Web-based Randomization

Central randomization of patients is an important attribute of multi-centre clinical trials.

WP 3 (CICS) has implemented a computerized, web-based randomization service. This service permits patient randomization into one of two or more treatment arms at any time without incurring the need for personnel continuously present at the central site at all times. The only prerequisite is the availability of a computer workstation equipped with an internet link and a standard browser for the world wide web.

The technical requirements were kept to a minimum in order to avoid any potential problems arising from different types of computers and site-specifi c network security measures. In particular, no download or installation is necessary to use the service. Patient privacy is guaranteed by using encrypted communication (SSL) and recording only a limited set of parameters: initials, sex and date of birth.

The randomization service has been in routine use since February 2002, providing randomization for approx. 3500 patients in different trials. The service is open to all suitable trials within the ELN.

Further questions should be addressed to the author: Dr. T. Müller

Presentations

Random-2007-01-29.pdf
Slides by Dr. T. Müller, IT Workshop I, 2007/29/01 in Heidelberg