Mandatory Use of Click IRB Begins on March 1

The IRB and Click Development Team are pleased to announce that all barriers to the universal use of the Click IRB system have been removed or mitigated. Accordingly, the delayed move to mandatory use of Click IRB has been rescheduled for March 1.

As of March 1 all work – new applications, modifications, renewals, etc. – will need to be submitted to the IRB via Click. There is a short-term exception to this requirement. Because Click requires an existing study and its activities to be in a complete state before new work can be generated, those studies that, as of March 1, have existing actions in process with the IRB will be permitted to submit additional actions relating to that study using the existing legacy forms up until the study activities reach a complete state. If you are in another exceptional circumstance that means you cannot comply with the March 1 mandatory use date, then please contact the IRB via email.

The IRB and the Click Team continue to provide training on Click IRB for all who desire it, and will continue to provide classes for the foreseeable future. Since October 2015, there have been 37 classes held. You can register through the Learning Center for upcoming classes.

We’re excited for this next phase in the support of human subjects research at Seattle Children’s. We do understand that change can be difficult, but our feedback from early adopters of Click IRB has been positive, with some users reporting significant reductions in the time it takes to prepare work for submission to the IRB. On the IRB side, we believe that the retirement of the existing forms, and the systems that support them, will free up resources and enable greater standardization in the way work is performed, and an increased ability to move work more quickly to final approval. Step 1 is to get the entire user community using Click IRB, and that step begins on March 1.

Important: When is my study transitioned to Click IRB?

When study teams initiate Smart Forms in Click IRB, even before the transaction is submitted to the IRB, they have effectively transitioned the study into Click IRB. This initiation results when the study team clicks Continue in a Smart Form page or saves the first page of a Smart Form.

What does this mean for study teams?

Unless you have actions pending in the legacy system or received a special exemption from the IRB, you will need to conduct all study business in Click IRB. Do not enter information into Click until you are prepared to move forward with all other actions in Click. Please refer to the Quick Guide – Tips for Migrated Studies (PDF) or contact the IRB for more information.

Further Information

  • The Click IRB software is the result of years of analysis and development by experts in the field of human subjects research. Our deployment of the system will bring a number of advantages to the federally-mandated management of human subjects research at Seattle Children’s, including increased efficiency and greater standardization across documents and processes used by the IRB, and increased visibility during the review process.

  • You are invited to log in and explore Click IRB – but you are advised to get prepared with Click IRB training (see below) prior to making any submissions in Click IRB. The Investigator Manual is recommended reading and is found in the Click Library on the General tab. To access Click IRB:

    1. Go to Citrix to open the list of viewable applications.
    2. Select the Click application icon. You will be presented with a Click session login screen in Internet Explorer 9.0.
    3. Log in with your Seattle Children’s username and password.
  • We strongly recommend receiving training on the Click IRB system before using it for your submissions. The training consists of a series of instructor-led classes involving hands-on interaction with the system, beginning with Click IRB Essentials for Investigators and Study Teams. The Essentials workshop will provide a broad overview of the Click IRB module that will prepare you to make submissions in the Click IRB system, including understanding key changes in roles and business processes with Click IRB.

    Depending on your role in a study, you may also want to attend the Click IRB Deep Dive classes for a more comprehensive training experience. The two-part Deep Dive course will help you move through basic viewing to initiating activities in the system that cue team members and the IRB to engage with the study. The Essentials workshop is a prerequisite to the Deep Dive course, but you can register for both Deep Dive workshops before you complete the Essentials training.

    Register for these open workshops through the Learning Center.

Essential Resources

Click Short Form Consent and Assent Forms