Table 2. Variables classified as problematic on visited sites. Visit-EDC asynchrony EMR-EDC non-interoperability CRC-data entry discontinuity Lab-EDC non-interoperability Decentralized accounting for drug dispensation Lack of decision support systems to assist CRC Workflow in Clinical Trial Sites and Data Quality The CRC does not have the time to transcribe the content from the paper-based or electronic medical record to the computerized electronic data capture (EDC) in a timely manner. Electronic medical record (EMR) not integrated with EDC, therefore may cause error or lack of information during transcription from one the EMR computer screen to the one for the EDC. At the time of the encounter with the subject, investigator takes notes on the EMR, nurse takes note on nurse plan and CRC makes the final data entry into EDC. Laboratory system not integrated with EMR, requiring re-entry with potential for transcription errors. System for drug stock control between pharmacy and trials use different systems, with a potential for discrepancy and error. CRC frequently has to consult a variety of documents not available at the time of interaction with research subject. This factor is compounded by a single CRC being in charge of multiple studies supported with paper-based documentation, which might lead to confusion and error. doi:10.1371/journal.pone.0039671.t002 potential for flow quality issues, i.e., following the near-miss event concept, were also identified, mapped and simulated. In total, we observed the activities of four Clinical Research Co-ordinators (CRCs), and identified a total of 139 tasks (Refer to supporting information S1). Ethnographic Field Observations and Workflow Mapping using UML Activity Diagrams General observations. The UML-AD detected four major activities in the workflow, namely (a) evaluation of potential research subjects prior to signature of informed consent (S2), (b) visit to obtain subjects informed consent (S3), (c) regular data collection sessions following study protocol (S4), and (d) closure of study protocol for a given project. Activity A, prior to the signature of the informed consent, the potential research subject underwent a clinical exam as well as additional laboratory exams as per clinical site routine. These are common pathological exams and work as a pre-screening method. The results of these exams help in the evaluation of inclusion and exclusion criteria. During activity B - the visit to obtain subjects informed consent, potential subjects received an explanation about the entire study, described in the informed consent form while being offered the opportunity to ask questions. The PI then requested the subject to sign the informed consent. At this point an individual schedule for the study subject was established. Activity involved a series of encounters representing regular data collection sessions following the variations across different study protocols. Finally, during activity D, the subject either reached completion or was excluded from the study protocol, when study closure was achieved, including the collection of any remaining interventional drug when applicable and also included the plan for any further follow-up when required by protocol. Since each of these activities is distinct, they were represented by different UML-ADs (Refer Supporting information S2, S3, S4). Observations of workflow tasks with higher likelihood of quality issues. Our field observations pointed to three major emerging themes (based on table 1) corresponding to areas where workflow was associated with potential near miss events for data quality issues. Lack of standardized process for data registration at source document. The first emerging theme resulted from the presence of a number of intermediate documents in the transfer of data from research subject to the electronic CRF by CRC. Examples include: (a) Nurse reports were paper-based and later manually transferred to an electronic data capture system; b) Drug stock control was made on tables of text editor or spreadsheet and then printed; c) Results from laboratory exams were printed from their home pages or received by email and subsequently printed, or printed from laboratory computer system applications. Although all of these sources do not violate any current Good Clinical Practice regulations, as CRFs were filled out based on the original source data, the presence of intermediate documents – even if used only for care purposes - increases the odds of error secondary to unintentional transcription errors. In addition, these intermediate steps represent rework. Multiplicity of data repositories. We observed that the information being transferred was registered in different binary files such as Microsoft Word and Excel files. The files were not linked and later were manually transferred using a copy and paste functionality. In one of the sites, documents directly filled out with subjects information were not directly inserted into the CRF by the CRC, but remained in paper-format (source document) for later transcription into the electronic CRF. The paper-based documentation trail also results in search- ability problems, in that, locating specific data fields for validating systems in the area or when checking for possible errors was time- consuming. Adding to the complexity of this process, research nurses were required to fill out multiple forms in accordance to study protocol, this information being transcribed by investigators and later copied and finally pasted by the CRCs. Other parallel systems also contained different, non inter-operable systems such as pharmacy services using multiple Microsoft Excel and Word documents for stock control, drug validity, and medication disposal. Scarcity of decision support systems at the point of research intervention. Given that a single CRC is concom- itantly in charge of multiple studies, it is not unusual that the information about specific details pertaining to each study were sometimes forgotten. This oversight resulted in a major rework loop, in that the correction could only be accomplished through the central coordinating center located in the European Union, not before having to contact the central coordinator for Brazil. The total rework process resulted in a total time loss of approximately two uninterrupted hours. In another instance, the complete period to complete a CRF lasted about one hour, reportedly at least three times more than what that task would PLoS ONE | www.plosone.org 4 June 2012 | Volume 7 | Issue 6 | e39671