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Research Events Round-Up

The Office of the Vice Provost for Research & Scholarship gathers all the research events posted to our listservs into a once-weekly email, and we also feature them on our new online calendar. Check out our primer on how to promote your event or email vprs@miami.edu for help.

 

SPOTLIGHT

Join Us for a Demo on May 4th!

New Adobe Self-Sign Digital ID for FDA-Regulated Research

As announced on April 20, 2023, the Adobe Self-Sign Digital ID electronic signature process has been validated and is considered compliant with FDA’s 21 CFR Part 11 regulation.

Who should use this e-signature process?

Researchers conducting FDA-regulated studies under an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application must in the absence of wet signatures, apply e-signatures using a 21 CFR Part 11 compliant system.

Training and More Information:

Join us for a live demonstration on May 4th at noon. Register in advance for the Zoom session.  

  • Sign up for an online module entitled, Adobe Self Sign Digital ID Electronic Signature, which was developed and is available in ULearn. Search keyword: digital id.
  • View Frequently Asked Questions here.
Read more.

 

Upcoming Events

Thursday, May 4, 9:00 a.m. - 11:00 a.m.

Applications for High Resolution Ultrasound Imaging in Mouse Models for Cancer Research: VisualSonics Vevo Imaging System

High-frequency ultrasound platforms enable noninvasive small animal imaging that can characterize tumor tissue, detect lesions, and monitor tumor development in vivo to facilitate translational research.  This workshop will cover applications of high resolution, noninvasive, in vivo ultrasound imaging for cancer research, including early tumor/disease detection; quantification of tumors in 2D and 3D; longitudinal studies of orthotopic and subcutaneous tumors; visualization and quantification of angiogenesis, vasculature, and perfusion; image-guided needle injections; and measuring hypoxia and nanoparticle imaging with photoacoustics.  The Sylvester Cancer Modeling Shared Resource (CMSR) has a FUJIFILM VisualSonics Vevo 3100 that is available to support your research.  This in-person and online seminar will be followed by a in-person training workshop in the CMSR. 

Seminar: 9:00 a.m. - 10:00 a.m.

Workshop: 10:00 a.m. - 11:00 a.m.

Location: (live streaming and in-person)  Sylvester Cancer Center, Conference Room 1301 Register in advance.

Friday, May 5, 9:00 a.m. - 12:00 p.m.

Results Reporting in ClinicalTrials.gov

Participants will have the opportunity for hands on data entry within the ClinicalTrials.gov Protocol Registration System (PRS) system with guidance.  This class is intended for those who are new to results data entry or need additional assistance in navigating the ClinicalTrials.gov results data entry system.
Level: INTERMEDIATE

At the end of this ILT, participants will be able to:
·         Describe the requirements per FDAAA and ClinicalTrials.gov and how to navigate the ClinicalTrials.gov results data entry system. 
·         Identify how to streamline results entry to minimize repeat entry, reduce reviewer comments and maximize efficiency.
·         Analyze common mistakes to avoid by trouble-shooting system errors and warning messages
·         Recognize how to minimize ClinicalTRials.gov review comments and get results accepted with minimal iterations.
·         Discuss approaches that are used for different study designs.

Register in advance in ULearn.

Yolanda Davis

+1 (305) 2430494

y.p.davis@miami.edu

Friday, May 5, 10:00 a.m. - 12:00 p.m.

Understanding Other Support, Disclosures & Foreign Influences

This class is part of the RAU Curriculum.

The webinar covers the importance and responsibility of disclosures to sponsors and the University of Miami regarding support and engagement with domestic or foreign entities.

Please register to the RAU Curriculum in ULearn first and access this session through the Curriculum. It is important to complete this class in the order that the Curriculum is set up. If you would like to take this class as a standalone course, please contact vprs@miami.edu.

Register in advance in ULearn

Tuesday, May 9, 12:00 p.m. - 1:00 p.m.

Concept to Commercialization: Intellectual Property Considerations in Artificial Intelligence

U Innovation welcome Paul Tanpitukpongse, J.D, Principal at Meunier, Carlin & Curfman, for a discussion on patenting basics and IP considerations when working with AI developed innnovations.. Paul practices patent law with a focus on AI innovations  in a number of disciplines and technologies, including prothesies and robotics, medical diagnostics, bioinformatics, drug discovery, manufacturing, logistics, computer security and networking and consumer products.  He regularly counsels companies ranging from start-ups to multinationals, as well as academic institutions, on their IP strategy and patent portfilios. Register in advance.

Wednesday, May 10, 9:30 a.m. - 11:00 a.m.

Review of FDA Warning Letters

This presentation includes a review and discussion of Warning Letters for Principal Investigators (Clinical Investigators), Sponsor-Investigators and Institutional Review Boards, issued by the FDA.  Recent examples of Warning Letters will be analyzed and causes, significance, and consequences of Warning Letters will be discussed. Register in advance in ULearn.

Wednesday, May 10, 10:00 a.m. - 12:00 p.m.

Medicare Coverage Analysis (MCA) in Clinical Research

The Office of the Vice Provost for Research is offering a course for Principal Investigators, Clinical Research Coordinators, Research Financial Administrators, departments’ regulatory personnel, research patients schedulers, and anyone involved in review of Medicare Coverage Analysis (MCA), a document which lists all items and services to be provided as part of a clinical trial with notations of what should be billed to the research sponsor and what can be billed to Medicare.

The course reviews the fundamentals, variables, and process of developing Medicare Coverage Analysis and its impact on the clinical research financial sustainability, research billing compliance and ability to recruit and retain research patients. Practical cases will be presented and discussed and hands-on materials provided, followed by Q & A time in the end.

Register in advance in ULearn. 

Thursday, May 11, 10:00 a.m. - 12:00 p.m.

Understanding Cost Transfers

This class is part of the RAU Curriculum.

The webinar provides training for the processing of both labor and non-labor cost transfers. The purpose of this course is to increase awareness and understanding of Federal regulations related to cost transfers, examine UM’s policies and procedures, and identify the process to prepare, document, approve, and submit a cost transfer. 

Please register to the RAU Curriculum in ULearn first and access this CBL through the Curriculum. It is important to complete this session in the order that the Curriculum is set up. If you would like to take this class as a standalone course, please contact vprs@miami.edu. Register in advance in ULearn

Wednesday, May 17, 10:00 a.m. - 12:00 p.m.

Manage Awards for Financial Success

This class is part of the RAU Curriculum. 

The webinar provides a comprehensive understanding of how to manage sponsored projects at the University of Miami focusing on compliance and responsibilities to ensure financial success of the project.

Please register to the RAU Curriculum in ULearn first and access this session through the Curriculum. It is important to complete this class in the order that the Curriculum is set up. If you would like to take this class as a standalone online course, please contact vprs@miami.edu.

Thursday, May 18, 12:00 p.m. - 1:00 p.m.

Lunch with Laura

Lunch with Laura is a monthly discussion session with Laura Kozma, Associate Vice President for Research Administration. There will be new focus each month, including hot topics in research administration, new and significant policies, and changes in the Office of Research Administration (ORA).

May 2023: Monitoring Subawards: Why this Matters and When to Call ORA

June 2023:  Effort Reporting Deadlines and Salary Management

September 2023: F&A Rate Negotiation: The Space Survey

October 2023: Partnering with Research Administration to Expedite Clinical Trials

Registration is required. Register through Zoom for one or all sessions.   

Monday, May 22, 1:30 a.m. - 4:00 p.m.

VPRS Administrative Update Meeting

Join leaders from the Office of the Vice Provost for Research + Scholarship for this update meeting which is designed to provide information to the University research community on policy, procedural and process changes related to research activities.  Agenda items for the upcoming meeting will be provided prior to the meeting.  

You have the opportunity to submit your questions prior to the meeting by clicking HERE

Register in advance for the virtual Zoom meeting by clicking HERE.

Tuesday, May 23, 9:30 a.m. - 12:30 a.m.

IBISResearch: Create and Submit a Proposal

This class is part of the RAU Curriculum and a pre-requisite to IBISResearch: Managing Awards.

This hands-on workshop focuses on proposals and is intended for administrators and researchers to learn how to navigate the system, create a funding proposal, SF424 federal application, and budgets (including cost share and subaward budgets) in IBISResearch.  Participants will route a proposal for department approval and submit to Research Administration for final review and submission to the sponsor. 

The learning objectives of this session are:

·        Describe IBISResearch terminology 

·        Demonstrate the navigation of IBISResearch

·        Practice how to create a funding proposal and budgets (including cost share and subaward) in IBISResearch

If you would like to get credit for the RAU curriculum, please register to the RAU Curriculum in ULearn first and access this class through the Curriculum. It is important to complete this class in the order that the Curriculum is set up. If you would like to take this class as a standalone online course, please contact vprs@miami.edu.

Note: You must complete the following in order to access this class: Introduction to ORA Class, Introduction to IBISResearch CBL and the IBISResearch Create and Submit a Proposal video.

Register in ULearn.

Wednesday, May 24, 10:00 a.m. - 12:00 p.m.

IBISResearch: Agreements

This hands-on workshop focusing Agreements, is intended for administrators and researchers to learn how to navigate the system and create agreements in IBISResearch. Individuals who submit contracts or agreements to ORA regularly are encouraged to attend this workshop. Additionally, it is recommended that Individuals take the IBISResearch: Create and Submit a Proposal for a more in-depth knowledge of IBISResearch prior to attending this workshop.  

The objectives of this session are:

1. Demonstrate the new terminology and navigation of the system.

2. Practice how to create agreements in IBISResearch.

This is an elective course in the RAU Curriculum. 

Register in advance in ULearn

Thursday, May 25, 10:00 a.m. - 12:00 p.m.

IBISResearch: Managing Awards

This hands-on workshop focusing on award management, is intended for administrators and researchers involved in setting up and managing sponsored activities in IBISResearch. Participants will create a continuation, revision, and resubmission application. They will also learn how to submit a Just-In-Time request, or respond to an Agency Request, request an award modification and create an agreement from a related proposal.

The objectives of this session are:

1. Practice how to edit and complete the Funding Award in IBISResearch.

2. Identify how to create an award modification in IBISResearch.

3. Demonstrate how to create follow-up proposals (continuation, revision, resubmission, and renewal).

This class is part of the RAU Curriculum and it is the fourth module in the IBISResearch Training. If you would like to get credit for the RAU curriculum, please register to the RAU Curriculum in ULearn first and access this class through the Curriculum. It is important to complete this module in the order that the Curriculum is set up. The pre-requisites for this class are: Introduction to IBISResearch, IBISResearch Submit and Create a Proposal Video and the IBISResearch Submit and Create a Proposal Hands-on Workshop.

Register in advance in ULearn. 

Wednesdays 1:00 p.m. - 2:00 p.m.

Complion Office Hours

The OVPRS Research Intelligence and Data Infrastructure team will start offering Complion office hours Wednesdays from 1:00-2:00p. This is an informal session (Q&A format) to address your questions, issues, requirements, and wish lists.  Stay as short or as long as you’d like. To learn more about Complion and the onboarding process, please visit https://research.miami.edu/about/admin-areas/raa/complion/index.html.  Please review the Use of Electronic Regulatory Binders in FDA-Regulated Research policy to understand if Complion is required for your study.

Register in advance for this meeting:

After registering, you will receive a confirmation email containing information about joining the meeting.

Tuesdays & Thursdays, 1:00 p.m. - 2:00 p.m.

Human Subjects Research Office Virtual Office Hours UPDATES

One-on-one opportunity to connect with Human Subjects Research Office team members for questions and guidance, open to anyone involved in human subjects research at the University of Miami or the Jackson Health System. First come, first serve, no appointments necessary. 

Read More >

 

Connect with OVPRS