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Step 3: For CoC Applications to NIH 

Learn What is Required for an NIH CoC Application

To complete your application, you will need the following documentation (items with a "*" are to be uploaded into the application system):

  1. To Login with NIH Single Sign-on; click here for more info
  2. Your Insitution’s Federalwide Assurance (FWA) Number. FWAs are issued by OHRP; click here for more info on obtaining an FWA
  3. Documentation of final IRB approval of you project* OR approval contingent ONLY on getting a CoC
  4. A copy of your IRB approved consent form with appropriate language about the COC* (click here for suggested consent language). If the study has multiple consent forms, please combine all into one document prior to uploading
  5. A list of key personnel. You may either enter information about each key personnel into the system or you may upload a document listing all key personnel
  6. For studies NOT funded by NIH that will administer drugs, the application requires that you identify the drug(s) to be administered and provide information about the methods of an authorization for administration.
  7. For studies in which controlled drugs will be administered, a copy of the DEA certificate/registration*
  8. An assurance document signed by the Principal Investigator and an Institutional Official*; click here to access the template for this Assurance form
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