Impact of monitoring approaches on data quality in clinical trials
Author:
Affiliation:
1. Sanos A/S Herlev Denmark
2. NBCD A/S Herlev Denmark
Publisher
Wiley
Subject
Pharmacology (medical),Pharmacology
Link
https://onlinelibrary.wiley.com/doi/pdf/10.1111/bcp.15615
Reference17 articles.
1. Impact of source data verification on data quality in clinical trials: an empiricalpost hocanalysis of three phase 3 randomized clinical trials
2. Quality assurance within the scope of Good Clinical Practice (GCP)-what is the cost of GCP-related activities? A survey within the Swedish Association of the Pharmaceutical Industry (LIF)'s members
3. Guidance for industry oversight of clinical investigations — a risk‐based approach to monitoring;Food and Drug Administration;US Food Drug Adm,2013
4. Reflection paper on risk based quality management in clinical trials;European Medicines Agency (EMA);Compliance Insp,2013
Cited by 2 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献
1. Navigating the challenges of clinical trial professionals in the healthcare sector;Frontiers in Medicine;2024-06-03
2. Source Data Verification (SDV) quality in clinical research: A scoping review;Journal of Clinical and Translational Science;2024
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