Tag Archives: Grant Runner

April 2018 SAGE Grant Runner Release

SAGE Grant Runner

NIH Required Fields Added to HSCT

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.

March 2018 SAGE Grant Runner Release

SAGE Grant Runner

Grant Runner Support for Fellowship Opportunities

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.

Fix: SAGE Personnel Chooser Doesn’t Always Search by Pressing “Enter” Key

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.

 

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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.

Introduction

1.  Introduction to Application (for Resubmission applications)

Note: This will only display for the appropriate application types.

Fellowship Applicant Section

2.  Applicant’s Background and Goals for Fellowship Training

Notes…

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.

 Other Research Training Plan Section

Are Vertebrate Animals Used?

Select Yes or No.

12.  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.

13.  Vertebrate Animals

Required for all applications.

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.  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.

16.  Authentication of Key Biological and/or Chemical Resources

Required for all applications.

Additional Information Section

17. 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.

18.  Alternate Phone Number

Enter a phone number.

19.  Degree Sought During Proposed Award

Select the appropriate degree from the drop-down menu and indicate the Expected Completion Date.

20.  Field of Training for Current Proposal

Select the appropriate field from the drop-down menu.

21.  Current or Prior Kirschstein-NRSA Support?

Select Yes or No. If you answer Yes, complete the additional fields.

22.  Applications for Concurrent Support

Select Yes or No.

23.  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.

24.  Change of Sponsoring Institution

Select Yes or No. If you answer Yes, then enter the name of the former institution.

Budget Section

25. 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.

26. Present Institutional Base Salary

Enter the Amount, select the appropriate Academic Period from the drop-down menu, and enter the Number of Months.

27. 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

28.  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.

January 2018 SAGE Grant Runner Release

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.

December 2017 SAGE Grant Runner Release

FORMS-E Changes to Existing Forms

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:

  • RR Budget and Subaward Budget
  • RR Other Project information

NIH Form Change Resources

Review more information on:

High level FORMS-E summary of changes across all impacted forms

NIH: New Human Subjects Clinical Trial Form

NIH: FAQS for Application Forms, Form Updates, and Choosing the Correct Forms

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
  • Master 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.

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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 Human Subjects Section, at the top of the form, displays the responses to the Human Subjects question from the R&R Other Project Info form. Depending on how you answered that question, you will see different sections on the Human Subjects & Clinical Trials (HSCT) form.

If you answered “No” on the Other Project Info form, then you’ll see just two items to complete:

  • The Human Specimens question
  • The Other Requested Info attachment

If you answered “Yes” on the Other Project Info form, then you’ll see

  • The Add Studies section where you can add studies
  • The Other Requested Info attachment

The Human Specimens question and the Other Requested Info attachment are described below.  Open the Adding HSCT Studies article for information on that section.

Human Specimens

human specimens question answered yes and showing required explanation attachment

If you answer Yes to the “Does the proposed research involve human specimens and/or data?” question, you will see an additional item.  Attach a PDF formatted file providing an explanation of why the application does not involve human subjects research. See your funding opportunity announcement and agency-specific instructions for additional guidance.

Other Requested Info

other requested info attachment

Attach a PDF formatted file. See your funding opportunity announcement and agency-specific instructions for additional guidance.

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You can add two types of studies to your Human Studies & Clinical Trails (HSCT) form.

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. 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.

Note: You must include a Study Title (item 1.1) and answer all of the questions 1.4.a-1.4.d before you can import your PDF. 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. 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:

  1. Basic Information
  2. Study Population Characteristics
    • Inclusion Enrollment Report subsection
  3. Protection and Monitoring Plan
  4. Protocol Synopsis
    • Interventions subsection
    • Outcomes and Measures subsection
  5. Other Clinical Trial Related Attachments

When you select Add New Full Study, the first page you will see is called “Full Study Details” as shown in the image below.

full study summary page showing five sections

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 no required data is missing.
  • 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 required questions. Answer each Yes or No as appropriate.  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.
2.4. Inclusion of Women, Minorities, and Children 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 Subject 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.
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.

If you answer Yes, you must add an attachment, describing the single IRB plan.

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 once you have answered “Yes” to all of the questions 1.4 a-d.

Field Description
4.1. Brief Summary Enter a brief description of objectives of the protocol, including the primary and secondary endpoints.
4.2. Study Design This item consists of sub items a through g, described in the following table rows.
4.2.a Narrative Study Description Enter the description of the protocol.
4.2.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”
4.2.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:

  • Drug (including placebo)
  • Device (including sham)
  • Biological/Vaccine
  • Procedure/Surgery
  • Radiation
  • Behavioral (e.g., Psychotherapy, Lifestyle Counseling)
  • Genetic (including gene transfer, stem cell and recombinant DNA)
  • Dietary Supplement (e.g., vitamins, minerals)
  • Combination Product
  • Diagnostic Test
  • Other
4.2.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?”

4.2.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”
4.2.f Masking Type Select Yes or No.  If yes, you must also answer Yes or No to four masking types:

  • Participant
  • Care Provider
  • Investigator
  • Outcomes Assessor
 4.2.g Allocation Select a value from the drop-down menu. Choices are:

  • N/A
  • Randomized
  • Non-randomized
4.3. Outcomes and 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.

4.4. Statistical Design and Power Attach a PDF formatted file.
4.5. 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.
4.6. Will the study use an FDA-regulated intervention? 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.
4.7. 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.

delayed onset study page

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.

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You must include this NIH form with your application.

1. Vertebrate Animals Section

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.

2. Program Income Section

program income section with one budget period added

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.

  • Budget Period: select a value (1 to 10) from the drop-down menu
  • Anticipated Amount ($): enter the dollar amount for this period
  • Source(s): indicate the source of the amount

Click the Add button again to include up to 5 budget periods.

You can use the Delete link to remove any existing period.

3. Human Embryonic Stem Cells Section

Human Embryonic Stem Cells section

Click 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.

4. Inventions and Patents Section (For renewal applications only)

If you indicate Yes for Inventions and Patents, you will also need to indicate if the information has been Previously Reported.

5. Change of Investigator / Change of Institution Section

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.

August 2017 SAGE Grant Runner Release

Grant Runner Updates

Grant Runner Support for Career Development Opportunities

Grant Runner now includes the PHS 398 Career Development Award Supplemental form, allowing you to use Grant Runner for most Career Development (K) Award opportunities.

One exception exists for those mentored opportunities in which the PI listed in the SF 424 application form is not the same as the UW PI on the eGC1. This situation occurs when the PI on the application form does not meet UW PI eligibility requirements and the mentor is listed as the eGC1 PI. For these K Award activity codes that draw applications from individuals ineligible to be a UW PI, another method should be used for sponsor form completion, or wait to complete the eGC1 until the mid-September SAGE release when that capability will be delivered.

Expanded On-Form Validations

While checking for errors on individual forms in Grant Runner, you see more of the NIH validation errors display. This expansion focuses on identifying those fields required by NIH but not by Grants.gov. For Example: the Research Plan – Specific Aims attachment, which is required by NIH for opportunities other than DP1 and DP2.

Individual Form PDFs for Forms D

You can now view or print a single Grant Runner form and its related attachments in the PDF format used by NIH reviewers. This feature offers an easy side-by-side comparison of the form with the eGC1.

FORMS-E Work

NIH requires the use of application packages with a Competition ID of ‘FORMS-E’ for due dates on or after January 25, 2018.

Opportunities using FORMS-E will begin to post on October 25, 2017. In preparation, we have completed development on  FORMS-E for all existing Grant Runner forms, plus the new Career Development form. These changes will not be visible to users until the FORMS-E opportunities begin to post in October 2017.

The following FORMS-E Grant Runner forms are ready to go, when the opportunities that utilize them post in October:

  • Cover Page Supplement
  • Assignment Request
  • Research Plan
  • Career Development Award Supplement

The new Human Subjects and Clinical Trials form will be released in October, 2017, and more information on that form will be shared out closer to that time.

Update of Progress Bar Language for PDF Generation

When you click the “View Grant Runner Forms (PDF)” link, you no longer see the word “submitting” while the system is generating the PDF. This change prevents unnecessary confusion.

Fix:  PDF File Size Too Large for Viewing

Large file sizes on Grant Runner attachments were preventing the full application PDF from rendering, due to size limitations enforced by the server. The size threshold has been increased to the level recommended by Grants.Gov.

eGC1 Updates

OAW Removal as Reviewer on Non-Competing eGC1s

The Office of Animal Welfare changed their business processes and will no longer review the following eGC1 application types:

  • Non-Competing Revision
  • Non-Competing Renewal
  • Non-Competing Supplement

eGC1 users no longer see the “Animal Subjects” reviewer on the approval graph, for the above application types.

Fix:  Broken links in the footer of the eGC1 task list

At the bottom of the task list, the “About SAGE” and “Learning” links are fixed and you are directed to the appropriate support documentation for those topics.

FIDS Update

Fix:  Investigator Title Changes Being Overwritten by Workday Titles

An issue arose following the Workday implementation whereby manual updates that investigators made to their title were not saving properly, and instead were being overwritten by the Workday titles. This issue has been resolved.

SAGE Budget

Fix:  Sea Pay period update page closes worksheet section when saved

An issue has been fixed for SAGE Budgets that utilize Sea Pay where previously opened/expanded sections of the budget worksheet were closing on SAVE.  These sections will now remain open on SAVE.  

Fix:  Sea Pay period update page has SAVE button in wrong place

The Update Periods page for SAGE Budgets that utilize Sea Pay has been updated to move the SAVE button from the bottom to the top of the page, for a more consistent user experience.

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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, 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.

Introduction

1.  Introduction to Application

Note: This will only display for the application types of Resubmission and Revision. NIH requires the attachment.

Candidate Section

2. Candidate Information and Goals for Career Development

Required for all NIH applications.

Research Plan Section

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 types of  Renewal and Resubmission.

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.

Other Candidate Information Section

7. Candidate’s Plan to Provide Mentoring

This is required for some NIH funding opportunities.

Mentor, Co-Mentor, Consultant, Collaborators Section

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.

Environment and Institutional Commitment to Candidate Section

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.

Human Subjects Section

Note: For more information on using human subjects, see GIM 20 Activities Involving Human Subjects,Including Clinical Research and the UW Human Subjects Division web site.

12.  Protection of Human Subjects

Complete this section if you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information Form.  If you answered No to the question, but your proposed research involves human specimens and/or data from subjects, you must provide a justification in this section or your claim that no human subjects are involved. Follow the instructions provided in the Application Guide and the FOA regarding the Protection of Human Subject attachment.

13.  Data Safety Monitoring Plan

This is required if you answered “Yes” to the “Clinical Trial?” question on the R&R Cover Page Supplemental Form.

14.  Inclusion of Women & Minorities

Complete this section if you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information Form and the research does not fall under Exemption 4.

15.  Inclusion of Children

Complete this section if you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information Form and the research does not fall under Exemption 4.

Other Research Plan Section

16.  Vertebrate Animals

Complete this section if you answered Yes to the question Are Vertebrate Animals Used? on the R&R Other Project Information Form.

17.  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/.

18.  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.

19.  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.

20.  Authentication of Key Biological and/or Chemical Resources

Not required.

Appendix Section

21.  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.

Citizen 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

  • Permanent U.S. Resident Visa
  • Temporary U.S. Visa
  • Not residing in U.S.

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.