This is a required attachment. The link to add the attachment appears below the budget periods, and just before the Cumulative Budget section.
Note: For applications submitting a Data Management and Sharing Plan, include a brief Data Management and Sharing Justification.
For information on file naming and uploading attachments, see the eGC1 and Grant Runner Attachments article.
This optional form allows you to enter data about your modular budget. The Modular Grant application does not require a categorical breakdown of direct costs requested in the application; however, other requirements still apply. Review the application directions for specific modular instructions.
For more information about the use of Modular Budgets, view the NIH Modular Research Grant Applications page.
When you click Add New Budget Periods an accordion will open for you to enter the data for the period.
The system pre-populates the Budget Period Start and End Dates based on your project dates. You can change the values.
For each budget period you will need to enter the following data:
If you need additional entries for Indirect Costs, use the Add New B. Indirect Costs button to create another data entry row.
See GIM 13 Facilities and Administrative (F&A) Rates for more information.
You can click Collapse to close the accordion at any time.
The periods you entered will display on the page with dates and total values. The last row of the table will display the overall totals.
To Make Changes: Click on the Expand link to make changes to the data entered.
To Remove a Period: Use the Delete link to remove the period from the list.
The system calculates the values for this section. You can expand the section accordion to review the values.
The budget justification is an important section in any proposal. Use it to state why an item costs what it does, and to indicate how each item relates to the research plan. Be sure to provide sufficiently detailed information to address all sponsor concerns with respect to cost and need. In general, explanations should be more detailed for competing than for non-competing applications (Include project salary, percent effort, fringe benefits, travel, supplies, analyses, equipment, F&A rate and unallowable costs.)
You can add attachments for Personnel Justification, Consortium Justification and Additional Narrative Justification. Consult your sponsor instructions to determine which of these you might want to add.
In the Consortium Justification, list the individuals and/or organizations with whom you have (or will) make consortium or contractual arrangements, the percent of effort of key personnel and their role on the project, and indicate whether the collaborating organization is foreign or domestic. If you propose a contract/consortium arrangement, include a letter of commitment or intent.
Note: For NIH applications submitting a Data Management and Sharing Plan, Data Management, Sharing Costs and a brief Data Management and Sharing Justification must be provided as part of the Additional Narrative Justification
The following image shows the attachments section:
Note: If you connect a SAGE Budget to your Grant Runner application when using the RR Detailed Budget, the system will automatically add periods and data to the RR Detailed Budget form. The form will become read-only, except for the link to add the Budget Justification attachment. In addition, a link to the Sponsor Budget Map page will appear on the left navigation menu. The Sponsor Budget Map shows how your SAGE Budget data flows into the RR Detailed Budget form.
The information on this page covers an application without a connected SAGE Budget.
This help page covers the following sections of the budget:
In a new budget period, this section has headings and an Add New Equipment button.
Each time you click the button, a new row displays, as shown.
Maximum Items Rule
You can add up to a maximum of 10 items. Once the maximum is reached, the Add New Equipment button is no longer selectable. A link to add an attachment, summarizing any additional equipment costs, will appear. The attachment is not required.
If you do add the attachment, then you must enter the total costs of the equipment described in the attachment.
Use this section to enter domestic or foreign travel costs, if any.
The Total Travel Cost field is automatically calculated for you.
Use this section to enter any costs related to participant and/or trainee support. Be sure to enter the Number of Participants/Trainees following the totals line.
Note: You must enter both a description and the dollar amount if you use the Other (specify) row.
The Total Participants/Trainee Support Costs field is automatically calculated for you.
Use this section to enter in any other direct costs for your proposal. You can include up to 10 custom descriptions with values. If you add a description, you must enter a value. Similarly, if you add a value, you must enter a description.
Note: For applications submitting a Data Management and Sharing Plan, Data Management and Sharing Costs must be noted as a single line item.
The Total Other Direct Costs value is automatically calculated for you.
The following image shows this section:
This section displays the calculated total for sections A through F.
By default, a new budget period will include one blank Indirect Cost row. OSP requires at least one set of data.
If you need to add additional rows, select the Add New Indirect Cost button. You may add up to a maximum of 4 indirect costs. Once the maximum is reached, the Add New Indirect Cost button is no longer selectable.
Each row includes a Delete link at the far right which will completely remove the row and all of its data values.
The Total Indirect Costs field is automatically calculated for you.
This section displays the calculated total for all direct (Section G) and indirect (Section H) costs for this budget period.
This section displays the entered value for any fees associated with this budget period.
Note: a Subaward budget does not include this section.
The section displays the total of sections I and J for this budget period.
Note: a Subaward budget does not include this section.
You must include this NIH form with your application. For descriptions of the attachments, see the specific instructions for your opportunity and OSP’s Grants.gov page.
Use the corresponding links to add each attachment. Follow the formatting and length specifications in the sponsor’s instructions for each specific attachment. All attachments must be PDFs. For general information about managing Grant Runner attachments, see eGC1 and Grant Runner Attachments.
Grant Runner File Names: All Grant Runner attachment names must be unique across all forms. The NIH allows file names that contain alpha-numeric characters, hyphens (-), and underscores (_), followed by a single period (.) and the extension “pdf” in lowercase. NIH does not allow spaces in the file name.
1. Introduction to Application (for RESUBMISSION or REVISIONS only)
Note: This will only display for the appropriate application types.
2. Specific Aims
The NIH requires the Specific Aims attachment unless otherwise specified in the Funding Opportunity Announcement.
3. Research Strategy
Required for all applications.
4. Progress Report Publication List
List the titles and complete references to all appropriate publications, manuscripts accepted for publication, patents, and other printed materials that have resulted from the project since it was last reviewed competitively.
5. Vertebrate Animals
Complete this section if you answered Yes to the question Are Vertebrate Animals Used? on the R&R Other Project Information Form.
6. Select Agent Research
Select agents are hazardous biological agents and toxins which DHHS or USDA have identified as having the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal and plant products. The CDC and the Animal APHIS Select Agent Programs jointly maintain a list of these agents at http://www.selectagents.gov/.
7. Multiple PD/PI Leadership Plan
For applications designating multiple PD/PIs, you must include a leadership plan.
8. Consortium/Contractual Arrangements
Explain the programmatic, fiscal, and administrative arrangements to be made between the applicant organization and the consortium organization(s).
9. Letters of Support
Provide all appropriate letters of support, including any letters necessary to demonstrate the support of consortium participants and collaborators such as Senior/Key Personnel and Other Significant Contributors included in the grant application.
10. Resource Sharing Plan(s)
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When you have developed resources with NIH funds and published the associated research findings or provided them to NIH, it is important that the resources are readily available for research purposes to qualified individuals within the scientific community.
11. Other Plan(s)
The NIH Data Management and Sharing Plan can be attached here.
12. Authentication of Key Biological and/or Chemical Resources
Not required.
13. Appendix
According to OSP, you should only add an appendix if it is specifically called for in the instructions. Otherwise, it may affect your submission.
You can upload one or more PDF documents (maximum of 10) to satisfy the sponsor requirements for this section.
You must include this NIH form with your application if the Activity Code is a K type. For descriptions of the attachments, see the specific instructions for your opportunity and OSP’s Grants.gov page.
Use the corresponding links to add each attachment. Follow the formatting and length specifications in the sponsor’s instructions for each specific attachment. All attachments must be PDFs. For general information about managing Grant Runner attachments, including file naming rules, see eGC1 and Grant Runner Attachments.
1. Introduction to Application
Note: This will only display for the application types of Resubmission and Revision. NIH requires the attachment.
2. Candidate Information and Goals for Career Development
Required for all NIH applications.
3. Specific Aims
The NIH requires the Specific Aims attachment unless otherwise specified in the Funding Opportunity Announcement.
4. Research Strategy
Required for all applications.
5. Progress Report Publication List
Note: This will only display for the application type of Renewal.
List the titles and complete references to all appropriate publications, manuscripts accepted for publication, patents, and other printed materials that have resulted from the project since it was last reviewed competitively.
6. Training in Responsible Conduct of Research
Required for all NIH applications.
7. Candidate’s Plan to Provide Mentoring
This is required for some NIH funding opportunities.
8. Plans and Statements of Mentor and Co-Mentor(s)
This is required for some NIH funding opportunities.
9. Letters of Support
Provide all appropriate letters of support, including any letters necessary to demonstrate the support of consortium participants and collaborators such as Senior/Key Personnel and Other Significant Contributors included in the grant application.
10. Description of Institutional Environment
This is required for some NIH funding opportunities.
11. Institutional Commitment to Candidate’s Research Career Development
This is required for some NIH funding opportunities.
12. Description of Candidate’s Contribution to the Program goals
This may be required for some NIH funding opportunities.
13. Vertebrate Animals
Complete this section if you answered Yes to the question Are Vertebrate Animals Used? on the R&R Other Project Information Form.
14. Select Agent Research
Select agents are hazardous biological agents and toxins which DHHS or USDA have identified as having the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal and plant products. The CDC and the Animal APHIS Select Agent Programs jointly maintain a list of these agents at http://www.selectagents.gov/.
15. Consortium/Contractual Arrangements
Explain the programmatic, fiscal, and administrative arrangements to be made between the applicant organization and the consortium organization(s). Check your funding opportunity instructions to determine if the attachment is required.
16. Resource Sharing Plan(s)
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When you have developed resources with NIH funds and published the associated research findings or provided them to NIH, it is important that the resources are readily available for research purposes to qualified individuals within the scientific community.
17. Other Plan(s)
The NIH Data Management and Sharing Plan will be provided in this new attachment. Updated instructions accordingly.
18. Authentication of Key Biological and/or Chemical Resources
This is an optional attachment.
19. Appendix
According to OSP, you should only add an appendix if it is specifically called for in the instructions. Otherwise, it may affect your submission.
You can upload one or more PDF documents (maximum of 10) to satisfy the sponsor requirements for this section.
U.S. Citizen or Non-Citizen National?
You must answer Yes or No to this question. If you answer No, the following question will display.
If no, select most appropriate Non-U.S. Citizen option
The options are:
If you select “Temporary U.S. Visa” the following optional statement appears. Check the box, if appropriate.
If you are a non-U.S. citizen with a temporary visa applying for an award that requires permanent residency status, and expect to be granted a permanent resident visa by the start date of the award, check here.
You must include this NIH form with your application for a fellowship opportunity. For descriptions of the attachments, see the specific instructions for your opportunity and OSP’s Grants.gov page.
Use the corresponding links to add each attachment. Follow the formatting and length specifications in the sponsor’s instructions for each specific attachment. All attachments must be PDFs. For general information about managing Grant Runner attachments, including the rules for naming your PDF, see eGC1 and Grant Runner Attachments.
1. Introduction to Application (for Resubmission or Revision applications)
Note: This will only display for the appropriate application types.
2. Applicant Background and Goals for Fellowship Training
Required for all applications.
3. Specific Aims
Required for all applications.
4. Research Strategy
Required for all applications.
5. Respective Contributions
Required for all applications.
6. Selection of Sponsor and Institution
Required for all applications.
7. Progress Report Publication List (for Renewal applications)
Required for renewal applications.
8. Training in the Responsible Conduct of Research
Required for all applications.
9. Sponsor and Co-Sponsor Statements
Required for all applications.
10. Letters of Support from Collaborators, Contributors, and Consultants
Required for all applications.
11. Description of Institutional Environment and Commitment to Training
Required for all applications.
12. Description of Candidate’s Contribution to the Program goals
Required for all applications.
Are Vertebrate Animals Used?
The Yes or No choice for this item is taken from the RR Other Project Information form and repeated here for your reference. Any change to this item must be made on that form.
13. Are vertebrate animals euthanized?
Select Yes or No. If you answer Yes, then the following question appears:
Is method consistent with American Veterinary Medical Association (AVMA) guidelines?
If you answer No, then use the text box to describe the method used and provide scientific justification.
14. Vertebrate Animals
Required for all applications.
15. Select Agent Research
Select agents are hazardous biological agents and toxins which DHHS or USDA have identified as having the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal and plant products. The CDC and the Animal APHIS Select Agent Programs jointly maintain a list of these agents at http://www.selectagents.gov/.
16. Resource Sharing Plan(s)
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When you have developed resources with NIH funds and published the associated research findings or provided them to NIH, it is important that the resources are readily available for research purposes to qualified individuals within the scientific community.
17. Other Plan(s)
Although NIH Data Sharing Policies are not applicable to fellowship applications, the attachment was added for potential future use with other plans.
18. Authentication of Key Biological and/or Chemical Resources
Required for all applications.
19. Human Embryonic Stem Cells
Select Yes if this application involves the use and/or creation of human embryonic stem cells in any portion of this research project.
If you answer Yes, additional fields will display. You will need to either use the check box to indicate that the specific cell line cannot be referenced at this time or enter the specific line(s) being used.
To enter cell line information, click on the Add New Cell Line Registration Numbers button. This will display a text box in which you can enter the cell line registration number. Click the button again to add more cell lines as needed up to a maximum of 200 stem cell lines. For more information, see GIM 36 Human Embryonic Stem Cell Research Policy and Guidelines and the NIH’s Stem Cell Registry.
20. Alternate Phone Number
Enter a phone number.
21. Degree Sought During Proposed Award
Select the appropriate degree from the drop-down menu and indicate the Expected Completion Date.
22. Field of Training for Current Proposal
Select the appropriate field from the drop-down menu.
23. Current or Prior Kirschstein-NRSA Support?
Select Yes or No. If you answer Yes, complete the additional fields.
24. Applications for Concurrent Support
Select Yes or No.
25. Citizen
Select Yes or No. If you answer No, the following question will display.
If no, select most appropriate Non-U.S. Citizen option
The options are: Permanent U.S. Resident Visa or Temporary U.S. Visa.
If you select “Temporary U.S. Visa” the following optional statement appears. Check the box, if appropriate.
If you are a non-U.S. citizen with a temporary visa applying for an award that requires permanent residency status, and expect to be granted a permanent resident visa by the start date of the award, check here.
26. Change of Sponsoring Institution
Select Yes or No. If you answer Yes, then enter the name of the former institution.
27. Tuition and Fees
Select Funds Requested or None Requested. If you select Funds Requested, then enter the appropriate dollar amounts for Year 1 through Year 6. The system will calculate the Total Funds Requested.
28. Childcare Costs
Select Funds Requested or None Requested. If you select Funds Requested, then enter the appropriate dollar amounts for Year 1 through Year 6. The system will calculate the Total Funds Requested.
29. Present Institutional Base Salary
Enter the Amount, select the appropriate Academic Period from the drop-down menu, and enter the Number of Months.
30. Stipends/Salary During First Year of Proposed Fellowship
In part a. Federal Stipend Requested, enter the Amount and Number of Months.
In part b. Supplementation from Other Sources, enter the Amount, the Number of Months, the Type, and the Source.
31. Appendix
You can upload one or more PDF documents (maximum of 10) to satisfy the sponsor requirements for this section, if your opportunity instructions specifically call for it.
Note: If you connect a SAGE Budget to your Grant Runner application when using the RR Detailed Budget, the system will automatically add periods and data to the RR Detailed Budget form. The form will become read-only, except for the link to add the Budget Justification attachment. In addition, a link to the Sponsor Budget Map page will appear on the left navigation menu. The Sponsor Budget Map shows how your SAGE Budget data flows into the RR Detailed Budget form.
The information on this page covers an application without a connected SAGE Budget.
In this section, you need to include all of the senior or key research personnel.
Select Add New Key Person to add a row to the section. Complete the following fields.
| Field | Description | ||
|---|---|---|---|
| Name | Use the multiple field entry to add name information. Only the first and last names are required (indicated by the red outline).
Once you add the name information, the page will shift to displaying the name followed by “(edit)”. Click on the name to make any necessary changes. |
||
| Project Role | Use the text box to enter the appropriate role for each person entered.
Note: For the Detailed Budget, you must add at least one person with the specific role of “PD/PI” in each budget period. The first person you list with that role must match the PI listed on the SF 424 form. If the PI for the eGC1 is different than the PI for the Grant Runner application, use the Application PI role type on the eGC1 PI, Personnel, & Organizations page. The first PD/PI you list must then match the Application PI’s information. The match is based on first and last name only. Commonly used roles are:
|
||
| Base Salary | Enter the base salary for each person listed. This field is not required. | ||
| Calendar, Academic, and Summer Months | Use these columns to indicate the amount of time each person will be working on the project for this budget period. Some amount of effort is required. Enter either the number of calendar months or a combination of academic and summer months.
For example, the first three rows below have valid entries. The last one is not valid, as indicated by the red outline, because there are values in all three columns.
|
||
| Requested Salary, Fringe Benefits | Enter the amount of salary and any fringe benefits requested for each person listed. These are required fields, but the value may be zero. | ||
| Funds Requested | This final column is automatically calculated and is the sum of the Requested Salary and Fringe Benefits values. The field is displayed as read-only. | ||
| Delete Link | A Delete link displays at the far right of the table for each person listed. Use this link to completely remove the data for that person. You will be prompted to confirm the deletion. |
SAGE will calculate the value for the “Total Funds for Key Persons” field.
Once you have added 8 key personnel, the Add New Key Person button can no longer be selected and the message “Maximum allowable by the Sponsor has been reached” will display. A link to add an attachment for any additional personnel will appear, as shown in the following image.
In this section, include the other general categories of personnel who will be working on the research. The form automatically includes the first four Project Roles. You can also add other categories of personnel by clicking on the Add New Other Personnel button.
This example shows an added row for a Data Analyst.
You can add up to 6 additional rows for other personnel types. Once you have added 6 rows, the Add New Other Personnel button can no longer be selected and the explanation “Maximum allowable by the Sponsor has been reached” will display.
| Field | Description |
|---|---|
| Number of Personnel | Use this field to indicate how many individuals are in this role. |
| Project Role | There are 4 fixed roles built into the form. |
| Calendar, Academic, and Summer Months | As in Section A, use these columns to indicate the total amount of time this group of people will be working on the project for this budget period. Some amount of effort is required. Enter the total number of calendar, academic, and summer months. |
| Requested Salary, Fringe Benefits | Enter the total amount of salary and any fringe benefits requested for this group of people. These are required fields, but the value may be zero. |
| Funds Requested | This final column is automatically calculated and is the sum of the Requested Salary and Fringe Benefits values. The field is displayed as read-only. |
| Delete Link | A Delete link only displays (at the far right of the table) for custom personnel roles. Use this link to completely remove the data. You will be prompted to confirm the deletion. |
SAGE will calculate the values for the Total Number of Personnel and the Total Other Personnel Costs ($) fields.
This form is required for all NIH applications using Grant Runner.
Select PHS Human Subjects & Clinical Trials from the left navigation menu to open the form. The form consists of several sections:
This section displays the answers to the Other Project Info form’s Human Subjects questions.
In this section, you must indicate if your research will involve human specimens or data.
If you answer “Yes” then a link to add an attachment will display. Attach a PDF formatted file explaining any use of human specimens and/or data not considered to be human subjects research. See your funding opportunity announcement and agency-specific instructions for additional guidance.
If you answered “Yes” to Are Human Subjects Involved on the Other Project Info form, this section will display.
Add a record for each proposed Human Subject study by selecting Add New Full Study or Add New Delayed Onset Study. There is also an option to import a study. For specific details on the steps involved, please see the Adding HSCT Studies article.
Attach any other relevant documents as requested by the sponsor. The attachment should be a PDF formatted file. See your funding opportunity announcement and agency-specific instructions for additional guidance.
Download Alert: If you are trying to download the subaward form when using Chrome, you may get what appears to be an error page. See the steps for Chrome below for instructions.
Use the Add Studies section to add the appropriate studies to your Human Studies & Clinical Trails (HSCT) form.
You can add two types of studies:
To add a full study, you can select Add New Full Study in the Add Studies section of the form to directly enter your data.
You also have the option of completing all or part of a PDF version of the full study, and then importing the PDF data into your Grant Runner application.
Use the Download Blank Study Form link to get a copy of the PDF form. Note: Other versions of this form will not upload properly.
Known issue: Steps for Chrome
When you click the “Download Blank Study Form” link, a page displays that refers to the version of Adobe Acrobat being used, and the file is not immediately downloaded. Look for the standard download icon on the upper, right corner of the page. Move your mouse to that area if the icon is not visible. Once you use the download icon, you will need to indicate where to save the file. Once saved, you can open the file and enter data.
Once you’re done filling in the form, select Import New Study to import your PDF. You can then edit the imported data, if needed.
You must include a Study Title (item 1.1) and answer all of the questions 1.4.a-1.4.d on your PDF before you can import it. If your opportunity does not allow clinical trials, or you have not answered “Yes” to all of the questions 1.4.a-1.4.d, then any data in your PDF for sections 4 and 5 will not be imported. For assistance in answering questions 1.4.a-1.4.d, review the NIH’s Definition of a Clinical Trial.
The full study part of the form is long, so we’ve given each section its own editable page in SAGE. As you work your way through completing the form, you can navigate back to any higher-level page by using the breadcrumb at the top of the page. At the bottom of each page is a button to return to the next higher-level page. Sections two and four also have subsections with the same navigation choices.
The sections and subsections for the Full Study are:
When you select Add New Full Study, the first page you will see is called “Full Study Details” as shown in the image below.
This page has several items to note:
To enter data into a form section, select Edit Section to open the page for that section. Use the breadcrumb or the button at the bottom of each section page to navigate back to the Study Details page.
This section contains the following fields. Please refer to your funding opportunity announcement and agency-specific instructions for additional guidance.
| Field | Description |
|---|---|
| 1.1. Study Title | You must enter a unique title that describes the study. Your title will display at the top of the each page of the study. |
| 1.2. Is this Study Exempt from Federal Regulations?
1.3. Exemption Numbers |
You must answer Yes or No to this question.
If you answer Yes, you must indicate at least one Exemption Number. |
| 1.4. Clinical Trial Questionnaire | There are four questions. By default, question 1.4.a will be answered Yes and not be editable, since study records are only available when Human Subjects is Yes. Answer Yes or No as appropriate for the other 3 questions.
If the answers to all four questions are yes, then your study meets the definition of a Clinical Trial. For assistance in answering, review the NIH’s Definition of a Clinical Trial. The questions are:
|
| 1.5. Provide the ClinicalTrails.gov Identifier (e.g., NCT87654321) for this trial, if applicable | Enter your identifier. It starts with NCT and contains 8 digits. Once you have entered the full identifier, the button will be enabled. When you select the Import from ClinicalTrials.gov button, Grant Runner will check if the identifier is valid, and if so, will populate the HSCT Full Study with the following ClinicalTrials.gov fields:
The imported data will replace any previously entered data on the HSCT Full Study. After import, you can edit any of the information as necessary. |
This section contains the following fields. Please refer to your funding opportunity announcement and agency-specific instructions for additional guidance.
| Field | Description |
|---|---|
| 2.1. Condition or Focus of Study | Select the Add New Condition link to enter the name(s) of the condition(s) you are studying or the focus of the study. See funding opportunity announcement and agency-specific instructions for additional guidance. |
| 2.2. Eligibility Criteria | List the study’s inclusion and exclusion criteria. |
| 2.3. Age Limits | Use these pairs of fields to enter the Minimum and Maximum Ages. Pick the relevant time unit from the drop-down menu. If data is entered for one of these field, it must be entered for both unless you select N/A (no limit) from the drop-down. |
| 2.3.a. Inclusion of Individuals Across the Lifespan | Add an attachment, if appropriate. |
| 2.4. Inclusion of Women and Minorities | Add an attachment, if appropriate. |
| 2.5. Recruitment and Retention Plan | Add an attachment, if appropriate. |
| 2.6. Recruitment Status | Select a value from the drop-down menu, if appropriate. Choices are:
|
| 2.7. Study Timeline | Add an attachment, if appropriate. |
| 2.8. Enrollment of First Participant | Enter an Enrollment Date, and select either Anticipated or Actual from the accompanying drop-down menu. If data is entered for one of these field, it must be entered for both. |
| 2.9 Inclusion Enrollment Report | Select the Add New Inclusion Enrollment Report link to open the subsection page. |
This section contains the following fields. Please refer to your funding opportunity announcement and agency-specific instructions for additional guidance.
| Field | Description |
|---|---|
| 3.1. Protection of Human Subjects | Add an attachment, if appropriate. |
| 3.2. Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site?
Single IRB plan |
Select Yes, No, or Not Applicable as appropriate. This question is not required.
Add an attachment, describing the Single IRB Plan, per your opportunity instructions |
| 3.3. Data and Safety Monitoring Plan | Add an attachment, if appropriate. |
| 3.4. Will a Data and Safety Monitoring Board be appointed for this study? | Select Yes or No, as appropriate. |
| 3.5. Overall Structure of the Study Team | Add an attachment, if appropriate. |
This section contains the following fields. Please refer to your funding opportunity announcement and agency-specific instructions for additional guidance.
Note: If your opportunity does not allow clinical trials, then this section will not be editable. If your opportunity does allow clinical trials, this section will become editable when questions 1.4 a-d are all answered “Yes”.
| Field | Description |
|---|---|
| 4.1. Study Design | This item consists of sub items a through g, described in the following table rows. |
| 4.1.a Detailed Description | Enter the description of the protocol. |
| 4.1.b Primary Purpose | Select a value from the drop-down menu. Choices are:
|
| 4.1.c Interventions | Use the Add Intervention link to open a subsection. All three fields are required for each intervention you add. The fields are Intervention Type (choices listed below), Name, and Description. Use the breadcrumb or Return button to re-display Section Four.
Intervention Types are:
|
| 4.1.d Study Phase | Select a value from the drop-down menu. Choices are:
Also answer yes or no to the question “Is this an NIH-defined Phase III clinical trial?” |
| 4.1.e Intervention Model | Select a value from the drop-down menu. Choices are:
|
| 4.1.f Masking | Select Yes or No. If yes, you must also answer Yes or No to four masking types:
|
| 4.1.g Allocation | Select a value from the drop-down menu. Choices are:
|
| 4.2. Outcome Measures | Use the Add New Outcome or Measure link to open a subsection page. All four fields are required for each outcome or measure you add. The fields are:
Use the breadcrumb or Return button to re-display Section Four. |
| 4.3. Statistical Design and Power | Attach a PDF formatted file. |
| 4.4. Subject Participation Duration | Enter the time it will take for each individual participant to complete all study visits. See agency-specific instructions for additional guidance. |
| 4.5. Will the study use an FDA-regulated intervention?
4.5.a. If yes… |
Answer Yes or No.
If yes, attach a file that describes the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status. |
| 4.6. Is this an application clinical trial under FDAAA? | Answer Yes or No. |
| 4.7. Dissemination Plan | Attach a PDF file. |
This section has just one item: 5.1. Other Clinical Trial-related Attachments. Use the Add Attachment link to attach one or more files.
Note: If your opportunity does not allow clinical trials, then this section will not be editable. If your opportunity does allow clinical trials, this section will become editable once you have answered “Yes” to all of the questions 1.4 a-d.
To include a delayed onset study, select Add New Delayed Onset Study in the Add Studies section of the summary page. Delayed onset studies are those for which there is no well-defined plan for human subject involvement at the time of submission, per agency policies on Delayed Onset Studies.
You must provide a Study Title, answer Yes or No to the Anticipated Clinical Trial question, and add a Delayed Onset Study Justification attachment for the omission of human subjects study information.
You must include this NIH form with your application.
Indicate if animals will be euthanized.
If Yes, then indicate if the method is consistent with AVMA guidelines. If No, then use the text box to describe the method used and provide scientific justification.
The answer to the question Is program income anticipated during the periods for which the grant support is requested displays as read-only, and is based on data you entered on the SF 424.
If you provide a value greater than zero for Estimated Project Income (in the Estimated Project Funding section of the SF 424), the value for Program Income will be Yes; if the Estimated Program Income is zero, the value is No.
When Program Income is Yes, then you must include at least one Budget Period. Click on the Add New Income Budget Period button. The page will refresh and show a budget period entry line. Enter the appropriate values for these additional fields:
Click the Add button again to include up to 5 budget periods.
You can use the Delete link to remove any existing period.
Select Yes if this application or subaward involves the use and/or creation of human embryonic stem cells in any portion of this research project.
If you answer Yes, additional fields will display. You will need to either use the check box to indicate that the specific cell line cannot be referenced at this time or enter the specific line(s) being used.
To enter cell line information, click on the Add New Cell Line Registration Numbers button. This will display a text box in which you can enter the cell line registration number. Click the button again to add more cell lines as needed up to a maximum of 200 stem cell lines. For more information, see GIM 36 Human Embryonic Stem Cell Research Policy and Guidelines and the NIH’s Stem Cell Registry.
Select Yes if this application involves human fetal tissue obtained from elective abortions.
If you answer Yes, then two attachments are required:
If you indicate Yes for Inventions and Patents, you will also need to indicate if the information has been Previously Reported.
Indicate whether the Investigator and/or Institution has changed.
For a change of Institution, enter the name of the former institution.
For a change of Investigator, enter the name of the former PI/PD.
