Trial Start-Up

• Sponsor site selection visits
• Investigator and staff training
• Regulatory compliance
• Regulatory packet preparation and submission
• IRB submission
• Contracting and budgeting
• Site coordination

Trial Conduct

• Site set-up
• Staff in-services and training
• eCRFs (electronic case report forms)
• Study product management
• Patient recruitment and advertising
• Informed consent process
• Enrollment and study visits
• Site monitoring visits
• IRB reporting
• Sponsor communication
• Patient retention and follow-up
• Invoicing and data collection
• Adverse event reporting
• Study closure and site audits

After the Trial

• Results analysis
• Publications
• Planning for future projects

Contact us at 304.691.1836 to get started!

The Marshall University IRB and Office of Research Integrity (ORI) provide guidance on SOPs, required education and training and other research resources.

• IRB Website: http://muwww-new.marshall.edu/ori/
• IRB Telephone: 304.696.7320
• MCRC Telephone: 304.691.1836

The IRB uses IRBNet, a paperless system for submissions, continuing review, and oversight. All forms and instructions, including the IRBNet User Manual, are available online:

• IRBNet Website: https://www.irbnet.org/release/index.html

Contact the IRB or MCRC if you have questions that aren’t addressed online.

The IRB and MCRC are here to assist you, not to create obstacles. Guidance is designed to ensure compliance and streamline the research process.

Marshall University is AAHRPP-accredited, which requires strict adherence to regulatory and ethical standards. Compliance is mandatory for all investigators.

If documentation seems repetitive or overly complex, your feedback is welcome. The IRB and MCRC can clarify requirements and explain the rationale behind forms and processes.

Tips for success:

• Stay focused on the goal
• Complete all questions and sections fully
• Reach out to the IRB or MCRC if you need assistance

For physicians interested in pursuing their own research ideas, the MCRC offers full support:

• Study design
• Data collection and statistical analysis
• Staffing and training

Investigator-initiated projects also enhance professional growth through publications, grant opportunities, and recognition as a leader in your field.

Sponsors seek physician investigators to host clinical drug trials. The process typically begins with a site qualification questionnaire and visit—MCRC provides support to ensure readiness.

Key considerations:

• Evaluate whether the trial fits your patients and practice
• Review inclusion/exclusion criteria carefully
• Provide realistic enrollment estimates—avoid overpromising
• Don’t base decisions solely on the budget; high reimbursement may reflect higher demands
• Make time for monitoring visits and sponsor communication to build long-term relationships
• Declining a trial that isn’t a good fit preserves credibility and future opportunities

The MCRC assists with negotiating contracts and ensures compliance with West Virginia law and local regulations. All legal documents with Marshall Health must be signed by a corporate officer. Typical timelines:

• Confidentiality agreements: 1-2 weeks
• Contract negotiations: 2-4 weeks

Most physicians can incorporate clinical trials into their existing schedules. Study visits are typically part of routine care and require minimal additional time. The MCRC team guides you through extra visits or tasks to keep the process efficient.

Regular responsibilities may include:

• Meeting with study coordinators
• Reviewing study issues and providing oversight
• Attending sponsor site visits (usually every 1–3 months, depending on the contract)