An automated patient registration and treatment randomization system for multicenter clinical trials.
This article describes an automated patient registration/treatment randomization system for multicenter clinical trials. Registrations take place centrally using telephone keypads (tone-dial) for data entry and synthesized speech (at the coordinating center) for confirmation. The system permits a wide variety of protocol designs and treatment assignment schemes and presently supports more than 85 protocols of the Pediatric Oncology Group. It is developed in modules to permit easy addition/deletion of studies and treating sites. The system permits uninterrupted, unattended operation at the coordinating center 7 days a week, 24 hours a day.
Krischer
J P
JP
University of Florida, Gainesville.
Hurley
C
C
Pillalamarri
M
M
Pant
S
S
Bleichfeld
C
C
Opel
M
M
Shuster
J J
JJ
D002985:Clinical Protocols; D002986:Clinical Trials as Topic / Q000379:methods*; D004608:Eligibility Determination; D008838:Microcomputers; D015337:Multicenter Studies as Topic / Q000379:methods*; D011381:Programming Languages; D011897:Random Allocation; D012984:Software; D013689:Telephone; D014584:User-Computer Interface