- Sponsor and project team have decided to postpone the remaining IRB tasks until after the re-accreditation process has completed (~May 2018)
- Grants development and implementation will continue with full resources and expects to be completed by March 2018
- Preliminary discussions have taken place on the Agreements module. Looking to kick-off the module in January
- Discussions are currently taken place to implement hardware and software for the Agreements, IACUC, and Safety/Stem Cells modules
- IRB Training and Testing plans have been discussed
- Requirement gathering and development continue for the Grants module
- Preliminary discussions have taken place to dedicate all resources to the Grants module and postpone the remaining IRB tasks until after re-accreditation tasks have completed
- COI module has over 1500 submissions to date.
- IRB development has completed
- Planning for IRB training has commenced.
- Requirement gathering meetings and preliminary development have started for the Grants module.
- Integration updates have been completed.
- COI module has seen ~1300 submissions since Go-live.
- Development for IRB will be completed at the end of this month and development on the Grants module will begin ramping up in the coming weeks.
- Formal testing has completed on the IRB module.
- A training tool that will help facilitate the training process will look to be implemented in the coming weeks
- Integration updates between the different modules are currently being implemented and need to be completed prior to Grants development commencing.
- COI module has seen ~950 submissions since Go-live.
- IRB module is ~65% complete.
- Go-live for IRB is currently slated for mid-September.
- Development for IRB is winding down and preliminary testing has been conducted by select faculty/staff.
- Formal testing processes are set to begin at the end of the month.
- Discussions about training have begun.
- COI module has seen ~700 submissions since Go-live.
- IRB Module is ~55% complete.
- Requirements gathering is wrapping up, while development continues for IRB.
- SB is currently working with the vendor on IRBNet data migration tasks and will be ready to go prior to Go-live.
- Grants onboarding completed on May 25th and requirement gathering sessions have been scheduled over the next few weeks.
- IRB Module is ~38% complete.
- Requirements gathering is currently in process and should be finalized in the next couple of weeks.
- Discussions are ongoing regarding data conversion tasks for data coming from IRBNet.
- The IRB module was presented to several staff members and two IRB committees and initial feedback has been very positive.
- Grants module onboarding took place May 23-25; requirements gathering will begin the first week in June.
- The COI module went live on April 17, 2017.
- IRB development continues as the team wraps up requirements meetings with the IRB staff.
- Data conversion tasks required for the IRB module will commence this month.
- Additional meetings will be scheduled to finalize Go-Live period, taking the Common Rule decisions, Single IRB integration, and re-accreditation timeline into account.
- The production servers were setup and all software was installed and configured in preparation for the COI implementation, set for 4/17/17.
- COI testing has begun and will continue through the middle of the month.
- Single Sign On will be configured, tested and implemented in production by the end of the month.
- Training videos and documentation are currently being planned and worked on. All content will be ready by Go-Live.
- The team is currently conducting requirement sessions with key IRB stakeholders and will look to begin development this month.
- Team will look to finalize specifications for the Production Environment hardware by the end of February and begin procurement processes shortly, thereafter.
- COI - Most development work has been completed and we are in the final stages of internal testing.
- COI - Connections to CITI and Single Sign-On are currently being worked on.
- COI - Upcoming Activities Include:
- User Acceptance Testing (March 1-15)
- Implement Single Sign-On (SSO) for COI, initially (March 15)
- Training Development (March 20)
- Move to Production (April 4)
- Quality Assurance Processes (April 7)
- Training and Communication Sessions (April 10)
- Go-Live with COI (April 17-30)
- IRB - Huron was on-site to discuss the solution with the IRB Office and discuss current
processes, Click processes and the gaps between the two.
- Key takeaways from the sessions included:
- Potential project impacts due to Single IRB and Final Common Rule regulations.
- Upcoming AAHRPP Re-accreditation timeline was also discussed.
- A decision was made to continue developing the IRB Module while the team awaits clarity on the Common Rule regulations.
- A final decision on the Go-Live Date will be made by June.
- Key takeaways from the sessions included:
- IRB - Upcoming activities include:
- Discuss Strategy of IRBNet to Click cutover (February 24)
- Onboarding - Business Process Review (February 28 - March 1)
- DAC Update (March 9)
- Grants - Project tasks for the Grants module will begin in early May; after COI Go-Live.
- COI Module is currently 30% completed.
- COI changes have been identified and are in the process of being implemented.
- Project Charter has been finalized and signatures received by all key stakeholders.
- IRB Onboarding needed to be pushed back to 1/24-1/25 and was completed, as rescheduled.
- IRB Design sessions will be scheduled within the next week, with spec documentation and analysis occurring shortly thereafter.
- The development and testing environments for COI, IRB and Grants are currently online.
- Specifications for the Production environment are being finalized and the procurement process is set to begin by 2/8/2017.
- COI Module is currently 20% completed.
- Project and Training Statements of Work (SOW's) have been signed by both SB team and consultant
- COI design sessions have completed and ~50 COI changes have been identified, documented and currently being worked on.
- Technical training for our development team completed last week (12/14).
- Project Charter has been finalized and signed off on by Sponsor and some of the key stakeholders; looking to acquire all signatures by the end of this week (12/23).
- IRB Onboarding will begin 1/4/2017.
- COI Process Analysis tasks set to be completed by 1/10/2017.
- IRB Design Sessions set to begin 1/10/2017.
- Project is 10% complete and currently in the planning stage.
- The team conducted a successful Kick-Off meeting at the end of September and formally introduced the Program to various stakeholders and sponsor.
- Design sessions for COI and IRB will begin this month.
- Installation of the software for COI, IRB and Grants will be completed next week.
- COI Onboarding will commence with the consultant next week.
The Huron Click project is to implement the following six modules to provide a single
system for researchers, students and staff to manage their proposal submissions and
- Conflict of Interest (COI). Disclosures (annual, travel and event-based), committee management, management plans, alerts and integrations to Grants
- Agreements. Management of research contracts and negotiations with sponsors and third-parties
- Institutional Review Board (IRB). Submission, review, renewals and amendments of all Human Subject protocols. Includes committee meeting management
- Grants. Speed budgeting, streamline eSubmission, and improve award management
- Institutional Animal Care and Use Committee (IACUC). Submission, review, renewals and amendments of all Animal Use protocols. Includes committee meeting management
- Biosafety/Stem Cells. Submission, review, renewals and amendments of all Biosafety and Stem Cell protocols. Includes committee meeting management
In 2013, Stony Brook conducted an extensive search for a system to replace COEUS and
IRBNet. That search involved input from the research community across the campus.
Based on the findings, and further review of the marketplace, SBU selected Huron Click
as the vendor with a comprehensive suite of modules, proven support capabilities and
successful implementations at other universities.
- The project will be a team effort and will include the Research Advisory Committee (RAC) , Departmental Administrator’s Committee (DAC) , OVPR Staff, Faculty Senate (Research Committee) and faculty and staff.
- Everyone can provide input and feedback through https://goo.gl/QEazGz. Design sessions will be held with OVPR staff and DAC and the implementation will be done by DoIT staff and Huron consultants. The RAC and Faculty Senate (Research) committees will make recommendations on business process changes and customizations, which will have to be approved by the project leadership.
- All updates will be provided on the project website at http://www.stonybrook.edu/commcms/projects/program/click-portal-solutions-implementation . Additional updates will be provided to the Department Administrator’s Committee, Research Advisory Committee, and the Faculty Senate. Quarterly Updates will be sent via Research News and email to the entire campus community.
- All key training and go-live dates will be communicated through several channels.
- Data and documents from COEUS will not be moved over to Huron Click. COEUS documents will be archived and available by request.
- Migration of data and documents from IRBNet needs further analysis. The migration strategy options will be reviewed and approved with a focus on balancing researcher burden and data portability. Most of the data is in MS Word applications and cannot be extracted. The documents themselves will continue to be available through an archive and/or IRBNet.
From: Richard J. Reeder, Interim Vice President for Research
Subject: Conflict of Interest Reporting Is Going Paperless with New myResearch (Huron Click)
The myResearch (Huron Click) Conflict of Interest Module is live!
This electronic submission process replaces our current PDF forms that need to be submitted with every proposal, at the time of PHS/NIH annual anniversaries, and as part of IRB submissions. Instead, you will complete an online Annual Certification of outside interests in an effort to streamline business processes and reduce faculty administrative burden. Research certifications may be required at the time of an award or protocol submission to clarify if a specific interest is related to a specific project. CITI Training remains unchanged as required within the last four years.
Beginning April 17th,
the following groups are required to start submitting an Annual Certification in myResearch.
1. Faculty members that participate in research;
2. Staff that meet the definition of Investigator and are named on a current funded project or proposal submitted within the last year; and
3. Staff named as study personnel on IRB submissions that have current or pending funding.
Beginning May 1st:
The PDF forms will no longer be required for any proposal submissions, PHS award anniversaries, or for staff named in IRB submissions.
During this May transition month, all faculty and staff (as required above) must have an Annual Certification in myResearch for new awards. PHS award anniversaries and new IRB submissions.
Beginning June 1st:
The myResearch COI Module will be fully implemented. Any changes in outside interests must be reported in myResearch within 30 days of acquiring said interest and Annual Certifications will be due each year by May 1st.
Login information, training videos, and CITI Training information are available at http://myresearch.stonybrook.edu .
- The Investigator Conflict of Interest Policy (P209) has been revised.
- Standard Operating Procedures are now posted on the ORC COI website.