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Clinical Research Process Content

Clinical Research Process Content. Brief Profile Proposal for 2011/12 presented to the Quality, Research & Public Health ( QRPH ) Planning Committee Vassil Peytchev (Epic), Landen Bain ( CDISC ) October 7, 2011. The Problem.

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Clinical Research Process Content

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  1. Clinical Research Process Content Brief Profile Proposal for 2011/12 presented to the Quality, Research & Public Health (QRPH) Planning Committee Vassil Peytchev (Epic), Landen Bain (CDISC) October 7, 2011

  2. The Problem • The US clinical research industry has difficulty in gaining participants for research studies, as shown by the increasing use of off-shore sites. One revealing statistic is that 66% of site-based investigators participate in one, and only one, study. A common complaint of site-based researchers is the difficulty of participating in studies, particularly managing the multiple systems required, often one for each study.

  3. The Problem • Research protocols guide the conduct of trials. Many of the interventions and clinical activities pertaining to a study are performed within healthcare organizations and often involve integrated use of the clinical medical record system. • Protocols are complex and in order to appropriately handle the scheduling, ordering, and billing related to those protocols, the EMR must be able to communicate certain information with the systems that manage the study. • The existing IHE profile Retrieve Process for Execution (RPE) acts as a general framework which providing messaging interactions, which could be used to convey the necessary information. The proposed Research Content profiles utilize RPE as a framework and solve the issues of exchanging detailed content specific to the research domain.

  4. Use Case – Basic Study Information IRB Management System User •  Study Name •  Study Code •  Brief Description • Plus: •  NCT # •  IRB # •  Study Type •  Principal Investigator • Study Coordinator • Study short name Research Study Management System User EMR Analyst/User

  5. Use Case – Protocol Definition • Time consuming instantiation of the same complex research protocol definition in multiple systems Study Orders Clinic and Ancillary Scheduling Integrated EMR Functionality Clinical Orders and Services Study Staff and EMR Analyst(s) Study Staff and Research Study Management System Health System Billing

  6. Summary Content Exchange Definition Needed

  7. Use Case • EMR-based recruitment methods Study Definition and Relevant Screening Criteria built into EMR Study Staff notified of potential candidate through EMR Potential Candidate Identified by EMR functionality and flagged as possible study candidate Study Staff Adds Patient to Candidate tracking in CTMS

  8. Summary Content Exchange Definition Needed Initiating System for Patient-Study Association May Be EMR

  9. Stakeholder Benefits

  10. Proposed Standards & Systems • Existing systems: • Clinical trials management systems (CTMS) • Electronic medical record systems (EMR) • Standards of interest: • IHE Retrieve Process for Execution • HL7 Study Design • HL7 Study Participation • CDISC’s Study Design Model • Business Process Management Notation (BPMN)

  11. Discussion • Level of effort: Medium • Profile Editor: Vassil Peytchev, Epic, vassil@epic.com • Questions/Comments?

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