05/09/2015
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CREDIT:
1. For sites that have the "Birthday Notification" setting Enabled in File Operations, there is a new field that allows for Notification in xx advanced days of the birth day. The setting is Protocol specific. On the Protocol Data page, if Enabled, there is a box to list the birthdays for patients that staff need email notification for "8,12,18,21" as an example.
2. There is a new IRB Revision Log, Revision ID option that can "Standardize" submissions to the IRB. Currently, the "Revision ID" is a free text field, which remains the default. However, if that field needs to be a selectable drop-down box, that is now an option. It requires 2 elements to be set. First one is in File Ops > IRB > Add Revision ID. Once all of the various "Standardized" IDs are loaded, the system needs to be Enabled. File Ops > System > System Variable Defaults > IRB "Revision ID" Uses "Revision ID Dropdown Select Box" needs to be Enabled. Going forward, whatever the Submitter selects from the Standardized Listing, will be captured as the IRB Revision Log ID for that event.
3. There are a series of new fields that can be Enabled via the System settings:
Risk Determination Level
Pediatric Risk Determination
Device Determination
There are also data merge Macros to suppor them:
@RiskDeterminationLevel
@PediatricRiskDetermination
@DeviceDetermination
4. The "Staffing Assignments" Peek-Thru on the Protocol Data Page is now sort ordered by the System setting that indicates which Types of Staff should be in the Peek-Thru. So, If the PI is not at the top of the list, and it is desired to do that: File Ops > System > System Variable Defaults > Protocol Data > Protocol Data Page Research Staff Peek-Throughs.
5. Unanticipated Problems can now be Enabled in the IRB Follow-up Sheets. File Ops > IRB > IRB Meeting Environment > Optional Pages to Include on IRB Follow-Up Sheets
IDEA:
1. See CREDIT: 1, 2, 3, 4
IRBANA:
1. See CREDIT: 2, 3, 4
2. In the IRB Logs, there has always been a link to "Documents" for each event. Those links allowed for Merging the event with a Document Template. Now, if the user has IRB Reviewer Access in their staff profile, there is a new set of links: Letter of Action. When clicked, there is a popup that lists the Letters from the Letter Generator. The listing is filtered to match the specific event the letter is for. Clicking on the specific letter link will create the merged letter for that event.
BIOSPEC:
1. See CREDIT: 1, 2, 3, 4 |