Regulatory Management: Pre-Application Checklist

Prior to starting an application, all Study Team members (including non-UM personnel) will need to obtain either a uniqname and UMICH password (for U-M staff and faculty),  or in some cases a Friend or Sponsored account (for non-UM personnel).
Note If you are a new non U-M user, refer to Obtaining Access to eResearch for non-UM users for more information.

Review the following important items below that you will need to complete an application.
Tip  Many questions can be answered by uploading documents within the appropriate section and then referring to that section when answering the question. You can also cut and paste from existing documents, but you may lose formatting when pasting into eResearch (for example, superscripting, Greek characters, and bolding). 

Checklist items

• General Study Information    
  • PI contact information
  • Faculty advisor contact info (if applicable)
  • Project title
  • Estimated start and end dates
  • Sponsor and funding information
• Key Personnel    
  • Contact information for all key personnel associated with study
  • Key Personnel must complete PEERRS certification before the application can be approved.
  • For non-affiliated investigators, provide an Individual Investigator Agreement
• Informed Consent    
  • Use a template when drafting your informed consent
  • Type of consent you are obtaining or waiver you are requesting
  • Related consent questions
  • See Consent Guidelines for additional guidance in completing this section
• Performance Sites    
  • Address information for all performance sites associated with study
  • Permission being obtained for each site
• Project Abstract    
  • Lay terminology/abstract level description of research
• Research Design    
  • Description of hypothesis/desired outcome
• FDA submission assessment
  • See MICHR IND/IDE Investigator Assistance Program (MIAP) for assistance
• Significance and Benefits    
  • Description of significance & benefits of research
• Risk to Subjects    
  • Description of risks to subjects
  • Assess minimal risk
• Recruitment    
  • Any recruitment materials, such as posters, fliers, websites, etc.
• Financial Documents    
  • IDS Fee Schedule
  • GCRC Budget

Furthermore, you will be asked to complete additional information regarding:

• Special Considerations and Vulnerable Subjects    
  • Specific questions regarding the following in your research:
    • Using deception
    • Studying minor children, prisoners, pregnant women, impaired adults
    • Studying illegal activities like drug use
    • Studying private activities like sexual behavior
• Exemption    
  • Indicate whether or not you are requesting an exemption for this research
  • See Exemption Criteria for additional guidance in completing this section
• Compensation    
  • Type of compensation you are providing to participants
  • Related compensation questions
• Recruitment    
  • Method of subject recruitment
  • Related recruitment questions
• Confidentiality    
  • How you are protecting the confidentiality of your participants
  • Related confidentiality questions