05/27/2006
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CREDIT:
1. For those installations that are CCOPs, the Protocol Report Name is limited to 17 characters for National Cancer Institute File submissions. So, if a protocol Sponsor is affiliated with the NCI, the user is alerted that this is a data violation and the Report Name is over sized. For those protocols that are NOT affiliated with the NCI, there is no limit to size.
2. There is a new title variable in File Operations > System > System Variable Defaults > #74: Primary Care Physician Title. By default it is set to: "Primary Physician". Both the title and description can be changed.
Note: the document macros for this field have not changed: @PDRFirst (Primary Dr. First Name) and all other macrors related to the Primary Physician remain the same and are pulled from this data entry.
3. The Patient Adverse Event entry can now be printed directly on data entry. Instead of using the "Save Adverse Event" button, there is a new button next to the existing one: "Save and Print this Adverse Event". The form used is the same one that the Patient Adverse Event Report.
4. IRB Revisions can now be inserted for multiple protocols. The multiple protocol selection box at the bottom of the page allows for adding and removing additional entries via protocol selection.
5. There are 2 new field columns available for editing in the Protocol Submission Log:
Requested (date)
Completed (date)
These can be changed in File Operations > System > System Variable Default Values
#22: Submission Log Date "Submission" Title
#23: Submission Log Date "Completed" Title
6. The Protocol Submission Log now does not require the DUE DATE.
7. The Report for Protocol Submissions now allows the selection of date titles as the target of the Date Range entries.
8. The Hospital Staff Calendar now captures the date and time the entry was created. When the event is "mouse overed", the authoring Staff Name as well as the entry date and time are shown. Historical events are defaulted to the first date the event is on the calendar.
9. The Pre-Study workups now allow for the selection of an Investigator.
10. The Pre-Study Listing Report now allows for pulling the data per Investigator. 2 New columns have been added for selection: Investigator and Data Manager.
11. If "Financials" are enabled for the installation, the study Sponsor mailing address information is now availabel in the File Operations > Protocol > Edit Sponsor for Protocol. By populating the information on this page, the Default Payor information can be copied in the Financial Pages for any given study.
12. CTSU RSS Form Creation: CREDIT can now complete the CTSU IRB Certification forms. The settings for this to occur are numerous, but well worth the time. In the Reports > IRB there is a new link to the form itself: CTSU RSS Form.
There are several new Document Macros used in the form template:
Macros Used in CTSU RSS Form
Description of Macro
@National
Protocol Identifier
@VersionDate
Current Protocol Version Date from Data Page (new)
@ProTitle
Protocol Title from the Data Page
@IRBPISal
PI Salutation from Staff Page
@IRBPIFirst
PI First Name from Staff Page
@IRBPIMiddle
PI Middle Name from Staff Page
@IRBPILast
PI Last Name from Staff Page
@IRBPINumber
PI NCI Number from Staff Page
@NSX
If the study is a “New Study”, replaces with an “X”
@AmendX
If the review was an Amendment, replaces with an “X”
@ERC
Replaced by 8a, 8b, or 8c from the CTSU Form
@RenX
If the review was “Continuing”, replaces with an “X”
@FBX
If the action was by Full Board, replaces with an “X”
@ExpX
If the action was Expedited, replaces with an “X”
@FacX
If the action was Facilitated, replaces with an “X”
@IRBMeetingDate
Meeting Date (mm / dd / yyyy)
@IRBNumber
IRB Identification Number (new)
@IRBExpireDate
Action Expiration Date (mm / dd / yyyy)
@IRBComments
The Memo field from the protocol Review page
End of CTSU RSS Form Macros
There are 2 new Macros created for this form: @VersionDate and @IRBNumber. The Current Version Date is now located on the Protocol Data page. The IRB Number is found under File Operations > IRB > Edit IRB Meeting Environment Defaults. The IRB Identifying Number is the First Field on the page.
Once the CTSU Form Template (with Macros) has been loaded into CREDIT, it can be run against a selected IRB Meeting Date. All of the Reviews for that meeting will be pulled and multiple documents will be created on the screen for immediate printing.
Save both of the attachments for activating the CTSU RSS Form in your system. The CTSUForm.txt file is a web html language version of the form. The word document is the instruction set for processing the text file.
13. There is a new "Current Protocol Version Date" that can be enabled in File Operations > System > System Variable Default Values > #30 Show Current Protocol Version Date. If enabled, the new field will display on the Protocol Data Page. This field is used in the CTSU form noted above.
14. If the institution has Financials enabled for studies, there is a new checkbox on the very top of each Protocol Data Page: Disable Financial Tracking: This box is checked to inform the system that no Financial Milestones will be collected for the study. By default, either this box needs to be checked OR at least one check needs to be placed in the Financial Milestone Collection box at the bottom right of the data page.
15. Both the IRB Adverse Event and IRB Revision Logs now allow for entering a unique Event Date if multiple IRBs are selected for inclusion in the Log entry. Please note: The multiple IRBs will NOT be populated unless the boxes are checked under the abbreviation for each IRB. For single IRB entry, ignore the default dates set in the Event Date settings. DO NOT Remove the dates as CREDIT inspects for valid dates just IN CASE you wanted multiple IRB entires.
16. The Patient Master Schedule Report now allows for "Filtering" of Activity Events per a new "Filter Word". This way, staff can pull all events that have the word "Form" or "RN" or any other series of search letters. This will not guarentee that ONLY Forms will come up, of course, as there are other activities with the letters "form" imbedded. And, if you specify "Forms" you will not get "Follow-up Form" as there is no "s" in "Form". If this is an area that you are considering filtering with, consider editing your Activities so that they have common character targets. You might change all of your different types of forms to begin with "Form:". Then you can pull all of the "Form:" matches.
17. The Pre-Study Patient Listing Report now allows for filtering by Consent Date.
IDEA:
See CREDIT items: 2, 3, 4, 5, 6, 7, 8
IRBANA:
See CREDIT items: 4, 5, 6, 7, 8, 12, 13, 14, 15 |