The Sponsor Budget Map page will initially show where the SAGE Budget expenses will appear, by default, on the RR Detailed Budget.
The following table is a quick reference of which codes map to which sections of the GR Detailed Budget form. For full details view the Grant Runner Sponsor Budget Map article.
You can use the Sponsor Budget Map page to understand how your SAGE Budget personnel data will initially flow to the RR Detailed Budget form.
In the (01) Salary and Wages section on the Sponsor Budget Map page, you will see one row for each person on your parent budget and any internal sub budgets.
Based on the Project Role you selected for each person in SAGE Budget, each person will map to either the RR Detailed Budget Section A. Senior/Key Person or Section B. Other Personnel.
The columns in this section of the Sponsor Budget Map are:
From SAGE Budget: displaying its Expense Type and Project Role
To RR Detailed Budget: displaying its Category and Project Role
Personnel Order: displaying the relative position in the Section A list for this person. Note: this column is unique to the 01 section.
Initially, you will see the personnel listed in the same Project Role order as on your SAGE Budget. Any personnel from internal sub budgets will display just after those on the parent budget, within each role.
You can adjust the default RR Detailed Budget Project Roles, except for the person who is the PD/PI. In some cases, you can change the default RR Detailed Budget Category (Section A or B).
Optionally, you can change the Personnel Order for those mapped to the RR Detailed Budget Section A by using the “Drag to Re-Order” feature (described below).
For personnel in Section B, in addition to the four default Project Roles, you can create customized ones.
Section A. Senior/Key Persons
When you first view the Sponsor Budget Map page, you will see the personnel listed in the same Project Role order as on your SAGE Budget. Any personnel from internal sub budgets will display just after those from the parent budget, within each role.
Mapping Rules
The following table defines the initial mapping rules and indicates whether the default value can be edited (changed).
SAGE Budget Project Role
RR Detailed Budget Project Role
Can the Role Be Edited?
Principal Investigator
PD/PI; if there is also an Applicant PI, then this role defaults to Faculty
Only if “Faculty” role
Application PI
PD/PI
No
Co-Investigator
Co-Investigator
No
Multiple PI
PD/PI
No
Key Personnel
Depends on the 01 sub-object code selected; defined below
Yes
Mentor
Faculty
Yes. Note: You can map this person to Section B, if appropriate
Faculty
Faculty
No
If you selected Key Personnel for someone’s project role on your SAGE Budget, their sub-object code will determine the default role on the RR Detailed Budget.
01 Sub-Object Codes
Project Role on Detailed Budget
10-14 Instruction & Research Faculty
Co-Investigator
20-24 Auxiliary Teaching Staff
Other Professional
30-34 Graduate School Student Appointments – Teaching
Graduate Student
40-44 Graduate School Student Appointments – Non-Teaching
Graduate Student
50-54 Postdoctoral Research Trainee
Post Doctoral Associates
60-64 Classified Staff
Other Professional
70-74 Professional Staff
Other Professional
80-87 Temporary Staff
Other Professional
88-89 Hourly
Undergraduate Students
90-94 Graduate Stipends
Graduate Students
As needed, you can change the role. Project Role choices for the RR Detailed Budget form are:
Co-PD/PI
Faculty
Post Doctoral
Post Doctoral Associates
Post Doctoral Scholar
Other Professional
Graduate Students
Undergraduate Students
Technician
Consultant
Co-Investigator
Drag to Re-Order Feature
You can use this feature to adjust the order of the personnel mapped to Section A of the RR Detailed Budget. The Personnel Order column displays the text “RR Detailed Budget Position” followed by a number, indicating that person’s place in the order.
The Application PI (if present) will display on the first row. If your budget does not include an Application PI, then the Principal Investigator will be listed first.
After the PD/PI or Application PI (if present), the default order of the personnel entries is by Category (Section A or B) and, within each category, by Project Role with Parent Budget and Sub-Budget personnel grouped together. For example:
Multiple PI (parent)
Multiple PI (sub budget)
Co-Investigator (parent)
Co-Investigator (sub-budget)
Key Personnel (parent)
Key Personnel (sub-budget)
You can use your mouse, or the keyboard, to choose a person’s row to re-order. Move the row up or down to update the position number for that person. Note that the form can list up to eight individuals. Any additional personnel are included in the Additional Senior Key Persons attachment, described below. The PD/PI must be one of the initial eight people listed.
Personnel mapped to Section B will have the note “Not applicable” in the Personnel Order column. You can drag them to a different position on the mapping page, but the next time you view the mapping page, the order will have returned to the Section A personnel followed by those mapped to Section B.
Any changes you make on your connected SAGE Budget or the Sponsor Budget Map page will be reflected on the RR Detailed Budget form when you view it. The ordering of Personnel on both the Sponsor Budget Map page and the RR Detailed Budget form will match the last ordered sequence you created and saved on the Sponsor Budget map page. Any newly entered Personnel, after the initial synchronization, will sort to the bottom of the Sponsor Budget Map page order by default.
Additional Senior Key Persons Attachment on RR Detailed Budget
Section A can display up to eight individuals on the RR Detailed Budget form. You must list any additional personnel in an attachment to the form. When you initially connect your SAGE Budget and Grant Runner application, SAGE will automatically generate and attach the PDF file listing any additional personnel. The file will be named to reflect the budget period. For example, the attachment for Period 3 of your budget will be named “Period_3_Personnel.pdf”. In addition, the system will calculate the Total Funds for Attached Persons value and display it.
Any time you add or remove Section A personnel from your SAGE Budget, or change their order on the Sponsor Budget Map page, the PDF attachment will automatically be recreated to reflect those changes, if necessary.
Section B. Other Personnel
Personnel that map to Section B are combined into the appropriate rows, with their data values totaled.
Mapping Rules
If you select one of these SAGE Budget Project Roles, the individual will be added to the corresponding role in Section B.
Post Doctoral Associates
Graduate Students
Undergraduate Students
Secretarial / Clerical
On the Sponsor Budget Map page, you can shift personnel with the Post Doctoral Associate role to the A: Senior/Key Persons section. You cannot edit the other project roles from the Sponsor Budget Map page. You would change them on your SAGE Budget.
If you select Other for someone’s project role on your SAGE Budget, that person’s sub-object code will determine the default role on the RR Detailed Budget.
SAGE Budget Personnel Sub-Object Code
RR Detailed Budget Project Role Default Value
10-14 – Instruction & Research Faculty
Select…
20-24 – Auxiliary Teaching Staff
Select…
30-34 – Graduate School Student Appointments – Teaching
Graduate Students
40-44 – Graduate School Student Appointments – Non-Teaching
Graduate Students
50-54 – Postdoctoral Research Trainee
Post Doctoral Associates
60-64 – Classified Staff
Secretarial / Clerical
70-74 – Professional Staff
Select…
80-87 – Temporary Staff
Select…
88, 89 – Hourly
Undergraduate Students
90-94 – Graduate Stipends
Graduate Students
When “Select…” displays, you can choose one of the four existing Section B roles listed above, or you create up to six different, customized roles.
Create a Customized Personnel Project Role
Click on “Select…” in the drop-down menu and choose “Other…”
A dialog will display where you can enter the customized name of your project role for Section B. Click Save to return to the Sponsor Budget Map page. The new project role will appear, followed by an Edit link.
Once you have added a customized role, it will appear in the drop-down so that you can choose it for additional personnel. If you edit the customized role, your changes will apply to all personnel with that role.
RR Detailed Budget Personnel Data Sources
Section A. Senior/Key Persons
The following table describes the source data for each RR Detailed Budget field in Section A.
RR Detailed Budget Field
Data Source
Name
SAGE Budget: First, Middle and Last Name
Project Role
Sponsor Budget Map: Project Role
Base Salary ($)
SAGE Budget: Line Setup Starting Monthly Salary * 12 (annualized) * the inflation rate for the period
Calendar Months
SAGE Budget: if Calendar is checked on Line Setup; from Update Periods: Person Months
Academic Months
SAGE Budget: if Academic/Summer is checked on Line Setup; from Update Periods: Academic Person Months
Summer Months
SAGE Budget: if Academic/Summer is checked on Line Setup; from Update Periods: Summer Person Months
Requested Salary ($)
SAGE Budget: from Worksheet (01 item) period amount or Update Periods: Period Total Salary
Fringe Benefits ($)
SAGE Budget: from Worksheet (07 item) period amount or Update Periods: Total Benefits
Funds Requested ($)
System calculated: Requested Salary plus Fringe Benefits
Section B. Other Personnel
The source data for each RR Detailed Budget field in Section B is the same as that for Section A. In this section, the values for a given row are a sum of the values for all personnel with that specific Project Role.
Number of Personnel: the total number of personnel with the specific Project Role
Project Role: the first four rows are the fixed project roles; any custom roles you create will appear below these. There is a maximum of 6 custom roles.
Calendar, Academic, Summer Months: the sums of each type of person months for personnel with the specific Project Role.
Requested Salary ($): the sum of all Requested Salaries for personnel with this Project Role
Fringe Benefits ($): the sum of all Total Benefits for personnel with this Project Role
Funds Requested ($): System calculated: Requested Salary plus Fringe Benefits
The Sponsor Budget Map page shows where the expenses from your connected SAGE Budget will flow to on the RR Detailed Budget form.
A link to the Sponsor Budget Map page will appear on the left navigation menu once you connect your SAGE Budget to your Grant Runner application and the RR Detailed Budget form is either mandatory for your opportunity, or you have selected it.
Use the Sponsor Budget Map page when you have expenses that are not mapped to default fields on the RR Detailed Budget form, or you need to adjust the defaults. A red exclamation “validation icon” will display if you need to complete any mappings.
Note: The Sponsor Budget Map page does not show dollar amounts. It shows you how the various expenses on your budget are categorized for the RR Detailed Budget form. For some expenses, you can use the Sponsor Budget Map to change where and how your data displays on the RR Detailed Budget form.
The following image shows the Sponsor Budget Map link on the left navigation menu.
Note: If the budget you connect does not yet contain any expenses (costs), you will see an alert message. It reads “Whoops! You connected a budget with no expenses. Navigate to your SAGE Budget to add expenses.”
The following image shows the message.
Data Synchronization
After the initial connection of your SAGE Budget and Grant Runner application, any data changes you make to your SAGE Budget will be synchronized with both the RR Detailed Budget form and Sponsor Budget Map page. Any changes you make on the Sponsor Budget Map page will be reflected on the RR Detailed Budget form when you view it.
Your data changes will also be reflected in the PDF generated when you select View Grant Runner forms (PDF) on the left navigation menu.
Using the Sponsor Budget Map
The Sponsor Budget Map page initially shows where the SAGE Budget expenses will appear, by default, on the RR Detailed Budget. Where editable, you can choose to shift those expenses to a different category on the RR Detailed Budget. You can also specify the order of the personnel entries for Section A. Senior/Key Persons.
The Map page includes a link to your budget, just above the first section, that displays the budget number and title. For example: “B32836 Guide: Example Budget” as shown in the following image.
Below the link, there is a section for each expense type (object code) on your connected SAGE Budget. By default, the sections are all collapsed when you first view the page. You can “Expand All” sections or just individual ones.
The sections you see will match those where you have entered data in your parent SAGE Budget and any sub budgets. The possible sections are:
(01) Salaries and Wages, which includes the (07) Retirement and Benefits data (this links to a separate article)
SAGE Budget data is displayed on the left side of the page, in the same order as your SAGE Budget. The RR Detailed Budget expense category to which the expense will be mapped is shown on the right side.
Each section will display a status icon to indicate the status of the data within the section. A red exclamation point indicates that there are one or more expenses from your SAGE Budget that you need to map to an RR Detailed Budget category or sub-category. A green check mark indicates that all mappings are resolved. The Participant/Trainee Support Costs section shows a gray check mark icon if one or more of the optional mappings are unresolved.
The following images show examples of each type of status icon: green, red, and gray.
Adjust Expense Categories
You can change a number of SAGE Budget expense categories from the default value to another category on the RR Detailed Budget. Use the drop-down menus in the right-hand column to make changes to the default mapping between SAGE Budget and the RR Detailed Budget form. Some selections are grayed-out to indicate that the SAGE Budget object code cannot be mapped to that selection. For example, Travel costs cannot be assigned to Other Personnel.
Create Customized Categories
For some expenses that map to Section F: Other Direct Costs, there is no default sub-category. You must make a selection. These expenses are:
Supplies & Materials 05-47, 05-48
Student Aid 08-00, 08-02, 08-05
Unallocated 38-00
You can either select one of the existing sub-categories, or create a customized one. You can add up to 3 custom (user defined) sub-categories for Section F.
Click on “Select…” in the drop-down menu and choose “Other…” You made need to scroll down the list.
A dialog will display where you can enter the customized name of your sub-category. Click Save to return to the Map page. The new sub-category will appear, followed by an Edit link.
Once you have added a customized sub-category, it will appear in the drop-down so that you can choose it for additional expenses. If you edit the name of your customized sub-category, all items you associated with that sub-category will be updated.
Participant Support Costs
You can change some SAGE Budget expense items from the default mapping value to Section E. Participant/Trainee Support Costs.
Note: If you have any Participant Support Costs, you must use the section at the end of the Sponsor Budget Map page to indicate the associated numbers of participants for those budget periods.
By default, the expenses for this object code, on a parent budget or internal sub budget, will map to Section F. Other Direct Costs, subcategory Consultant Services.
You can change the RR Detailed Budget Category to either D. Travel, or E. Participant/Trainee Support Costs.
Within this category you can select the appropriate subcategory for your expense item.
(03) Other Contractual Services
By default, the expenses for this object code, on a parent budget or internal sub budget, will map to Section F. Other Direct Costs. The default subcategory depends on the SAGE Budget sub-object code for the expense. Consult the table below.
Generally, you can change the RR Detailed Budget Category to either D. Travel, or E. Participant/Trainee Support Costs. The exception is an 03-62 expense, a subcontract sub budget. You cannot change its mapping.
By default, the expenses for the (04) Travel object code, on a parent or internal sub budget, will map to Section D. Travel on the RR Detailed Budget form. The expense will map to either Domestic Travel Cost or Foreign Travel Cost, depending on your SAGE Budget Destination choice.
You can change the RR Detailed Budget Category to E. Participant/Trainee Support Costs. The subcategory will default to Travel.
(05) Supplies & Materials
By default, the expenses for this object code, on a parent budget or internal sub budget, will map to Section F. Other Direct Costs, with the subcategory of Materials Supplies.
You can change the RR Detailed Budget Category to E. Participant/Trainee Support Costs, except for sub-object codes 47 and 48 “Non-Capitalized Equipment”.
Within the category you can select the appropriate subcategory for your expense item.
(06) Equipment
The expenses for this object code, on a parent budget or internal sub budget, will map to Section C. Equipment, and you cannot change the mapping.
Additional Equipment Items Attachment
Section C. Equipment on the RR Detailed Budget form can display up to ten items. Any additional items must be included in an attachment to the form. When you initially connect your SAGE Budget and Grant Runner application, SAGE will automatically generate and attach the PDF file listing any additional equipment items, as needed. The file will be named to reflect the budget period. For example, the attachment for Period 3 of your budget will be named “Period_3_Equipment.pdf”.
Any time you add or remove equipment items from your SAGE Budget, the PDF attachment will automatically be recreated (or removed) to reflect those changes, as needed.
(08) Student Aid
By default, the expenses for this object code, on a parent budget or internal sub budget, will map to Section F. Other Direct Costs. You will need to select a sub-category on the Sponsor Budget Map page, or create a custom one.
(10) Capital Projects
The expenses for this object code, on a parent budget or internal sub budget, will map to Section F. Alterations and Renovations, and you cannot change the mapping.
(19) APL
The expenses for APL Prorated Direct Costs (PDC), on a parent or internal sub budget, will map to Section H. Indirect Costs
The non-PDC expenses will map to section F: Other DIrect Costs. You will need to select a sub-category on the Sponsor Budget Map page, or create a custom one.
(38) Unallocated
By default, the expenses for this object code, on a parent budget or internal sub budget, will map to Section F. Other Direct Costs.You will need to select a sub-category on the Sponsor Budget Map page, or create a custom one.
You can change the sub-category to any value for Section F, except Subaward/Consortium/Contractual Costs.
You can also change the RR Detailed Budget Category to either D. Travel or E. Participant/Trainee Support Costs.
(25) Facilities and Administrative
The expenses for this object code, on a parent budget or internal sub budget, will map to Section H. Indirect Costs, and you cannot change the mapping.
The RR Detailed Budget form allows a maximum of four distinct indirect cost base/rate rows.
Participant/Trainee Support Costs
Use this section to indicate how many participants and/or trainees there are for each period.
There will be an entry field for each period.
If there are not any participants in a period, leave the field blank.
To assist researchers in filling out the Human Subjects & Clinical Trials (HSCT) form, NIH required fields are now indicated with an asterisk and red highlighting. These same fields will have validation messages when the user clicks “Show Form Errors” at the top of the form. All NIH errors and validations will continue to show when the full application is checked by clicking “Check for Errors” in the left navigation of SAGE.
eGC1 Data Sync Improvements with Grant Runner Forms
To help prevent data inconsistencies when multiple browser sessions are open, the data sync between the eGC1 and Grant Runner forms has been improved. When you make updates to information in the eGC1 that flows through to Grant Runner forms, those updates will now automatically sync with each save/refresh of the eGC1.
Improved Accessibility for Keyboard and Tab Order Functionality
To meet accessibility standards, all Grant Runner forms are now accessible using keyboard only functionality. In addition, tab order has been improved to be more logical and intuitive, reducing the number of times the user has to press the tab key.
Error Messages Enhanced
Question numbers have been added to error messages on all Grant Runner forms. This update will help users quickly identify the specific error within a form. This will be especially helpful for longer forms such as the new Human Subjects & Clinical Trials form.
Grant Runner can now be used for Fellowship (F) Award opportunities with the inclusion of the PHS Fellowship Supplemental Form.
Import ClinicalTrials.gov Data into Human Subjects & Clinical Trials Form
For studies where a ClinicalTrials.gov record is already present, researchers can now choose to import a subset of that data into the new Human Subjects & Clinical Trials (HSCT) form in Grant Runner. This will save entry time. Users will now see a button next to the ClinicalTrials.Gov Identifier (question 1.5) labeled “Import from ClinicalTrials.gov”. On Import from ClinicalTrials.gov, Grant Runner will verify that the identifier is valid, and if so, will populate the HSCT Full Study with the following ClinicalTrials.gov fields:
Study Title
Conditions or Focus
Eligibility Criteria
Age Limits (minimum, maximum age)
Recruitment Status
Brief Summary
Narrative Study Description
Primary Purpose
Interventions (type, name, description)
Study Phase
Intervention Model
Masking
Allocation
Outcomes and Measures (name, type, timeframe, description)
Any previously entered data on the HSCT Full Study will be overwritten.
After import, the eGC1 preparer is free to edit any of the information as necessary.
ClinicalTrials.gov data is NOT updated directly from SAGE. It is still the PI’s responsibility to maintain accuracy of data on the ClinicalTrials.gov site.
SAGE eGC1
Provide warning when Application PI or Multiple PI does not have an ASTRA role
When adding an Application PI or a Multiple PI on the PI, Personnel, & Organizations page, if the selected personnel does not have an ASTRA role that grants them access to SAGE, you will now receive a warning. This information will allow eGC1 preparers to request ASTRA roles in advance to avoid delays at time of routing and approval.
Fix: Adding the Same Person Twice in Contacts & Assign Access Results in Error
Users were getting confusing validation messages when attempting to add themselves or another person to more than one role on the Contacts & Assign Access page. This validation issue has been resolved.
SAGE General Updates
Data Source Update
SAGE Suite will now use the new version of Person Web Service (PWSv2). PWSv2 is commonly used in the SAGE Personnel Chooser when searching for non-UW people.
In some areas of SAGE, the Personnel Chooser was requiring users to click on “Enter” to search. This issue has been resolved and now you can search by either clicking on or pressing the “Enter” key.
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.
Introduction
1. Introduction to Application (for Resubmission or Revision applications)
Note: This will only display for the appropriate application types.
Fellowship Applicant Section
2. Applicant Background and Goals for Fellowship Training
Required for all applications.
Research Training Plan Section
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.
Sponsor(s), Collaborator(s), and Consultant(s) Section
9. Sponsor and Co-Sponsor Statements
Required for all applications.
10. Letters of Support from Collaborators, Contributors, and Consultants
Required for all applications.
Institutional Environment and Commitment to Training Section
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.
Other Research Training Plan Section
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. Authentication of Key Biological and/or Chemical Resources
Required for all applications.
Additional Information Section
18. 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.
19. Alternate Phone Number
Enter a phone number.
20. Degree Sought During Proposed Award
Select the appropriate degree from the drop-down menu and indicate the Expected Completion Date.
21. Field of Training for Current Proposal
Select the appropriate field from the drop-down menu.
22. Current or Prior Kirschstein-NRSA Support?
Select Yes or No. If you answer Yes, complete the additional fields.
23. Applications for Concurrent Support
Select Yes or No.
24. 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.
25. Change of Sponsoring Institution
Select Yes or No. If you answer Yes, then enter the name of the former institution.
Budget Section
26. Tuition and Fees
Select Yes or No. If you answer Yes, then enter the appropriate dollar amounts for Year 1 through Year 6. The system will calculate the Total Funds Requested.
27. Present Institutional Base Salary
Enter the Amount, select the appropriate Academic Period from the drop-down menu, and enter the Number of Months.
28. 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.
Appendix
29. 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.
Human Subjects & Clinical Trials Form Usability Improvements
The following areas were given some fine-tuning and polish, in order to improve the usability of the new Human Subjects & Clinical Trials (HSCT) form:
Display a warning message when you change the Human Subjects response from YES to NO on the Other Project Info form, to indicate that HSCT form data will be removed as a result
Fix defects related to navigation within the form
Improve usability in form display, navigation, and error messaging
Required Fields for Study Import from PDF
When importing a study to the Human Subjects & Clinical Trials form using the fillable PDF, you are now required to complete the following fields at minimum:
Study Title
Clinical Trials questions 1.4.a through 1.4.d
Obtaining the responses to these questions upon import will better enable the SAGE system to communicate clear form rules and requirements to users through validations and on-screen prompts.
Improved Clinical Trial Required Fields Logic for HSCT Form
SAGE will now use the NIH Clinical Trials Code provided with each opportunity to enable or disable relevant sections on the HSCT form.
The system will also factor in the responses to the four Clinical Trials questions (1.4.a through 1.4.d) on HSCT, to determine when the clinical trials sections should be enabled.
These updates will provide clarity for users on what sections of the form are required and which are not applicable. The rules are implemented as follows:
When clinical trials are NOT allowed per the opportunity:
Sections 4 and 5 are disabled for entry, and
When you import a study from a fillable PDF which contains entry in sections 4 & 5, any data entered in those sections is removed upon import and will not be included in submission
When clinical trials questions 1.4.a through 1.4.d include at least one NO response, then the application is NOT considered a clinical trial, and sections 4 & 5 are disabled for entry
Form Order Update in Left Navigation
Due to the dependencies between forms, the Other Project Information form now displays above the Human Subjects & Clinical Trials form. This helps you complete the forms is a logical order, thereby reducing confusion when opening the Human Subjects & Clinical Trials form for the first time.
Opportunity Opening and Closing Date Updates
Due to time zone differences and the date/time stamp used by NIH on the opportunities posted on Grants.Gov, the open and close dates were displaying in Grant Runner as one day earlier than on the Grants.Gov and NIH websites. SAGE now factors in this 3-hour time difference so that the open and close dates display correctly.
Fix: Application PI Validation on RR Detailed Budget
An issue was resolved which now allows the RR Detailed Budget PD/PI validation to work properly when an Application PI is listed on the eGC1. The validation will now ensure that the first and last name of the first PD/PI listed match those of the Application PI, when present, and as shown on the SF 424. This is an NIH requirement.
eGC1 Fix: Printing Draft Routing Sheet Results in Error
Users will no longer receive an error when attempting to print the Draft Routing Sheet from the Certify & Route page of the eGC1.
NIH will require the use of FORMS-E application packages for due dates on or after January 25, 2018. Grant Runner now includes the FORMS-E version for the following agency specific forms.
PHS 398 Cover Page Supplement
PHS 398 Research Plan
PHS 398 Career Development Award Supplemental
PHS 398 Modular Budget (expire date change only)
PHS Assignment Request
PHS Human Subjects and Clinical Trials Information (New!!)
Federal-wide form updates that will also be incorporated into FORMS-E packages, and which are supported by Grant Runner, include:
New Human Subjects and Clinical Trials Information Form
Grant Runner now includes the new PHS Human Subjects and Clinical Trials Information Form. You will have the option of completing the form in its entirety directly in Grant Runner, or importing a completed PDF version of the form into Grant Runner. Due to the length of this form, it is recommended that you preview the form in Grant Runner or in PDF format, early in the proposal development process to plan appropriately for the information collection involved.
SAGE Subawards
Subrecipient Re-Certification Status and Form
When completing the subaward request in SAGE, a prompt will display below the subrecipient’s name if their certification status is in an expired state and needs re-certification. This prompt will have a link to the Subrecipient Certification PDF form that can be uploaded in the Attachments section of the Subaward Request once completed. Attachment of the Subrecipient Certification form is not required prior to submission of the subaward request. This status prompt and link will also display in the Subaward Overview Summary section.
SAGE eGC1
Non-Award Agreement Application Types
SAGE now provides a dedicated, streamlined eGC1 format for submitting Non-Award Agreements to OSP by requiring only the set of fields necessary for these application types. You will now select Application Types “Non-Award Agreement (new)” or “Non-Award Agreement (continuation)” for the following types of agreement:
Confidentiality Agreement
Data Use Agreement
Memorandum of Understanding
Unfunded Collaborative Agreement
Unfunded Research Agreement
Affiliation Agreement
Material Transfer Agreement
Note that you should select “Non-Award Agreement (continuation)” to extend an existing agreement beyond the initial term.
Activity Locations Survey
We want your feedback on the new look and feel of the Activity Locations page. Click the “Give Feedback” link at the top of that page and let us know what you do/don’t like about the design as we evaluate updates to other parts of SAGE.
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:
Human Subjects Section with responses from R&R Other Project Info Form
Human Specimens section
If Yes to Human Subjects section, conditionally displays
Add Studies
Other Requested Info
Responses from R&R Other Project Info Form
This section displays the answers to the Other Project Info form’s Human Subjects questions.
Use of Human Specimens and/or Data
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 Yes to Human Subjects
If you answered “Yes” to Are Human Subjects Involved on the Other Project Info form, this section will display.
Add Studies
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.
Other Requested Info
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.
Full Study, which has five sections. There is also an option to import a full study.
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 are 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.
Navigating Full Studies
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:
The breadcrumb, which on this summary page is “FORM SUMMARY > FULL STUDY DETAILS”. Use it to navigate through the parts of the study form.
The study title, which is initially “Untitled Study” until you add your own title in Section One.
The heading “Full Study Details” (with help icon)
The list of the five sections that make up the Full Study. Each section has a box that will change color as you move your mouse across it. Each section box contains
Its label, such as “Section One: Basic Information” with a “caret” to the left of the section label. Clicking on the caret expands the section in a read-only mode.
An EDIT SECTION link to the right of the label; use it to open the section to add or edit data.
An icon at the far right: a red exclamation point indicates required data is missing; a green check mark indicates that all required data has been added.
Below the sections list is a button to “Return to Form Summary”. Selecting this re-displays the Form Summary page.
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.
Section One: Basic Information
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:
1.4.a Does the study involve human participants?
1.4.b Are the participants prospectively assigned to an intervention?
1.4.c Is the study designed to evaluate the effect of the intervention on the participants?
1.4.d Is the effect that will be evaluated a health-related, biomedical, or behavioral outcome?
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. 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:
Study Title
Conditions or Focus
Eligibility Criteria
Age Limits (minimum, maximum age)
Recruitment Status
Brief Summary
Narrative Study Description
Primary Purpose
Interventions (type, name, description)
Study Phase
Intervention Model
Masking
Allocation
Outcomes and Measures (name, type, timeframe, description)
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.
Section Two: Study Population Characteristics
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:
Not yet recruiting
Recruiting
Enrolling by invitation
Active, not recruiting
Completed
Suspended
Terminated (Halted Prematurely)
Withdrawn (No Participants Enrolled)
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.
Section Three: Protection and Monitoring Plan
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?
If yes, describe the 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.
Section Four: Protocol Synopsis
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:
Treatment
Prevention
Diagnostics
Supportive Care
Screening
Health Services Research
Basic Science
Device Feasibility
Other – if you select Other, you must also enter a description for “Other Primary Purpose”
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.
Genetic (including gene transfer, stem cell and recombinant DNA)
Dietary Supplement (e.g., vitamins, minerals)
Combination Product
Diagnostic Test
Other
4.1.d Study Phase
Select a value from the drop-down menu. Choices are:
Early Phase 1 (or Phase 0)
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
Phase 4
Other – if you select Other, you must also enter a description for “Other Study Phase”
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:
Single Group
Parallel
Cross-Over
Factorial
Sequential
Other – if you select Other, you must also enter a description for “Other Intervention Model”
4.1.f Masking
Select Yes or No. If yes, you must also answer Yes or No to four masking types:
Participant
Care Provider
Investigator
Outcomes Assessor
4.1.g Allocation
Select a value from the drop-down menu. Choices are:
N/A
Randomized
Non-randomized
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:
Name: Enter the name of the individual outcome or measure
Type: Select one of the following
Primary
Secondary
Other
Time Frame: Indicate when a measure will be collected for analysis
Brief Description: Enter a brief description of the outcome or measure.
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.
Section Five: Other Clinical Trial Related Attachments
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.
Delayed Onset Study
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.
