March 2006

Generic Validations Summary
(Applies to all grant applications)

NIH conducts a detailed electronic check (validation) of each SF424 (R&R) application to ensure that it follows the instructions outlined in the SF424 (R&R) Application Guide as well as the Funding Opportunity Announcement. Here is a listing of the generic validations.

  1. ‘Pre-applications’ are not allowed, unless specifically indicated for a mechanism (e.g., X02).
  2. If a resubmission, revision, or renewal, Federal Identifier must match a prior grant in the IMPAC II database.
  3. If a resubmission, prior grant must have been reviewed but not awarded.
  4. Allow up to 3 revisions/amendments (with warning on the third).
    Note: NIH policy to allow only two revisions/amendments (now called resubmission in Grants.gov) of an application (unless an exception is granted because of a change in study section between revisions/amendments, etc.) remains in place. The software is coded to allow for exceptions. The Warning provided on the third revision/amendment will alert staff to verify appropriateness and permissibility of the revision/amendment.
  5. DUNS for applicant organization must match DUNS recorded in the Commons for that organization.
  6. State required for US and Canada, must be blank for all others.
  7. Zip code required for US.
  8. Type of application accepted: New, Resubmission, Revision or Renewal.
  9. Either Exemption Number or Assurance Number must be specified if Human Subjects are involved.
  10. Exemption Number must be “E1” through “E6.”
  11. Provide warning if Human Subject Assurance Number doesn’t match IPF human subject assurance number for this organization.
  12. If Vertebrate animals are used, one of the following must be provided:
    1. Assurance Number + IACUC Approval Date
    2. Assurance Number + IACUC Approval Pending
    3. The word ‘None’
  13. Animal welfare assurance number should match animal welfare assurance number for this organization.
  14. Project Summary limited to one page.
  15. Project Narrative (Public Health Relevance Statement) limited to one page.
  16. Provide warning if PD/PI name doesn’t match name in Commons account, unless application is for Change of PI.
  17. Commons ID must be provided on the Key Person page for the PD/PI.
  18. The Commons account must be affiliated with the applicant organization.
  19. Biosketch limited to four pages.
  20. Accept ‘Additional’ Senior/Key Person Profiles and attachments only if all distinct profiles have been listed.
  21. Budget start date, if provided, must be the same as the project start date.
  22. PD/PI listed on budget page must be the same as PD/PI designated for the application.
  23. Provide warning if both academic and calendar months have been provided for a person for a budget year.
  24. Provide warning if Other Direct Costs  for the project budget is not equal to the sum of Total Direct and Indirect Costs for all consortium/contractual budgets.
  25. A fee cannot be entered for a subaward/consortium budget.
  26. Provide a warning if PD/PI degrees don’t match a subset of degrees listed on the Commons, or if no degrees have been included.
  27. An answer is required to Human Subjects Clinical Trial (Y/N) if the answer to ‘Human Subjects Involved’ is "Yes".
  28. An answer to Human Subjects NIH-Defined Phase III Clinical Trial (Y/N) is required if the answer to ‘Human Subjects Clinical Trial’ is "Yes".
  29. If HESC involved=’Y’, must include cell lines or ‘Can’t be Referenced’.  Cell lines must match cell lines in IMPAC II database.
  30. For a modular budget, direct costs must be <= 250K, and must be a multiple of 25K for each budget year.
  31. Name of former PI must be included if application is for change of PI.
  32. Introduction must be included for resubmissions.
  33. Progress Report must be included for renewals.
  34. Research Design and Methods required for all submissions, unless specifically excepted for the mechanism.
  35. Inclusion of Women and Minorities, Targeted/Planned Enrollment Table, and Inclusion of Children required if Human Subjects is true and Exemption is not E4.
  36. Data and Safety Monitoring Plan required if Human Subjects is true and Clinical Trial question is true.
  37. Vertebrate Animals attachment required if vertebrate animals are used.
  38. Appendixes limited to 10.