, International council for Harmonisation of Technical Requirements for Pharmaceuticals for human Use (ICH), 2017.

L. Houston, Y. Probst, and A. Humphries, Measuring Data Quality Through a Source Data Verification Audit in a, Clinical Research Setting. Stud Health Technol Inform, vol.214, pp.107-120, 2015.

S. Funning, A. Grahnén, K. Eriksson, and Å. Kettis-linblad, 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.

T. Smith, C. Stocken, D. D. Dunn, J. Cox, T. Ghaneh et al., The value of source data verification in a cancer clinical trial, PloS One, vol.7, issue.12, p.51623, 2012.

B. W. Morrison, C. J. Cochran, J. G. White, J. Harley, C. F. Kleppinger et al., 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.

J. R. Andersen, I. Byrjalsen, A. Bihlet, F. Kalakou, H. C. Hoeck et al., 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.

N. Sheetz, B. Wilson, J. Benedict, E. Huffman, A. Lawton et al., Evaluating Source Data Verification as a Quality Control Measure in Clinical Trials, Ther Innov Regul Sci, vol.48, issue.6, pp.671-80, 2014.

V. Tantsyura, I. M. Dunn, K. Fendt, Y. J. Kim, J. Waters et al., 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.

S. Yusuf, J. Bosch, P. J. Devereaux, P. J. Devereaus, R. Collins et al., Sensible guidelines for the conduct of large randomized trials, Clin Trials Lond Engl, vol.5, issue.1, pp.38-47, 2008.

A. Sertkaya, H. Wong, A. Jessup, and T. Beleche, Key cost drivers of pharmaceutical clinical trials in the United States, Clin Trials Lond Engl, vol.13, issue.2, pp.117-143, 2016.

E. L. Eisenstein, R. Collins, B. S. Cracknell, O. Podesta, E. D. Reid et al., Sensible approaches for reducing clinical trial costs, Clin Trials Lond Engl, vol.5, issue.1, pp.75-84, 2008.

L. Duley, K. Antman, J. Arena, A. Avezum, M. Blumenthal et al., 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.

A. European-medicines, Reflection paper on risk-based quality management in clinical trials, 2017.

M. Project, , p.31, 2011.

C. Hurley, F. Shiely, J. Power, M. Clarke, J. A. Eustace et al., Risk based monitoring (RBM) tools for clinical trials: A systematic review, Contemp Clin Trials, vol.51, pp.15-27, 2016.

O. Brosteanu, P. Houben, K. Ihrig, C. Ohmann, U. Paulus et al., Risk analysis and risk adapted on-site monitoring in noncommercial clinical trials, Clin Trials Lond Engl, vol.6, issue.6, pp.585-96, 2009.

R. Olsen, A. R. Bihlet, F. Kalakou, and J. R. Andersen, 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.

L. Houston, Y. Probst, and A. Martin, 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.

L. Houston, Y. Probst, P. Yu, and A. Martin, Exploring Data Quality Management within Clinical Trials, Appl Clin Inform, vol.9, issue.1, pp.72-81, 2018.

R. M. Califf, S. L. Karnash, and L. H. Woodlief, Developing systems for cost-effective auditing of clinical trials, Control Clin Trials, vol.18, issue.6, pp.661-666, 1997.

R. C. Macefield, A. D. Beswick, J. M. Blazeby, and J. A. Lane, 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.

J. Bakobaki, N. Joffe, S. Burdett, J. Tierney, S. Meredith et al., 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.

M. Mealer, J. Kittelson, B. T. Thompson, A. P. Wheeler, J. C. Magee et al., Remote source document verification in two national clinical trials networks: a pilot study, PloS One, vol.8, issue.12, p.81890, 2013.

S. N. Duda, B. E. Shepherd, C. S. Gadd, D. R. Masys, and C. C. Mcgowan, Measuring the quality of observational study data in an international HIV research network, PloS One, vol.7, issue.4, p.33908, 2012.

G. Favalli, J. B. Vermorken, K. Vantongelen, R. J. Van-oosterom, A. T. Pecorelli et al., 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.

K. Vantongelen, N. Rotmensz, and E. Van-der-schueren, 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.

E. Pronker, B. F. Geerts, A. Cohen, and H. Pieterse, 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.

S. P. Stenning, W. J. Cragg, N. Joffe, C. Diaz-montana, R. Choudhury et al., 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.

K. H. Hullsiek, J. M. Kagan, N. Engen, J. Grarup, F. Hudson et al., 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.

V. Journot, J. Pignon, C. Gaultier, V. Daurat, A. Bouxin-métro et al., 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.

O. Brosteanu, G. Schwarz, P. Houben, U. Paulus, A. Strenge-hesse et al., Risk-adapted monitoring is not inferior to extensive on-site monitoring: Results of the ADAMON cluster-randomised study, Clin Trials Lond Engl, 2017.

S. C. Uren, M. B. Kirkman, B. S. Dalton, and J. R. Zalcberg, 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.

P. Gallien, G. Amarenco, N. Benoit, V. Bonniaud, C. Donzé et al., 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

P. Seguin, C. Locher, K. Boudjema, C. Hamon, C. Mouchel et al., 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

K. Boudjema, C. Camus, F. Saliba, Y. Calmus, E. Salamé et al., 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

M. Tanguy, P. Seguin, B. Laviolle, J. Bleichner, X. Morandi et al., 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