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.
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.
Community-engaged research (CEnR) occurs when academic institutions and community organizations come together to make real and lasting change in the form of practices, programs, and ultimately policies that mobilize resources and influence systems.
The Detroit Area Mental Health Leadership Team, a community-engaged research partnership with MICHR, collaborated with community-academic partners in Metropolitan Detroit to develop an advocacy brief examining the impact of stigma in cases of opioid use disorder (OUD) and recommend public health approaches to re-designing recovery services during the COVID-19 pandemic.
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.
This page includes decision worksheets for investigators who may need to submit an Investigational New Drug or Investigational Device Exemption Application.
In 2016, the Michigan Institute for Clinical & Health Research (MICHR) met with community partners in Flint to identify ways it could support their recovery. The meeting resulted in MICHR funding several research projects focused on the Flint Water Crisis.
This pages includes decision worksheets and FDA guidance documents for investigators who may need to submit an Investigational New Drug or Investigational Device Exemption Application.
To address the need for consistent training and assessment of research skills, MICHR has collaborated three other universities to create the DIAMOND portal. The portal is a digital collection that serves as a sustainable, federated database for members of clinical and translational research study teams to share and access training and assessment resources.
Are you new to team science or not sure what it even is? The following videos will give you a taste of the skills, knowledge and resources that are important for doing team science well.
The videos were developed in collaboration with the Michigan Medicine Office of Faculty Development. Videos are based on the Top 10 Take Aways and other content from the National Cancer Institute’s Collaboration and Team Science: A Field Guide.
This toolkit has information and resources to help prepare you to apply for large scale grants.
The Statistical Analysis Plan (SAP) Sample Template for Clinical Trials is a technical document that describes the planned statistical analysis of a clinical trial as outlined in the protocol.
This self-guided course is designed to introduce you to regulatory responsibilities of sponsors and investigators of drug and device studies.