05/13/2006
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CREDIT:
1. When Cascading Patient Calendars, if there are Staff Notations within the calendars, those entries are moved in concert with the actual check-off events.
2. The Report: On/Off Study\Birth\Death now includes the ability to filter by Off Treatment Date.
3. The Patient Mailing Label generator now allows for selection by Staff. It also includes the ability to select patients per Month of their Birthdate.
4. Under each Protocol Arm, there is a new Mini-Menu option: "Change Arm Identifier". This option allows for the re-assignment of an Arm to another identifier (A to E or UNK to A, as an example).
5. The Adverse Event entry page has been updated to include:
Expected
Unexpected
Unassigned
These are "Radio Buttons", and the default selection is "Expected". To enable this feature, the File Operations > System > System Variable Default Values #19 needs to be Enabled: Show Protocol Adverse Event "Expected\Unexpected" Option.
6. The Protocol IRB Adverse Event page now has a field for entering the Patient ID Number is provided by the study sponsor. The page also allows for adding in the MedWatch number. For this feature to be seen, it needs to be Enabled in File Operations > System > System Variable Default Values > #20: Show Protocol Adverse Event "MedWatch" Number.
7. The Protocol IRB Adverse Event page now has the ability to "Print" the institution's Adverse Event Report. Typically the printing is done under Generate Reports > IRB Adverse Event Reporting. This utilizes the eWebEditPro document processor to create the actual AE Report. The document then has imbedded Macros (data placeholders) so the template is universal to any and all Adverse Events.
Now, that same printing output is available directly on the protocol AE page. The "Print" link is located beneath each "Edit" for each entry. Click the link to Print and a popup appears with the AE data inserted into the document, ready for printing.
8. When adding a new Adverse Event into a Protocol, there is a new ADD button at the bottom of the page: "Add and Print this Adverse Event". Clicking this option not only adds the event in, it pops up the Report for the AE ready to print. This option is ONLY available for systems that have the Verbose Reporting enabled in File Operations > System > System Variable Default Values" > #18:Use Extensive Protocol Adverse Event Recording.
The automatic printing feature even captures multiple AE entries when an event is also loaded into other protocols at the same time. So, creating the event, and assigning it to 5 other studies creates the Printing Pop-up with all 5 AE Reports loaded!
Here is the list of available Macros for the AE Report template:
Protocol Adverse Event Macros
@National
National identifier for the Protocol (S0000)
@Local
Local identifier for the Protocol (HSR-20-1234)
@InitialApproval
The oldest dated entry for Protocol Reviews for the study
@IRBPIFIRST01
IRB Principal Investigator's first name for this protocol
@IRBPILAST01
IRB Principal Investigator's last name for this protocol
@IRBPIPhone01
IRB Principal Investigator's work phone number
@AlternateLocalID
The alternate local ID for the study. This field can (and normally is) renamed by the institution. However, whatever it is titled, the macro remains the same.
@ProtoTitle
The title of the protocol as entered on the protocol data page.
@AEIdentification
The Adverse Event Identifier as entered for the event
@AEMemo
The Memo portion of the Adverse Event as entered
@AEWordDate
The Date of the Adverse Event in word format
@AEAffiliated
Return either “Affiliated” or “Non-Affiliated”
@AEPatientID
The ID number of the patient if loaded in the Adverse Event
@AEMedWatch
The MedWatch Number if loaded in the Adverse Event
@AEIntensity
Returns the Intensity of the event as selected in the event entry (institutions vary on these selections):
Not Serious
Serious/Non-Life Threatening
Life Threatening
Fatal
@AEExpected
Returns either: Expected or Unexpected
@AEAttribution
Returns the Attribution list as selected in the event entry:
Not Related
Unlikely
Possibly
Probably
Definitely
Cannot Determine
@AEConsent
Returns either: Yes or No for whether there was a consent form change due to the Adverse Event Entry
@AEPatientConsent
Returns either: Yes or No for whether there was a consent form change that requires patient notification due to the Adverse Event Entry
@AEStatus
The current status of the protocol at the time of document merging: OPEN, CLOSED TO ACCRUAL, etc…
@AEActiveTreatment
Returns either: Yes or No depending if patients in the institution (or affiliates) are still taking study drugs.
@HOSP
Returns the acronym for the institution (SJMH, LSUMC, etc…)
End of Adverse Event Macros
9. On the Patient Protocol Page, the titles for "Off Treatment" and "Off Study" have been changed to become System variables, which means the title for the date boxes can be changed. File Operations > System > System Variable Default Values > #43: Off Treatment Date Title #44 is the description, #45 Off Study Date Title with #46 being the variable title description. By default, the titles are set to: "Off Treatment" and "Off Study" respectively.
10. Staff Mailing labels can now be filtered per:
Investigators
Coordinators
Data Managers
Primary Care Doctors
11. There is a new setting available on the Patient Protocol page: Require Withdrawal Reason.
It is controlled via: File Operations > System > System Variable Default Values > #119 Withdrawal Patient Status Trigger: Default Status. This is where the selection of Patient Status is set to the trigger (i.e.: Withdrew).
Also note that #118: Show Patient Withdrawal Reason needs to be enabled.
Once the settings are set, and a staff selects the Withdrawal status for a patient, they will be prompted to select a Withdrawal Reason upon saving.
12. The On Study Report can now be selected to:
Patient Count with Listing
Patient Count Only
This is available for accrual counting per physician, gender per protocol, and race per protocol.
IDEA:
See CREDIT items: 1,2,3,4,5,6,7,8,9,10,11,12
IRBANA:
See CREDIT items: 5,6,7,8
The IRB Meeting Agenda now has a new set of macros:
C. Administrative Review
@IRBAdministrative
@IRBAdministrative_number |