We are new to Human Ethics. I know how to set a date for Admin Check-in for an Exempt protocol; however, HOW do they submit a check in when reminded? Is it a modification? Do Exempt protocols have a renewal option? Our Exempt submissions "expire" after 3 years. I am assuming the check in date can be updated if they submit a modification; however, if they have no changes, is a renewal an option?
We use the Administrative Check-In date option and set it for 3 years from the approval date for exempt studies. Our workflow in Cayuse is set up to send reminders for the check-ins 30 days prior to that date. Then we use the Renewal submission template. We started using Cayuse in October 2020 so we will be coming up on the first set of renewals for Exempt studies soon so hopefully this definitely works like we planned. Feel free to message me if you have other questions.
Thank you! Our Legacy upload had expiration dates. We have a few Exempt expirations coming up soon. We have time limits in our policies; however, before Cayuse we had no way of enforcing them.
We too use a renewal template, which has worked well. The check-in as post approval monitoring provides information to assure the category of review is still correct. The study closed upon completion and moves to archives.
Exempt protocols have a renewal option; once the renewal is approved a new administrative check-in date can be added by the reviewer.
Our institution do not have an expiration date for Exempt studies. Therefore, our administrative check-ins are simply to remind researchers to submit modifications or any other reports needed at the time of the check-in. We generally set our check-ins for 6 months after the approval of the study.
We use the Renewal submission for admin check-ins.
The first question on the Renewal Submission is
Are you requesting a Renewal or is this an admin check-in? The answer triggers different sections.
Here is a graphic of our design and I'm pretty sure the template is in the library Simon created if you want to look at it in your training environment.
We have set up our Renewal Submission to be used for both Continuing Reviews and Admin Check Ins. Investigators get an initial question that sends them to a different set of questions based on their response, with the questions for Admin Check Ins being less "robust" than those in the Cont Rev option. I'd be happy to share/show you our template if you are interested.Warmly,Jenn
As a quick not for this thread: Even though an Admin Check-In Date can be added when completing the Make Decision task for a Modification, this date is not reflected in the actual Admin Check-In Date that triggers the admin check-in email. In other words, the date on the Modification is meaningless and only the date from the Initial/most recent Renewal is relevant.
We would love to be able to modify the actual admin check-in date with modifications. We use the admin check-in email simply as a reminder (i.e., no action, including a renewal, is required), so anytime somebody submits a modification we consider that as them telling us that they're aware of the IRB protocol and the requirements for it so we'd want to extend the date for the admin check-in date. We've had instances where PIs will have a modification approved and a couple days later they receive the admin check-in email and they ask us "Why are you reminding me about this study? I just submitted a modification."
Thank you Scott, this is helpful. If they do close the submission and it is archived, will the automatic reminder still go out?
That's a great question, Tina. I'd presume that once a study is archived no admin check-in/expiration emails are sent, and I don't believe we've ever had a researcher ask us why they're receiving an email for a closed study. But, I'm not absolutely positive, so maybe this is something Cayuse can confirm.
Hello!To confirm, once a study is closed/archived no further action can be taken on it including the generation of automated notifications.Also, @Darcy Hammar, what a great use of your renewal form!I'll generally hear feedback that researchers are just emailing the research office answers to those general check-in questions for Exempt or Expedited (i.e., how many have you enrolled to date? are you in data analysis stage? do you intend to closeout the study and if so here are the steps...) or something akin to this.This is a great discussion! Thank you so much for all of your contributions!
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