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Implementing a Study
Locate personalized support, best practices, and resources for study and data management, intervention development, multisite research opportunities, post-award data analysis, participant recruitment, and more.
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Guiding Questions
Offerings available to:
Free
Connect with epidemiologists, biostatisticians, data analysts, and data scientists across U-M to enhance your health research outcomes
Free
Delineates the systematic storage, tracking and retrieval of clinical research records
Initial consultations are free. Staff statisticians are available at $90/hour for short-term projects or on an FTE basis for longer-term projects, such as clinical trials.
Engage with data analysis experts to ensure rigor in your clinical and translational research
Range from $50 – $326 per hour (detailed breakdown under “What is this offering?”)
Supports outcome assessments for clinical trials that include measures of development, cognition, quality of life, adaptive functioning, and mental health
Free
Comprehensive assistance that ensures your clinical trials meet public and regulatory standards on time
Facilitator cost, studio supplies, and staff time are covered by MICHR. Research teams are asked to pay for expert compensation.
Interactive session where researchers can enhance their projects with input from patients, caregivers, health care providers and community members
Free
Consultation to facilitate research participation by reducing potential barriers to participation and making research opportunities more accessible
Free
Traceable Case Report Forms crafted to connect each data point back to its origin, ensuring data integrity
Free
Mentoring on tools and techniques that promote high-quality data from an experienced data manager
Fee-based at $90/hour
Partner with a MICHR study developer to construct a database that promotes secure and efficient management of your data
Free
Support for navigating the FDA’s Expanded Access Program to obtain investigational drugs, biologics or devices for patients with no other clinical options
Fee-based at $81/hour.
Support and expertise to prepare and submit investigational new drug (IND) and investigational device exemption (IDE) applications to the FDA
Fee-based at $81/hour.
Support for all submissions to the FDA for sponsor-investigated studies conducted under an investigational new device (IND) or investigational device exemption (IDE).
Free
Guidance in assessing if you need an investigational new drug (IND) or investigational device exemption (IDE) for your study
Initial consultations are free. Further services are fee-based at $110/hour.
Consultation to streamline a study with MICHR’s advanced informatics tools like REDCap, EMERSE, and UMHealthResearch.org, alongside custom data solutions
Free
End-to-end customer support for key research applications, including i2b2/SHRINE, REDCap and UMHealthResearch.org
Free
A guide for diligent management of IRB applications and reporting obligations through meticulous documentation and tracking of responsibilities
Free
A guide to tailor internal audits to the study’s context and history, documenting all resolutions for continuous improvement and adherence to ethical, safe, and high-quality research protocols