Possible combinations of electronic data capture and randomization systems: Principles and the realization with RANDI2 and OpenClinica

Methods of Information in Medicine

Volumn 53, Issue 3, 2014, Pages 202-207

  Schrimpf, Daniel ^a   Haag, M ^b   Pilz, L R ^c  

^a GERMAN CANCER RESEARCH CENTER DKFZ   (Germany)

^b HEILBRONN UNIVERSITY   (Germany)

^c UNIVERSITY OF HEIDELBERG   (Germany)

Author keywords

Electronic data capture; Open source; Random allocation; Randomized controlled trial; Software design

Indexed keywords

COMPUTER NETWORK; COMPUTER PROGRAM; ELECTRONIC MEDICAL RECORD; HUMAN; INFORMATION PROCESSING; MEDICAL INFORMATICS; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL (TOPIC);

AUTOMATIC DATA PROCESSING; COMPUTER COMMUNICATION NETWORKS; HUMANS; MEDICAL INFORMATICS COMPUTING; MEDICAL RECORDS SYSTEMS, COMPUTERIZED; RANDOM ALLOCATION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SOFTWARE DESIGN;

EID: 84901497421     PISSN: 00261270     EISSN: None     Source Type: Journal    
DOI: 10.3414/ME13-01-0074     Document Type: Article

References (27)

1. Schwartz D, Flamant R, Lellouch J. Clinical Trials. New York: Academic Press Inc; 1980.
2. Altman DG, Bland JM. Treatment allocation in controlled trials: why randomise? BMJ 1999; 318 (7192): 1209-1209.
3. Kernan WN, Viscoli CM, Makuch RW, Brass LM, Horwitz RI. Stratified Randomization for Clinical Trials. J Clin Epidemiol 1999; 52 (1): 19-26.
4. Hu F, Rosenberger WF. The Theory of Response-Adaptive Randomization in Clinical Trials. 1st ed. John Wiley & Sons; 2006.
5. Welker JA. Implementation of electronic data capture systems: Barriers and solutions. Contemp Clin Trials 2007; 28 (3): 329-336.
6. Pavlović I, Kern T, MiklavĉI D. Comparison of paper-based and electronic data collection process in clinical trials: Costs simulation study. Contemp Clin Trials 2009; 30 (4): 300-316.
7. Meyer J, Fredrich D, Piegsa J, Habes M, van den Berg N, Hoffmann W. A mobile and asynchronous electronic data capture system for epidemiologic studies. Comput Methods Programs Biomed 2013; 110 (3): 369-379.
8. Franklin JD, Guidry A, Brinkley J F. A partnership approach for Electronic Data Capture in small-scale clinical trials. J Biomed Inform 2011; 44 (Supplement 1): S103-S108.
9. Zelen M. Play the winner rule and the controlled clinical trail. J Am Stat Assoc 1969; 64: 131-146.
10. Day S, Fayers P, Harvey D. Double Data Entry: What Value, What Price? Control Clin Trials 1998; 19 (1): 15-24.
11. CDISC ODM (Internet). Clinical Data Interchange Standards Consortium; c2013 (cited June 28). CDISC Operational Data Model; Available from: http://www.cdisc.org/odm
12. Kuchinke W, Wiegelmann S, Verplancke P, Ohmann C. Extended Cooperation in Clinical Studies through Exchange of CDISC Metadata between Different Study Software Solutions. Methods Inf Med 2006; 45: 441-446.
13. Kuchinke W, Aerts J, Semler SC, Ohmann C: CDISC Standard-based Electronic Archiving of Clinical Trials: Methods Inf Med 2009; 48: 408-413.
14. Curbera F, Duftler M, Khalaf R, Nagy W, Mukhi N, Weerawarana S. Unraveling the Web services web: an introduction to SOAP, WSDL, and UDDI. Ieee Internet Comput 2002; 6 (2): 86-93.
15. W3C (Internet). World Wide Web Consortium; c2013 (cited December 02). Available from: http://www.w3.org/secuTrial [Internet]. interActive Systems GmbH; c2013 [cited December 02].
16. SecuTrial® - web-based data capture in clinical trials. Available from: http://www.secutrial.com/
17. OpenClinica (Internet). OpenClinica, LLC; c2013 (cited December 02). OpenClinica 3.1 User Documentation; Available from: https://docs.openclinica.com/3.1/
18. Randomizer (Internet). Medical Univeristy of Graz; c2013 (cited December 02). Web-Based Patient Randomization (Randomisation) Service for Multi-Center Clinical Trials. Available from: http://www.randomizer.at
19. RANDI2 (Internet); c2013 (cited December 02). RANDI2 open-source web-based randomization. Available from: http://www.randi2.org
20. Saghaei M. Implementation of an open-source customizable minimization program for allocation of patients to parallel groups in clinical trials. Journal of Biomedical Science and Engineering 2011; 4: 734-739.
21. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research Electronic Data Capture (REDCap) - A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009; 42: 377-381.
22. Schrimpf D, Plotnicki L, Pilz L. Web-based open source application for the randomization process of clinical trials: RANDI2. Int J Clin Pharmacol Ther 2010; 48: 465-467.
23. Rosenberger WF, Lachin JM. Randomization in Clinical Trials: Theory and Practice. 1st ed. John Wiley & Sons; 2002.
24. Zelen M. The randomization and stratification of patients to clinical trials. J Chronic Dis 1974; 27 (7-8): 365-375.
25. Wei LJ, Lachin JM. Properties of the urn randomization in clinical trials. Control Clin Trials 1988; 9 (4): 345-364.
26. Han B, Enas NH, McEntegart D. Randomization by minimization for unbalaced treatment allocation. Stat Med 2009; 28: 3329-3346.
27. Liang Y, Carriere KC. Stratified and randomized play-the-winner rule. Stat Methods Med Res 2008; 17 (6): 581-593.