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.
- ‘Pre-applications’ are
not allowed, unless specifically indicated for a mechanism (e.g., X02).
- If
a resubmission, revision, or renewal, Federal Identifier must match a prior
grant in the IMPAC II database.
- If
a resubmission, prior grant must have been reviewed but not awarded.
- 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.
- DUNS
for applicant organization must match DUNS recorded in the Commons for that organization.
- State
required for US and Canada,
must be blank for all others.
- Zip
code required for US.
- Type
of application accepted: New, Resubmission, Revision or Renewal.
- Either
Exemption Number or Assurance Number must be specified if Human Subjects
are involved.
- Exemption
Number must be “E1” through “E6.”
- Provide warning if Human Subject Assurance Number doesn’t
match IPF human subject assurance number for this organization.
- If
Vertebrate animals
are used, one of
the following must be provided:
- Assurance
Number + IACUC Approval Date
- Assurance
Number + IACUC Approval Pending
- The
word ‘None’
- Animal welfare assurance
number should match animal welfare assurance number for this organization.
- Project
Summary limited to one page.
- Project
Narrative (Public Health Relevance Statement) limited to one page.
- Provide
warning if PD/PI name doesn’t match name in Commons
account, unless application is for Change of PI.
- Commons ID must be provided on the Key
Person page for the PD/PI.
- The
Commons account must be affiliated with the applicant organization.
- Biosketch
limited to four pages.
- Accept ‘Additional’ Senior/Key Person Profiles and attachments only if all
distinct profiles have been listed.
- Budget
start date, if provided, must be the same as the project start date.
- PD/PI
listed on budget page must be the same as PD/PI designated for the application.
- Provide
warning if both academic and calendar months have been provided for a person
for a budget year.
- 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.
- A fee cannot be entered
for a subaward/consortium budget.
- 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.
- An answer is required
to Human Subjects Clinical Trial (Y/N) if the answer to ‘Human Subjects
Involved’ is "Yes".
- 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".
- If HESC involved=’Y’,
must include cell lines or ‘Can’t be Referenced’. Cell lines must match
cell lines in IMPAC II database.
- For a modular budget, direct costs must be <= 250K, and must be
a multiple of 25K for each budget year.
- Name of former PI must
be included if application is for change of PI.
- Introduction must be
included for resubmissions.
- Progress Report must
be included for renewals.
- Research Design and Methods
required for all submissions, unless specifically excepted for the mechanism.
- Inclusion of Women and
Minorities, Targeted/Planned Enrollment Table, and Inclusion of Children
required if Human Subjects is true and Exemption is not E4.
- Data and Safety Monitoring
Plan required if Human Subjects is true and Clinical Trial question is true.
- Vertebrate Animals attachment
required if vertebrate animals are used.
- Appendixes limited to
10.