Steps to Initiating Industry Sponsored Research
- ORA Budget/Contract Development
- Training & IRB Submission
- Medicare Approval for IDE Studies
|1.||Principal Investigator (PI) and/or delegated study staff receive the Confidentiality Disclosure Agreement (CDA) from the sponsor or sponsor’s agent (Contract Research Organization, CRO) and protocol synopsis (if provided). The PI does not sign CDA: it is the sponsor that contracts with the University, not the PI.
Not all Sponsors require a CDA before they provide the study documents. It is up to the provider of the confidential information if they require a CDA to be in place.
|2.||PI emails unsigned CDA to Office of Research Administration (ORA) for review via email@example.com. UM ORA is the point of contact for CDAs.
Note: If Jackson Health System (JHS) is included on the CDA, the JHS protocol and contract review process will be expedited.
|3.||ORA reviews/negotiates, and Executive Director signs the CDA. PI does not sign CDA.
Note: ORA will send the PI a copy of the signed CDA, which must be filed in the Regulatory Binder.
|4.||Principal Investigator (PI) and delegated study staff obtain Regulatory Package (informed consent, protocol, regulatory documents, operations and lab manuals, etc.) and draft contracts/budget from the sponsor (typically in electronic format).|
|5.||The PI’s department reviews the protocol/budget with the PI to determine feasibility of study, inclusion/exclusion criteria, and decision to move forward based upon budget and conditions of contract.
Note regarding study feasibility: 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.
PI or delegated study staff complete the Feasibility Questionnaire and Site Contact Form provided by the sponsor, and return to sponsor (may be requested by sponsor or CRO before CDA)
|6.||PI and PI-delegated study staff strategize about study implementation: who is doing what, where and when and how, etc.
For example: recruitment strategy, including advertisement plan, personnel time (percent effort), where participants will be seen, where tests will be conducted, pharmacy requirements, other departments and divisions, etc.
Include all potential sites (e.g., University of Miami (UM), Jackson Health System (JHS), Miami Veterans Affairs Healthcare System (VA), Community Partners (e.g., Health Council of South Florida, Consortium for Healthier Miami Dade, etc.).
|7.||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, 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.
|8.||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.|
|9.||Concurrently, initiate communication with collaborative institutions (University of Miami Hospitals (UMH), Jackson Health System, Miami Veterans Affairs Healthcare System (VA), etc.).|
|10.|| 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), follow the Submission and Negotiation Process When JHS Involved Under New Master Research Collaboration Agreement process.
|11.||Concurrently, initiate communication with all third party facilities (e.g., Clinical Research Units, Comprehensive Treatment Unit, Pharmacy, Radiology, hospital wards, etc.)
Contact Clinical Research Operations and Regulatory Support (CRORS) to discuss regulatory support possible QI/QC plan, as applicable. Include JHS Research Pharmacy, JHS Nursing Team, as applicable.
NOTE: 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.
|12.||Medicare Approval for Investigational Device Exemption (IDE) studies:
1. For IDE studies approved by the FDA AFTER January 1, 2015, the regulatory sponsor*, i.e the IDE holder, is responsible for obtaining Medicare Approval directly from Centers for Medicare and Medicaid Services (CMS).
2. For IDE studies approved by the FDA PRIOR to January 1, 2015, or for studies extensions approved by the FDA PRIOR to January 1, 2015:
** The First Coast Service Option, Inc. review process can take up to 45 business days (traceable paper submission).
***The Wisconsin Physician Services review process usually takes 14-21 business days (electronic submission).
|13.||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.)
IRB training requirements are listed in the HSRO Investigator Manual
PI and study staff complete required interest disclosure process in the UDisclose System
Carefully read the HSRO Investigator Manual. 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.
|14.||Concurrently PI and/or delegated study staff prepare IRB Submission. Protocol and consent templates are located on the HSRO website
If the study involves Jackson Health Systems (JHS), follow the Submission and Negotiation Process When JHS Involved Under New Master Research Collaboration Agreement process, and ensure that JHS has been selected as a site at time of IRB submission to view the study documentation. If unable to view study documentation, the JHS review process cannot be initiated.
For submitting new External IRB studies, refer to latest instructions provided in ePROST IRB 8.2.4
|15.||If the study involves JHS, complete all training required by JHS. See section 11 above.|
|16.||PI and delegated study staff complete all IRB submissions (including supporting documents, e.g., local protocol supplement which describes the study team’s procedures/processes for study implementation.
Complete and upload all applicable IRB ancillary committee forms (e.g., University of Miami Hospitals (UMH), pathology, radiology, Clinical and Translational Research Site (CTRS, previously known as CRC, Clinical Research Center), Jackson Health System etc.).
|18.||PI or delegated study staff will receive an email identifying the name/s of Office of Research Administration (ORA) budget and/or contract analyst/s assigned. Office of Research Administration (ORA) personnel will reach out to PI/Study Team if they require additional information, documentation, etc.
PI/Study Team member’s timely response to Office of Research Administration (ORA) personnel will help facilitate improved processing times.
|17.||PI or delegated study staff review the PCRF-L instructions, complete the PCRF-L accurately and submits PCRF-L with required signatures, protocol, budget, draft contract (word document) and informed consent form to Office of Research Administration (ORA) via firstname.lastname@example.org. The “Budget Information, Including Faculty & Study Personnel Time and Study-Specific Items” of the PCRF-L is required to facilitate budget development. In order to ensure timely and accurate processing, full IRB submission should have occurred prior to submitting your package to the Office of Research Administration (ORA) allowing ORA and IRB processing to occur simultaneously. If an external IRB will be utilized, please disclose this to ORA when submitting your package. If it is later determined that protocol will be amended, or that the study is placed on hold, or that UM was dropped from study consideration, etc., please notify the Office of Research Administration immediately.|
|19.|| Office of Research Administration (ORA) personnel will provide PI and delegated study staff the Budget and Medicare Coverage Analysis (MCA). PI and delegated study staff must review both, and inform the Office of Research Administration of needed revisions (if necessary). Otherwise, PI should approve and return Budget and Medicare Coverage Analysis, so it can be reflected as approved and processed accordingly.
PLEASE NOTE: MCA is an internal document and should never be provided to individuals/entities outside of UM.
|20.||PI and study staff must closely monitor all communications from eProst (email@example.com) for questions/issues/clarifications, and respond accordingly.
NOTE: Regulations require the IRB to maintain records of all communications with the PI and study team. After the study has been submitted through eProst, investigators and study staff should use eProst Comments to communicate with the HSRO team.
|21.||The Office of Research Administration (ORA) negotiates and executes the contracts. PI/Study Team member’s timely response to Office of Research Administration (ORA) personnel will help facilitate improved processing times. The contract must be signed by (1) the PI AND (2) the Executive Director of ORA (who signs on behalf of the University). ORA sends the signed contract (including budget) to the sponsor.|
|22.||The sponsor signs the contract and returns to ORA. The PI will receive a copy of the signed contract from ORA.
IMPORTANT: Study enrollment must NOT begin without a fully executed contract, IRB approval(s), and approvals from all collaborative institutions (Jackson Health System, Miami Veterans Affairs Healthcare System, University of Miami Hospitals, etc.)