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.
On the Non-Fiscal Compliance page, in the Data & Technology section, if you answer Yes to questions D-2 and/or D-4, the system will automatically add a hold for Export Control. The hold will be added when the eGC1 reaches In OSP status.
Funding Actions
When OSP creates a child Funding Action (FA) for an awarded eGC1, the system will automatically create compliance holds, if appropriate.
The system applies automatic holds to the FA based on the conditions in the following chart.
Details page has an Originating Sponsor listed with a Sponsor Type of Federal Government
SFI/FCOI
One or more investigators on the PI, Personnel, & Organizations page has an SFI value of Yes or Unknown
Export Control
Non-Fiscal Compliance page: if Yes for any one of questions E-2, D-1, D-2, D-3, D-4.
IACUC
Non-Fiscal Compliance page: question AU-1 = Yes
FCOI Training
One or more investigators on the PI, Personnel, & Organizations page has either not done the sponsor-required FCOI training or the training has expired.
Use this section to indicate if and how specific types of information and technologies will be involved in the project so that reviewers can determine if special guidelines or restrictions apply. Contact exports@uw.edu for guidance on export control limitations related to sharing of data and technology. For information about the Washington Innovation Advantage Program (WIAP), visit the CoMotion site or contact osp@uw.edu with further questions.
As with other eGC1 pages, you can partially complete your entries and save the eGC1. You must complete the required fields before you route your eGC1 for approval.
Select Start Section to open the section initially, and then Edit Section to add or update existing data.
D-1. Does this project involve any of the following?
Answer: Check all that apply:
Proprietary Information
Export Controlled/Controlled Unclassified Information
Classified Information
Other Sensitive Information (Excludes personal or patient information)
None of the above
You must make at least one selection. If “None of the above” is selected, the system will clear any other boxes that were checked.
D1-A displays if for D-1 you select any value other than “None of the above”
D-1A. Will this information be shared with foreign nationals in the United States or abroad (including UW faculty, staff, or students)?
Answer: Yes or No
Note: U.S. Permanent Residents are not considered foreign nationals. The actual country of citizenship/residency of foreign nationals is not required at this time.
D1-B displays if for D-1 you select “Other Sensitive Information (Excludes personal or patient information)”
D1-B. Please describe the other sensitive information
D-2. Is this project intended to assist any foreign country’s military or space activities?
Answer: Yes or No
D-2A displays if D-2 = Yes
D-2A. Please describe.
D-3. As far as you know, will the sponsor require approval prior to foreign national participation or prior to publication of the research results of this project?
Answer: Yes or No
D-4. Will the project involve travel to or collaboration with a person or entity in a sanctioned country (e.g., Cuba, Iran, North Korea, Sudan, Syria)?
Answer: Yes or No
Question T-1 displays if the Sponsor Type and/or Originating Sponsor Type (as indicated on the Details page) is one of the following:
Use this section to provide information about the use of vertebrate animals in the project to allow reviewers to determine compliance with UW and sponsor requirements. If you have questions regarding the use of Vertebrate Animals, please contact the Office of Animal Welfare.
Note: Hoverboard data will be refreshed each time you view this page.
As with other eGC1 pages, you can partially complete your entries and save the eGC1. You must complete the required fields before you route your eGC1 for approval.
Select Start Section to open the section initially, and then Edit Section to add or update existing data.
AU-1. Will the project involve the use of vertebrate animals?
Answer: Yes or No
A table for Animal Use Protocols and an Add Protocol button display if AU-1 = Yes
Note: If AU-1 = Yes, then you must include at least one protocol.
Add Protocol
You can add a protocol in three ways. Start by selecting Add Protocol. By default, the UW Protocol choice displays. Select the appropriate protocol type link from there.
Use this to search Hoverboard and import your data. Start by entering at least 3 digits of your protocol number. The search will return any items that contain the digits you enter. Click in the results list to select the appropriate item. The following image shows a results list after search for “234”.
When you select a protocol from the results list, the following data displays in the dialog window:
Protocol Title
Protocol PI
Primate Center Involved – Yes or No
Expiration Date
Select Next to continue the process. The dialog will display the question “Does the protocol require an amendment?” Answer Yes or No.
Select Save to return to the Animal Use section.
Note: If the value for Primate Center Involved is Yes, the Primate Center will be added to the approval flow as an Approver.
The following image show the amendment question in the dialog window, with Yes selected.
External Protocol
Select this choice in the Add Protocol dialog to enter an External Protocol. Select the appropriate institution from the drop-down menu.
The choices are:
Fred Hutchinson Cancer Research Center (FHCRC)
VA Puget Sound Health Care System (VAPSHCS)
Seattle Children’s Research Institute (SCRI)
Benaroya Research Institute of Virginia Mason (BRI)
Center for Infectious Disease Research (CIDR)
Allen Institute
Add a New Institute
The following image shows the initial screen with the drop-down menu expanded.
When you select one of the existing institutions from the menu, its details will display. These fields are
Institution Assurance Number
Institution Country
Institution City
You can find more information about assurance numbers on these NIH web pages:
The following image shows the details for Fred Hutchinson Cancer Center (FHCC).
Select Next to enter your Protocol Number and the Expiration Date.
The following image shows this step, with some example data entered.
Select Save to complete your entry. You can save a partial entry. It must be complete prior to routing your application.
The following image shows the expanded table row from this entry on the compliance summary page.
Add a New Institution
If you select “Add a New Institution” from the External Protocol list, the dialog will display the following fields:
Institution
Assurance Number (optional)
Institution Country
Add the appropriate information for these fields. Note that if you select any country other than the United States of America, you must also enter an Institution City.
The following image shows the first page of the dialog.
Select Next to display the section page of the dialog. Enter the Protocol Number and its Expiration Date.
Select Save to complete your entry. You can save a partial entry. It must be complete prior to routing your application. The added information will display similarly to the existing external institution entries.
New Protocol
If you will be establishing a new protocol, select that option from the initial Add Protocol dialog box. You just need to answer yes or no to the question “Will the Primate Center be involved in the research?”
If you select Yes, the Primate Center will be added to the approval flow as an Approver.
The following image shows the New Protocol dialog with the Primate Center question.
Use this section to indicate whether EH&S agents or activities are going to be used during the project. Responses to the EH&S section provide additional guidance on regulations and approvals needed to perform the work. Contact Environmental Health & Safety with questions.
As with other eGC1 pages, you can partially complete your entries and save the eGC1. You must complete the required fields before you route your eGC1 for approval.
Select Start Section to open the section initially, and then Edit Section to add or update existing data.
EHS-1. Will this project involve any of the following?
Answer: Check all that apply:
Biohazards
Select Agents and Toxins
Radioactive Materials
SCUBA Diving
Chemical Thresholds (toxic, unstable, explosive)
None of the Above
You must make at least one selection. If “None of the Above” is selected, the system will clear any other boxes that were checked.
Additional information will display when a box is selected.
Biohazards: Biological Use Authorization from the UW Institutional Biosafety Committee is required as defined on the EH&S webpage. Please note that some categories of research require BUA prior to initiation. The BUA application submission deadlines are also posted on this website.
Select Agents and Toxins: EH&S will work with the PI to obtain necessary federal clearances, approvals, and training. Documentation of due diligence is required for any transfer of Select Toxins in any amount. Some Select Agent and Select Toxin research is subject to review by the Dual Use Research of Concern (DURC) Institutional Review Entity (IRE). See the EH&S website for information about Select Agents and Select Toxins, Select Toxin Due Diligence, and DURC.
Radioactive Materials: Approval of this application will be contingent on whether or not a Radiation Use Authorization (RUA), issued to the Principal Investigator (PI), sufficiently covers the proposed radioactive material work.
SCUBA Diving: Anyone diving under the University of Washington’s auspices must have current certification as a University of Washington Scientific Diver and adhere to the standards set forth in the UW’s Diving Safety Manual. EH&S will contact you to assist in meeting Diving Safety Program requirements prior to diving. For more information, please see: https://www.ehs.washington.edu/research-lab/diving-safety-program
Chemical Thresholds (toxic, unstable, explosive): EH&S will contact you for planning assistance as fire department requirements may not allow these quantities in your space or may require building modifications.
NOTE: To enable improved collaboration, you can send a direct link to the PI and Reviewers
From any standard eGC1 page (excluding Grant Runner forms), the URL is now a direct link that you can copy and share with others who have access to that eGC1. This will be particularly useful when collaborating with the PI on completing the Non-Fiscal Compliance page.
Non-Fiscal Compliance Overview
Use this page to provide details related to non-fiscal compliance information. These details will:
Identify special considerations in this application and bring them to the attention of reviewers.
Provide information necessary for the UW approval process.
Provide information that may help campus unit and central office approvers review your application quickly.
Facilitate proposal review and central office review at time of award.
There are five sections on this summary page and each is covered in more detail in its own article.
Human Subjects (questions HS-1 and HS-2, and conditionally HS-1A and HS-1B)
Data & Technology (question D-1, D-2, D-3, D-4, and conditionally D-1A, D-2A, and T-1)
NOTE: If you are viewing an older application, you will see the questions you answered at that time, displayed in read-only mode and organized into the sections listed above.
On this summary page, select “Start Section” to open a section for data entry.
Once you have started a section, when you return to the summary page, you will see a link to Edit Section. In addition, an Expand + link will display on the right of the section. Select it to open the section and view the data in read-only mode. The link will change to Collapse – when the section is expanded.
This page also has Expand All and Collapse All links above the first section, on the right side of the page. Use the Expand All link to open all of the sections in read-only mode. Collapse All will close all of the sections.
In the following image, the second section, Animal Use, shows the Edit Section link. The third section, Environmental Health & Safety, shows a section in the expanded, read-only view.
Occasionally, there could be a difference in the eGC1 PI and the PI on the sponsor’s application, for example, in the case of career development applications.
To designate an Application PI, select that role for the person after adding them to the PI, Personnel, & Organizations page. For additional information on research team roles, review the UW Research Personnel page.
If the Application PI is a UW person, SAGE will add the Application PI to the Approval Flow and send an approval required email notification at the appropriate time. If the person selected does not already have an ASTRA role for SAGE, a warning message of “no access: ASTRA permissions required” will display in red once you select the Application PI role. You will need to give them access, so that they can approve the application. There are two non-PI researcher ASTRA roles that could be used.
As part of the approval process, the UW Application PIs are required to certify the PI Assurance Statement which appears in the approval dialog.
The statement reads:
Principal Investigator/Program Director Assurance: I certify that the statements in this eGC1 and the related sponsor application are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application.
The approval/agreement reads:
I am the PI and I have read and agree with the PI Assurance Statement. I understand that approving this eGC1 electronically is equivalent to my signature.
The following image shows the assurance statement in the approval dialog.
For Grant Runner applications, the person designated as the Application PI will appear as the PD/PI on the SF 424 and Key Person Expanded forms.
Non-UW Application PI Assurance Statement Instructions
If the Application PI is a non-UW person (an affiliate), SAGE will not add them to the approval graph. Since they have a NetID, they could be given access to SAGE and added as an ad hoc approver to the graph. The eGC1 PI is responsible for securing assurance statements for those non-UW Application PIs. The following steps describe the paper process.
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.
Select an answer for the question “Will this project involve any new construction or renovation of existing facilities?”
If you select “Yes” additional fields display. You must complete the “Who provided approval?” field.
The optional fields are:
Approval date
Where is the space
Additional Explanation
The following image shows the question answered Yes and the fields displayed.
Use the “Back to Activity Locations Summary” link at the bottom of the page to return to the main Activity Locations page. The section will now a link to “Edit Section” if needed, and a Expand + link. Expand displays the data entered, and switches to Collapse when used. The following image shows the section expanded with some sample data.
