, International council for Harmonisation of Technical Requirements for Pharmaceuticals for human Use (ICH), 2017.
Measuring Data Quality Through a Source Data Verification Audit in a, Clinical Research Setting. Stud Health Technol Inform, vol.214, pp.107-120, 2015. ,
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, Qual Assur J, vol.12, issue.1, pp.3-7, 2009. ,
The value of source data verification in a cancer clinical trial, PloS One, vol.7, issue.12, p.51623, 2012. ,
Monitoring the quality of conduct of clinical trials: a survey of current practices, Clin Trials Lond Engl, vol.8, issue.3, pp.342-351, 2011. ,
Impact of source data verification on data quality in clinical trials: an empirical post hoc analysis of three phase 3 randomized clinical trials, Br J Clin Pharmacol, vol.79, issue.4, pp.660-668, 2015. ,
Evaluating Source Data Verification as a Quality Control Measure in Clinical Trials, Ther Innov Regul Sci, vol.48, issue.6, pp.671-80, 2014. ,
Risk-Based Monitoring: A Closer Statistical Look at Source Document Verification, Queries, Study Size Effects, and Data Quality, Ther Innov Regul Sci, vol.49, issue.6, pp.903-913, 2015. ,
Sensible guidelines for the conduct of large randomized trials, Clin Trials Lond Engl, vol.5, issue.1, pp.38-47, 2008. ,
Key cost drivers of pharmaceutical clinical trials in the United States, Clin Trials Lond Engl, vol.13, issue.2, pp.117-143, 2016. ,
Sensible approaches for reducing clinical trial costs, Clin Trials Lond Engl, vol.5, issue.1, pp.75-84, 2008. ,
Specific barriers to the conduct of randomized trials, Clin Trials Lond Engl, vol.5, issue.1, pp.40-48, 2008. ,
, Guidance for Industry Oversight of Clinical Investigations -A Risk-Based Approach to Monitoring, US Food and Drug Administration, 2017.
Reflection paper on risk-based quality management in clinical trials, 2017. ,
, , p.31, 2011.
Risk based monitoring (RBM) tools for clinical trials: A systematic review, Contemp Clin Trials, vol.51, pp.15-27, 2016. ,
Risk analysis and risk adapted on-site monitoring in noncommercial clinical trials, Clin Trials Lond Engl, vol.6, issue.6, pp.585-96, 2009. ,
The impact of clinical trial monitoring approaches on data integrity and cost--a review of current literature, Eur J Clin Pharmacol, vol.72, issue.4, pp.399-412, 2016. ,
Assessing data quality and the variability of source data verification auditing methods in clinical research settings, J Biomed Inform, vol.83, pp.25-32, 2018. ,
Exploring Data Quality Management within Clinical Trials, Appl Clin Inform, vol.9, issue.1, pp.72-81, 2018. ,
Developing systems for cost-effective auditing of clinical trials, Control Clin Trials, vol.18, issue.6, pp.661-666, 1997. ,
A systematic review of on-site monitoring methods for health-care randomised controlled trials, Clin Trials Lond Engl, vol.10, issue.1, pp.104-128, 2013. ,
A systematic search for reports of site monitoring technique comparisons in clinical trials, Clin Trials Lond Engl, vol.9, issue.6, pp.777-80, 2012. ,
Remote source document verification in two national clinical trials networks: a pilot study, PloS One, vol.8, issue.12, p.81890, 2013. ,
Measuring the quality of observational study data in an international HIV research network, PloS One, vol.7, issue.4, p.33908, 2012. ,
Quality control in multicentric clinical trials. An experience of the EORTC Gynecological Cancer Cooperative Group, Eur J Cancer Oxf Engl, vol.36, issue.9, pp.1125-1158, 1990. ,
Quality control of validity of data collected in clinical trials. EORTC Study Group on Data Management (SGDM), Eur J Cancer Clin Oncol, vol.25, issue.8, pp.1241-1248, 1989. ,
Improving the quality of drug research or simply increasing its cost? An evidence-based study of the cost for data monitoring in clinical trials, Br J Clin Pharmacol, vol.71, issue.3, pp.467-70, 2011. ,
Triggered or routine site monitoring visits for randomised controlled trials: results of TEMPER, a prospective, matched-pair study, Clin Trials Lond Engl, vol.15, issue.6, pp.600-609, 2018. ,
INVESTIGATING THE EFFICACY OF CLINICAL TRIAL MONITORING STRATEGIES: Design and Implementation of the Cluster Randomized START Monitoring Substudy, Ther Innov Regul Sci, vol.49, issue.2, pp.225-258, 2015. ,
Validation of a risk-assessment scale and a risk-adapted monitoring plan for academic clinical research studies--the Pre-Optimon study, Contemp Clin Trials, vol.32, issue.1, pp.16-24, 2011. ,
URL : https://hal.archives-ouvertes.fr/hal-00878962
, Optimisation of Monitoring for Clinical Research Studies -Full Text View -ClinicalTrials.gov, 2017.
Risk-adapted monitoring is not inferior to extensive on-site monitoring: Results of the ADAMON cluster-randomised study, Clin Trials Lond Engl, 2017. ,
Reducing Clinical Trial Monitoring Resource Allocation and Costs Through Remote Access to Electronic Medical Records, J Oncol Pract, vol.9, issue.1, pp.13-19, 2013. ,
Cranberry versus placebo in the prevention of urinary infections in multiple sclerosis: a multicenter, randomized, placebo-controlled, double-blind trial, Mult Scler Houndmills Basingstoke Engl, vol.20, issue.9, pp.1252-1261, 2014. ,
URL : https://hal.archives-ouvertes.fr/hal-01147022
Effect of a Perioperative Nutritional Supplementation with Oral Impact® in Patients undergoing Hepatic Surgery for Liver Cancer: A Prospective, Placebo-Controlled, Randomized, Double-Blind Study, Nutr Cancer, vol.68, issue.3, pp.464-72, 2016. ,
URL : https://hal.archives-ouvertes.fr/hal-01295673
Reduced-dose tacrolimus with mycophenolate mofetil vs. standard-dose tacrolimus in liver transplantation: a randomized study, Am J Transplant Off J Am Soc Transplant Am Soc Transpl Surg, vol.11, issue.5, pp.965-76, 2011. ,
URL : https://hal.archives-ouvertes.fr/hal-00739379
Cerebral microdialysis effects of propofol versus midazolam in severe traumatic brain injury, J Neurotrauma, vol.29, issue.6, pp.1105-1115, 2012. ,
URL : https://hal.archives-ouvertes.fr/inserm-00865024