Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM)

Efficient communication of a clinical study protocol and case report forms during all stages of a human clinical study is important for many stakeholders. An electronic and structured study representation format that can be used throughout the whole study life-span can improve such communication and potentially lower total study costs. The most relevant standard for representing clinical study data, applicable to unregulated as well as regulated studies, is the Operational Data Model (ODM) in development since 1999 by the Clinical Data Interchange Standards Consortium (CDISC). ODM’s initial objective was exchange of case report forms data but it is increasingly utilized in other contexts. An ODM extension called Study Design Model, introduced in 2011, provides additional protocol representation elements.Using a case study approach, we evaluated ODM’s ability to capture all necessary protocol elements during a complete clinical study lifecycle in the Intramural Research Program of the National Institutes of Health. ODM offers the advantage of a single format for institutions that deal with hundreds or thousands of concurrent clinical studies and maintain a data warehouse for these studies. For each study stage, we present a list of gaps in the ODM standard and identify necessary vendor or institutional extensions that can compensate for such gaps. The current version of ODM (1.3.2) has only partial support for study protocol and study registration data mainly because it is outside the original development goal. ODM provides comprehensive support for representation of case report forms (in both the design stage and with patient level data). Inclusion of requirements of observational, non-regulated or investigator-initiated studies (outside Food and Drug Administration (FDA) regulation) can further improve future revisions of the standard.     

Treatment,deterrence or labelling: mentally disordered offenders’ perspectives on social control

Mentally disordered offenders are a group of service users who experience substantial amounts of control and supervision. This article uses theories of social control to analyse the way in which mechanisms of control are understood by this group. Semi‐structured interviews with mentally disordered offenders in England who were subject to a restriction order under the Mental Health Act 1983 (as amended by the Mental Health Act 2007) provided the empirical basis for this study. The offenders had a number of perspectives on the restriction order. Firstly, it was seen as a mechanism for identifying those suffering from a mental disorder and for providing appropriate treatment. Secondly, the restriction order was viewed as a form of disciplinary control through which societal norms might be internalised. Thirdly, it was seen as labelling offenders in a manner that was experienced as limiting and oppressive. A number of research participants were aware that the order acted to limit staff actions. These participants saw the order as a means by which they might shape the support that they received in order to further their own aims.A video abstract of this article can be found at: https://www.youtube.com/watch?v=qwIwDI2sOTY&feature=youtu.be