Study Oversight
UMMS Study Conduct
The principal investigator assumes full responsibility for the conduct of their IRB-approved clinical research study (21 CFR 312).
A Principal Investigator must have medical staff privileges or be Doctorally prepared in nursing or patient care services. Non-clinical staff, non-affiliated physicians, or other non-UMMS Affiliated employed clinical individuals interested in conducting clinical research will be expected to have an assigned research mentor or sub-investigator from the study department, or a full-time employee, or a contracted physician at a University of Maryland Medical System Member Organization in order to perform a clinical study at each Institution.
Study approval process for investigators at UMMS Member Organizations
- UMMS Research Compliance, Research Revenue Integrity and representatives from the UMMS Office of General Counsel review the proposed Clinical Trial Agreements (CTA) and negotiate appropriate study budgets. Some may be processed through collaboration with the UMB Center for Clinical Trials (CCT), as part of the study approval process.
- Researchers may begin the review process by submitting a Research Investigators Packet that includes the following: an electronic copy of the CTA, protocol and supporting documents, lay summary of the protocol, informed consent form(s), proposed budget and all supporting study and regulatory documents as well as contact information to umms.research@umm.edu.
- Communication between the UMMS Member Organization and the Research Revenue Integrity team can also be supported by the completion of the Research Smart sheet access spreadsheet via attachment of required documents.
- Review and approval of the research study will be conducted by the internal UMMS Member Organization Research Review Committee before research can be conducted at each UMMS Member Organization.
- The Member Organization approval process will be held until all regulatory documents have been completed and provided to OCRC.
- The Research Revenue Integrity (RRI) clinical trial analyst will determine research charges and provide the final coverage analysis CA.
- The signed CA, budget and CTA signed by the investigator, sponsor, UMMS, and Member Organization Chief Financial Officer must be completed and filed with OCRC and RRI prior to the study initiation along with documentation of the final approval by the IRB of record.
Study approval process for University of Maryland, Baltimore (UMB) investigators at University of Maryland Medical Center (UMMC) ONLY
- Study team submits all regulatory & contract documents to UMBiz (CCT)
- Study team submits research protocol documents to CICERO (HRPO/IRB)
- Study team contacts hospital department and nursing managers to review protocol involvement
- CCT sends request for coverage analysis to UMMS Research Revenue Integrity Team
- Clinical Trial Analyst prepares Event Schedule per protocol & ICF
- Study Team identifies:
- Research vs clinical care costs (R vs C)
- Department(s) where each service will occur
- Departmental review committee approval to proceed achieved
- Clinical Trial Analyst completes coverage analysis based upon Medicare regulations & treatment guidelines
- PI reviews & approves final coverage analysis
- Clinical Trial Analyst submits coverage analysis with pricing to CCT/SPA
- CCT negotiates budget with sponsor
- CCT provides internal budget to Clinical Trial Analyst
- Clinical Trial Analyst reviews internal budget
- IRB approved study application
- Study team provides final ICF to Clinical Trial Analyst
- Clinical Trial Analyst or Study Coordinator compares ICF costs to participants section to coverage analysis – modifies ICF/CA/budget as needed
- Clinical Trial Analyst submits request for Epic RSH record & fee schedule creation
- UMMS signs FUA with sponsor
- Research being conducted at a UMMS Member Organization must also obtain the approval of the Research Review Committee at each of the Member Organizations that have been identified as a research site in the IRB submission.
Research Review Committee
The Role of the UMMS Member Organization Research Review Committee
- Each UMMS Member Organization has their own independent Research Review Committee (RRC) to review human subjects research conducted at their institution.
- The role of the RRC is to provide local review of human subjects research activities to ensure the Member Organization has the resources and expertise to meet the needs of the proposed research.
- RRC operates within the framework of national and local guidelines. Committee independence and the avoidance of conflict of interest are maintained by excluding any member with a direct financial interest in a proposal from participating in its review.
- All human subjects research studies require an IRB determination. Applications are subject to audit by the RRC & The research Compliance Officer followed by reporting to the Research Operations and Compliance Committee.
- The Research Review Committee Chair will provide an overview/summary of the clinical research activity & recent developments at the University of Maryland Medical System Member Organization to the Medical Executive Committee and the Research Operations and Compliance Committee on a regular basis.
- PLEASE NOTE: RRC DOES NOT REPLACE THE IRB APPROVAL PROCESS FOR HUMAN SUBJECTS RESEARCH STUDIES.
Meeting Schedules and Submission Dates
The Research Review Committee at each UMMS Member Organization will meet on an as needed basis for that Member Organization. Please refer to the website contact personnel for each UMMS Affiliate to verify the current times and locations.
Applying for Initial Research Review in Human Subjects Research
The following information is required by the Research Review Committee for consideration of a study to be conducted at a University of Maryland Medical System Member Organization.
- Financial Conflict of Interest
- Study Protocol
- UMMS Submission Investigator Packet(summary easily understood by non MD or non scientific reader; two-four pages included in the Investigator packet)
- Informed consent form
- All supporting protocol documents (The list below is not meant to be an all-inclusive list, but provides examples of supporting documents to be submitted):
- investigators brochure
- amendments
- questionnaires
- advertisements
- informed consent form
- Clinical Trial Agreement from sponsor (or outside institution/research organization)
- A copy of completed grant must accompany the application documents if clinical trial is grant funded
- Budget or billing plan for project submitted to umms.research @umm.edu
- CV and License of Principal Investigator and Sub-Investigators
- CITI certification or re-certification of Human Subjects Training education obtained within the past 3 years must accompany each new application to the Research Review Committee before the protocol will be reviewed
- The CITI course may be accessed through https://www.citiprogram.org
- To register, UMMS Affiliate Investigators and Coordinators should select: Associated with University of Maryland, Baltimore
- Fill in a unique login and password and complete the registration screen
- Choose Group I Biomedical Research and Good Clinical Practice for Investigators and Key Personnel for the quiz
- Please email a copy of certification to umms.research@umm.edu
- IRB Submission Application:
How to Submit Materials for Initial Review
Please submit the Research Investigator Packet described above at least two weeks prior to the desired review date to guarantee a timely response:
Initial Review by the Research Review Committee
- The principal investigator of a study may be asked to give a presentation of the study and answer questions at the meeting for which it was submitted.
- A Research Review Committee member may be designated to be the primary reviewer for the protocol will then summarize and present the study, suggest changes, if needed, as well as make a recommendation for consideration by the Research Review Committee.
- The protocol may be discussed in open forum by all members not involved with the study and concludes with a call to vote by the Chair for:
- Approval - the study is approved as submitted.
- Approval with Clarifications/Contingent - the protocol and/or consent form are approved provided that clarification(s) are submitted in writing to the satisfaction of the Chair and/or Committee. The Chair may approve the study upon receipt of the clarification(s) without going before the convened RRC.
- Not Approved – study issues stated by the Committee outweigh the merit and safety of conducting the study at the University of Maryland Medical System Member Organization.
- Deferral – issues with the protocol and/or consent form would negatively impact the conduct of the study at the University of Maryland Medical System Member Organization and must be addressed by the investigator before research may be initiated at the Member Organization. The investigator's written response will be reviewed and a new vote may be called to request approval.
- The Research Review Committee will notify the investigator in writing of the Committee’s decision.
Emergency and Therapeutic Use
Approval for emergency and therapeutic use of investigational new drugs (INDs) or investigational device exemptions (IDE) must complete notification to the Research Review Committee and the Institutional Review Board.
Standard Operating Procedure: Emergency Use of Test Article and Compassionate Use
Revenue Integrity
Study team:
- Associates research participants to Epic RSH record on the day of consent as enrolled or consented
- Selects Research Coordinator
- Enters study start date
- Enters research comments inEPIC for ongoing study status
- Links Encounters and Research Orders to the RSH record
- Documents in Notes the necessary information supporting the research activity
EPIC:
- All enrolled patient accounts from the study start date are flagged as research
- Accounts fall in Clinical Trial Analysts’ review report
Clinical Trial Analyst:
- Reviews all accounts for all patients associated with RSH study
- Moves charges to research or to insurance based on final coverage analysis, internal budget, and research documentation or enrollment notes
*Participants and/or insurance are billed in the absence of study association