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)