Workflow in Clinical Trial Sites and Data Quality Figure 3. Dynamic model with the policies suggested (circled). Available for best visualization in http://goo.gl/XydTd. doi:10.1371/journal.pone.0039671.g003 represents workflow with the implementation of policies where the time to complete CRF was reduced. The ideal workflow may depend on factors that of not immediate implementation, therefore the implementation of the policies had a small reduction of rework and still kept it. Discussion To the best of our knowledge, this is the first study evaluating and mapping workflow at clinical trial sites while also conducting a simulation to represent the potential for improvement once the main issues were addressed. In our study, several factors affecting workflow pointed towards the lack of interoperability between the electronic medical record and electronic data capture system at the clinical trial site, namely visit-EDC asynchrony, EMR-EDC non-interoperability, lab-EDC non-interoperability, decentralized accounting for drug dispensa- tion). Factors affecting this relation included the presence of standalone and disconnected systems taking care of schedule management, administration, lab reporting, medical records, and research databases. This results in fragmented and siloed data that are seldom useful for research purposes. In many cases, it has been noted that the data from EMR cannot be directly utilized in a clinical trial environment on account of incompatible data formats and non adherence to clinical research regulations [41]. As a consequence, despite the availability of state of art systems, information is frequently recorded manually on charts followed by separate data entry into the EMR and EDC. The lack of interoperability thus leads to less efficiency, duplication [41], and errors, leading to disruption of the clinical trial pipeline and damages estimated in million dollars/year. In our study, near miss events for data quality were also influenced by a discontinuity in performance of a specific task. Specifically, rather than having one individual performing the entire task, the process was broken and implemented by more than one individual. Although this practice is aimed at workflow distribution and enhancing productivity and efficiency of different individuals it also serves to increase the possible flow quality PLoS ONE | www.plosone.org 7 June 2012 | Volume 7 | Issue 6 | e39671