ALL CLEAR

IBISRESEARCH – IRB, GRANTS

Dear Users:

Please note that system maintenance on the IBISResearch Suite (IRB, Grants) has been completed.

HOW DOES THIS MAINTENANCE IMPACT YOU?

IRB & Grants

The Research Categories question (see below) for all IBISResearch Projects captured in the IBISResearch system (under Question #Q3, the IRB Study Scope page, and under #Q8, the Grants Funding Proposal’s IBIS Proposal Information page) has been removed.

New questions are introduced as part of this update to the IRB and Grants systems:

NOTE: If a value other than None is selected for Primary Category, then the Secondary Category option will appear:

There are ongoing efforts to identify the correct Primary and Secondary categories for existing submissions in IRB and Grants. This migration effort may continue for a week.  If you do not see the migrated values on your submission, please contact OVPRS Help Desk: (305-243-2314; OVPRShelpdesk@miami.edu)

IRB

The Billable question in the IRB Study Scope page (Question 5) now indicates needing to assign the MCA Review Group if this question is marked as Yes.  Previously, it was indicating that the CTD group was the ancillary review group to select if this question was entered as Yes.

If IRB Scope Q5 is Yes, please add MCA Review Group as a Non-Required Ancillary Reviewer group.

CONTACT US

For any system issues, questions, or general assistance:

OVPRS Help Desk (305-243-2314; OVPRShelpdesk@miami.edu)

Please be advised the IT team will be performing a firewall upgrade on Sunday, February 11, from 2:00 a.m. to 4:30 a.m. During this time, you may experience intermittent connectivity to Velos. If you lose connection, please log out of Velos and relaunch the application. We apologize for any inconvenience this may cause. 

Thank You,

Research IT Team

If you have any questions, please contact the IT Service Desk by emailing help@med.miami.edu or calling (305) 243-5999.

Click here to obtain real-time, IT-related system statuses.

We apologize for any inconvenience.

CONTACT US

OVPRS Help Desk (305-243-2314; OVPRShelpdesk@miami.edu) is available for any system issues, questions, or general assistance.

Dear colleagues,

On behalf of the Office of the Vice Provost for Research +Scholarship,

the Human Subject Research Office

would like to extend its warmest wishes this holiday season.

We are looking forward to many exciting initiatives we will be working on together in 2024!

Our thoughts turn gratefully to you and all you do in support of

the University’s research mission and its Human Research Protection Program!

 Please refer to our Institutional Review Board meeting dates for important deadline information as we approach the holidays/ year end.

IRB Meeting Dates | Human Subject Research Office | University of Miami

We appreciate working with you and hope that the holidays and the coming year will bring you bountiful health, happiness and success.

Your HSRO

Dear Users:

Please note that system maintenance will be conducted on the IBISResearch Suite (IRB, Grants, Agreements) on Thursday, September 21^st beginning at 5:00 PM EST until Friday, September 22^nd at 9:00 AM EST. 

Downtime is expected to be about 14 hours for this maintenance window and will extend to UDisclose (see below) and Velos D-link.

• IBISResearch IRB, Grants, Agreements: September 21^st at 5:00 PM EST until Friday, September 22^nd at 9:00 AM EST
• IBISResearch: September 21^st at 5:00 PM EST until September 21^st at 7:00 PM EST

HOW WILL THIS MAINTENANCE IMPACT YOU?

IRB, GRANTS, & AGREEMENTS

A new Manage Relationships activity will be introduced in each solution that allows project teams to link related projects to each other that will provide a bi-directional access to the projects identified by the activity across the other solutions.

• The existing Manage Relationship activity existing in Grants and Agreements modules will be deprecated and replaced by this new custom activity.
• The existing Manage Related Grants activity in IRB module will be deprecated and replaced by this new custom activity.

A tip sheet with additional details will be available later this week.

CONTACT US

OVPRS Help Desk (305-243-2314; OVPRShelpdesk@miami.edu) is available for any system issues, questions, or general assistance.

Dear colleagues-

In lieu of a training the HSRO will be hosting tomorrow, Thursday, September 14th, we will not be holding office hours.  We will resume the regular schedule next Tuesday, September 19th.

https://hsro.uresearch.miami.edu/contact-us/virtual-office-hours/index.html

In the meantime, if you experience any issues, please reach out to ovprshelpdesk@miami.edu.

Thank you.

Dear MSOM Research Community,

The Miller School of Medicine (MSOM) established the Research Performance Review Committee (RPC) to monitor non-oncology clinical research performance, following study activation.

This process is designed to optimize the allocation of institutional resources and effort, while improving the overall performance of clinical research at the MSOM. Historically, trials that have not accrued any subjects within the initial twelve (12) month approval period are at high-risk for failure, strain institutional resources and negatively impact MSOM’s ability to attract future studies.

The RPC is comprised of MSOM faculty and administrators who are committed to the success of the researchers and the clinical trials.

Does this apply to my existing studies?
Yes. The following clinical research categories will be considered for performance review by the RPC:

• Prospective, hypothesis-driven clinical research studies which include industry-sponsored, multicenter, interventional studies, where the study protocol originated with the industry sponsor.
• Investigator Initiated Studies (IIS) developed by University of Miami faculty with funding from the institution, a nonpeer reviewing agency, or industry sponsor where UHealth subjects are prospectively recruited and enrolled.
• Multi-institutional IIS where the study Principal Investigator (“PI”) has an appointment at another institution and UHealth subjects are prospectively recruited and enrolled.

The initial RPC focus is on studies that have not had any recent recruitment activity or screening and/or enrolling less than or equal to 50% of their enrollment goal. To evaluate performance, the RPC will review accrual-related data from Velos.

What do I need to do?
Principal investigators should ensure the following:

• enrollment goal information is entered and accurate in the IBIS IRB application (in the Clinical Trial activity on the left side of each study page)
• all enrollment data and project status information in the Velos CTMS system is up to date.

Should any enrollment information required to complete the evaluation process be missing, the RPC will reach out.

What happens after the RPC completes its evaluation of my study (or studies)?
If you receive RPC correspondence for one of your studies indicating an unacceptable rating, an Accrual Action Plan will need to be developed and submitted in the requested timeframe to the RPC for consideration.

Who do I contact with questions?
Should you have any questions, please email msomresearchperformance@med.miami.edu.
Sincerely,
Sanoj Punnen, M.D.
Chair, MSOM Research Performance Review Committee

DEF no longer required for human subjects research in IBIS Research-IRB

Effective 8/23/2023 - Data Exchange Form (DEF) no longer required for human subjects research projects routed in IBIS Research-IRB

Dear Colleagues:

Given the mutual commitment of Jackson Health System and the University of Miami to jointly advance research, streamline workflows, and reduce administrative burden in accordance with the ONENESS Initiative, the Data Exchange Form (DEF) is no longer required for research projects routed in IBIS Research-IRB.  This change is effective for all projects submitted to the IRB on or after August 23, 2023.

In keeping with Investigator responsibilities, when submitting human subject research in IBIS Research-IRB, you are certifying compliance to items highlighted below, which will now include review and acknowledgment of the Revised Master Mutual Data Use Agreement (DUA) between both institutions.

**For studies involving Jackson Health System:

• You assure compliance with the terms outlined in the Revised Master Mutual Data Use Agreement (click the link to view the Agreement).

This is in effect under the PI assurance statement on the Submit activity for the submission types below:

1. Initial Studies
2. IRB Sites
3. Modifications

For those already in queue, a separate email will be sent out to those impacted for acknowledgement.

Additional information will be forthcoming.  In the meantime, if you experience any issues, please reach out to ovprshelpdesk@miami.edu.

Research Intelligence & Data Infrastructure
305-243-2314

IRB8/eProst Legacy system moved behind Firewall

IRB8/eProst Legacy System is behind the UM Firewall

The old eProst Legacy (IRB8) system has recently been placed behind the UM Firewall in order to prevent security risks due to being on outdated servers. Please make sure you are logged into GlobalProtect VPN in order to access the IRB8/eProst Legacy system (www.eprost.med.miami.edu) moving forward.  Click here for more information on GlobalProtect VPN.

If you have any questions, please contact the OVPRS Help Desk at ovprshelpdesk@miami.edu.

System Downtime: Tuesday, July 18th from 9:00 p.m. to 11:00 p.m.

New Clinical Trial Activity in IRB

In an effort to improve Clinical Trials reporting in IBISResearch - IRB, a new Clinical Trials activity will be added to all study workspaces to help streamline clinical trial data capture on the NCT#, study duration, enrollment dates, and sample size (see screenshot below).

The IRB/Velos integration will be updated in the coming weeks to allow for a seamless flow of information from IRB to Velos. This clinical trial data will be entered in IRB through the new activity, instead of in Velos.

Once the data is populated in IRB, it will no longer be editable in Velos. Future changes to the existing information in Velos will need to occur in the IRB Clinical Trials activity. This updated integration will not impact the data that is currently in Velos, as existing data will only be overwritten if/when information is added in the IRB Clinical Trials activity.

The existing Velos data will not be backfilled into IRB and thus this new process will apply to new studies and studies that need to modify their clinical trial information.

Kindly note:

• This new activity must be completed for all Clinical Trials upon submission to the IRB. However, this activity will not be reviewed by the IRB nor impact the IRB review process.
• The activity will be available in all system states and can be accessed/edited by the PI, study team, committee reviewers, and ancillary reviewers. 
• All fields in the activity will be required. 
• The activity will retain all field data and can be edited as needed if protocol information changes. 

Should you have any questions regarding this change, please reach out to OVPRShelpdesk@miami.edu. 

Thank you, as always, for your continued support!

OFFICE OF THE VICE PROVOST FOR RESEARCH + SCHOLARSHIP

Dear Colleagues,

It is with great pleasure that I announce that the University of Miami has been awarded full reaccreditation for five years by The Council on Accreditation of the Association for the Accreditation of Human Research Protection Program (AAHRPP). This is an important achievement which reflects our organization’s commitment to protecting the rights and welfare of research participants.

University of Miami’s HRPP had the following strengths:

• The Vice Provost for Research and Scholarship, IRB members, staff, and researchers demonstrated a dedicated commitment to involving community members in every stage of research, from inception to dissemination of research results. The Clinical and Translational Science Institute played a pivotal role in cultivating relationships between University of Miami researchers and the local community to foster research that addressed the nuanced needs and perspectives of the community. (Elements I.4.B. and I.4.C.)
  
  
• The collaborative, continuous quality improvement model employed by University of Miami's HRPP provided researchers with efficient, effective, and innovative processes. Notable among these processes were the feasibility review, IRB review, and IND support services. The sponsorship of INDs included regulatory guidance and monitoring support for the sponsor-researcher and other researcher-initiated studies. (Element I.5.B.)
  
  
• The retention of employees across all domains of the HRPP and research (e.g., administration, faculty, and staff) led to formation of a dedicated team of highly knowledgeable and skilled professionals. University of Miami’s emphasis on the value of its employees, demonstrated through training, professional development, and the provision of necessary resources, created a culture of collaboration, stability, and trust within the University of Miami. (Element I.5.B.)

On behalf of the Office of the Vice Provost for Research + Scholarship, I would like to express my sincere gratitude for all the hard work and dedication spent on making this significant accomplishment possible. Thank you for all that U do!

Best,

Erin Kobetz, PhD, MPH

Vice Provost for Research + Scholarship

Associate Director, Population Sciences and Cancer Disparity, Sylvester Comprehensive Cancer Center

John K. and Judy H. Schulte Senior Endowed Chair in Cancer Research

Effective on 5/22/2023, the HSROletterrequest@miami.edu is available for the following requests:

·         Preparatory to Research Exception (HIPAA E) 

·         Completed GDS Certification Form 

·         COC for Non-NIH Funded Studies 

·         Not Human Subject Research (NHSR) 

For existing unaddressed requests, please re-direct to the new email address.

For future requests, please email the new address.

For general questions about submission and procedures, please visit the HSRO Contact Page to locate the relevant contact

Dear MSOM Research Community,

Per recent communication from Dr. Nimer on April 5, 2023, the Miller School of Medicine (MSOM) established the Research Performance Review Committee (RPC) to monitor non-oncology clinical research performance following study activation.

This process is designed to optimize the allocation of institutional resources and effort, while improving the overall erformance of clinical research at the MSOM. Studies that do not accrue any subjects within the initial twelve (12) month period are at high-risk for failure, strain available institutional resources, and negatively impact MSOM’s ability to attract future studies.

What will happen to my existing studies?
Eligible studies for review include the following as set forth by the RPC:

• Prospective, hypothesis-driven clinical research studies which include industry-sponsored, multicenter, interventional studies, where the study protocol originated with the industry sponsor.
• Investigator Initiated Studies (IIS) developed by University of Miami faculty with funding from the institution, a non-peer reviewing agency, or industry sponsor where UHealth subjects are prospectively recruited and enrolled.
• Multi-institutional IIS where the study Principal Investigator (“PI”) has an appointment at another institution and UHealth subjects are prospectively recruited and enrolled.

The initial RPC focus will be on studies enrolling less than or equal to 50% of their annual enrollment goal. The RPC will review accrual data from Velos as the basis of determining performance. The RPC will provide an electronic letter to the PI to indicate an Acceptable or Unacceptable rating. If an Acceptable rating is received, no further action by the PI is required. If an Unacceptable rating is received, the PI will have 30 calendar days to provide an Accrual Action Plan. The RPC will review the Accrual Action Plan and approve continuation with a six (6) month interval period for the next review or recommend study closure if the action plan is
insufficient.

What do I need to do?
Principal investigators should make sure all enrollment data and project status information in the Velos CTMS system is up to date. If you receive RPC correspondence for one of your studies indicating an unacceptable rating, an Accrual Action Plan will need to be developed and submitted timely to the RPC committee for consideration. 

Who do I contact with questions?
Should you have any questions, please email msomresearchperformance@med.miami.edu.

Sincerely,
Sanoj Punnen, MD, MAS
Pap Corps Champions for Cancer Research Endowed Chair in Solid Tumor Research
Associate Professor and Vice Chair of Research, Desai Sethi Urology Institute
Co-Chair of Genitourinary Site Disease Group, Sylvester Comprehensive Cancer Center
Chair, MSOM Research Performance Review Committee

Date: April 5, 2023

From: Offices of the Miller School of Medicine Executive Dean for Research and Miami Clinical &
Translational Science Institute

To: University of Miami Leonard M. Miller School of Medicine Research Community

We are pleased to announce the formation of the Miller School of Medicine Research
Performance Review Committee (RPC). This committee will monitor non-oncology clinical
research performance following study activation. The performance review committee has already
met several times, and they have begun drafting critically important research policies that will
assess the optimization of institutional resources of open clinical trials, to make sure we improve
the overall performance of clinical research at the MSOM.

To begin this process, the RPC will review accrual data from Velos as the basis of determining
performance for active clinical trials. The focus will be on studies enrolling less than or equal to
50% of their annual enrollment goal. After review, the RPC will provide an electronic letter to the
PI to indicate its findings. PIs should ensure that all enrollment data and project status
information in the Velos CTMS system is up to date prior to the commencement of this review on
04/17/23.

We thank you in advance for your cooperation in this important endeavor. If you have any
questions, please feel free to contact my teams at msomresearchperformance@med.miami.edu.

Sincerely,

Stephen D. Nimer, MD

SYSTEMS ALL CLEAR

The Research Suite modules listed below have been successfully upgraded.

• Grants 10.0 has been upgraded to Grants 10.1
• Agreements 10.0 has been upgraded to Agreements 10.1
• COI 10.2 has been upgraded to COI 10.3

All sites, including IRB, are now back online!

Thank you all for your patience and cooperation as we work to continue to enhance our University of Miami Research Systems. We appreciate your support!

CONTACT US

OVPRS Help Desk (305-243-2314; OVPRShelpdesk@miami.edu)

SYSTEM UPGRADE AND DOWNTIME

The Research Suite modules listed below will be undergoing an upgrade beginning today February 10th, 2023 at 6:00 PM EST.

• Grants 10.0 will be upgraded to Grants 10.1
• Agreements 10.0 will be upgraded to Agreements 10.1
• COI 10.2 will be upgraded to COI 10.3

All sites, including IRB, will be down starting TODAY Friday, February 10th at 6:00 PM EST and will be back online by Monday, February 13th at 8:00 AM EST. 

An all clear will be sent to users as soon as the upgrade is completed, and all sites are back online.

Thank you all for your patience and cooperation as we work to continue to enhance our University of Miami Research Systems. We appreciate your support!

CONTACT US

OVPRS Help Desk (305-243-2314; OVPRShelpdesk@miami.edu)

SYSTEM UPGRADE AND DOWNTIME

The Research Suite modules listed below will be undergoing an upgrade beginning on February 10th, 2023 at 6:00 PM EST.

• Grants 10.0 will be upgraded to Grants 10.1
• Agreements 10.0 will be upgraded to Agreements 10.1
• COI 10.2 will be upgraded to COI 10.3

All sites, including IRB, will be down starting Friday, February 10th at 6:00 PM EST and will be back online by Monday, February 13th at 8:00 AM EST. 

An all clear will be sent to users as soon as the upgrade is completed, and all sites are back online.

Thank you all for your patience and cooperation as we work to continue to enhance our University of Miami Research Systems. We appreciate your support!

CONTACT US

OVPRS Help Desk (305-243-2314; OVPRShelpdesk@miami.edu)

SF424 Upgrade

IBISResearch - SF424 v.10.5 Upgrade

The IBISResearch SF424 upgrade to version 10.5 is slated to go live on Wednesday, December 21^st. In preparation for this upgrade, the Grants system will be down on the evening of Tuesday, December 20^th starting at 7:00pm EST. Please be sure to plan accordingly. Below you will find highlights on the SF424 v10.5 upgrade.

Highlights

• Added support for the following forms: 
  • AFRI Project Type V2.0
  • Dept of Education Budget Information for Non-Construction Programs (ED-524) V1.4
  • Dept of Education Supplemental Information V3.0
  • EPA Form 4700-4 V5.0
  • Evidence Form V2.0
  • HUD-52768 V4.0
  • NAT Program Specific Data Forms V1.2
  • NFLP Program Specific Data Forms V1.2
  • Objective Work Plan V1.2
  • SDS Program Specific Data Forms V2.0
  • Standardized Work Plan (SWP) V1.0
  • PHS 398 Research Plan V5.0 (NIH Forms-H)
  • PHS 398 Research Training Program Plan V5.0 (NIH Forms-H)
  • PHS 398 Career Development Award Supplemental Form V6.0 (NIH Forms-H)
  • PHS Fellowship Supplemental Form V7.0 (NIH Forms-H)
• Updated PHS Inclusion Enrollment Report V1.0
• Updated NIH activity code list

If you have any questions, please contact the OVPRS Help Desk at ovprshelpdesk@miami.edu.

eProst Archive Has Been Decommissioned

The old eProst Archive system (IRB5) has been decommissioned as of December 15^th. All data has been converted into a flat file that remains accessible to the Research Intelligence and Data Infrastructure (RIDI) team. If any files are needed from this system (previously accessed at eprostarchive.med.miami.edu), please submit a request via email to OVPRSHelpDesk@miami.edu. The RIDI team will review the request and provide all available files/documents.

If you have any questions, please contact the OVPRS Help Desk at ovprshelpdesk@miami.edu.

Research Intelligence & Data Infrastructure

305-243-2314

 UM AAHRPP REACCREDITATION

APPLICATION AND SITE VISIT INFORMATION

The University of Miami’s Human Research Protection Program (HRPP) has successfully completed Steps 1 and 2 of the Association for the Accreditation of Human Research Protection Programs (AAHRPP’s) application review. This is a testament to all your valuable contributions: your hard work, time, and dedication.

AAHRPP is a visible indicator to research participants, regulators, and sponsors that our institution is committed to excellence and ongoing quality improvement. AAHRPP is an independent accrediting body that is non-profit and uses a voluntary, peer driven and educational model. They are colleagues from other institutions that assess at different intervals how we perform as an HRPP.  

The next step is the most involved and requires that our research community come together for this important initiative. Our site visit will be held virtually (via Zoom) on:

March 2, 2023 - March 3, 2023

Those individuals that are selected for interview will be notified upon receipt of draft agenda. 

We will continue to promptly communicate information as it becomes available.

https://www.aahrpp.org

If you have any questions regarding this process, Kenia Viamonte, Director for Human Subject Research, (kviamonte@med.miami.edu) is our AAHRPP accreditation contact and will be able to address these accordingly.

CONTACT US

Human Subjects Research Office (305-243-3195; hsro@miami.edu)

OVPRS Help Desk (305-243-2314; OVPRShelpdesk@miami.edu) 

UPCOMING SYSTEM MAINTENANCE
IBISRESEARCH - IRB 

Dear Users:

Please note that maintenance will be conducted on the IRB system Monday, October 17^th beginning at 7:00pm ET. 

Downtime is expected to be about an hour for this maintenance window.

HOW WILL THIS MAINTENANCE IMPACT YOU?

New ‘Manage Related Grants’ Activity

1. A new activity will be added to the IRB project workspace: Manage Related Grants. This activity will allow investigators and study team members to add related Funding Proposals and Awards to IRB submissions. 
   
   
2.  The related Funding Proposals and Awards will be displayed on the Funding tab of the IRB project workspace.
   
   
3.  Review the IRB Integrations Job Aid for more details.

CONTACT US

OVPRS Help Desk (305-243-2314; OVPRShelpdesk@miami.edu) is available for any system issues, questions, or general assistance.

UPCOMING SYSTEM MAINTENANCE
IBISRESEARCH - IRB 

Dear Users:

Please note that maintenance will be conducted on the IRB system Monday, October 17^th beginning at 7:00pm ET. 

Downtime is expected to be about an hour for this maintenance window.

HOW WILL THIS MAINTENANCE IMPACT YOU?

New ‘Manage Related Grants’ Activity

1. A new activity will be added to the IRB project workspace: Manage Related Grants. This activity will allow investigators and study team members to add related Funding Proposals and Awards to IRB submissions. 
   
   
2.  The related Funding Proposals and Awards will be displayed on the Funding tab of the IRB project workspace.
   
   
3.  Review the IRB Integrations Job Aid for more details.

CONTACT US

OVPRS Help Desk (305-243-2314; OVPRShelpdesk@miami.edu) is available for any system issues, questions, or general assistance.

IRB10 & VELOS INTEGRATION
UPDATE

Dear Users,

Please note that effective today – the IBISResearch-IRB and Velos Integration is now fully functional, including:

• D-Link: Functionality that provides access in Velos to the latest study documents in IBISResearch-IRB and IRB8 (eProst)
• Functional Integration: Allows for the creation and activation of studies in Velos, based on IBISResearch-IRB submissions

OTHER IRB INTEGRATIONS

For information on the other IRB system integrations, please review this IRB Integration Job Aid.

While the system delivered integrations allow for better interoperability and an integrated dashboard for users, there are several known limitations with the delivered integrations. We will continue to share updates with the community if/when enhancements are released.

GET HELP

• Human Subjects Research Office(305-243-3195; hsro@miami.edu)  
• OVPRS Help Desk (305-243-2314; OVPRShelpdesk@miami.edu)

Dear MSOM Research Community,

Per our communication last month, the Miller School of Medicine (MSOM) Research Feasibility
Committee (RFC) will review the feasibility of clinical research studies prior to IRB submission. The feasibility process begins on September 1, 2022 for all new, industry-sponsored clinical research studies.

A previous assessment of our research program showed that 69% of active trials at MSOM were not meeting enrollment targets, which was 20% higher than the national average.

This process is intended to optimize the allocation of institutional resources and effort, while improving the overall performance of clinical research at the MSOM.

What will happen to my existing studies?
Existing studies that have already been submitted for IRB approval will not require submission to MSOM RFC for feasibility review. This will apply to new study submissions as of September 1, 2022.

What do I need to do?
Study teams will be required to complete the MSOM RFC feasibility Intake Form for all new, industrysponsored clinical research studies, prior to IRB submission and ORA contracting.
Additional information including the Feasibility Intake Form, MSOM RFC workflow diagram, and training modules can be found at http://miamictsi.org/researchers/feasibility.

Who do I contact with questions?
If you have any questions, please feel free to contact the RFC at msomfeasibility@med.miami.edu.

Sincerely,
Maria Alcaide, M.D., FIDSA
MSOM EDR Director of Clinical Research and RFC Chair

Dear Users,

The below issue has been effectively resolved, and all systems are behaving as expected now.

Should you encounter any other issues or require system support, please reach out to our help desk via OVPRShelpdesk@miami.edu

NAVIGATION ISSUE
IBISRESEARCH & UDISCLOSE

Dear User:

Although our IBISResearch (Grants & Agreements) & UDisclose (COI Systems) are back online, we have encountered an issue when attempting to navigate between the modules (Grants/Agreements/COI).

For instance, if you are in Grants and try to navigate to COI, you will receive an error. Similarly, if you try to click into a record from a different module that you are in from your dashboard inbox, you will receive an error.

This is a temporary issue, but in the meantime please access each module individually:

Grants: https://umiami.huronresearchsuite.com/Grants
Agreements: https://umiami.huronresearchsuite.com/Agreements
COI: https://udisclose.miami.edu

We have escalated this to the vendor and are working diligently to get this resolved as soon as possible. We will send a communication out once the issue has been resolved.   

Thank you,

OVPRS Help Desk

SYSTEMS BACK ONLINE
IBISRESEARCH & UDISCLOSE

Dear User:

Please note that our IBISResearch (Grants & Agreements) & UDisclose (COI Systems) are back online at this time.

Should you encounter any issues now that systems have resumed, please reach out to our help desk via OVPRShelpdesk@miami.edu.

Additional Updates:

• The eProst Systemis now an archived read-only site.
  
  
• We are currently in our IRB system downtime (until Aug 29^th). Details on interim process can be found below.
  
  
• The new IRBwill be part of the IBISResearch suite and will go live on August 29th at 8am ET. For more information on this project, including FAQs, please visit the IRB10 Project webpage.

IRB SYSTEM DOWNTIME DETAILS

The 2-week IRB process downtime for the transition from IRB8 (eProst) to IRB10 is in effect until Monday, August 29, 2022.

The HSRO has a temporary business process in place to review urgent items (impacting subject safety). The HSRO can ONLY accept urgent Reportable New Information (RNI) submissions during downtime, but will resume accepting all submissions in the new IRB System within IBISResearch on Monday, August 29, 2022.

CONTACT US

Human Subjects Research Office(305-243-3195; hsro@miami.edu) is available to answer any questions regarding the IRB process downtime. Additionally, the HSRO will be offering virtual office hours during go live on the below dates (via Zoom here):

• Monday – 8/29 2:00pm – 4:00pm
• Tuesday – 8/30 1:00pm – 3:00pm
• Thursday – 9/1 1:00pm – 3:00pm
• Tuesday – 9/6 1:00pm – 3:00pm
• Thursday – 9/8 1:00pm – 3:00pm

 OVPRS Help Desk(305-243-2314; OVPRShelpdesk@miami.edu) is available for any system issues, questions on downtimes, or general assistance.

SYSTEM INTERRUPTIONS

NOW IN EFFECT

Please note the following system downtimes that have now gone into effect:

• IBISResearch (Grants & Agreements) and UDisclose (COI) Systems are temporarily offline at this time, and are expected to resume on Monday, August 15^th. An all clear communication will be sent once they are back online. 
  
  
• eProst (current IRB) system has now been taken offline, and will become a read-only archive system beginning tomorrow, August 13th. 
  
  
• The new IRB will be part of the IBISResearch suite and will go live on August 29th at 8am ET. For more information on this project, including FAQs, please visit the IRB10 Project webpage.  Details on the IRB Downtime Process can be found below.

IRB SYSTEM DOWNTIME DETAILS

The 2-week IRB process downtime for the transition from IRB8 (eProst) to IRB10 has now began. This downtime will be effect until Monday, August 29, 2022.

The HSRO has a temporary business process in place to review urgent items (impacting subject safety). The HSRO can ONLY accept urgent Modifications or Reportable New Information submissions during downtime, but will resume accepting all submissions in the new IRB System within IBISResearch on Monday, August 29, 2022.

CONTACT US

Human Subjects Research Office (305-243-3195; hsro@miami.edu) is available to answer any questions regarding the IRB process downtime. Additionally, the HSRO will be offering virtual office hours during go live on the below dates (via Zoom here):

• Monday – 8/29 2:00pm – 4:00pm
• Tuesday – 8/30 1:00pm – 3:00pm
• Thursday – 9/1 1:00pm – 3:00pm
• Tuesday – 9/6 1:00pm – 3:00pm
• Thursday – 9/8 1:00pm – 3:00pm

The below communication contains important information regarding upcoming research suite integrations, effective 8/29. Please review carefully & share with relevant personnel.

NEW IBISRESEARCH INTEGRATIONS

The new IRB system will be live Monday, August 29^th on the existing IBISResearch suite. In preparation for the new integrations that will exist, please review this IRB Integration Job Aid. This job aid contains important details to assist in understanding how the systems will communicate with each other.

While the integrations allow for better interoperability and an integrated dashboard for users, there are several known limitations with these integrations. These restrictions are being discussed with the vendor and we will continue to share updates with the community as enhancements are released.

We appreciate your continued commitment and support of this project!

CONTACT US

Human Subjects Research Office (305-243-3195; hsro@miami.edu) is available to answer any questions regarding the IRB system downtime. Additionally, the HSRO will be offering virtual office hours during go live on the below dates (via Zoom here):

• Monday – 8/29 2:00pm – 4:00pm
• Tuesday – 8/30 1:00pm – 3:00pm
• Thursday – 9/1 1:00pm – 3:00pm
• Tuesday – 9/6 1:00pm – 3:00pm
• Thursday – 9/8 1:00pm – 3:00pm

OVPRS Help Desk (305-243-2314; OVPRShelpdesk@miami.edu) is available for any system issues, questions on downtimes, or general assistance.

UPCOMING SYSTEM INTERRUPTIONS
NEW IRB GO-LIVE

Dear Users:

We have several upcoming anticipated downtimes for our Research suite:

• IBISResearch (Grants & Agreements) and UDisclose (COI) Systems will be temporarily offline between August 12^th@  6pm - August 15th @ 8am ET.
  
  
• eProst (current IRB) system will be taken down on August 12th @ 6pm ET and will become a read-only archive system beginning August 13th. 
  
  
• The new IRB will be part of the IBISResearch suite and will go live on August 29th at 8am ET. For more information on this project, including FAQs, please visit the IRB10 Project webpage.  Details on the IRB Downtime Process can be found below.

IRB SYSTEM DOWNTIME DETAILS

There will be a 2-week IRB process downtime between the transition from IRB8 (eProst) to IRB10. This downtime will start on Friday, August 12, 2022, at 6:00pm and run through Sunday, August 28, 2022.