A. and C. H. Mondor, Unité de Recherche Clinique-Paris Est-Mondor, F-94010 Créteil, The CompaRec investigators CRUs P. Maison, p.75012

A. Hôpital-de-la-pitié-salpêtrière, Unité de Recherche Clinique- Pitié Salpêtrière-Charles Foix, F-75013 Paris, France) and F. Maugard (AP-HP, Hôpital Saint Louis, Mallet, p.75010

(. Bouillanne, H. Émile-roux, and . Service-de-gérontologie, Service d'Hypertension Arterielle, p.75018

F. ). Clichy, D. Annane-(-ap-hp, and H. Pointcarré, Service de Réanimation Médicale

T. , C. Necker-enfants, and . Malades, Service de Néphrologie Pédiatrique, F-75019 Paris, France), D. Bremond-Gignac (AP-HP, Hôpital Robert Debré, Service d'Ophtalmologie Pédiatrique, Unité fonctionnelle d'explorations fonctionnelles respiratoires Y.E. Claessens (Centre Hospitalier Princesse Grace, p.7501475013

F. ). Paris, G. Cheronap-hp, C. Necker-enfants-maladesap-hp, C. Necker-enfants, and . Malades, Service des urgences pédiatriques Service de Nephrologie, F-75015 Paris, France), L. Guillevin (AP-HP, Groupe Hospitalier Cochin-Saint-Vincent-de-Paul, Service de médecine interne et Centre de Référence Maladies Rares) and D. Thabut (AP-HP, Hôpital de la Pitié-Salpêtrière, Service d'Hépato-Gastroentérologie, F-75013

S. Day, P. Fayers, and D. Harvey, Double Data Entry: What Value, What Price?, Controlled Clinical Trials, vol.19, issue.1, pp.15-24, 1998.
DOI : 10.1016/S0197-2456(97)00096-2

M. Nahm, C. Pieper, and M. Cunningham, Quantifying Data Quality for Clinical Trials Using Electronic Data Capture, PLoS ONE, vol.35, issue.8, p.3049, 2008.
DOI : 10.1371/journal.pone.0003049.g004

W. Kuchinke, C. Ohmann, Q. Yang, N. Salas, J. Lauritsen et al., Heterogeneity prevails: the state of clinical trial data management in Europe - results of a survey of ECRIN centres, Trials, vol.48, issue.1, p.79, 2010.
DOI : 10.1371/journal.pmed.0050006

E. Emam, K. Jonker, E. Sampson, M. Krleza-jeri?, K. Neisa et al., The Use of Electronic Data Capture Tools in Clinical Trials: Web-Survey of 259 Canadian Trials, Journal of Medical Internet Research, vol.11, issue.1, p.8, 2009.
DOI : 10.2196/jmir.1120

J. Litchfield, J. Freeman, H. Schou, M. Elsley, R. Fuller et al., Is the future for clinical trials internet-based? A cluster randomized clinical trial, Clinical Trials, vol.2, issue.1, pp.72-79, 2005.
DOI : 10.1191/1740774505cn069oa

C. Estellat, F. Tubach, Y. Costa, I. Hoffmann, J. Mantz et al., Data capture by digital pen in clinical trials: A qualitative and quantitative study, Contemporary Clinical Trials, vol.29, issue.3, pp.314-323, 2008.
DOI : 10.1016/j.cct.2007.09.007
URL : https://hal.archives-ouvertes.fr/inserm-00202203

S. Brophy, C. Burrows, C. Brooks, M. Gravenor, S. Siebert et al., Internet-based randomised controlled trials for the evaluation of complementary and alternative medicines: probiotics in spondyloarthropathy, BMC Musculoskeletal Disorders, vol.334, issue.7413, p.4, 2008.
DOI : 10.1136/bmj.39192.475382.AD

R. Kush, L. Alschuler, R. Ruggeri, S. Cassells, N. Gupta et al., Implementing Single Source: The STARBRITE Proof-of-Concept Study, Journal of the American Medical Informatics Association, vol.14, issue.5, pp.662-673, 2007.
DOI : 10.1197/jamia.M2157

E. Cole, E. Pisano, G. Clary, D. Zeng, M. Koomen et al., A comparative study of mobile electronic data entry systems for clinical trials data collection, International Journal of Medical Informatics, vol.75, issue.10-11, pp.722-729, 2006.
DOI : 10.1016/j.ijmedinf.2005.10.007

C. Brandt, S. Argraves, R. Money, G. Ananth, N. Trocky et al., Informatics tools to improve clinical research study implementation, Contemporary Clinical Trials, vol.27, issue.2, pp.112-122, 2006.
DOI : 10.1016/j.cct.2005.11.013

J. Galliher, T. Stewart, P. Pathak, J. Werner, L. Dickinson et al., Data Collection Outcomes Comparing Paper Forms With PDA Forms in an Office-Based Patient Survey, The Annals of Family Medicine, vol.6, issue.2, pp.154-160, 2008.
DOI : 10.1370/afm.762

S. Herzberg, K. Rahbar, L. Stegger, M. Schäfers, and M. Dugas, Concept and implementation of a computer-based reminder system to increase completeness in clinical documentation, International Journal of Medical Informatics, vol.80, issue.5, pp.351-358, 2011.
DOI : 10.1016/j.ijmedinf.2011.02.004

S. Thwin, K. Clough-gorr, M. Mccarty, T. Lash, S. Alford et al., Automated inter-rater reliability assessment and electronic data collection in a multi-center breast cancer study, BMC Medical Research Methodology, vol.26, issue.1, p.23, 2007.
DOI : 10.1016/j.cct.2005.01.012

B. Walther, S. Hossin, J. Townend, N. Abernethy, D. Parker et al., Comparison of Electronic Data Capture (EDC) with the Standard Data Capture Method for Clinical Trial Data, PLoS ONE, vol.6, issue.9, p.25348, 2011.
DOI : 10.1371/journal.pone.0025348.s002

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, Contemporary Clinical Trials, vol.32, issue.1, pp.16-24, 2011.
DOI : 10.1016/j.cct.2010.10.001
URL : https://hal.archives-ouvertes.fr/hal-00878962

J. Paul, R. Seib, and T. Prescott, The Internet and Clinical Trials: Background, Online Resources, Examples and Issues, Journal of Medical Internet Research, vol.7, issue.1, p.5, 2005.
DOI : 10.2196/jmir.7.1.e5

K. Dorman, G. Saade, H. Smith, and K. Moise, USE OF THE WORLD WIDE WEB IN RESEARCH, Obstetrics & Gynecology, vol.96, issue.4, pp.636-639, 2000.
DOI : 10.1097/00006250-200010000-00030

I. Pavlovi?, T. Kern, and D. Miklavcic, Comparison of paper-based and electronic data collection process in clinical trials: Costs simulation study, Contemporary Clinical Trials, vol.30, issue.4, pp.300-316, 2009.
DOI : 10.1016/j.cct.2009.03.008

R. Marks, Validating electronic source data in clinical trials, Controlled Clinical Trials, vol.25, issue.5, pp.437-446, 2004.
DOI : 10.1016/j.cct.2004.07.001

C. Lallas, G. Preminger, M. Pearle, R. Leveillee, J. Lingeman et al., Internet Based Multi-Institutional Clinical Research: A Convenient and Secure Option, The Journal of Urology, vol.171, issue.5, pp.1880-1885, 2004.
DOI : 10.1097/01.ju.0000120221.39184.3c

C. López-carrero, E. Arriaza, E. Bolaños, A. Ciudad, M. Municio et al., Internet in clinical research based on a pilot experience, Contemporary Clinical Trials, vol.26, issue.2, pp.234-243, 2005.
DOI : 10.1016/j.cct.2004.11.017

J. Welker, Implementation of electronic data capture systems: Barriers and solutions, Contemporary Clinical Trials, vol.28, issue.3, pp.329-336, 2007.
DOI : 10.1016/j.cct.2007.01.001

W. Ventres, S. Kooienga, N. Vuckovic, R. Marlin, P. Nygren et al., Physicians, Patients, and the Electronic Health Record: An Ethnographic Analysis, The Annals of Family Medicine, vol.4, issue.2, pp.124-131, 2006.
DOI : 10.1370/afm.425

J. Lium, A. Tjora, and A. Faxvaag, No paper, but the same routines: a qualitative exploration of experiences in two Norwegian hospitals deprived of the paper based medical record, BMC Medical Informatics and Decision Making, vol.124, issue.2, 2008.
DOI : 10.1016/S1386-5056(99)00011-8

J. Barber and S. Thompson, Analysis of cost data in randomized trials: an application of the non-parametric bootstrap, Statistics in Medicine, vol.15, issue.23, pp.3219-3236, 2000.
DOI : 10.1002/1097-0258(20001215)19:23<3219::AID-SIM623>3.0.CO;2-P

R. Marks, M. Conlon, and S. Ruberg, Paradigm shifts in clinical trials enabled by information technology, Statistics in Medicine, vol.16, issue.17-18, pp.2683-2696, 2001.
DOI : 10.1002/sim.736

B. Weber, H. Yarandi, M. Rowe, and J. Weber, A comparison study: paper-based versus web-based data collection and management, Applied Nursing Research, vol.18, issue.3, pp.182-185, 2005.
DOI : 10.1016/j.apnr.2004.11.003

T. Bart, Comparison of electronic data capture with paper data collection ? Is there really an advantage? In business briefing, pp.1-4, 2003.