title: On selecting a clinical trial management system for large scale, multi-centre, multi-modal clinical research study.
abstract: Clinical research studies offer many challenges for their supporting information systems. AIBL assembled 1112 participants who volunteered crucial information for a comprehensive study on neurodegenerative diseases. This paper discusses the shortcomings of the clinical trial management system chosen to record the results of the study. A set of guidelines was devised and a critique of five systems ensued. OpenClinica was selected as the most appropriate option. The main contribution of this paper is: (i) proposing a set of guidelines to determine the appropriateness of Clinical Trial Management Systems (CTMS) solution; (ii) providing a brief critique of existing commercial and open-sourced CTMS; and (iii) alluding to some data migration issues and providing cues on how to address them. We conclude that open-source CTMS are viable alternatives to the more expensive commercial systems to conduct, record and manage clinical studies.
authors: The Australian E-Health Research Centre.
authors: Hugo
authors: H
authors: Leroux
authors: Simon
authors: S
authors: McBride
authors: Simon
authors: S
authors: Gibson
mesh_terms: D001315:Australia; D057189:Checklist; D002755:Choice Behavior; D002986:Clinical Trials as Topic; D020000:Decision Support Systems, Clinical / Q000592:standards*; D008490:Medical Informatics; D015337:Multicenter Studies as Topic