11/25/2006
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CREDIT:
1. The Prestudy Patient Listing Report can now be viewed in SUMMARY Mode. See the Selection Page right side INTENSITY area.
2. The Prestudy Patient Workup now allows for Screening Location to be stored.
3. The Protocol Current Status Report now allows for inclusion of Protocol Document Links. These are documents that have been uploaded under the protocol module titled either "CCOP Protocol Documents" or "Patient Protocol Documents".
4. The Link Patients & Protocols report can now be Ordered (sorted) by Patient Status. The display output also totals each status.
5. Selected staff can now be notified when and IRB activity requires patient reconsenting. The existing system also makes a log entry into each patient consent form log associated with the study. The Notification Flag is set in Main Menu > File Operations > System > Edit Staff Notifications of Patient Activities.
6. Protocol Adverse Events has a new field available for those who have "Verbose" reporting enabled (System #18): "Attribution: Disease". The existing Attribution for SAEs continues to be enabled. The "Attribution: Disease" option is available in File Ops > System > System Variable Default Values > #21. If Enabled, the SAE recording page opens up the second Attribution assignment. When enabled, the existing Attribution is relabeled: "Attribution (Drug)", and the new display selection is labeled "Attribution (Disease)".
7. There is a new Macro for printing on the SAE Report Form: @AEDiseaseAttribution. This macro corresponds to item #6 above.
8. The Protocol Adverse Events Report now includes the Disease Attribution if the system is Enabled in File Operations.
9. The Patient Adverse Event Report Form now has several new macros: @AEIRBDate, @AESponsorNotifyDate, @AEDiseaseAttribution, @ProtocolArm. Correspondingly, there are new fields on the Patient Adverse Event Reporting Page to hold those new values.
10. When Archiving a Protocol, a patient listing will also be included for those patients that are not already archived. Staff can put a check in a box to select which patients should be Auto-Archived along with the Protocol. The information for the Protocol Archiving will be echoed in the patient archive. This process CANNOT be reversed. If the protocol is unachieved, each individual patient that resides in the Archive file will manually need to be unachieved as needed. To enable this system, File Ops > System > System Variable Default Values > #66 (Allow Automated Archiving of Patients
When Protocol is Archived).
11. The Logout Button has been moved to the upper right corner of the page.
12. The REPORTS button has replaced the DOCUMENTS button on the Navigation Bar.
13. When a local Patient Adverse Event is loaded, there is now an option to have that event copied over into the Protocol Adverse Event Log of IRB Review. To enable this option, it is suggested that #123 (Show Verbose Patient Adverse Event Columns) be enabled in System Variable Default Values. Item #128 (Show "Sent to IRB Date" on Patient Adverse Event Recording page) Must be enabled!
14. The When On\Off Study Report now allows filtering for Protocol Type. For this feature to be active, the Protocol Type field must be enabled in File Ops > System > System Variable Defaults > #48 (Show Type Of Study).
15. The Protocol Adverse Event Report now has an additional data element that can be used. When the Table Intensity is selected to be One Protocol Per Page, there is now a "Footnote" that can be appended to the bottom of each output sheet. To edit the contents of the Footnote, click on the link directly on the AE Selection page. A window will pop-up with the editor inside. Whatever is typed in and saved will appear on the bottom of each output protocol page.
IDEA:
1. See CREDIT items: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15
IRBANA:
1. See CREDIT items: 3, 6, 7, 8, 11, 12, 15 |