FORMS E
Important Changes to NIH Forms
NIH will require the use of application packages with a Competition ID of ‘FORMS-E’ for due dates on or after
January 25, 2018.
Applications prepared using the prior ‘FORMS-D’ packages for due dates after
January 24, 2018 will be rejected without review by NIH.
Changes are focused on human subjects questions and clinical trials but other changes apply to all applications:
1.
If your research involves human subjects in any way,
including human specimens and data, please be aware of the new questions below:
2.
If “yes” to Human Subjects you will need to create a Study Record:
*Study Record Screen Shots Appear After the Resource Links Below*
Links to resources:
Is my project a clinical trial?
Decision-making tool:
https://grants.nih.gov/policy/clinical-trials/definition.htm
See example case studies here:
https://grants.nih.gov/policy/clinical-trials/case-studies.htm
FAQ:
https://grants.nih.gov/grants/policy/faq_clinical_trial_definition.htm
Training Video for the Study Record:
https://grants.nih.gov/policy/clinical-trials/new-human-subject-clinical-trial-info-form.htm
Instructions the Study Record:
https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general/g.500-phs-human-subjects-and-clinical-trials-information.htm
Screen Shots of New Form and Study Record:
Data
Collection
for
Delayed
Onset
Study
Study
Record:
PHS
Human
Subjects
and
Clinical
Trials
Information
Full
study
records
are
comprised
of 5
sections.
Inclusion Enrollment
Report
Data
Collection will be in Study Record