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. Quality, Research & Public Health (QRPH) Planning Committee 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. Quality, Research & Public Health (QRPH) Planning Committee 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.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.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.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. Quality, Research & Public Health (QRPH) Planning Committee Use Case – Basic Study Information Research Study Management System User EMR Analyst/User IRB Management System User

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

6. Quality, Research & Public Health (QRPH) Planning Committee Summary Content Exchange Definition Needed ElementCurrent StateRisk NCT#Multiple system manual entryManual entry errors IRB#Multiple system manual entry and maintenance (with renewal/updates) Manual entry errors Updates not made in all systems Short NameMultiple system manual entryInconsistency in entry in multiple systems Study TypeMultiple system manual entryManual entry errors Study PI/key staffMultiple system entry and maintenanceEntries/updates not made in all systems. Information unreliable; functionality may be inappropriately limited by failure to maintain Protocol Definition/Schedule of Events Duplicate system entry and updates/maintenance- Time consuming, labor intensive build in multiple systems -High risk for inconsistency introduction -High risk for protocol definitions becoming out of sync in multiple systems - Clinical and billing compliance at risk if errors or maintenance not in sync

7. Quality, Research & Public Health (QRPH) Planning Committee Use Case EMR-based recruitment methodsEMR-based recruitment methods Study Staff notified of potential candidate through EMR Potential Candidate Identified by EMR functionality and flagged as possible study candidate Study Definition and Relevant Screening Criteria built into EMR Study Staff Adds Patient to Candidate tracking in CTMS

8. Quality, Research & Public Health (QRPH) Planning Committee Summary Content Exchange Definition Needed ElementCurrent StateRisk Eligibility CriteriaTranslate from Protocol Information to Screening tool configuration in EMR - Inefficiency, additional resources required for setting up screens - Potential candidates missed EMR user identifies potential candidate Sends candidate information to CTMS study tracking Initiating System for Patient-Study Association May Be EMR

9. Quality, Research & Public Health (QRPH) Planning Committee Stakeholder Benefits

10. Quality, Research & Public Health (QRPH) Planning Committee Proposed Standards & Systems Existing systems:Existing systems: –Clinical trials management systems (CTMS) –Electronic medical record systems (EMR) Standards of interest: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. Quality, Research & Public Health (QRPH) Planning Committee Discussion Level of effort: MediumLevel of effort: Medium Profile Editor: Vassil Peytchev, Epic, vassil@epic.comProfile Editor: Vassil Peytchev, Epic, vassil@epic.com Questions/Comments?Questions/Comments?