05/09/2009
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CREDIT:
1. There is a new "IRB of Record" system that has been installed. This will take some time to explain, so
When we examine how an institution is attached to an IRB, we can see how a new system was needed.
Consider that an institution has several “components (children)” that are reliant on the “mother” institution for IRB activity. When Mom submits a study for annual review, it does so also on behalf of the “Children”. That all works perfectly.
Now consider if the Mother institution has a CIRB review the study. Really, that is a different institution than the normal. So what we now have is the Mother has multiple institutions that can be flagged for “who does the reviews”. This breaks the straight line association of Institution IRB to Mother to Children.
In the past we allowed for staff to simply type in the IRB of Record. But, we noted that the Children were still looking to the Mom IRB for association. In reality, when Mom used the CIRB, it was the CIRB that the Kids should have been associated with.
The new system allows for this convention. Those institutions that desire to enable this “Automatic” association of a study to a CIRB, including mom and the kids, will need to add a new Institution (Hospital) in File Ops > IRB > Add Hospital\Institution (Central IRB… CIRB). Hold it right there… do not do this *yet*!
*IF* you do the above, you will need to give all logon staff who manage protocols access to this new institution. You will also need to go into the Mom Hospital (Edit Hospital) and check the new box to allow mom to have a… well… Mom… the new CIRB.
Having done that, each protocol that has a CIRB (or other… you will need to add them all in as Institutions), will need to have *that* Component have Access to the study, and have a status set. IRB Meeting Dates for these CIRBs will also need to be loaded. It is recommended that the “Local” Meeting Dates be loaded for all CIRBs. When this is done, on the Mom Protocol Data page, the single line display for IRB of Record will become a dropdown box. Then, Mom can select “CIRB” from the dropdown box for that study.
Appropriately, then, all CIRB Regulatory entries *should* be housed under the new CIRB institution. And, all *other* External IRBs will do the same.
The above explanation offers a true capacity to separate out the Regulatory per reviewing agency. Now for the option.
IF you are not interested in going in the direction outlined above, you can still manage IRB of Record from a simple dropdown box. In File Ops > System > System Variable Default Values > Method of Selection for IRB of Record Display.
The options are for Automatic vs. Manual. The default is Automatic. Change it to Manual and Save. Now the Protocol Data Pages will contain all the original hand entered CIRBs. You may discover several that mean the same thing, but were mistakenly typed incorrectly in various studies. Hence, File Ops > Protocol > Add\Edit\Delete IRB of Record.
In the new File Ops, one can Edit an IRB of Record they wish to delete. You cannot delete an IRB of Record unless it is not attached to any study. So, the Edit mode has “Show Attachments” button in the upper left corner. You will need to print those attachments out so that you can open the studies and re-assign to some other CIRB entry. When all associations are cleared, you will be able to File Ops > Protocols > Delete IRB of Record.
Note that the above (Manual) option allows for all regulatory to be housed under one institution (even though other CIRBs are actually doing the reviews). Additionally, the Manual system eliminates future typos for CIRBs as it is a dropdown box instead of a simple text box.
If your institution decides to follow through on the Automatic IRB of Record rather than switching to Manual IRB of Record, you may want to “Move Regulatory” logs from your institution to the CIRB institution. IF you decide to do this (and you are not required to do so), there is a File Ops > System > System Variable…. > IRB > Allow Regulatory Logs to Migrate from One IRB to Another
If this is “Enabled” (default is Disabled), a button will appear on the Protocol Data page (top left) “Move Regulatory”. This button allows for moving all logged entries over to another IRB. This should *only* be done if the intention is to maintain multiple IRBs in the system.
In a nutshell, if you want to manually manage your CIRBs, you will need to select that feature in File Ops as noted above. Otherwise, you will only have one true IRB (and no dropdown box) for assignment per protocol.
IDEA:
1. See CREDIT items: 1
IRBANA:
1. See CREDIT items: 1 |