Steps to Initiating Department of Defense (DoD) 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 firstname.lastname@example.org.|
|2.||Principal Investigator (PI) and research study team meet to discuss the submission and review the guidance as soon as possible after the Request for Applications/Program Announcement (RFA/PA) are announced, and establish study grant deadlines.
Download application package (PDF) and program announcement from specified Funding Opportunity Number (and Owning Agency) from Grants.gov and download general instruction from Congressionally Directed Medical Research Programs (CDMRP).
|3.||PI determines the type of submission – new or resubmission.|
|4.||If this is a resubmission, PI reviews guidance and previous Summary Statement comments from Department of Defense (DoD).|
|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, initiate communication with collaborative institutions (e.g., Jackson Health System (JHS), University of Miami Hospital, Veterans Affairs, 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 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; 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), consult with JHS Office of Research regarding activities occurring within their facilities and their potential role in study.
|9.||Ensure that all third party facilities (e.g., Clinical Research Units, Comprehensive Treatment Unit, Pharmacy, Radiology, hospital wards, etc.) have been identified and engaged.|
|10.||Contact Clinical Research Operations and Regulatory Support (CRORS) to discuss regulatory support and monitoring plan, as applicable. You may have to incorporate this support into your budget.
For all Investigational New Drug (IND) or Investigational Device Exemption (IDE) studies, a monitoring plan is required.
|11.||PI requests an Electronic Biomedical Research Application Portal (eBRAP) account and the Office of Research Administration (ORA) affiliates with UM.|
|15.||PI and study personnel complete all applicable required training (i.e., Collaborative Institutional Training Initiative (CITI), Conflict Of Interest (COI)*, Velos, HIPAA training, New PI training**, UChart training***, Cerner training**** (Jackson electronic medical records), etc.)
PI and study staff complete required interest disclosure process in the Disclosure Profile System (DPS)
Become familiar with all Human Subjects – related policies and Standard Operating Procedures at the University.
*For questions about COI, contact the Office of Disclosures & COI Management (DCM).
**For New PI Training, contact Clinical Research Operations and Regulatory Support (CRORS).
*** For UChart training, click here.
****For Web-Based Training, contact MiracleTraining@JHSMiami.org; for JHS Cerner credentials/JHS Security Request form, contact CSC@JHSMiami.org.
|13.||If applicable, PI and/or delegated study staff submit the pre-application, and upload pre-proposal, supporting documentation (PI’s biosketch and references) and other required documents (e.g., preliminary budget) as indicated on program announcement into the eBRAP System.
Notify appropriate departmental support that the pre-application has been submitted. If a pre-application needs to be submitted by the institutional signing official, it must be provided to the Office of Research Administration (ORA) via firstname.lastname@example.org.
Provide funding opportunity number to your appropriate departmental support so he/she can download PDF application to complete administrative portions.
|14.||PI receives the pre-application notification letter (invitation to apply for award).
The pre-application notification letter must be forwarded to your Pre-Award administrator.
|12.||PI prepares/reviews/updates the required Biosketches. Templates are available at Congressionally Directed Medical Research Programs (CDMRP) Biographical Sketch.|
|16.||PI/delegated study staff and/or Pre-Award administrator/appropriate departmental support area create a preliminary budget (UM Rate Information).
Budgets for other involved facilities should be discussed and prepared in collaboration with these facilities.
|17.||Review the Proposal/Contract Routing Form-L (PCRF-L) Instructions, prepare the Proposal/Contract Routing Form-L (PCRF-L) and submit to PI’s appropriate departmental support.
Once the final budget has been approved, Pre-Award administrator will complete PCRF-L.
NOTE: If Department of Medicine signatures are required, 5 days are required to review and obtain signature(s).
|18.||PI and/or designated study staff/Pre-Award administrator/appropriate departmental support begin building the PDF application.|
|19.||PI drafts narrative. Delegated study staff assist with narrative, obtain references/publications needed for completing the grant submission, obtain biosketches for all key personnel, and obtain other support information, including previous research support (5–year history), currently active and pending research support from all key personnel (e.g., co-Investigators). Biosketch templates are available at CDMRP eBRAP System Biographical Sketch
NOTE: Pay careful attention to application instructions for required content and additional attachments.
|20.||PI and/or appropriate departmental support create and upload submission attachments as required (e.g., 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 into PDF application.
Your Pre-Award administrator can assist in uploading PDF documents.
NOTE: PAY CAREFUL ATTENTION TO FORMAT REQUIREMENTS (e.g., font type/size, page limitations, margins, file names, etc.)
|21.||PI and/or Pre-Award administrator/appropriate departmental support format the budget, and complete the personnel section.|
|22.||PI and/or delegated study staff request Letters of Support as appropriate, and send to authorized individuals for signatures.
Concurrently, obtain institutional Letters of Support as appropriate from UM subcontractors.
Forward all letters to your appropriate departmental support.
|23.||Upon PI’s approval, PI and/or delegated study staff/Pre-Award administrator/appropriate departmental support enter the budget into the PDF application.|
|24.||PI and/or delegated study staff complete all necessary internal documents for submission, and notify Pre-Award administrator/appropriate departmental support to begin the budget review process AT LEAST TWO WEEKS before the grant deadline (e.g., PCRF-L, subcontracts, letters of intent, biosketches, budget, etc.).|
|25.||PI and/or appropriate departmental support requests and uploads Biosketches for Key Personnel. Templates are available at Congressionally Directed Medical Research Programs (CDMRP) Biographical Sketch.|
|26.||PI and/or appropriate departmental support must ensure that all documents and required paperwork are completed, uploaded into application, and routed to Office of Research Administration (ORA) 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 ORA.
Your Pre-Award administrator should have a final proposal in hand 5 WORKING DAYS BEFORE THE GRANT DEADLINE.
|29.||PI logs into their Electronic Biomedical Research Application Portal (eBRAP) account to check status of the grant submission. PI receives confirmation of submission (email) from eBRAP.|
|27.||PI confirms and documents eBRAP Final Status of grant submission.
PI approves final PDF, and appropriate departmental support routes to Office of Research Administration (ORA).
|28.||PI monitors all communications from ORA and/or Grants.gov grant submission.
Correct any submission errors.