How do I migrate my studies from ARIA to CLARA?
We’ve started the migration process by creating an account and an archive in CLARA for each study that was open in ARIA.
To complete the entry of a migrated study, submit an initial Modification, which is similar to a new submission in terms of the number and types of questions that will be asked. Include your most recently approved protocol and consents (it is not necessary to upload all active documents).
Other forms (such as Continuing Reviews) cannot be submitted on the study until this initial modification has been acknowledged by the IRB.
How do I take an action on an open study in CLARA?
CLARA uses forms to take actions on studies. The purpose of most forms can be gleaned from their titles.
To maintain the accuracy of study information, you can have only one form in process at any given time. So for example, you can’t create a Continuing Review form while you have a Modification in process, and vice versa.
The only exception to this rule is Reportable New Information forms, which can be submitted at any time.
How do I signoff on a form in CLARA?
Highlight the form you are submitting (which will have a status of Pending PI Endorsement), and click the Edit button on the right.
When the form opens, click Review and Submit on the bottom of the menu on the right.
Enter your user name and password and click Sign and Submit for Review.
Where are my contingencies in CLARA?
All contingencies from the IRB and notes from other review committees can be found on a form’s Notes by Committee tab.
To access Notes by Committee, open the form under review, and click the Notes by Committee tab on the right side of the screen.
How do I respond to contingencies in CLARA?
Do not submit a modification in response to contingencies!
CLARA allows you to make changes directly to the form in question, rather than submit a separate modification.
To respond to contingencies, open the form under review (which will have a status of Revision Requested), and click the Revise button on the right. You can then edit the form directly, add documents, and respond to contingencies (using the Comment function under each).
When you are finished, be sure to click Complete at the bottom right of the screen. You will then be able to electronically sign the submission and forward it to the IRB for processing and review.
If you close out of CLARA without clicking Complete, the submission will not be sent on to the IRB, so it will not be reviewed.