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Coeus Lite - IRB Protocols

irb_create_revised_exemption

IMPORTANT:  Do NOT attempt to create and submit an Amendment for a previously Approved IRB Exemption.  Your submission WILL BE RETURNED and a new/revised Exemption will be required.

The Coeus system does NOT permit the submission of Amendments to IRB Exemptions.  If an Exemption Request is granted, any changes to that approved Exemption will then change the scope and negate the granted Exemption.  Therefore it is necessary to submit a New Exemption Request if there are Investigator initiated changes to a previously approved Exempt protocol.

To reduce the burden on the Investigator User, there are two methods available for creating Revised Exemptions.  First is that a new Exemption record can be created and completed from scratch if the PI chooses.  The second option is to create a copy of the previously approved Exemption record.  This reduces the effort required to complete by pre-populating all the original information and only requiring the new information to be incorporated prior to submission.  Using this “copy” method, the amount of effort required by the Investigator is the same as the standard Amendment process.

bulletCreate Revised Exemption by Copy

A User may make a copy of a previously granted Coeus IRB Exemption record if they both have the ability to create new protocols and also have the appropriate accesses to view the pre-existing protocol.

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1. Open the previously approved Exemption record to be copied.

2. In the left navigation, got to the Record Tools section and click “Copy Protocol”

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3. To include all uploaded documents in the copy, check the box for “Copy Attachments”

4. To include all previously completed Questionnaires in the copy, check the box for “Copy Questionnaires”

5. Click “Copy Protocol”

6. A new Exempt protocol record will open with all information copied from the original to include Attachments and Questionnaires if selected and ready for completion of revisions.

noteNOTE:  The new Exemption will be its own distinct protocol record and will have no connection to the originally approved Exemption