|DDOTSTM 1997-2006 Navigator|
Translating Technology to Improve Patient Outcomes, Enhance Quality, and Reduce Costs
Protocol “Deviation Log” added to Systems
New Deviation Log Allows for Tracking Protocol Entries
For as long as the software packages of CREDIT©, IDEA©, and IRBANA© have existed, there have been IRB Regulatory Logs maintained per IRB\Study. Now, a new log has been activated that allows for study "Deviations" to be stored. But that is not the simple end of the module.The new log comes with a complete Merge Document that allows for immediate printing of the deviation for submission to the IRB. This Document is customizable to each institution using simple "macros" as data place holders. These place holders are located on the Document to indicate where the data should be inserted for the Deviation.The new form is located in the Reports area under the IRB column: Deviation Report Form.The data input area is located under each specific Protocol and is IRB Specific, although multiple IRB entries can be made from the single page. The Emergency Deviation and Non-Emergency Deviation Lists are controlled in the File Operations of the system. The entries are at the complete control of the institution.There are also (not shown) input text boxes for: Deviation Explanation:Deviation Reason:Deviation Action:Institution controlled questions can dynamically appear on the data load page. As an example:Did the deviation affect the rights, safety, or welfare of the subject? (if YES, explain)The options are YES, NO, UNKNOWN with an explanation box. We all thank Tina Monique Korreng, at the Atlanta CCOP for her ideas and input. She has logged over 2300 hours in the CREDIT© system!
The Deviation Form is Customizable
Notice the “@Sponsor”, as an example. The sponsor for the Deviation Protocol will be inserted at that point.
Deviation Data Entry Screen (partial)
When the Deviation is Added, the Form can be Immediately Printed from a Popup Window!
(Optionally, it can be printed anytime after entry.)
Notice the “Macros” have been replaced with the specific information pulled from the Protocol as well as the Deviation Entry. Notice, as an example, the @Sponsor macro was replaced with “National Surgical Adjuvant Breast & Bowel Program”. The Dates were pulled from the Data Load page as well as the Type of Deviations; both Emergency and Non-Emergency listings. The questions are appropriately answered. If there were explanations, they too would be displayed.
The lower portion of the document is for signatures and dates. This “default” form originated at the Atlanta CCOP. We thank Tina Monique Korreng for both the Deviation Form and the help developing this powerful module!
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The DDOTS Navigator is published to introduce news that has occurred in the ongoing development of Cancer Research Environmental Data Information Tracking (CREDIT)..
Since 1995 CREDIT© has been in constant growth. May of 2006, marked the 11th anniversary of this powerful system. Installed at sites across the country, CREDIT© is the leader in Collaborative Clinical Research Administration.
Web Demonstrations Available On-Line at No Cost to Staff!
Probably the easiest way for interested staff to see CREDIT is to have an On-Line demonstration. This is accomplished by contacting technical support at DDOTS by phone or email to: firstname.lastname@example.org Plan on about an hour when staff can assemble around a computer or, better yet, in a conference room where a projection system can display the demonstration.
At the agreed upon time, a representative from DDOTS will call your selected station on the phone for the audio portion of the presentation.
Advanced planning is the key to the demonstration. Make a list of important elements that staff needs to see. Be sure to forward the list to DDOTS about a week before the demonstration is to occur. All elements from the list will be incorporated into the presentation.