A Newsletter for: Clinical Research Environmental Data Information Tracking:                 May, 2006 : Issue XLV

 DDOTSTM 1997-2006   Navigator

Translating Technology to Improve Patient Outcomes, Enhance Quality, and Reduce Costs

Unblinding Study Notifications Made Easy

CREDIT© Assists in Patient Notification at Study Unblinding


Notifying hundreds of patients about Study Unblinding can be an enormous task for staff.  While this is an important (and required) step in many Prevention and Control Studies, it devours staff time.


CREDIT© contains the tools to make this huge task as simple as running a report.  Patient\Protocol Unblinding is now a new Report under the Patient Column.  There are 3 steps that result in the creation of patient specific letters of notification, and they begin in Reports > Patients.  As an example, to unblind the P-2 study, and create letters and mailing labels, the following process is followed:


a) Unblind Protocol Patients  then select the Protocol (P-2).   All patients on P-2 will come up with a checkbox for indicating which drug the patient received.  When all patient checkboxes are completed, the entries are saved. (see pg. 2)


b) Unblinded Patients  Again, select the Protocol (P-2). Then, EXPORT TO MERGE FILE, and give the file an appropriate name (Ralox-On Study, or Ralox-Off Study) depending on your selections on that page.  All patients will come up for your selection.  More importantly, the Merge File for the Document Processor will have been created.

(This report is created for each Distinct Letter planned for mailing to patients;  one for Ralox-On Study, one for Ralox-Off Study, one for Tam-On Study, one for Tam-Off Study.) (see pg. 2)

c) It is the Document Processor where the 4 letter templates are created and ready for merging


The Screens Below Depict the Final Steps for Creating Patient Specific Letters for Unblinding


The above document has several "Macros" that are placeholders for patient information.  Once the document is run against the patient report file, a letter to each unique patient will be created.

(The letter body can be copied and pasted!)




Final letters are merged and appear on the page ready for printing.  Notice the data was imported, including the signature!  Nearly 200 letters are created in about 45 seconds!

(Only the Patient Letters Print, the Navigation Menu does not print.)



Patients are Assigned the Unblinded Drug

The patients are first unblinded to the specific study drug by checking the appropriate box per entry, according to the unblinding notices.


Patients are Assigned the Unblinded Drug


Patients are then reported by the study drug of unblinding (Raloxifene in this example).  At the same time, a merging file is created for Patient Notificaion Letters.  The merge file is used as noted below in combination with the notification letter template (pg. 1, top image).


Merge File Joins Letter Template


Finally, the Merge File is joined with the Letter Template (pg. 1, top image) to create the final letters (pg. 1, bottom image).  In this case, only 5 letters will be created, however, CREDIT© can produce hundreds of letters at one time.  The letters are all displayed in CREDIT© as one long page.  When printing, however, the letters are broken into individual document, each letter on its own page.

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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.  This issue, May of 2006, marks the 11th anniversary of this powerful system.  Installed at sites across the country, CREDIT© is the leader in Collaborative Clinical Research Administration.

Staff Signatures Upload into CREDIT for Letter Signing


In the File Operations area, scanned staff signatures can be uploaded for use in Merging.  Those signatures need to be produced with a wide tip felt pen as scanning reduces the thickness by about two-thirds.


The scans are saved in a size that is about 1 inch high, with a resolution of 72 dpi.  The 72 dpi is web standard.  Anything greater than that simply enlarges the signature until it results in a web 72 dpi.  Finally, the scanned file name needs to be the staff name in GIF format: StephenWBurke.gif.


When the requested signature is needed in the letters, the simple macro identifies which signature to pull from the file: