21 CFR Part 11 

If you would like to create a project to use with an EXISTING study, follow the steps below:  

  1. Open a support ticket and select these options:
    1. 21 CFR Part 11 Validated REDCap service 
    2. Request a new research project 
    3. Create new REDCap Project shell in REDCap P11

You will be asked the following questions:

  1. List the IRB/HIC number for the protocol, full name of PI and full study name
  2. Is there data that needs to be imported into the project? How much? Please describe.
  3. Does the project need to use the REDCap API?
  4. Does the project require any external modules? If so, which?
  5. Will your project be collecting participant e-surveys or patient reported outcomes?
  6. If you are not building/designing the project, include name and NetID of REDCap Project builder
  7. Do you need REDCapPRO enabled?