Introduction to the New IRB Software System: ClickTM Research Compliance Fall 2017

Welcome to the Zoom Session, Introduction to the New IRB Software System: ClickTM Research Compliance Zoom Session Structure 45 minutes for the presentation and live system demonstration Because of the session size, during the presentation, we ask that attendees please use the mute function to reduce background noise and save any questions for the end of the presentation If you have a question that you do not want to forget during the presentation portion, please feel free to submit the question through the Zoom chat 15 minutes for questions and answers Questions received through the chat will be answered during this time We will follow-up with any questions that we are unable to answer or are not able to get through because of the end of the session NOTE: This meeting is being recorded.

Agenda Introduction Live Demo Data Conversion Resources Questions

ClickTM Research Compliance System Implementation at MSU includes modules for: Institutional Review Board Institutional Animal Care and Use Committee Environmental Health and Safety Biosafety Radiation Stem Cell Vended product in use at peer institutions IRB go live – December 4, 2017 After go live, all new submissions will be through ClickTM

Transfer of Projects into ClickTM Exempt Determinations Active Expedited and Full Board Will projects be transferred into ClickTM? No Yes, for projects that have current IRB approval What data will be in ClickTM? None Minimal data to pre-populate SmartForm fields What will researchers be asked to do after go-live? NA At the time of a modification or continuing review: Confirm pre-populated data is correct and enter some data Add study team members Upload documents (dependent upon study status) Describe the current status of the study

Transfer of Projects and Data Freeze To transfer data between the MSU IRB online system to the ClickTM system, a data freeze for active expedited and full board projects is required A data freeze means that between 11/23/2017 and 12/3/2017, researchers will not be able to submit new: Modifications for active expedited or full board projects Continuing review for active expedited or full board projects Expedited or full board applications

Transfer of Projects and Data Freeze: Impact on Other Submission Types Impact on exemptions, determinations of human subject research, and 45 CFR 46.118 designations: These applications can still be submitted between 11/22/2017 and 12/4/2017 because they are not being transferred into ClickTM However, if the project does not qualify for the requested submission (e.g. exempt project is expedited), the submission will need to be re-entered into ClickTM on December 4 Impact on new submissions under review for expedited and full board projects as of 11/22 Will be transferred to ClickTM manually after go live

Sunset of MSU IRB Online System Planned to be available to researchers for one year after go live (until December 4, 2018) Will be used for projects still under review as of November 22, 2017

Website for Resources Live session training dates – now available FAQs – now available Videos – now available Quick guides – now available User guides – now available

Live Zoom Training Sessions: New IRB Software System Instructor-led Zoom sessions are offered for Click's IRB module Registration now open! Zoom Instructor-led Demonstrations Dates Wednesday, November 29 at 4:00 pm Thursday, December 7 at 1:00 pm Thursday, December 12 at 1:00 pm https://ra-project.vprgs.msu.edu/user-education

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