08/26/2006
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CREDIT:
1. Last update for CCOPs allowed for data collection for the NCI Tables 6A, 6B, and 6C. Data for these tables is pulled from the Staff Profile page. This requires each Investigator to have data entry on the staff page. There is now a new file operation available for CCOPs that allow for bulk updating of staff for those tables: Update Investigator Practice Mode. This allows for setting the flag for "CCOP Physician" as well as the 3 year "Practice Mode" for each staff.
2. The Protocol Adverse Event Report now allows for text search entry on the Adverse Event ID. All matching entries will be displayed. The search is selective via: Starts With, Ends With, or Contains.
3. The Protocol Adverse Event Reporter now allows for Editing or Mimicking any adverse event. This is done via linking the Adverse Event ID.
4. There is a new field in the Staff Profile Page: "Pager". It is located under the email and cell phone fields.
5. The Protocol Current Status Report now allows for selecting columns: Data Manager, with a sub-column: Pager.
6. The Protocol Current Status Report now has staff "memory". This means it joins a handful of other reports that remember the selections of each staff from the last time it was used. Those selections become the staff "default" selections when the selection page initializes. Changes made to the selections become the new Defaults for the logon staff.
7. There is a new field in the Hospital Profile (File Ops > IRB > Edit Hospital...) titled: Show CTSU Form for Amendments. This selection (Active, Inactive) determines if a new checkbox will appear on the entry page for IRB Revisions under each protocol.
8. There is a new field in the Protocol IRB Revisions Log (assuming #7 above is checked) that tells CREDIT if a specific entry should be included in the Reports for Protocols: Adverse Event Reporting. This report holds the template for the CTSU Form and historically was only available for New Studies or Reviews of Studies. Now, when requesting the Create Forms option, the user is prompted to use the study Review Log or the study Revision\Amendment Log. Flagged Revisions will be included in the output.
9. There is a new System Default Values feature (File Ops > System > System Variable Default Values > #77) When Patient Workup is Activated, Set Outcome to: The new dropdown selection box allows for the selection of a specific outcome to be assigned if the patient is ACTIVATED via the Pre-Study Workup page. (i.e.: Went On Study)
10. Per #9 above, when a Prestudy Patient Workup is Activated, and the Outcome is set in the #9 above, the Prestudy Patient Workup Outcome is set to that selection. (i.e.: Went On Study)
11. There is a new link on the Patient and Prestudy pages. When a Prestudy Patient folder is opened, AND the Patient has been "Activated", the upper right corner of the page now displays: Patient has been activated Go There If clicked, immediate navigation takes the user to the Patient File Cabinet into the Active Patient Demographic (Photo) Page. Likewise, on the Patient Photo page, if the patient is also in prestudy, the link there is: (Patient Also in Pre-Study) Go There. Clicking on this link migrates the user immediately into the Prestudy Patient Demographic page.
12. There is a new data table: "Stratifications". To enable capturing data for patients from this table, the field needs to be activated: File Ops > System > System Variable Defaults > #130: Show Patient Stratification on Patient\Protocol Page. If enabled, on the Patient Protocol Page (Event Focus), the follow selections are available in the table:
"er+,er-,pr+,pr-,HERneu+,HER2neu-,Ph+,Ph-,LN+,LN-"
13. The Link Patients to Protocols Report now allows for selection of "Stratification" for filtering. Stratification is also a selectable column for the report.
14. There is a new optional format available for the Protocol Adverse Event report. On the right side of the Selection Page are now 3 options for output format: All Events in One Table vs. Separate Pages Per Protocol, vs Protocols Per Adverse Event. The first format is the traditional display. The second, however, is intended to be for a selected IRB Meeting Date and clusters all SAEs for each protocol on new pages per protocol. The header information is shown on the top of each Protocol\Page. This format was designed to facilitate creating IRB Documents. The third will list each Adverse Event and a table of Protocols that are involved with the Event. Note: Option #3 will result in as many pages as there are Adverse Events!
15. The Link Patients to Events report now allows for filtering by Sponsor Affiliation.
16. When Adding a Manual Event into the Patient Calendar, the Mimic function now has a START DATE for echoing the new event to an existing event. This allows for adding in the new event from the date forward, eliminating adding old historical events that needed to be Ignored.
17. The Add Manual Events into Patient Calendar module has been updated to allow more flexibility. In the "Multiple Dated Entries" section, users can now specify the Repeat Frequency of the event. For instance, Repeat Every 21 Days, or Repeat Every 6 Months, or Repeat Every 2 Weeks, etc... The frequency is a text box for entering numeric values.
18. The Patient Protocol Arm Notes found on the Event Focus page are now linked to popup the notepad and launch for printing. It was requested that staff be able to just print the Patient Arm Notes.
19. In the Document Processor, under the FILE MERGE module, there exists the ability to "Manually Create Patient File". The page to actually populate the file has been updated to allow for seeing all authorized patients for "All Protocols" or change the protocol dropdown for the listing of only patients associated with the protocol. This helps filter the Patient selection file for easier location of patients.
20. When entering Prestudy Patients, the Gender, Race, and Ethnic Category can now be set to a default value. These are done in File Ops > System > System Variable Default Values. In the Pre-Study section the entries will be found. Additionally, the Pre-Study Patient Social Security number can be hidden. In this same area, there is the ability to change the titling of the Workup "Consent Date". Some institutions are using the date for when they sent the consent out. So, they might change the title of the field to "Consent Sent".
IDEA:
1. See CREDIT items: 2, 3, 4, 5, 6, 12, 13, 14, 15, 16, 17, 18, 19
IRBANA:
1. See CREDIT items: 2, 3, 4, 5, 6, 14 |