FORMS-E - grants.nih.gov

FORMS-E Good stuff to know when developing support in system-to-system solutions for FORMS-E application forms. August 2017 1 S2S WEB PAGES Development Resources 2 FORMS UPDATED IN FORMS-E Agency-specific forms Federal-wide forms PHS 398 Career Dev. Award Supp. SF424 (R&R)

PHS 398 Cover Page Supplement Form Project/Performance Site Location(s) PHS 398 Modular Budget R&R Other Project Info PHS 398 Research Plan PHS 398 Research Training Program Plan R&R Sr/Key Person Profile (Expanded) PHS 398 Training Budget & Subaward R&R Budget & Subaward 5 YR, 10 YR, MP PHS Additional Indirect Costs SF424C Construction Budget PHS Assignment Request Form

PHS Fellowship Supp. Form PHS Inclusion Enrollment Report No longer used Rolled into new PHS Human Subjects and Clinical Trials Information form SBIR/STTR Information Resources Annotated Form Sets High-level Summary of Form Changes in FORMS-E Application Packages Preview of FORMS-E Grant Application Form Changes 3 SCHEMAS AND DATS FORMS-E Schemas and DATs can be found on Grants.govs forms repository in the training environment

https://training.grants.gov/web/grants/forms/r-r-family.html#sortby=1 4 STUDY RECORD Grants.gov has posted the Study Record: PHS Human Subjects and Clinical Trials Information form on the main page of the form repository This fall they will update their system to allow it to be listed with other R&R Forms Currently unable to list subforms that cant act as a stand-alone form in an application package 5 CHANGES Majority of changes related to human subjects and clinical trials data collection Consolidation of data fields collected on multiple forms into new PHS Human

Subjects and Clinical Trials Information form 6 COMMON RULE We are preparing our systems for the expected implementation of the Common Rule this January. Although HHS has not yet confirmed the targeted January 2018 implementation date, we hope to include the new exemption codes in FORMSE to avoid multiple form updates Will use validations to prevent use of new codes if implementation date is delayed Only change to our application forms is the addition of two human subjects exemption codes (7 and 8) R&R Other Project Information Waiting on OMB approval PHS Human Subjects & Clinical Trials Information Learn more about the Common Rule https:// www.hhs.gov/ohrp/regulations-and-policy/regulations/finali zed-revisions-common-rule/index.html

7 NEW HUMAN SUBJECT EXEMPTION CODES 8 TIMING OF FORMS-E ROLL-OUT FORMS-E application packages MUST be used for applications to due dates on or after January 25, 2018 and CANNOT be used for earlier due dates. Application guide instructions will be posted ~September 25, 2017 eRA will deploy FORMS-E support to production ~October 11, 2017 We will begin posting FORMS-E packages ~October 25, 2017 Some FOAs will be posted prior to Oct. 25 without packages (e.g., PAR-17301) FORMS-E will be added to all active non-clinical trial FOAs with due dates on/after Jan. 25 between Oct. 25 and Nov. 25 NOT-OD-17-062 - Newtrials NIH "FORMS-E" Grant Application Forms

and be FOAs that will allow clinical using FORMS-E on/after Jan. 25 will reissuedInstructions Coming for Due Dates On or After January 25, 2018 9 GENERAL POSTING RULES Posting rules for updates to existing FOAs with due dates on/after Jan. 25, 2018 FORMS-D package Competition Title change to Use for due dates on or before January 24, 2018 Close date January 24, 2018 Grace period 21 days (Feb 7 for continuous submitters, plus a week padding) FORMS-E package

Competition ID FORMS-E Competition Title Use for due dates on or after January 25, 2018 Open date posting date Close date original close date of FOA Grace period 35 days (standard) 10 ADMIN REQUEST POSTING RULES Posting rules for Type 6, Type 7 and Admin Supp (Type 3) FORMS-E Issue new FORMS-E FOAs on January 25, 2018 FORMS-D Close FORMS-D FOAs on February 24, 2018 Gives applicants 1 month to complete submissions Grace period 0 days 11 PARENT ANNOUNCEMENTS All parent announcements will be reissued

Posting rules for Parent FOAs (except Admin Supp/Type 6/Type 7) FORMS-D FOAs Close January 24, 2018 Grace period 21 days (Feb 7 for continuous submitters, plus a week padding) In Related Notices section indicate - This PA has been reissued as PA-17-xxx for due dates on or after January 25, 2018. FORMS-E FOAs Reissue targeted for at least 60 days prior to first use In Announcement Type section indicate Reissue of PA-xx-xxx for due dates on or after January 25, 2018 12 CLINICAL-TRIAL SPECIFIC FOAS For due dates on or after January 25, 2018, NIH requires that all applications involving one or more clinical trials be submitted through a Funding Opportunity Announcement (FOA) specifically designed for clinical trials. New FOAs will specify allowability of clinical trials in the FOA title NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) Exploratory Clinical Trial Grants in Arthritis and Musculoskeletal and Skin Diseases (R21 Clinical Trial Allowed) Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Admin Supp Clinical Trial Optional)

Ruth L. Kirschstein National Research Service Award (NRSA) Individual Postdoctoral Fellowship (Parent F32 No Independent Clinical Trials) All FOAs will specify the allowability of clinical trials in Section II. Award Information NOT-OD-17-043 - Update on Clinical Trial Funding Opportunity Announcement Policy 13 FOA SECTION II 14 CLINICAL TRIALS FOA DESIGNATIONS Fellowship FOAs Not Allowed: Only accepting applications that do not propose independent clinical trials. Note: Applicants may propose to gain experience in a clinical trial led by a sponsor/co-sponsor as part of their research training. Career Development FOAs Required: Only accepting applications that propose independent clinical trial(s) Not Allowed: Only accepting applications that do not propose independent clinical trials

Note: Applicants may propose to gain experience in a clinical trial led by a mentor/co-mentor as part of their research career development. All Other FOAs Not Allowed: Only accepting applications that do not propose clinical trial(s) Required: Only accepting applications that propose clinical trials Optional: Accepting applications that either propose or do not propose clinical trial(s) 15 SYSTEMATIC IDENTIFICATION OF CLINICAL TRIAL FOA DESIGNATION New clinicalTrialCode data element in FOA Information Request response in Submission Agency Data Service (SADS) Indicates whether the FOA supports a clinical trial This is a string with possible values: N, O, R and I N = Not Allowed

O = Optional R = Required I = Required (Infrastructure) Resource S2S Client Transaction Guide - DRAFT 16 GET FOA INFO Request Response 17 INFRASTRUCTURE Shows as Required in Section II of the FOA Behind the scenes, relaxes validations so that only the following study record fields are required

1.1 1.2 1.3 1.4 2.1 2.4 3.1 3.2 3.3 4.7 Study Title Is this Study Exempt from Federal Regulations?

Exemption Number Clinical Trial Questionnaire Conditions or Focus of Study Inclusion of Women, Minorities, and Children Protection of Human Subjects Is this a multi-site study... question and associated Single IRB plan Data and Safety Monitoring Plan Dissemination Plan 18 SAMPLE VALIDATION RELAXING FIELD REQUIREMENTS FOR INFRASTRUCTURE FOAS 19 PHS HUMAN SUBJECTS AND CLINICAL TRIALS INFORMATION FORM 20 NEW FORM & APPLICATION PACKAGES New PHS Human Subjects and Clinical Trials Information form is a

mandatory form in most NIH application packages Exceptions Form not included in package Training - T15, T32, T34, T35, T36, T37, D71, U2R, T01, T02, T03, T14, T42, T90, T90/R90, TU2 Shared Instrumentation S10 Construction C06/UC6, G20 Resource Awards X01 Form optional Admin Supp Type 3 research, career dev, fellowship, institutional training (K12 and D43) Type 6 & Type 7 - research,Resource career dev, fellowship NIH Application Forms and Activity Code Mapping - FORMS-E 21 RELATIONSHIP BETWEEN FORMS Human Subjects data on R&R Other

Project Info form drives behavior on new form Schema does not force consistency of data across forms so, you must! 22 WHEN HS=NO WHEN HS=YES must include at least one full or delayed onset study record. Full Study Record Delayed Onset Study

SAMPLE VALIDATIONS ENFORCING AT LEAST 1 STUDY RECORD 25 OTHER REQUESTED INFORMATION Only use for information specifically requested in FOA or application guide instructions. E.g., used for crossreferencing when studies are shared across multiple components in multi-project applications. Always active (i.e., active when HS = Yes & HS=No). DELAYED ONSET STUDIES

Glossary of NIH Terms All study titles (both delayed onset and full study records) must be unique within the application (global validation 000.41) A delayed onset study is considered a clinical trial if Anticipated Clinical Trial box is checked AND FOA allows clinical trials. D43 & K12 The D43 and K12 programs only allow delayed onset studies Enforced via validations 28 Required for Human Subjects studies Required for Clinical Trial studies Fields 1.1, 1.2, and 1.4 are required and enforced by schema.

A study record is considered a clinical trial if Yes to all Questionnaire questions AND FOA allows clinical trials. Commas removed Aug. 2017 Section 2 is required for Required for Human Subjects studies all human subject studies Required for Clinical Trial studies (except exemption 4) and all clinical trial studies. Cannot provide a number if unit of time is N/A (Rule 034.6.11). Cannot provide a number if unit of time is N/A (Rule 034.6.4).

Multi-select, the eRA team will show you how we are handling it Existence of a comment relaxes some validations Planned enrollment required when Using an Existing Dataset or Resource = No. Validations do not cover all expected scenarios. It is possible to have both tables in one report. Cumulative enrollment required when Using an Existing Dataset or Resource = Yes. 3.1 and 3.2 are required for human subject studies (3.3-3.5 are optional). All fields in Section 3 are required for clinical trial studies.

Required for Human Subjects studies Required for Clinical Trial studies Required for Clinical Trial studies For each intervention, all fields are required (schema enforced). Validations prevent section 4 data for non-CT study records (at least 1 No answer on Clinical Trial Questionnaire) Fellowship applications Career Dev applications to Clinical Trials Not Allowed FOAs

SAMPLE VALIDATIONS CONTROLLING SECTION 4 & 5 35 Required for Clinical Trial studies For each outcome measure, all fields are required (schema enforced). FILENAME UNIQUENESS Filenames must be unique within a single-project application and within a component of a multi-project application Given an application can have multiple study records, watch out for folks attaching the same filename in different studies 37 Required for Clinical Trial studies Validations prevent section 5 attachments for

non-CT study records (at least 1 No answer on Clinical Trial Questionnaire) Fellowship applications Career Dev applications to Clinical Trials Not Allowed FOAs MULTI-PROJECT FORM included in all components (i.e., Overall and Other Components) Each study must be specified only once in an application and not repeated Each study title must be unique Any HS=Yes component (except Overall) must have at least one proposed study record (can be delayed onset if meets the policy definition) Exception: for studies that cross projects in a multi-project application, components must refer to study associated with Overall using the Other Requested Information attachment on the HS/CT form. The Other Requested Information attachment in the Overall must reference all involved components. 39 We enforce that if any component has HS=Yes, then HS=Yes in

Overall component. Component Component Type: Type: Admin Admin Core Core Admin Admin Core-001 Core-001 Project Project Title: Title: Admin Core Admin Core Project Project Lead: Lead: Jed Jed I.I. Knight Knight Organization:

Organization: A A HS=No HS=No Overall Overall Component Component PD/PIs: PD/PIs: Cher Cher D. D. Money, Money, Ben Ben A. A. Round Round Organization: Organization: A A Project Project Title: Title: Research

Research Center Center to to Cure the Diseases of the World Cure the Diseases of the World Other Other Project Project Info Info -- HS=Yes HS=Yes STUDIES SELF-CONTAINED IN COMPONENTS No study record needed in Overall. Component

Component Type: Type: Project Project Component Component Type: Type: Core Core Core-001 Core-001 Project Project Title: Title: Core Core 11 Project Lead: Project Lead: Ben Ben A. Round A. Round Organization: Organization: A

A HS=No HS=No Core-002 Core-002 Project Project Title: Title: Core Core 22 Project Lead: Project Lead: Abel Abel Tu Lead Tu Lead Organization: Organization: B B In each (non-Overall) component where HS = Yes, at least one study record is required

Project-001 Project-001 Project Project Title: Title: Fabulous Fabulous Research Research Focus Focus 11 Project Project Lead: Lead: Cher Cher D. D. Money Money Organization: Organization: A A HS=Yes HS=Yes

HS/CT Project-001, form Study 1 - CT = Yes Complete Sections 1, 2, 3, 4, 5 Project-001, Study 2 CT = No Must complete Sections 1, 2, 3; 4 & 5 blocked via validations Project-002 Project-002 Project Project Title: Title: Fabulous Fabulous Research Focus Research Focus 22 Project Project Lead:

Lead: Quin Quin T. T. Sential Sential Organization: Organization: B B HS=No HS=No Project-003 Project-003 Project Project Title: Title: Fabulous Fabulous Research Research Focus Focus 33 Project Project Lead:

Lead: Ima Ima Doer Doer Organization: Organization: C C H =Yes H =Yes HS/CT form Study record can be delayed onset. Project-003, Study 1 Delayed Onset Study Indicate whether CT is anticipated; attach justification; no other info needed

40 Include details of study in overall. Use Other Requested Information attachment to reference components. Overall Overall Component Component PD/PIs: PD/PIs: Cher Cher D. D. Money, Money, Ben Ben A. A. Round Round Organization: Organization: A A Project Project Title: Title: Research

Research Center Center to to Cure the Diseases of the World Cure the Diseases of the World HS=Yes HS=Yes Component Component Type: Type: Admin Admin Core Core Admin Admin Core-001 Core-001 Project Project Title: Title:

Admin Core Admin Core Project Project Lead: Lead: Jed Jed I.I. Knight Knight Organization: Organization: A A HS=No HS=No MULTIPLE COMPONENTS WORKING ON HS/CT form SAME STUDY Overall, Study 1 CT = Yes

Shared study record Other Requested Information attachment: Reflects shared study in Project-001 and Project003. Component Component Type: Type: Project Project Component Component Type: Type: Core Core Core-001 Core-001 Project Project Title: Title: Core Core 11 Project Lead:

Project Lead: Ben Ben A. A. Round Round Organization: Organization: A A HS=No HS=No Core-002 Core-002 Project Project Title: Title: Core Core 22 Project Lead: Project Lead: Abel Abel Tu Tu Lead Lead

Organization: Organization: B B HS=No HS=No Project-001 Project-001 Project Project Title: Title: Fabulous Fabulous Research Research Focus Focus 11 Project Project Lead: Lead: Cher Cher D. D. Money Money Organization:

Organization: A A HS=Yes HS=Yes HS/CT form Shared study record Use Other Requested Info attachment to refer to study in overall Project-002 Project-002 Project Project Title: Title: Fabulous Fabulous Research Focus Research Focus 22 Project Project Lead:

Lead: Quin Quin T. T. Sential Sential Organization: Organization: B B HS=No HS=No Project-003 Project-003 Project Project Title: Title: Fabulous Fabulous Research Research Focus Focus 33 Project Project Lead:

Lead: Ima Ima Doer Doer Organization: Organization: C C H =Yes H =Yes HS/CT form Shared study record Use Other Requested Info attachment to refer to study in overall Both Both projects projects working working on on same same study.

study. Each Each project project uses uses Other Other Requested Requested Information attachment to refer to study in overall. Overall. No No other other details details needed needed here. here. 41 RETIREMENT OF DOWNLOADABLE FORMS Downloadable forms will not be a back-up option for FORMS-E You need to be prepared to use either ASSIST or Workspace for FORMS-E application packages Reminder: NIHs system issue policy only applies to federal systems.

42 EXPECT SOME LATE TWEAKS eRA uses Agile development practices Adjustments to requirements continue make sure your systems are flexible Take advantage of eRA web services rather than recoding Submission Agency Data Service (SADS) Submission Validation Service (SVS) Submission Image Service (SIL) Code overrides for the validations you choose to implement Stay tuned for Go No Go for Common Rule implementation Validations for new exemption codes - TBD 43 FINAL QUESTIONS 44

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