07/19/2008
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CREDIT:
1. "Occupation" has been added to Columns to Include in the Link Patients & Protocols Report.
2. The Protocol Submission Forms Log Report is now interactive. Entries can now be recorded via the report.
3. The Master Schedule Report now includes the column "Sponsor" and can be sorted on that column.
4. For institutions with the Regulatory ORC Enabled, when you create your first New Study Review entry for SENT TO IRB, CREDIT automatically set the ORC Reports to "Inactive"
5. The Protocol Audit report now has an "End Date" so the complete date range of the audit for the protocol can be captured. There is also a new "Memo" field for text entry.
6. For institutions that have the Protocol Summary Enabled, the report now has a Printer Link for pop-up printing.
7. "Today" links have been added to all Prestudy Protocol Workup Date Fields.
8. If a Patient Off-Treatment or Off-Study date is entered and saved, CREDIT Ignores patient calendar events. This function has been standard since 1997. Now, however, if the entry was mistakenly made, and the user deletes the Off-Treatment or Off-Study Dates, CREDIT Un-Ignores the events in the patient calendar that were Ignored by the first action. This re-institutes the calendar for future use.
In order for this option to appear for selected staff, their profile may need to be changed to include this Access. By default, all staff with Dispense capability also have this Access.
9. There is a new Date Field available for Enabling for IRB Revisions. In File Ops > System > System Variable Default Values the last entry in the Protocol IRB Section is where the event can be Enabled. By default it is Disabled. When Enabled, the IRB Revision Log will display and capture the "Actual Event Date".
10. There is a new report: Protocol IRB Review Expire Date. This report is only available to those institutions who have the Annual Review Expire Date Enabled in File Operations. Further, the title "Expire Date" can now be changed in File Operations.
11. Each Protocol has an IRB Follow-Up Sheet for Annual Review and Audit Submission. This set of documents can now be formatted such that events that occurred PRIOR to, and INCLUDING the Last Review, can be "Grayed-Out", leaving the current events (since last review) in normal color. By default, the documents remain as they are currently, all full color. The control for this is in File Operations > System > System Variable Default Values > Protocol IRB Follow-up Sheets: Normal Display (Default) vs. Grey-Out.
IDEA:
1. See CREDIT items: 1, 2, 3, 5, 6, 7, 8, 9, 10, 11
2. When a staff with Pharm Staff Position views the Patient 1 Column Calendar, only the Drug Events display.
3. If, during the Dispense Action, an Outstanding Patient Consent is open, there is a link on the Dispense Page to allow the user to migrate over to the Patient Module to record and\or investigate the consent.
4. The Dispense Log Report now includes the Form and Quantity of the Inventory Dispensed. As an example:
C225 Cetuximab (413 mg : 5 vials of 100 mg)
5. The Pharmacy Module inside of a Protocol has a new entry in the Mini-Menu: "Documents Upload\Download". With this addition, pharmacy documents (scripts, labels, etc....) can be scanned and uploaded for audit\retrieval purposes. As an example, if a Drug Transport document is physically signed by the Receiving Pharmacy, that document can be scanned and uploaded to provide support the event physically happened. This, then, allows for the original paper document to be destroyed as the uploaded document is now electronic.
IRBANA:
1. See CREDIT items: 2, 5, 6, 9, 10, 11
2. When Importing Meeting Activities from CREDIT, if the event has a Consent Change, it is colored Red. If patients need reconsenting, the color is Blue.
3. There is a new Report for the IRB: Meeting Documents for Review. This new report allows for the selection of submission types similar to the Meeting Activity Recorder. The difference here is that all uploaded Documents are displayed with the Agenda Entry so a Reviewer can click on the link and download the file. The file automatically opens in whatever format it needs. There are a few rules that should be noted. First of all, New Studies should have all documents uploaded under the protocol in the new Mini-Menu Option: New Documents for Review. When documents are loaded there, they show up on the new Report, but with one twist. IRBANA keeps a date and time log of who and when a staff clicked on the link to download the document. This is only true of the NEW DOCUMENTS FOR REVIEW. The other upload area, which has been used under each protocol is the "IRB Documents". Those, too, are linked in the new Report as "Existing Documents". IRBANA keeps no log of who has visited those existing documents, only the new ones. |