Interacting Electronically with NIH

(1)

Interacting Electronically with NIH

Megan Columbus

NIH Program Manager for Electronic Receipt of Grant Applications

Electronic Research Administration

Sheri Cummins

eRA Customer Relationship Manager Electronic Research Administration

(2)

NIH Moving Forward

From your ideas…

(3)

Electronic Interaction Points

Learn About Grants at NIH Find Opportunities Submit Application Check Submission Status Download App Package View Assembled Application Image Check Review Assignment Submit Pre-Award Information Check Review Outcome Prepare/Submit Post-Award Reports Closeout Grants NIH Guide NIH Grant Web site Grants.gov eRA Commons

(4)

Learn About Grants

eRA, Commons, eSubmission POLICY NIH GUIDE GLOSSARY, FAQS INITIATIVES GET CONECTED http://grants.nih.gov/ BASICS

(5)

eSubmission Transition Status

Approximately 85% of all applications

require electronic submission except

for the following mechanisms:

• Fellowship*

•Training (T&D)*

•Complex, Multi-project Applications

(Project/Centers)*

(6)

K, F and T Transition Plans

JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC

2009

K F T

February 12 – Research Career Development (K)

Transitioned

August 8 - Individual National Research Service Awards (F)

January 25 - Institutional National Research Service Awards

and Other Training Grants (T, D) (tentatively scheduled) * Complex applications to be determined

(7)

eSubmission Process

Prepare to Apply

Find Opportunity and Download Application Package

Submit Application to Grants.gov

Prepare Application

Check Submission Status Check Assembled Application

Submission Complete

If errors, correct & submit again

(8)

Two Systems Working Together

• Grants.gov – the Federal government’s single online portal to find and apply for Federal grant funding

– Used by all 26 Federal grant-making agencies

• eRA Commons – electronic Research

Administration system that allows applicants,

grantees and Federal staff to access, share and transmit information related to their applications and grants

– Used by NIH and a few other HHS components

(9)

Registration – Grants.gov

Grants.gov – Organization

• Applicant Organization only (one time)

• Many organizations are already registered - ask your Office of Sponsored Research

• Registration steps outlined at:

http://www.grants.gov/applicants/get_registered.jsp

• Important Tip: Update your Central Contractor

Registry information yearly to keep your Grants.gov credentials active.

START EARLY! Can take 2–4 weeks; up to 8 weeks for newly established or foreign businesses

(10)

Registration – eRA Commons

eRA Commons – Organization

• Register your organization/institution (one time); designate your Signing Official (SO)

– List of registered orgs:

http://era.nih.gov/commons/quick_queries/commons_reg istered_orgs.cfm

– Not listed? Register here:

https://commons.era.nih.gov/commons/registration/regist rationInstructions.jsp

• May be completed simultaneously with Grants.gov registration once the DUNS # is obtained

(11)

11

Registration – eRA Commons

eRA Commons – PD/PI

• Project Director/Principal Investigators (PD/PIs) must work through their institution’s Signing

Official (SO) or others with account

administration authority to ensure appropriate registration/affiliation

• PIs have one account that follows them throughout their careers

– Can be affiliated with multiple organizations

• The PI and SO need separate accounts in eRA Commons because each has different privileges

(12)

Make a Submission Plan

There is more than one way

to submit an electronic

application. Check with your

Office of Sponsored Research

to find out what you use:

– Forms-based submission

– System-to-System using XML data stream – Services of a commercial service provider

(13)

Internal Process Considerations

Find Out How Your Organization Manages…

• Internal review & approval processes

• Sharing applications in progress

• Last minute queue at Sponsored Programs

Administrators

and PIs must

work together

on applications

(14)

Obtain Compatible Software

• Form software: Free Adobe Reader software required

– Only specific Adobe Reader versions are compatible with Grants.gov forms

– Currently Adobe Reader 8.1.3 or higher is required

– Stay Tuned to Grants.gov’s Download Software Page for Changes

– A pop-up usually warns if you have a wrong version

– Opening Forms with non-compatible Adobe Reader may

corrupt application and prevent successful submission!

• PDF conversion program – text attachments must be converted to PDF

– If using an Adobe Acrobat Product to create PDFs, check

Grants.gov’s Web site to ensure the application reader opens in the correct version of Adobe

(15)

eSubmission Process

(16)

Find Opportunity & Download Package

• ALL applications must be submitted in

response to a Funding Opportunity

Announcement (FOA)

• NIH simultaneously posts FOAs on:

– NIH Guide for Grants and Contracts

http://grants.nih.gov/grants/guide/index.html

• Announcements include button to download package and instructions from Grants.gov

– Grants.gov

(17)

Investigator–Initiated Research

• NIH is committed to investigator-initiated

research and we want your unsolicited

applications!

• All applications must be submitted in

response to an FOA

– “Parent” FOAs are available with generic

packages

– Apply using the Parent FOA for

your chosen activity code

Parent announcements listed at:

(18)

Parent FOAs

NIH Office of Extramural Research

(19)

Unsolicited or Investigator Initiated Apps

Submit unsolicited or Investigator Initiated applications using the appropriate Parent

(20)

Finding FOAs in NIH Guide

Enter search string or click

Advanced Search

NIH Guide for Grants & Contracts

(21)

Finding FOAs in NIH Guide

Enter search parameters

(22)

Finding FOAs in NIH Guide

• Review list of FOAs matching your criteria

and find FOA of interest

(23)

Announcement Notes

• Carefully read the entire announcement • Key dates:

– Release/Posted Date: package and instructions available for download

– Opening Date: application can be submitted

– Application Due or Submission/Receipt Date: submission deadline – Expiration Date: announcement closed

(24)

Announcement Notes

• FOAs in the NIH Guide include button to

download app from Grants.gov

(25)

Download Package

(26)

eSubmission Process

Submit Application to Grants.gov (AOR only)

(27)

27

Grant Application Package Screen

Save locally

Check Application Guide to determine which Optional Documents to submit Complete the SF424 (R&R) first – populates fields in other forms Mandatory Grants.gov fields highlighted; Check App Guide for additional NIH required fields Header info is pre-populated and not editable

(28)

Application Guide

• Read and follow

application

guide

instructions

• Agency-specific

instructions are

marked with the

HHS logo

(29)

Announcement

• Read and follow

announcement

instructions

• Pay special attention to

Section IV. Application and

Submission Information

– Includes any FOA-specific submission instructions

– Instructions in FOA trump

instructions in the application guide

(30)

eSubmission Process

Submit Application to Grants.gov (AOR only)

(31)

Submit Application

Check Package for Errors only checks

Grants.gov errors. You must Submit the application for it to go through the NIH validation process. NIH errors will be shown in the eRA Commons.

Save & Submit

button will not become active until:

•All fields marked as mandatory on the forms are completed •All Mandatory Documents are moved to Mandatory Documents for Submission box and completed •The application is Saved

(32)

Enter your Grants.gov username and password – you must be fully registered to successfully submit. Only the AOR can Submit application.

(33)

Submit Application

Click Sign and Submit

Application button to

record electronic

signature and initiate submission process to Grants.gov

(34)

Submit Application

Print/Save your Confirmation screen info Grants.gov Tracking # Date/Time Stamp - due 5 p.m. local time of the applicant org. on submission

(35)

Upon Submission Grants.gov Will Check to Ensure:

• All Grants.gov mandatory fields have been

completed

• All mandatory documents have been

completed and moved to the Completed

Documents box (Submission List)

• The validity of the organizational DUNS #

• Date format, e-mail address format, and

(36)

E-mail Notifications – Grants.gov

AOR receives Grants.gov e-mails

1. Submission Receipt – app received and

is being validated (Grants.gov validations only) 2. Rejection Notice – app is not validated because

of Grants.gov errors

OR

Submission Validation Receipt – app has been validated (Grants.gov validations only)

3. Grantor Agency Retrieval Receipt – app has been retrieved by the agency

4. Agency Tracking Number – app has been assigned a tracking number by the grantor agency (NIH)

(37)

Back to NIH

You’re not done yet!

Make sure you follow

the application

(38)

eSubmission Process

(39)

Application Processing in eRA Commons

• eRA system retrieves applications from Grants.gov and checks them against NIH business rules defined in application guide instructions and FOA

– Complete list of NIH validations:

http://era.nih.gov/ElectronicReceipt/prepare_app.htm#5

• Remember, the SF424 (R&R) forms are owned by Grants.gov and used by many agencies, so

unfortunately we cannot build agency-specific business rules into the forms

(40)

E-mail Notifications - eRA Commons AOR, PD/PI and Contact listed on SF424

R&R cover form receive e-mails

Validations Complete/Check Assembled Application Validations Complete/Check Assembled Application – Warnings Only

Action Required: Errors and/or Warnings

Action Required: Missing/Invalid Commons Username

Action Required: System Error

(41)

Check Status in Commons – PD/PI

Select Recent/Pending eSubmissions

Or provide Grants.gov tracking number from email notification

(42)

Status – eSub Errors/Warnings

Indicates eSubmission Error

Grants.gov

Tracking # Grants.gov tracking # and date are displayed followed by the list of errors/warnings for each submission

(43)

Status – eSub Errors/Warnings

• Errors stop application processing and

must be corrected

• Warnings do not stop application

submission and are corrected at the

discretion of the applicant

Helpful Links

Avoiding Common Errors page:

http://era.nih.gov/ElectronicReceipt/avoiding_errors.htm

Full list of Commons Validations

(44)

On-time Submission

• All registrations must be completed

prior to initial submission

• Submission must be accepted by

Grants.gov with a timestamp on or

before

5:00 p.m. local time

of submitting

organization on submission deadline date

• Errors/Warnings must be

corrected within the 2-business

day error correction window

(45)

Error Correction Window

• NIH currently allows applicants to

correct errors/warnings during the

two (2) business days

after the

submission deadline

– Referred to as “error correction window”

– Your original application submission must have been submitted on time with all appropriate

registrations in place

– Cover letter identifying changes required

See Notice in NIH Guide for Grants & Contracts (11/30/2007): http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-018.html

(46)

Correcting eSub Errors/Warnings

Make changes to address the error/warning

messages in the local copy of the application 1. Select Changed/Corrected on SF424 (R&R)

cover (box #1)

 Federal Identifier on SF424 (R&R) cover (box #4) is a required field when Changed/Corrected is selected

• If New is selected in box #8, use Grants.gov tracking number for original submission

• Otherwise, continue to use the Institute/Center and serial number from original grant award (ex. CA123456)

2. Include cover letter if after submission deadline 3. AOR must submit the entire changed/corrected

application to Grants.gov

(47)

eSubmission Process

(48)

Status – View Application Image

• Once an error-free application is

received, the eRA system will:

– Assemble the grant application image

– Insert headers (PI name) & footers (page

numbers) on all pages

– Generate Table of Contents and bookmark

important sections

– Post the assembled application image in

the PI’s eRA Commons account

(49)

Application Viewing Window

• Applicants have two (2) business days to view the assembled application before it automatically moves forward to NIH for further processing

• SO can Reject application within viewing window to address Warnings (if within error correction

window) or to address a system issue affecting the application image

– If Rejected after deadline for any other reason, application is subject to late policy

– PI will receive email notification if SO rejects application

(50)

Status – View Application Image

View Appendices and Cover Letter

Status is Pending Verification

Follow e-Application link to view assembled application image

(51)

Status – e-Application

TIP: Carefully review the entire application. This is your first chance to view/print the same application image that will be used by Reviewers!

(52)

Reject Application

Must have SO role

Click Search

(53)

Reject Application

Select Reject

eApplication

Enter comment to be sent with email notification

(54)

eSubmission Process

(55)

Submission Complete!

• If no action is taken during the two business

day viewing window, the application

automatically moves forward to NIH for

further processing

• Any subsequent application changes are

approved through and

at the discretion of the

Scientific Review

Officer in the form of

addenda

(56)

(57)

Trouble Submitting due to System Issues?

When Grants.gov or eRA system issues threaten your on-time submission…

• Contact appropriate support to try to get resolution

– If working with Grants.gov, contact eRA help desk to document issue and steps taken toward resolution. If verified system issue, this documentation can be used in place of tracking number and timestamp as proof of "on time" submission.

• Continue to work through submission issues to complete process within error correction window

• Document your issues and corrective actions including support ticket numbers in Cover Letter

(58)

More Electronic Interaction Points Check Review Assignment Submit Pre-Award Information Check Review Outcome Prepare/Submit Post-Award Reports eRA Commons

My application is submitted…

…now what?

Additional

eRA Commons

functionality

Update Personal Profile and Institutional Profile Information

(59)

eRA Commons

and Grant Administration through the

eRA Commons

(60)

Administration after Submission

eRA Commons Features:

– Profiles

– Application Tracking – Grant Status

– Just In Time (JIT)

– Electronic Streamlined Non-competing Award Process (eSNAP)

– Closeout

– No-Cost Extension

– Financial Status Report (FSR) – Internet Assisted Review

– xTrain

(61)

Institutional Profile

• Institutional Profile File (IPF)

– Central repository of information for organizations registered in Commons

– each applicant/grantee organization establishes and maintains their profile data

• Includes:

– Preferred institution name and contact information – Signing Official’s name(s), email, and phone number – Institutional DUNS number

– Institutional Assurances

– E-mail addresses for electronic distribution of Notice of Award and other communication notifications

(62)

Personal Profile (PPF)

• Personal Profile

– Established for every Commons user

• Single Point of Ownership

– You are responsible for keeping your information current – Very few staff members at NIH have access to change

information (for emergencies only)

• Periodically the system will require you to change your password for security reasons

– You will be placed in the Personal Profile tab - take a moment to review and update your information

(63)

PPF – Personal Information

TIP: Keep your email address current – needed if you forget your password.

(64)

PPF – Degrees/Residency

• Provide all degree information

– Remember to include information on degrees in progress and the expected completion date

(65)

PPF – Early Stage Investigator Status

DEGREE/RESIDENCY INFORMATION ALSO HELPS DETERMINE YOUR

EARLY STAGE INVESTIGATOR (ESI) ELIGIBILITY

• A Principal Investigator who has attained a terminal research degree or completed a medical residency

within the past 10 years and has not previously received a substantial NIH research grant, may be eligible to

qualify as an ESI for the purposes of a NIH R01 research grant application. An ESI is a subset of the New

(66)

Personal Profile – Degrees/Residency

• To ensure that NIH recognizes your eligibility as an ESI, PIs are urged to include their degree/residency

information under their Personal Profile

Note: PIs need to update their degree/residency data before they submit their R01 application.

Use Add Medical Residency button to provide information

(67)

67

PPF - Publications

• Publication information is used in progress reports • Pulls in manuscripts from NIH Manuscript

Submission (NIHMS) and publications from PubMed and PubMedCentral

TIP: Visit http://publicaccess.nih.gov/ for information on new Public Access policies.

(68)

PPF - Reference Letters

• Used for specific grant programs

– NIH Director’s Pioneer Program (DP1) – New Innovator Award (DP2)

– Career Development (Ks) – Research Fellowship (Fs)

• Can see that the reference letter has been submitted, but not the letter itself

(69)

Remember…

Information from your Personal Profile is

… used to determine Early Stage Investigator (ESI) eligibility …used to verify information submitted in grant applications

If not current, errors or warnings may be generated during the application submission process.

…used to pre-populate specific forms (e.g., Trainee Appointment and Termination Notices)

If not current, errors or warnings may be generated during the form submission process.

… allows for automatic population of publications registered in National Library of Medicine systems

…used for Agency notifications

If not current, we may not be able to contact you. Since many of these notifications are now automatic, we may not even be aware the notification did not reach you.

(70)

Admin - Delegation

Commons allows many functions to

be delegated to other users

• Delegate PI

– Delegation can be made to any other eRA Commons user at the institution

– Provides ability to complete eSNAP information for the PI’s grants (cannot Route or Recall)

• Delegate PPF Edit

– Delegation can be made to any other eRA Commons user at the institution

(71)

Admin - Delegation

• Delegate Status

– Delegation can be made to any eRA Commons user at the PI’s institution with the Assistant (ASST) role

– Provides access to PI’s Status information including the ability to check for application submission errors/warnings and to view the assembled application image

– DOES NOT provide access to application summary statement or priority score

• Delegate xTrain Authority

– Delegation can be made to any eRA Commons user at the PI’s institution with the Assistant (ASST) role

– Provides all the same authority within xTrain as the

Project Director/Principal Investigator except for the ability to Submit appointments to Agency

(72)

Delegation to PI

• Signing Official (SO) can “Delegate

Submit” authority to a PI

– Allows a PI to submit his/her own eSNAP information to Agency

(73)

Tracking Application Status as a PI

(74)

STATUS Hit List

1. Application ID is the link to the application details.

(75)

Track Assignment Info. in Status Details

Institute Assignment NIH Staff Contact Info Review Group Assignment

(76)

Track Review Outcome

Only the PI can see the Impact/Priority score and summary statement

(77)

Just In Time Submission

JIT

• Electronically submit Just-In-Time pieces of

the application

– Other Support, IRB and/or IACUC Approval Dates, Human Subjects Education info

• Not an indication that application will be

awarded.

• Wait for a request to submit the information

– You should receive either a system-generated email or be contacted by the Grants

Management Specialist (GMS)

(78)

Click on the JIT link in the Actions

(79)

Just In Time

PI can enter the Other Support File, IRB Date, IACUC date and HS Education information, but

(80)

Just In Time

• June 2008 JIT Enhancements

– Additional uploads

• Detailed Budget • Other Upload

– Uploads restricted to PDF documents – Ability to submit a subset JIT elements

– Multiple submission of each JIT element allowed in coordination with NIH grants management staff

(81)

eSNAP

Electronic Streamlined Non-competing

Award Process

• Electronic submission of annual SNAP

Progress Reports

– Most non-competing grants at NIH are streamlined

• SO can enable the organization to submit

eSNAPs

• Benefits:

– Submission deadline is 45 days prior to start date instead of 60 days

(82)

eSNAP

Electronic Streamlined Non-competing

Award Process

• PI or PI Delegate can begin the process,

upload progress report, and enter any or

all of the administrative data

• eSNAP can be routed to staff for approval

• SO submits the completed eSNAP to NIH

– SO can delegate submit privileges to any or all PIs at the organization

(83)

eSNAP

Begin the eSNAP either from the Action column of the

(84)

eSNAP Hit List

PI hit list shows all grants and applications with the Grant

(85)

Closeout

• Electronically submit required Closeout

documents for applications in Closeout status

• Grants Management Specialist at NIH must mark the grant “ready for close out” before link appears in Commons

– Contact assigned specialist if records are not appearing

• Items are:

– Final Financial Status Report - Final Progress Report

(86)

(87)

No-Cost Extension

• Electronically submit no-cost extension notification to NIH

• Grants in the last support year of the project

period may be extended 1 time, only by the SO, for 6, 9 or 12 months

• Extension may not involve any additional costs • Email notification sent to NIH Grants

Management staff when SO processes the extension

(88)

(89)

Financial Status Report

FSR

• Statement of expenditures usually due

within 90 days from end of budget period

or project period

• Schedule for submitting FSR is normally

specified in the Notice of Grant Award

• Can be searched by individual grant

number, FSRs for the institution or status

of the FSR

(90)

FSR Search Screen

(91)

(92)

xTrain

• Now open to all Kirschstein-NRSA Training

Grant (T32) grantees

• Allows users to electronically process the

required paperwork associated with

awarded training grants

• Grantee institution staff can use xTrain to:

– create, route and submit Appointments, Re-Appointments, Amendments and Termination Notices

(93)

xTrain Trainee Roster

Appointment Type: New Reappointment Amendment Appointment Status: In Progress PI In Progress Trainee

Pending Agency Review Accepted Terminated Appointment/Termination Source: Paper or Electronic Termination Status: In Progress BO In Progress PI In Progress Trainee

Pending Agency Review Accepted View: View 2271 View TN View Payback Action: 2271 Form Amend 2271 Initiate TN Term Notice

• Most work is done from Trainee

Roster

(94)

(95)

FCOI Institution Functionality

Financial Conflict of Interest (FCOI)

• Allows grantee institutions to:

– Initiate and prepare a FCOI notification

• Multiple FCOI officials and delegates can access and edit a notification while in Work In Progress (WIP) status

– Submit the FCOI notification and supporting documents electronically to Agency

• Can provide comments at time of submission that are included in email notification to Agency

– Search and View FCOI notifications previously submitted through Commons

• Does not provide visibility to any notifications previously submitted in paper

– Edit or rescind submitted notifications (requires Agency involvement)

(96)

Finding Help

(97)

Finding Help: Web Site Links

• Links to Applicant Resources

– NIH Grants Web site:

http://grants.nih.gov/

– electronic Research Administration:

http://era.nih.gov/

– eRA Commons:

(98)

(99)

Finding Help: Grants.gov

If help is needed with the Grants.gov

registration process, downloading forms, form behavior or with technical aspects of submitting through the Grants.gov system:

– Check the resources available on the

Grants.gov website (http://grants.gov/ )

– Grants.gov Contact Center

• Contact Center Phone: 1-800-518-4726 • Business Hours M-F 7 a.m.- 9 p.m. ET • Email [email protected]

(100)

Finding Help: eRA Commons

If help is needed with eRA Commons registration or system validations after submission through

Grants.gov:

– Check the eRA Commons website:

https://commons.era.nih.gov/commons/index.jsp

– eRA Commons Help Desk

Web support: http://ithelpdesk.nih.gov/eRA/

Phone: 301-402-7469 Toll Free: 866-504-9552 TTY: 301-451-5939

(101)

Finding Help: Grants Info

– Review the Application Instruction Guide – Review the FOA

– Grants Info:

Phone: 301-435-0714

Email [email protected]

Grants Information

If help is needed with grant policy, application

(102)

Feedback – Contact Us

eRA has established an e-mail address to

collect comments and/or suggestions from

users on eRA Commons and eSubmissions:

– [email protected]

– Share your successes and challenges with us! – We especially like specific suggestions for

improvement

– Please report your production support issues to the eRA Commons Help Desk and not this email address

(103)