1. Clinical Research Workflow
UMH listed as study site in ePRost
Research Analyst (RA) notified of research protocol via eProst automated or direct from ORA No
RA notifies study coordinator to add UMH as study/performance site
Yes
RA ensures UMH Clinical Research Services form uploaded to eProst and completed correctly, including required resources
RA reviews protocol details and requests additional information from study team as needed
Additional information may include:
CMS/FDA letter
Recruitment brochure
Sponsor details
RA works with study team to address requirements and prepare for Research Review Committee
Study team to prepare presentation template, to include resources, budget and contract requirements
Observational studies and chart review may not warrant approval by Research Review Committee
When budget and contract nearing finality, RA coordinates study team presentation to Research Review committee for approval
RA submits approval in eProst when approved by Research Review Committee and forwards approval letter to study team
Approval may be delayed pending final contract, budget or IRB issues
RA works with study team to coordinate Site Initiation Visit (SIV)
RA advises study team to initiate in-services for applicable departments
Staff training log to be ed to Research Analyst
RA confirms IRB Approval in eProst
RA coordinates appropriate access to UMH departments and Medical Records
Version Date: 04/11/2017