Frequently Asked Questions

General information

Q. What is Click?
A. Click is a research compliance management system. At MSU, it will manage IRB, IACUC, and EHS compliance activities. This Huron software product is currently in use at several peer institutions, including University of Michigan, Northwestern University, Rutgers University, Pennsylvania State University, and the University of Wisconsin.

Q. When will I start using the new system?
A. Investigators will begin using Click for IRB protocol submissions in December 2017. The software's IACUC and EHS functionality will go live in May 2018 and August 2018, respectively. Please see the timeline for more information about the software deployment.

Q. Does Click require two-factor authentication?
A. Yes

Q.Will I still be required to use the VPN to access Click modules?
A. No.

Q. Is Click accessible through different browsers?
A. Yes, Click supports most commonly used browsers, with the exception of Edge, which may have limited support.

Q. Will Click integrate with other systems?
A. Yes, Click will integrate with other MSU systems, including Kuali Coeus, the Learning Management System (LMS) for compliance training, MSU's Identity Management (IDM), and Organization of Interest (OOI) systems.

Transition to the new system

Q. Do I have to use the new system?
A. Yes, When Click is deployed on campus, legacy systems and processes for submitting IRB, IACUC and Safety protocols will be transitioned to Click™. More information about this transition will be shared on the RA Project and relevant compliance office website as it is available.

Q. How will I access Click?
A. Access to the Click system will be available in five locations: the Office of Regulatory Affairs' website, the Human Research Protection Program's website, the Animal Care Program's website, the Environmental Health and Safety website, the Institutional Stem Cell Research Committee website, and the EBS Portal.

User Education

Q. What kind of educational options are available?
A. Support materials will be available on the RA Project website, including video demonstrations, help guides, and online user manuals. Additionally, Safety will be available on the EHS website (https://ehs.msu.edu).

IRB

Q. When will I start using Click for IRB submissions?
A. Researchers will begin using Click for all new IRB submissions on 4 December 2017. This includes new submissions for:

  • Initial review of exempt, expedited, and full board studies
  • Renewals
  • Revisions
  • Human subject research determination
  • 45 CFR 46.118 determinations
  • Requests to use an external IRB
  • Unanticipated problems involving risks to subjects or others
  • Protocol deviations
  • Other reportable events
  • Closures

Q. How long will researchers have access to past IRB submissions in the MSU IRB Online System?
A.The MSU IRB Online System is planned to be available for one year after going live, until 4 December 2018.

Q. What if I need a document from the MSU IRB Online System after 4 December 2018?
A. You can request a document from the Human Research Protection Program, as they will continue to maintain study records as required by law or regulation. 

Q. Are there any specific cut-off dates that I should be aware of?
A. Yes. On 22 November 2017, the MSU IRB Online System will no longer accept the following types of new submissions for expedited and full board studies:

  • Initial review
  • Renewal
  • Revisions

New submissions for expedited and full board studies will resume in Click on 4 December 2017. This cut-off is needed to perform a partial transfer of data from the MSU IRB Online System into Click for active expedited and full board projects.

The 22 November 2017 cut-off date does not impact submissions for:

  • Exempt applications
  • Human subject research determinations
  • 45 CFR 46.118 determinations
  • Unanticipated problems involving risks to subjects or others
  • Requests to use an external IRB
  • Protocol deviations
  • Other reportable events
  • Closures

Q. What will happen to expedited or full board submissions that are pending as of 22 November 2017?
A. Any submissions for expedited or full board projects that are pending as of the cut-off date on 22 November 2017 will continue to be reviewed in the MSU IRB Online System until the review is complete. Submissions will then be transferred into Click on an ad hoc basis.

Q. How will Click's implementation affect my active IRB protocols?
A. The answer depends on the type of research project.

Projects in the expedited or full board review level with current IRB approval will move to Click prior to its deployment with a partial data conversion.

Projects determined to be exempt or closed expedited or full board projects are not being transferred from the MSU IRB Online System to Click.

Q. What information is being transferred into Click from the MSU IRB Online System
A. Projects in the expedited or full board review level with current IRB approval will move to Click prior to its deployment with a partial data conversion. The partial data conversion will include minimal data to create and save a record in Click from the MSU IRB Online System.

Examples of the types of data being converted include:

  • Title
  • Brief description
  • PI, Secondary Investigator, Study Coordinator as applicable
  • MSU Sponsored Programs funding number
  • Information about drugs, devices, external sites
  • Approval and expiration dates

Supporting documents such as consent forms, instruments, etc. will not be uploaded into Click.

Q. What information will I need to provide in Click for transferred expedited or full board projects?
A. At the time of continuing review or a modification of a transferred expedited or full board project, researchers will be asked to:

  • Review pre-populated SmartForm data to assure it is correct and edit if necessary
  • Input any additional SmartForm data
  • Add study team members
  • Link any active grants
  • Upload documents that are currently approved and in use (dependent upon study status)
  • Describe the current status of the study

Q. What are the most significant changes for researchers?

  • Eliminate the need for email supporting documents
  • Provide a more transparent history of actions taken
  • Provides the ability to update the study to reflect the current status of the study
  • A feature of My Inbox in Click, which provides researchers with a listing of all studies that require action on the part of the researcher or study team
  • Review questions from IRB members will be compiled into one communication to the researcher
  • Submission processes will use protocol templates to provide study-specific information
  • Eliminate use of the G-PID for guest investigators
  • Eliminate the use of VPN (Click uses two-factor authentication)
  • Easy access to all approved study materials
  • Ability to generate a comment to your IRB coordinator through Click

IACUC

Q. How will Click's implementation affect my active IACUC protocols?
A. Currently approved Animal Use Forms (AUFs) will continue in the legacy paper-based system until expiration of the AUF; amendments for these AUFs will be completed in the same process until expiration of the AUF.

Q. When will I start using the new system for IACUC protocols (AUFs)?
A. Currently approved AUFs will continue in our paper-based system until they expire. Investigators will be able to use Click for IACUC protocol submissions starting in May 2018. To facilitate the transition into Click, a 1-year approval on current AUFs will be granted for those submitted by 31 July 2018. On 1 August 2018, all protocols must be submitted within the Click system.

Q. What are the most significant changes for researchers?
A. There are notable changes upon transitioning to the Click system:

Research Teams The system uses this concept to ensure access and visibility across personnel – for instance, all personnel within a PI’s laboratory that require access to the protocol will be able to view the needed information. Each PI will have the ability to create their own research teams to develop protocol building blocks and define an organizational approach to the nomenclature. 

Protocol (AUF) Building Blocks To create a protocol, the PI will construct it using building blocks. This will involve first defining the procedures and substances, then creating experiments based on those procedures and substances, and finally combining the experiments into a comprehensive research protocol (AUF). Once created, the procedure and substance building blocks can be used repeatedly for additional experiments in a protocol or for other protocols belonging to the research team.

Animal Numbers After defining the number of animals for each experiment, the system will tally total animals by species through built-in calculations. In addition, the system will associate animals with funding sources.

Workflow Visibility The system creates improved transparency with the status of every submission. As mentioned, the system is secure and includes an audit trail of all activities – also of note, communication with the IACUC and its administrators will occur through the software.

Q. What if I cannot find the species I am looking for?
A. The IACUC approaches species from the general species level. For example, cow is under the name 'cattle'; pig is under the name 'swine.' If you are unable to locate a species, please contact the IACUC office at iacuc@msu.edu, 517-432-8103.

Q. What if I have additional questions?
A.
Please note the contact information below for the following topics:

Safety

Q. What submissions are included in the SAFETY module?
A. The Institutional Biosafety Committee (IBC), Radiation Safety Committee (RSC) and the Institutional Stem Cell Research Committee (ISCRC) submissions are included in the SAFETY module in Click.

Q. When will I start using the new system for IBC, RSC and ISCRC submissions?
A. The Click Safety module is scheduled to roll-out in August 2018. Anyone completing a new IBC, RSC or ISCRC submission in Click will use the SAFETY tab to access the submission sections for each.

Q. How will Click’s implementation affect my existing IBC, RSC and ISCRC protocols?
A. IBC: Approved/Existing Recombinant DNA and Biomaterial Registrations will continue in the legacy system until an amendment/annual assurance/expiration date occurs (whichever comes first). At that time, submissions will then be required to be entered into the Click Safety IBC module. All new submissions will be entered into the Click Safety IBC module starting in August, 2018.

RSC: Approved/existing Radiation Safety registrations will be converted from the legacy system into Click by the Radiation Safety office. Investigators with existing registrations will be contacted once their registration has been input into Click. At that time, they will need to verify accuracy of the record or amend it if any updates are needed.

ISCRC: Approved/existing ISCRC studies will not be transferred to Click. All new submissions will be submitted in the Click Safety module.

Q. When will I start using the new system for EHS Safety protocols?
A. IBC: All new submissions must be entered into the Click system when it is implemented in August, 2018. Currently approved registrations will stay in the legacy system until they require an assurance, amendment or they expire whichever scenario is anticipated first. However, there will be no penalty for those who wish to move their current registrations into Click before the assurance or expiration date.

RSC: For Radiation Safety registrations, all new submissions must be created in the Click system when it is launched on August 20, 2018. Also, investigators who have registrations converted from the legacy system will use Click to amend their registrations.

ISCRC: All new submissions must be submitted in the Click system when it is implemented in August 2018.

Q. What are the most significant changes for researchers? 
A. IBC has several notable changes upon transitioning to the Click system:

  • Submissions
    • Includes both the Biomaterial Registrations (BMR) and Recombinant/Synthetic DNA Registrations
    • Comprehensive table captures the construct information
  • User Access
    • All faculty, students and staff can create submissions
    • Personnel listed on the submissions can view/edit
    • Only Principal Investigator can submit
  • System Functionality
    • Copy existing submissions for renewal or new submissions
    • Indicate related IRB and IACUC protocols
    • Easily upload supporting documentation

RSC

  • Submissions
    • Online submission forms with branching logic
  • User Access
    • All faculty, students and staff can create submissions
    • Personnel listed on the submissions can view/edit
    • Only Principal Investigator can submit
  • System Functionality
    • Copy existing submissions for renewal or new submissions
    • Easily upload supporting documentation

ISCRC

  • Submissions
    • Online submission form with branching logic
  • User Access
    • All faculty, students and staff can create submissions
    • Personnel listed on the submissions can view/edit
    • Only Principal Investigator can submit
  • System Functionality
    • Easily upload supporting documentation

Q. What if I have additional questions?
A. Please note the contact information below.

Click system questions:

Click Help Desk
clickhelpdesk@msu.edu
517-355- 2000

IBC Submission questions:

MSU EHS Office
517-355-0153
Jamie Willard – cherryme@ehs.msu.edu
Chris Colvin – colvinch@ehs.msu.edu

RSC Submission questions:

MSU EHS Office
517-355-0153
Bryan Harris – harris@ehs.msu.edu
Curtis Hicks – hicks@ehs.msu.edu

ISCRC Submission questions:

Kristen Burt
burtkris@msu.edu
517-884-6020