Biosketches for all KEY personnel (5 page max) - see the checklist below. instructions & sample Budget justification - must match the budget spreadsheet we created. Word version is preferred Assignment Request Form (optional) - used to communicate specific application assignment and review requests to NIH. Information will not be part of your application, and it will not be made available to program staff or provided to reviewers. See page R-133 for details. Cover Letter (optional) – generally not included, unless for specific events. Include if using ‘continuous submission’ privileges. Project summary (not to exceed 30 lines) Project narrative (not to exceed 3 sentences) Bibliography/References Facilities/Resources – include all performance sites Equipment – list major items of equipment already available for this project and identify the location & pertinent capabilities. If none will be used, put “N/A”. Other Attachments – only applicable if specifically stated in FOA. ‘Foreign Justification’ goes here Introduction (1 page limit, R25 resubmission can be 3 pages) – only applicable to “resubmissions”
Specific Aims (1 page limit)
Research strategy (Typically 6 pages or 12 pages; refer to program announcement for page limit)
Progress Report Publication List - only required for “renewal” applications
Multi PI leadership plan (if applicable) - click here for examples
Consortium Letters – only applicable if your project has subawards/subcontracts
Letters of support (optional) - from consultants, collaborators, etc. Must be combined into one
single PDF file.
Resource Sharing Plan – see page R-93 for details. If submitting to NIMH follow these guidelines
Authentication of Key Biological or Chemical Resources (1 page max) – only required if project
involves biological and/or chemical resources.
Appendix (optional) – must be combined into one PDF file (make a T.O.C. if needed). See page R-95
for a list of allowable materials. Do not use appendix to circumvent page limits in other sections Human Subjects & Clinical Trials Information (starts on page R-105 form the link above):
If “yes” to human subject research - Add a record for each proposed Human Subject Study by selecting ‘Add New Study’ or ‘Add New Delayed Onset Study’ as appropriate on the HS & CT form. See below for details of what sections are required. Required if “yes” to HS research:
Section 1 – Basic Information:
1.1 – Study Title – enter text on form
1.2 – Is the Study Exempt? – answer y/n on form. If yes, identify exemption #
1.3 – If Yes to 1.2 – identify exemption # on form
1.4 - Clinical Trial? - answer y/n on form. If “yes” to all, study will be flagged as a CT 1.5 - ClinicalTrials.gov Identifier –optional. (N/A to newly proposed studies)
Required if “yes” to HS research and not exemption #4 (not required for E4 applications):
Section 2 – Study Population Characteristics:
2.1 – Conditions/Focus of Study – enter text on form
2.2 – Eligibility Criteria –enter text on form
2.3 – Age Limits – select from dropdown list
2.3a – Inclusion of Individuals Across the Lifespan- upload attachment. See page R-109
2.4 - Inclusion of Women & Minorities – upload attachment
2.5 - Recruitment & Retention Plan – upload attachment
2.6 - Recruitment Status - select from dropdown list
2.7 - Study Timeline - upload attachment (optional if not a clinical trial)
2.8 – Enrollment of First Participant – enter date, select ‘anticipated’ from dropdown list. Don’t
complete if using an existing data set.
2.9 - Inclusion Enrollment Report(s) –select date from dropdown and click “add new inclusion
enrollment report”. Populate all enrollment info.
Required if “yes” to HS research:
Section 3 – Protection and Monitoring Plans:
3.1 – Protection of Human Subjects – upload attachment. See page R-118 for details
3.2 – Multi site study with single IRB plan – answer y/n on form. If yes, must reach out to the
SOM IRB office and budget for costs.
Required for Clinical Trial studies only:
3.3 – Data and Safety Monitoring Plan – upload attachment. See page R-123 for content
3.4 – Will a Data & Safety Monitoring Board be appointed? answer y/n on form
3.5 – Overall Structure of the Study Team (optional, unless required by FOA) – upload
attachment
Section 4 – Protocol Synopsis:
4.1.a. – Detailed Description – enter text on form
4.1.b. – Primary Purpose - select from dropdown list
4.1.c. – Interventions- enter name, description, and select from dropdown list
4.1.d. - Study Phase – select from dropdown list
4.1.e. - Intervention Model – select from dropdown list
4.1.f. - Masking – answer y/n on form. If yes, select at least 1 from 4 choices on form
4.1.g. - Allocation – select from dropdown list
4.2 – Outcomes Measure – enter name, type, time frame, and description on form
4.3 – Statistical Design and Power – upload attachment. See page R-129 for content
4.4 – Subject Participation Duration – enter text on form
4.5 – FDA regulated intervention? – answer y/n on form. If yes, upload attachment to 4.5.a.
See page R-129 for content
4.6 - Applicable CT under FDAAA? – answer y/n on form.
4.7 – Dissemination Plan – upload attachment. See page R-131 for content
Required for Clinical Trial studies only and if requested by the announcement:
Section 5 – Other Clinical Trial related attachment | 