidance on good clinical practice (PMP/ICH/135/95) 2011
3. Monitoring the quality of conduct of clinical trials: a survey of current practices;Morrison;Clin Trials,2011
4. Food and Drug Administration Guidance for industry: guideline for monitoring of clinical investigations 1988
5. The potential for central monitoring techniques to replace on-site monitoring: findings from an international multi-centre clinical trial;Bakobaki;Clin Trials,2012
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