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Clinical Studies health research at the University of Michigan: https://umclinicalstudies.org/
- ICMJE Clinical Trial Registration Policy
- Clinical Trials Participation - FAQ for Parents
- Clinical Trials Registration & Results Reporting
- ClinicalTrials.gov Support Materials The ClinicalTrials.gov site contains all the information you need to register a study, edit a registration record, and report results from policies to specific procedures to data element definitions, templates, and checklists.
- Final Rule for Clinical Trials Registration and Results Information Submission
- How to Register a Clinical Trial
- How to Report Clinical Trial Results
- Maintaining and Updating ClinicalTrial.gov Records
- NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
- A fillable PDF worksheet with an extraction of some of the questions in FORMS-E for the SF424 forms set. This worksheet is intended to help Research Administrators (RAs) collect the detailed data and scientific questions they will need from their principal investigators (PIs) to more readily complete FORMS-E in the eResearch Proposal Management System.
Enterprise
Enterprise
As the nation’s largest public research university, the Office of the Vice President for Research (OVPR) aims to catalyze, support and safeguard U-M research and scholarship activity.
The Office of the Vice President for Research oversees a variety of interdisciplinary units that collaborate with faculty, staff, students and external partners to catalyze, support and safeguard research and scholarship activity.
ORSP manages pre-award and some post-award research activity for U-M. We review contracts for sponsored projects applying regulatory, statutory and organizational knowledge to balance the university's mission, the sponsor's objectives, and the investigator's intellectual pursuits.
Ethics and compliance in research covers a broad range of activity from general guidelines about conducting research responsibly to specific regulations governing a type of research (e.g., human subjects research, export controls, conflict of interest).
eResearch is U-M's site for electronic research administration. Access: Regulatory Management (for IRB or IBC rDNA applications); Proposal Management (eRPM) for the e-routing, approval, and submission of proposals (PAFs) and Unfunded Agreements (UFAs) to external entities); and Animal Management (for IACUC protocols and ULAM).
Sponsored Programs manages the post-award financial activities of U-M's research enterprise and other sponsored activities to ensure compliance with applicable federal, state, and local laws as well as sponsor regulations. The Office of Contract Administration (OCA) is also part of the Office of Finance - Sponsored Programs.