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 email@example.com.
|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.
If the study involves human subjects and will be conducted at multiple U.S. sites conducting the same protocol, one IRB must review all of the US sites. The PI should work with the collaborating sites to determine the appropriate IRB. The costs of the sIRB review should be included in the budget.
If the research involves human subjects, submit the research to the HSRO via eProst as soon as possible. Many federal funding agencies are requiring IRB approval before they will complete the award.
For submitting new External IRB studies, refer to latest instructions provided in ePROST IRB 8.2.4
|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 RCQA or Research IT for an FDA Part 11 validation of the system.|
|7.||Concurrently, initiate communication with collaborative institutions (e.g., University of Miami Hospital, Jackson Health System, 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 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 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, if the investigator holds the IND or IDE.
|11.||PI requests an Electronic Biomedical Research Application Portal (eBRAP) account and the Office of Research Administration (ORA) affiliates with UM. All PIs submitting a proposal to DoD must have an eBRAP account.|
|15.||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 UDisclose System, contact the UDisclose System helpline at (305) 243-0877.
**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 CERNER Access, contact CSC@JHSMiami.org.
****For UChart training, click here.
|13.||Some DoD submissions have a mandatory two-step application process. The PI will need to provide the DoD assigned number from the pre-app in the main proposal.
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 email@example.com.
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.|
|17.|| The department administrator will log into the assigned workspace account that was set up for their department by ORA. The admin will build the application for the PI via this account. Be sure that your account is active or contact ORA in advance.
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 review the PCRF-L for accuracy and completeness.
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/ 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. DoD requires attaching previous/current/pending support pages and specifies certain information is needed. For some PIs who have a lot of grants, this can take a day to prepare-if the information is not maintained current.
|20.||PI and/or appropriate departmentalsupport 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 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.
ORA requires a subrecipient commitment form to be completed for any subcontracts the UM PI would have as the prime. These can be uploaded in the application as letters of support from these institutions (see section 25 below).
Forward all letters to your appropriate departmental support.
|23.||Upon PI’s approval, PI and/or delegated study staff/administrator/appropriate departmental support enter the budget into the PDF application.SF424 R&R budget template
|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. Documents listing key personnel previous/current/pending support (see section 22 above) may be uploaded here.|
|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) via email firstname.lastname@example.org. 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 accesses and submits Pre-application content and forms at eBRAP
Completed application packages must be routed by PI/Department to ORA, which will submit the application to Grants.gov ORA
PI can view and modify the full application submissions in eBRAP.
|28.||PI monitors all communications from ORA and/or Grants.gov grant submission.
Correct any submission errors.