12/10/2011
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NCI CCOP Reporting: MA.32-QOL = 0.50 CC Credits. If you have not done so already, you will need to make a separate Arm Q for this credit. The Report Name should be "NCIC-MA.32-QOL". Register patients to this Arm who qualify for the 0.50 CC.
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NOTICE: We are once again planning a Summer Training Session in Ann Arbor, Michigan for CREDIT.
We have not yet set an agenda as we need to determine what topics to cover and who might attend.
So, you CAN REPLY to this email and Barbara will get it.
Let her know if you are interested in a training session, and what topics you would like covered.
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CREDIT:
1. There is a new Report: IRB > Activity Summary (By Protocol Type) that will allow for polling the data to determine the number of submissions per "Protocol Type", Review Type, and Action.
2. For the Protocol Research Teams, there is a new set of fields: "Financial Disclosure Amount" and "Financial Disclosure Date". These new data elements are also now included in the report: General > Staff Involvements. The report can be filtered per a Minimum Disclosure Amount. 0 (zero) disables filtering by Disclosure Amount. So, if a value of $"5000" is part of the filtration, only staff with Protocol Disclosures greater than or equal to $5000 are included in the output.
3. For Patient Deviations and Adverse Event entry, the checkbox for "Create IRB Entry" can now be defaulted to "Checked". This is enabled via: File Ops > System > System Variable Default Values > Patient/Study at the bottom of that section:
Default-Check "Create IRB Entry" for Patient Deviation
Default-Check "Create IRB Entry" for Patient Adverse Event
By default, these settings are "Disabled"
4. When IRB Logs require patient re-consenting, we have been using either the action of Approved or Continuing. We have now added Acknowledged to that trigger.
5. The IRB Report for First Review and Last Review now allow filtering per Sponsor Affiliation.
6. When Editing a protocol Adverse Event, if that event has multiple "other protocols" associated with it, listed in the top left of the popup window, if you check the boxes to "also update", and then attach a document for uploading, the attachment will be associated with all of the other checked studies. Upload once that letter of approval, and it will be seen in all of the other protocol IRB Document Libraries. *Note* if you Un-attach the document in Edit mode, for safety purposes, it *only* removes the letter from the currently edited entry. All other entries where the document was associated will still have that attachment.
7. User Defined Fields (UDF) are now available for "Order Table By:" in the Report On\Off Study.
8. The Time\Task Recorder is filtered by Protocol Status. Until now, all Status were selected. Now there is a System variable that allows for default status selection, which filters studies immediately. File Ops > System > System Variable Defaults > Financials > Default Time\Task Protocol Status List
IDEA:
1. See CREDIT items: 2
2. There is a link on the Patient Returns DARF that allows for popping up a Patient Specific DARF.
IRBANA:
1. See CREDIT items: 1, 2, 5, 6 |