Using Electronic Medical Records Systems for Clinical 使用电子病历系统的临床应用.pptVIP

Using Electronic Medical Records Systems for Clinical Research: Benefits and Challenges  Introduction Opportunities Availability of clinical, financial and administrative data in electronic form Challenges Using EMR Software for research operations Using EMR Data for research? Suitability of care-oriented data to clinical research needs. EMRs queried directly to answer research questions EMR/Clinical Research Information System (CRIS) Differences: Research Subjects Subjects are not necessarily “patients”. Personal Health Information may be optional. Not all screened subjects are enrolled. Simultaneous or sequential enrollment Eligibility Criteria EMR/CRIS Differences: The Study Calendar Events/Visits and Study Calendar: Specific evaluations or interventions are done at specific time points (events) relative to the start of the study. All patients are not enrolled at the same time. EMR/CRIS Differences: Electronic Data Capture (EDC) CRIS EDC is Far More Structured and Fine-grained – textual comments are only a last resort. CRISs may need to Support Real-Time Self-reporting of Subject Data CRIS EDC may not always be Real-Time. Quality Control considerations dictate many workflow steps. EMR/CRIS Differences: Trans-Institutional Scope For trans-institutional scope, Web technology is virtually mandated. Site restriction in Multi-Site studies – end-users and investigators access only their own site’s patients. Trans-National Issues: Software Localization/ Globalization – same software, different language/layout. EMR/CRIS Differences: User Roles CRISs support differential access to studies Most users of a CRIS are unaware of the other studies in the same database. Some users have read-only access to the data; some only view reports. Only certain users may be allowed to enter data in particular forms, or even view certain blinded data. Data analysts typically do not need to access PHI. However, in multi-institutional studies, they are not typically site-restricted