Clinical Trialists
MICHR works in collaboration with the Clinical Trials Support Office, the hub for clinical trials at Michigan Medicine. We also provide a number of services and resources for clinical trialists.
Featured Services for Clinical Trialists
The Clinical and Translational Science Pilot Award aims to support new and innovative research projects relevant to clinical & translational science (CTS). CTS is a field of investigation focused on understanding a scientific or operational principle that underlies a step of the translational process, with the goal of developing generalizable principles to accelerate translational research.
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 you develop and review recruitment materials, identifying obstacles that may affect participant recruitment for your study.
Featured Resources for Clinical Trialists
The Implementation Science Network (ISN) Toolkit outlines resources for investigators interested in pursuing implementation science research, with an eye towards building capacity for implementation science across U-M and beyond that also bridges community-based and health equity research to inform successful competitive research funding with the goal of reducing health disparities.
This document describes the FDA regulations specific for conducting a clinical trial with a non-significant risk (NSR) device.
This self-guided course is designed to outline best practices for clinical research. While these best practices are based in the principles of Good Clinical Practice (GCP) from the International Conference on Harmonization, this course is not able to fulfill requirements to complete GCP training.
The goal of this e-learning course is to enable learners to apply good clinical practice (GCP) principles to clinical research investigations involving human subjects as they specifically apply to social and behavioral research.
This job aide provides supplemental resources and tips for study team members responsible for the process of using electronic consent (eConsent) for clinical and translational research. It provides key messages and discusses issues involved with eConsent, with a particular focus on the issue of accessibility.
This is a protocol template for investigator-initiated clinical drug trials. It is not intended for use with medical device trials or hematology-oncology trials.
Upcoming Events
Have you completed basic instruction in clinical research but are looking for more? The Instruction in Monitoring, Procedures Documentation and ClinicalTrials.gov (IMPACT) workshop series is designed for study team members who are ready for an intermediate level of training for clinical trials skills. Participants will learn critical clinical research skills through a group learning environment and hands-on skills practice.
On May 21, 2024, BRISP will present a conference on “Advancing Behavioral Science through AI and Digital Health.” The conference is designed for BSSR scientists to learn about AI and applications to their research. It brings together several AI experts on campus and features Keynote Speaker Amy Bucher, Ph.D., Chief Behavioral Officer at Lirio.
In Winter/spring 2024, MICHR will offer the popular Responsible Conduct of Research (RCR) for K Awardees, a seminar that is designed to meet the requirements of the NIH K-23, or any federal or non-federal career development grant.
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.