Steps to Initiating National Institutes of Health (NIH) Sponsored Research
|1.||Principal Investigator (PI) develops the Research Question and assess feasibility of study.
PI determines feasibility of study, inclusion/exclusion criteria, and decision to move forward.
University Research Informatics Data Environment, or URIDE, is a research tool that allows for the exploration of de-identified patient data from the University’s multiple clinical and research systems. It can be used for study design, feasibility analysis, grant submission or other applications in which population assessments need to be conducted. For more information, contact URIDE at email@example.com.
|2.||PI and research study team discuss the submission, review the guidance, and establish submission preparation timeline, as soon as Request for Applications/Program Announcement (RFA/PA) are announced.|
|3.||PI determines type of submission (New, resubmission)|
|4.||If a resubmission, PI and research study team review the NIH Summary Statement.|
|5.||For PI-initiated studies (i.e., PI is the regulatory sponsor) involving an Investigational New Drug (IND) or Investigational Device Exemptions (IDE), submissions to U.S. Food and Drug Administration (FDA) are required.
The PI and/or study team prepare FDA submission. To determine if an IND or IDE is needed, please refer to HRP-306 – Worksheet – Drugs or HRP-307 – Worksheet – Devices from within the IRB Library when logged into eProst (http://eprost.med.miami.edu). For further information, contact the Institutional Review Board (IRB), Clinical Research Operations and Regulatory Support (CRORS), Research Compliance and Quality Assurance (RCQA) for guidance, or go to the FDA website (IND) or (IDE).
At the time of protocol submission to the FDA, CRORS must be notified to conduct an initial consultation (Policy NO. HSR-P-003, Clinical Research Trial Monitoring)
NOTE: the FDA acknowledgement letter must be uploaded with IRB submission within “study drug or device” section.
|6.||For Investigator-sponsored IND or IDE studies, plan to use Velos for all data management (including drafting data collection forms). For any other data management system, contact IT Strategic Operations for an FDA Part 11 validation review.|
|7.||Concurrently, PI or delegated study staff initiate communication with institutions to be involved, such as Jackson Health System (JHS), University of Miami Hospitals (UMH), Veterans Affairs (VA), Community Partners (e.g., Health Council of South Florida, Consortium for Healthier Miami Dade), etc. regarding resources, utilized staff effort (if any), procedures performed within these institutions on behalf of protocol (e.g., Screening, patient recruitment, etc.).|
|8.|| Identify roles (services vs. subcontractor, pursuant to Uniform Guidance). If you have questions/concerns regarding whether a stakeholder is a service provider or a subcontractor, please contact the Office of Research Administration (ORA) via email firstname.lastname@example.org.
If a subcontractor is anticipated, each subcontractor will usually be required to provide: letter of intent signed by Institutional Authorized Official; statement of work; budget; budget justification; as well as other required documents. Obtain other required documents from subcontractors, if applicable. Subcontracting to Another Entity.
If using Jackson Health System (JHS), follow the Submission and Negotiation Process When JHS Involved Under New Master Research Collaboration Agreement process.
|9.||Ensure all third party facilities have been identified and engaged (e.g., Clinical Translational Research Site (CTRS, previously known as CRC Clinical Research Center), Comprehensive Treatment Unit (CTU), Pharmacy, Radiology, hospital wards, etc.)|
|10.||Contact Clinical Research Operations and Regulatory Support (CRORS) to discuss regulatory support and monitoring plan, as applicable.
NOTE: For all Investigational New Drug (IND) or Investigational Device Exemption (IDE) studies, a monitoring plan is required.
|11.||Confirm InfoEd accounts are created for all personnel on the budget. If not, request them. As of July 1, 2015, UM requires the use of InfoEd Proposal Development (PD) for ALL NIH Applications which currently are available through grants.gov. Office of Research Administration offers regularly scheduled InfoEd Proposal Development Hands-On Workshops. Please schedule via ULearn.|
|12.||Confirm PI and delegated study staff have an eRA Commons account with appropriate UM affiliation, UM email address and NIH roles. If not, request them through the Office of Research Administration (ORA) NIH eRA Commons Account Form.
NOTE: Any study personnel working more than one calendar month on the project, will require an eRA Commons account as described above.
Identify roles (services vs. subcontractor, pursuant to Uniform Guidance). If you have questions/concerns regarding whether a stakeholder is a service provider or a subcontractor, please contact the Office of Research Administration via email email@example.com. If a subcontractor is anticipated, each subcontractor will usually be required to provide: letter of intent signed by Institutional Authorized Official, statement of work, budget, and budget justification, as well as other required documents. For more information, please go to the Office of Research Administration (ORA) Subcontracting to Another Entity page.
If using Jackson Health System (JHS), consult with JHS Office of Research regarding activities occurring within their facilities and their potential role in study.
|14.||PI or delegated study staff request/obtain Letters of Support (LOS) and the above-mentioned documents for each subcontractor, as appropriate.|
|15.||PI / delegated study staff prepare/review/update NIH required Biosketches , using the most current version of the Biosketch guidelines.|
|16.||PI and study staff complete applicable required training (e.g., Collaborative Institutional Training Initiative (CITI), Conflict Of Interest (COI)*, VELOS, HIPAA training, new PI training**, Cerner training*** (Jackson electronic medical records), UChart training****, etc.)
PI and study staff complete required interest disclosure process in the UDisclose System
Become familiar with all Human Subjects – related policies and Standard Operating Procedures at the University.
*For questions about COI and the DPS, contact the Office of Disclosures & COI Management (DCM).
**For new PI training, contact Clinical Research Operations and Regulatory Support (CRORS).
***For Web-Based Training, contact MiracleTraining@JHSMiami.org; for JHS Cerner credentials/JHS Security Request form, contact CSC@JHSMiami.org.
****For UChart training, click here.
|17.||PI creates a preliminary budget in collaboration with the research team, and Pre-Award administrator/appropriate departmental support area.
Budgets for other involved facilities should be discussed and prepared in collaboration with these facilities.
|18.||Review the Proposal/Contract Routing Form-L (PCRF-L) Instructions, prepare the Proposal/Contract Routing Form (PCRF-L) and submit to PI’s appropriate departmental support for review and approval.
NOTE: if Department of Medicine signature is required, 5 days are required to review and obtain signature(s).
|19.||PI/delegated study staff and appropriate departmental support begin building the application in the Proposal Development section of InfoEd.|
|20.||PI/delegated study staff obtain publications/references needed for completing the grant submission.|
|21.||PI/delegated study staff and appropriate departmental support format the budget, and complete the personnel section.|
|22.||Upon approval, PI/delegated study staff and appropriate departmental support enter the budget in the Proposal Development section of InfoEd.|
|23.||PI/delegated study staff complete all required internal documents for submission, and notifies appropriate departmental support to begin the budget review process at least 3 weeks before grant deadline (examples of internal documents: PCRF-L, including request for F&A Waiver, Cost Sharing, non-full time faculty to act as PI, familial relationships, institutional approvals, etc.).|
|24.||PI/delegated study staff and appropriate departmental support upload Biosketches for Key Personnel in the Proposal Development section of InfoEd.|
|25.||PI/delegated study staff create and upload submission sections required by NIH in the Proposal Development section of InfoEd. (examples of sections: Project Summary, Abstract, Budget Justification, Project Narrative, Facilities Section, Equipment Section, Specific Aims, Human Subjects Section, Targeted/Planned Enrollment Form, Inclusion of Women/Minorities and Inclusion of Children, Multiple PI Leadership Plan and Resource Sharing Plan, Signed Letters of Support, Cover letter, Research Strategy and References).
Upload PDF document(s) into InfoEd.
PAY CAREFUL ATTENTION TO FORMAT REQUIREMENTS (i.e. font type/size, page limitations, margins, etc.)
|26.||PI must ensure that all required documents are completed correctly, pursuant to funding announcement.|
|27.||All documents must be uploaded into the Proposal Development section of InfoEd (either by the PI / delegated study staff or appropriate departmental support), at least FIVE WORKING DAYS BEFORE THE GRANT DEADLINE pursuant to UM application submission Policy (Select Section B-Proposal Preparation) to ensure error-free grant submission by the Office of Research Administration (ORA) and successful receipt at National Institutes of Health.
PI approves the final version of InfoEd proposal.
NOTE: To send documents or notify that all documents were uploaded into InfoEd PD, please contact the Office of Research Administration (ORA) at firstname.lastname@example.org.
|28.||PI confirms and documents the Final Status of the grant submission in the Proposal Development section of InfoEd.
|29.||PI monitors closely all grant submission communications from ORA/Pre-Award administrator and/or Grants.gov.
If errors are detected, PI/delegated study staff will work with Office of Research Administration (ORA) to correct any submission errors in a timely fashion to facilitate submission to NIH.
|30.||PI logs into eRA Commons account, views final application, status of submission, assignment to Study Section, and final decision by Study Section.|