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

Quality, Research & Public Health (QRPH) Planning Committee The Problem What problem is this profile proposal hoping to address? 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.

Quality, Research & Public Health (QRPH) Planning Committee The Problem Identify any existing IHE profile gaps/overlaps that this proposal will improve upon CRPC will fill the ‘gap’ created by RPE, which requires process content for execution.CRPC will fill the ‘gap’ created by RPE, which requires process content for execution. What is the market readiness for this IHE profile proposal? As the problem statement shows, there is a high demand for improvements to clinical research execution.As the problem statement shows, there is a high demand for improvements to clinical research execution. Please provide examples to illustrate The trend to off-shore execution of clinical trials illustrates the need for simpler trial execution hereThe trend to off-shore execution of clinical trials illustrates the need for simpler trial execution here

Quality, Research & Public Health (QRPH) Planning Committee The Problem What is the risk of this proposal not being undertaken this cycle? There is always the risk that non-standard or competing approaches will emerge to fill the demand.There is always the risk that non-standard or competing approaches will emerge to fill the demand.

Quality, Research & Public Health (QRPH) Planning Committee Use Case Currently most study definition information, including basic information such as NCT#, Study Code, study type, and advanced information such as the study schedule of events, must be built and maintained manually in both the CTMS and the EMR. This profile will allow the study definition to be shared in a machine processable format. Currently it is typically assumed that recruitment happens outside the EMR and that the EMR is always the recipient on information about which patients are associated with which studies. When the EMR initiates the association, there needs to be a mechanism for exchanging the appropriate research participant information at the appropriate points in time.

Quality, Research & Public Health (QRPH) Planning Committee Use Case Today, information related to patient timelines must be maintained manually in both systems. Today, scheduling of research-related services relies extensively on manual workflows and human communication. Changes to patient timelines in one system, if not communicated and adjusted in the other system, can create confusion, at best, and potentially patient disqualification from a study if requisite timelines are not adjusted.

Quality, Research & Public Health (QRPH) Planning Committee Proposed Standards & Systems What standards and/or systems should be considered in addressing this proposal? 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) What alternatives exist?What alternatives exist?

Quality, Research & Public Health (QRPH) Planning Committee Discussion What level of effort do you foresee in developing this profile? Equivalent to CRD.Equivalent to CRD. Is there someone who is willing to act as profile editor? Please provide the name, organization, Vassil Peytchev, Epic