OnCore Draft Migration Schedule & Tracker
We will be partnering with investigators and their teams between October 2017 and July 2018 to migrate currently active clinical trials into OnCore, and transitioning studies under the support of a Clinical Trials Support Unit. Oncology trials will begin migrating later in 2018. We have developed a draft schedule and tracker (accessible via Level 1 password). This plan is preliminary. CTSO leadership will be systematically reaching out to schedule an in-person meeting at least two months in advance with each study team to meet and discuss next steps. More information is available from your CTSU Administrator or by emailing CTSOgroup@umich.edu.
Work Guides for Study Teams and CTSUs
Draft work aids developed from the redesigned workflows and in collaboration with departments, study teams, and the CTSUs are available by clicking the below link and entering in your Level 1 password.
CTSO Process Templates & Tools
- The NIH released the final protocol template developed in collaboration with the US Food and Drug Administration (FDA), which applies to NIH-funded Phase II and III clinical trials requiring investigational new drug application (IND) or investigational device exemption (IDE). The final version is available in Word Document format. There is also a Clinical e-Protocol Tool available to facilitate the development of these protocols.
- Standard Protocol Items Recommendations for Interventional Trials (SPIRIT) 2013 Fillable Checklist and related SPIRIT Guidelines. As published in BMJ, the guidelines provide full rationale and description, examples from actual protocols, and relevant references. Researchers are strongly encouraged to use the guidelines in conjunction with the SPIRIT Checklist.
Calendar Review & Analysis Office (CRAO)
CRAO completes a Medicare Coverage Analysis (MCA) and partners with the CTSUs to create billing calendars for all Human Subject Clinical Trials that have billable items and services to ensure consistency with the five core documents which are the Protocol, Informed Consent, Billing Calendar, Budget, and Contract and to allow for the appropriate adjudication of charges.
Michigan Institute for Clinical & Translational Research (MICHR) Resource Center
Explore this site to find resources that MICHR has created to help study teams, including best practices, standard operating procedures (SOPs), templates, toolkits, and more.
Office of Research & Sponsored Projects (ORSP)
The Office of Research and Sponsored Projects enables and safeguards the conduct of research and other sponsored activity for the University of Michigan.
MiChart Research Resources Site
Institutional Review Boards (IRBMED)
eResearch is the University of Michigan's site for electronic research administration.
UMHealthResearch.org facilitates communication between health researchers and volunteers so they can find one another and establish a partnership built on trust and mutual respect.
UM Nutrition Obesity Research Center (NORC)
The mission of UM Nutrition Obesity Research Center (NORC) is to identify improved methods for the prevention and treatment of obesity, supporting a continuum of care from primary, secondary, tertiary prevention.
ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.
NIH Clinical Trials Resources
The National Institute of Health provides in depth guidance for investigators and staff of clinical trials, including several protocol templates, NIH definition decision tree & FAQ, enrollment guidance, and more.