Category Archives: CONCEPTT

Responding Within the Discrepancy Note

When responding to queries, please respond by using the Update button to continue the chain of correspondence within the same note. Please do not create a new note. Correct: Incorrect:

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LOOKING BACK AT 2014 AND FORWARD TO A SUCCESSFUL 2015

Looking Forward

Looking back at our accomplishments in 2014 As part of the Expansion Plan, ten new CONCEPTT sites have been activated in 2014: JOIN US IN WELCOMING THE FOLLOWING NEW SITES TO THE CONCEPTT TRIAL! 1. Manchester University Hospital NHS Trust – Manchester -UK 2. Royal Infirmary of Edinburgh – Edinburgh – UK 3. Sheffield Teaching […]

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Season’s Greetings and Happy New Year

Denice Feig, Helen Murphy, and the CONCEPTT coordinating team at CMICR thank you for your ongoing support and hard work during the past year. We wish you a wonderful holiday season and a new year full of happiness, prosperity, and many CONCEPTT recruits!                    Please see below the […]

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Important Device Notes

Device Warranty: All devices in the CONCEPTT trial are under warranty as per the contract between the purchaser, CMICR and the supplier, Medtronic.  If a device becomes defective at your site during the warranty period, the device will be serviced or replaced by Medtronic.  Please ensure that any foreseeable device issues are processed before the […]

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TIPS FOR PARTICIPANTS RANDOMIZED TO THE RT-CGM GROUP

Dear Collaborators, Below are some tips for participants randomized to the RT-CGM group: a)      At each study/prenatal visit the RT-CGM group will have their CGM downloaded so that the Jaeb Center can review the data collected. Please, ensure that you have notified the Jaeb Center of all upcoming visits with CGM downloads’ via email at […]

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Temperature Logs

The blood samples that are collected at study visits are to be stored at -80OC temperatures in a temperature monitored freezer. It is preferred that the temperature of the freezer is monitored by a digital monitor. If the digital monitor has a printable report, the report must be filed and can be used to complete the […]

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Pre-pregnant Subjects that become Pregnant

The CONCEPTT coordinating centre needs to be notified once a pre-pregnant patient becomes pregnant during the course of the trial. When this occurs, the pregnant data forms are to be completed for the remainder of the trial. This Information has been updated in the manual of procedures. Kindest Regards,   The CONCEPTT Team       […]

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Subject IDs

Once a subject begins the run-in they are assigned a unique study subject ID. In OpenClinica, the subject ID is accompanied by either the letter “H” or ”C”. The “H” is used to represent subjects in the HGM group and “C” is used to represent the subjects in the RT-CGM group. This identifier is unique to […]

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Happy New Year from the CONCEPTT Team

The CONCEPTT team would like to wish everyone a happy and prosperous new year!

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CONCEPTT SEASON’s GREETINGS

    The CONCEPTT Team would like to extend our warmest wishes for a happy holiday season! Please note our offices will be closed on December 25 and 26, 2013 and January 1, 2014. “Thank you all for your hard work in getting started. Wishing you a happy, healthy and successful coming year! Happy Holidays” […]

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