Expanded Access to Investigational Products
MICHR’s expanded access support provides assistance for physicians throughout the process of requesting single patient expanded access.
MICHR’s expanded access support provides assistance for physicians throughout the process of requesting single patient expanded access.
Have you and your research benefitted from the support of a mentor or peer mentor? Does your mentor or peer mentor have a track record of successfully mentoring students, fellows, staff, or early career faculty at the University of Michigan? Consider nominating your mentor or peer mentor for the Distinguished Clinical & Translational Research Mentor Award or Peer Mentor Award. This award is part of MICHR's continuing efforts to foster a culture of learning, especially in the area of clinical and health research.
Our free in-person consultations offer personalized support and advice for your grant proposals or research ideas and are available to any U-M investigator.
MICHR's editor will carefully review your grant to identify red flags in the content; ensure logic, flow and clarity of ideas; eliminate jargon; improve sentence structure and grammar; and comment on unclear text.
MICHR’s biostatistics team consults and collaborates with researchers to provide expertise in all of your statistics needs.
MICHR provides customer service for applications it supports.
MICHR offers a variety of cutting-edge informatics software and services to help your study with data capture and clinical data management.
MICHR offers two online training courses for REDCap.
REDCap is a secure, HIPAA-compliant, web-based application offering a streamlined process for rapidly developing databases in support of data capture for research projects.
Study management mentoring services empower study teams to efficiently plan, initiate, and manage their research study using standard tools and best practices.
Our monitors will follow standard operating procedures and detailed monitoring plans (written in conjunction with the investigator) to provide a tailored approach for monitoring needs.
This training provides information on the Sponsor-Investigator requirements of an IND or IDE and resources to assist in order to be in compliance.
The MICHR IND/IDE Investigator Assistance Program (MIAP) provides support for all submissions that may be required by an active IND or IDE.
The MICHR IND/IDE Investigator Assistance Program (MIAP) provides support and expertise to prepare and submit Investigational New Drug and Investigational Device Exemption applications to the FDA.
MICHR can help determine whether our engaged participant registry, UMHealthResearch.org is an appropriate recruitment tool for your study and, if it is, teach you how to maximize the potential of UMHealthResearch.org for your study.
MICHR offers tailored educational presentations on topics related to community engagement. We can adapt the presentation content to fit the needs of specific audiences.
MICHR offers assistance in connecting potential research partners who have complementary interests and areas of expertise.
RCR4K is a four-session seminar exploring the responsible conduct of research, designed for early career faculty members who have been awarded a career development award.
Our skilled study developers work with your study team and other clinical research professionals to design project databases built for efficient collection, management, and analysis of research data.
Data management mentoring services empower study teams to efficiently collect and manage their research data using standard tools and best practices.