CPRN Registry IRB Protocol

The CPRN IRB Protocol

The following CPRN sites that have been approved/signed the master agreement for the National Pediatric Research Alliance (PEDSnet) follow:

Boston Children’s Hospital
Cincinnati Children’s Hospital
Children’s Hospital of Colorado
The University of Colorado, Denver
Nationwide Children’s Hospital
The Nemours Foundation
Seattle Children’s Hospital

Nationwide Children’s Hospital will have these IRB’s complete and send NCH their PEDSnet determination form and NCH project-specific checklist, which indicates their willingness to cede review to the NCH IRB.

For any sites that are not approved for PEDSnet, the site may sign a project-specific NCH Institutional Review Board (IRB) Authorization Agreement that is based on the OHRP format and NCH project-specific checklist.

agreement forms and checklist, but you may want to hold off on distribution until you can also include the NCH IRB application pdf and the NCH IRB approval letter – most relying IRBs will want to have these before they will cede review to NCH IRB. Also, I have asked PEDSnet for an updated determination form that includes the recently added CHLA and Children’s Mercy Hospital.

5. We will want relying sites to sign the IAA first and when you amend the NCH study to add their site, we will fully execute the IAA and send them the final document, along with the amendment approval letter. You will be able to add several sites to the study in one amendment to save time.