Michigan Institute for Clinical + Health Research
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Studies   Web contents

• My Studies
• My Account
• Instructions
  • How to Add a New Study
  • How to Edit a Study
  • How to Manage Research Participants
  • How to Delete a Study Posting
  • How to Manage Your Account Information
• Clinical Research Resources
  • Educate and Certify Your Team
  • Locate and Obtain Funding
  • Develop Protocol
  • Regulator Approval
  • Budgets and Contracts
  • Recruit Participants
  • Perform Research
  • Analyze and Publish Data
  • Recruitment of Multicultural Research Participation
  • Literature Sources
  • A Timeline of Human Subject Research Regulation

Need Help?

How to Add a New Study How to Edit a Study How to Manage Research Participants How to Delete a Study Posting How to Manage Your Account Information

Obtain Regulatory Approval

With the right approach, full regulatory approval can take as little as 2-3 months. This time can also be used to prepare for the project by obtaining materials, hiring and training staff, and securing space.

Help from an experienced partner will ensure that your approval goes quickly and smoothly.

Regulatory Approval

Assistance with achieving and maintaining regulatory compliance

• Michigan Clinical Research Unit (MCRU)
• Michigan Institute for Clinical and Health Research (MICHR)

All research projects must pass through the offices below for approval

• IRBMED
• Division of Research Development and Administration (DRDA)

Depending on your project, you may also need to contact the following University of Michigan offices

• Investigational Drug Services
• Privacy Board
• Conflict of interest committee
• Office of Technology Transfer

‘Outside the University' to ‘Depending on your project, you may also need to contact the following external offices'

• FDA, to file an Investigational New Drug Application
• FDA, to file an Investigational Device Exemption
• NIH, to obtain a Certificate of Confidentiality
• Many larger projects involve multiple sites. For assistance coordinating regulatory approval at multiple sites, contact the Michigan Institute for Clinical and Health Research(MICHR)

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