Study Start-up Guidance

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Contact us

To schedule a consultation, contact:

Françoise Crevel, PharmD
Lead Clinical Research Specialist, CTRS 
fmercadi@umn.edu
612-626-8681

Melissa Hansen
Research Navigator
ctsi@umn.edu
612-625-CTSI (2874)

Taking a research study from concept to initiation is a complicated and often challenging journey.

Our Research Preparation Group (RPG) is comprised of experienced Clinical Research Specialists who help researchers and study teams navigate the study start-up process by bringing together appropriate stakeholders and resources.

The RPG supports researchers in each phase of the start-up process; study planning and study activation. 

Phase 1: Study Planning

Clinical Research Specialists can provide the following support to researchers:

 1. Protocol development: 

    • Provide consultative protocol development support with the goal of improving the quality of investigator-initiated clinical research and reducing the time from study concept to final protocol that fulfills UMN Institutional Review Board (IRB) requirements.
    • A Clinical Research Specialist will be assigned to serve as a primary point-of-contact for researchers in navigating protocol development and engage cross-functional experts as needed. 
    • Researchers are provided with knowledge, tools, and resources to aid in the development of their protocol.

 2. Feasibility Review

    • A Clinical Research Specialist convenes a cross-functional team of experts to provide a CRSC Feasibility Review — an objective review of study readiness. 
    • The Feasibility Review includes a 1-week turnaround, free-of-charge review by experienced research professionals from more than 12 cross-functional groups. 
    • The goal of the feasibility review is to assist researchers in early identification of potential barriers or concerns, recommend study-specific enhancements to strengthen the protocol, connect researchers to resources and tools and to decrease the start-up timeline.

 3. Cross-Functional Collaboration

    • The RPG works diligently to convene a panel of specialists (cross-functional groups) specially selected to work collaboratively toward study-related questions so there is no longer the need to separately meet with experts. This support provides comprehensive solutions with increased efficiency and time savings for information that is exchanged between the researcher and experts.

4. Guidance in multisite study planning  

    • A Clinical Research Specialist can also provide researchers and study teams with study guidance for planning multisite clinical studies; this may include connecting them to other resources, such as the Trial Innovation Network (TIN) and Midwest Area Research Consortium for Health (MARCH). 
    • The specialists can also help facilitate consultations with cross-functional experts in the following areas:
      • Single IRB support
      • Standard agreements
      • Recruitment and retention plans
      • Community engagement studios
      • EHR-based cohort assessment
      • Study design
      • Study budget development

**Once regulatory approvals are obtained, RPG helps to streamline the study activation.  

Phase 2: Study Activation

Clinical Research Specialists further supports researchers and study teams to accelerate study activation. They coordinate closely with the Clinical Research Support Center staff to work through barriers and engage with stakeholders and leadership as needed. They are proactive in identifying issues, such as:

    • Study implementation in the clinic
    • Contract negotiation
    • Patient engagement in research
    • Issues involving health information compliance