CRC at CTSI

Process Mapping & Gap Analysis

Prepared by:Hilary ButlerDan Chen

Anand KulkarniGaurav Srivastava

Ingrid Warrner

Process overview

Stage 1 Stage 2 Stage 3

Protocol approval Protocol planning Patient visits

Submission Recruitment Scheduling

Budgeting Informed consent Implementation

Feasibility review Organizational meetings Compliance documentation

Advisory Committee review Screening Data Entry

Modifications Processing instructions Sample Processing

IRB and CRC approval

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Issues/Recommendations• Protocol Approval/ Stage 1

– Inefficient tracking mechanism for pre-approval of studies/ Implement “live” online tracking system which feasibility team could input feedback .

• Planning/Stage 2– SC and nursing staff fielding calls from

potential study recruits/ Create a centralized hub to pre-qualify/screen subjects and direct to proper information source

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Issues/Recommendations• Planning/ Stage 2

– Duplicate of demographic information entry/ Develop a “one-stop” database that can be accessed by PI teams and CRC personnel

• Patient Visits/ Stage 3– Operations Mgr overloaded with

Webcamp/offload data entry of demographic info to admin asst.

– Room scheduling/ Use Outlook type calendar system that would allow the SC or nurse to book the appt. when speaking with the pt.

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Developed a Process Map/ SOPs• A process map was created that will be a work

in progress and we will need to drill down to specifics

• Confirmed the need for us to organize the location and specific SOPs that are pertinent to the CRC and develop ones that are specific to the activity within the process map

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Gap analysis tool• Found a tool for us to use to ensure that our

SCs are meeting FDA GCP and ICH Guidelines • It is a starting point where we can update and

customize as we further develop our SOPs for each step of the process

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Key takeaways• Reduce manual processes by relying on

integrated electronic systems– Fully utilize WebCamp or some other

software to better track studies• Streamline scheduling and ICD verification

processes• Implement a centralized recruiting center• Improve documentation and develop SOPs