August 13, 2024

Common NIH-only Errors

The following information was included as part of an email communication sent on August 14 to users with the SAGE ASTRA roles of Proposal Preparer, SAGE Global Edit, OSP System Admin, OSP Subcontracts, and OSP Administrator.

---

Below is a list of some of the more common NIH business rules that will generate errors post-submission if not addressed, and that will not be found in Check for Errors on the eGC1 until the NIH connection is available.  These are rules common to R01, R03, and R21 opportunities.  The full list of NIH validations is here.

General Notes

• Keep Human Subjects and Vertebrate Animals responses consistent between forms.
• Budget amounts must not exceed the allowable limit on the FOA
• Check the page limits for your attachments, per the FOA

 

Form	NIH Error
R&R Other Project Info	The Project Summary/Abstract is limited to 30 lines of text.
R&R Other Project Info	The Project Narrative attachment should not be longer than 2 or 3 sentences.
PHS 398 Cover Page Supplement	You must answer the “Is method consistent with AVMA guidelines?” question if you answer Yes to the “Are animals euthanized?” question.
PHS 398 Cover Page Supplement	You must provide the euthanasia method and scientific justification if you answer No to the “Is method consistent with AVMA guidelines?” question.
PHS 398 Cover Page Supplement	You must provide specific human embryonic stem cell lines or check the “Specific stem cell lines cannot be referenced at this time” box if you answer Yes to the “Does the proposed project involve human embryonic stem cells?” question.
PHS 398 Cover Page Supplement	You must answer the “AgencyDefined Phase III Clinical Trial” question if you answer Yes to the “Clinical Trial?” question.
PHS 398 Cover Page Supplement	You must answer the “Inventions and Patents” question if you select Renewal as the Type of Application on the SF424 (R&R) Form.
PHS 398 Cover Page Supplement	The HFT Compliance Assurance and HFT Sample IRB Consent Form attachments are required if the question ‘Does the proposed project involve human fetal tissue obtained from elective abortions?’ is ‘Yes’.
PHS Human Subjects & Clinical Trials	If you answered “Yes” to the “Are Human Subjects Involved” question on the Other Project Information form, you must provide at least one Study Record or Delayed Onset Study.
PHS Human Subjects & Clinical Trials	Note:  There are extensive and complex validations for the HSCT form that are not outlined here, but can be referenced in the full NIH Validations Guide.  You can also consider using ASSIST if concerned about missing error checks pre-submission.
PHS 398 Research Plan	Data Management and Sharing Plan attachment required
PHS 398 Research Plan	The Vertebrate Animals attachment is required if the response to the Vertebrate/Animals Subject Used question on the Other Project Information is “Yes”
PHS 398 Research Plan	The Multiple PI Leadership Plan attachment on the PHS 398 Research Plan must be included if multiple PD/PIs have been included on the Senior/Key Person Profile.
PHS 398 Research Plan	The Data Safety Monitoring Plan attachment is required if the response to the Clinical Trial question on the cover Page Supplement is “Yes”.
RESUBMISSIONS, REVISIONS, CHANGE/CORRECTED APPLICATIONS
SF424	A Federal Identifier is required for Resubmission, Revision and Renewal applications. Include only the institute code and serial number of the prior application/grant number in the Federal Identifier field (e.g., use CA987654 extracted from full application/grant number 1R01CA987654-A1).
SF424	The Previous Grants.gov Tracking ID is required if the application is marked as ‘Changed/Corrected’.
SF424	“Progress Report Publication List” or the “Progress Report” attachment is not required for Resubmission of a New application.
PHS Research Plan	The Introduction attachment for revision/resubmission/renewal application is limited to one (1) page.

Warnings Only

Form	NIH Error	R01	R03	R21	Resubmits
PHS 398 Modular Budget	In most cases, a Personnel Justification attachment should be included.	X	X
RR Other Project Info	In most cases, a Bibliography and References Cited attachment should be included.	X	X
SR424  (from general info start & end dates on eGC1)	Be sure that you have complied with the allowable project period limitations for this Opportunity Announcement. Applications that do not comply with these instructions may be delayed or not accepted for review.  (If project period > 2 years long)		X	X