Author Archives: EMPOWER

Study Medication and The Study Medication Accountability Log

Any study medication (SM) being used in clinical research must be strictly and completely accounted for to ensure participant compliance and trial data integrity.  Study Medication accountability includes keeping records of: the receipt and inventory of the drug, storage of drugs, temperature monitoring, dispensing of drugs, and return or disposal of the drugs. The storage of the SM should […]

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Casebook Signoff

The subject casebook can be signed by the QI once data for all eCRFs has been entered, reviewed, and all queries resolved and the eCRF is marked as completed.     An eCRF that has been started but does not contain any data will prevent casebook signoff. If an eCRF has been started (as identified […]

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Video Tutorial: Responding to Queries

Watch the short video below to see how to respond to queries! Remember to: 1. Select ‘update’ to respond to the discrepancy note, 2. Revise the data within the form (if applicable) and press save! *Please be aware that when you revise data in an eCRF that has been previously signed off by the QI, […]

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EMPOWER eCRF Modifications

In order to assist you with accurate completion of the eCRFs, we have updated our data forms to highlight specific items that require your attention. For example: Please note: The modifications are limited to aesthetics; we have not revised, removed, or added any  questions. Are you using the most updated version of the form? Data Form […]

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Tip Tuesday

Recruitment Tip: Schedule regular weekly meetings  Set aside a day each week to meet with core members of your research team as well as the lactation consultants at your site. Scheduling regular weekly meetings will: Provide an opportunity to review potential new recruits, update the team on the status of study participants, and discuss recruitment […]

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Study Binders

The Study Binder is often the first item reviewed during audits and inspections. The Study Binder is an important component in the conduct of a trial and can be divided into one or more binders if needed; however, it is important to know where all documents are located.  The binder should contain all study-specific and essential […]

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Season’s Greetings and Happy New Year!

The EMPOWER Team send their Best Wishes for a Wonderful Holiday and a very Happy New Year.   Please note our offices will be closed on December 25 and 26, 2014 and January 1, 2015.  

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EMPOWER Patient Diary

Greetings EMPOWER Collaborators, The EMPOWER Patient Diary is a very important study tool as it is used to collect our primary outcome data. Here are some helpful strategies to ensure the Patient Diaries are accurate and complete. Before giving the Patient Diary to a new recruit Complete the diary Contact Information page Fill out the […]

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EMPOWER Recruitment Campaign

Greetings EMPOWER Collaborators, Our 2014 recruitment campaign is underway! Thank you to the five active sites that have completed the EMPOWER recruitment survey. For the remaining active sites, please respond to our survey as soon as possible. Your responses are important to help us understand recruitment challenges and develop strategies to boost recruitment! Click here […]

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EMPOWER and Flu Season

Dear EMPOWER Collaborators, Flu season is upon us in the Northern hemisphere, and with the flu comes increased occurrence of diarrhea and vomiting, which can lead to electrolyte imbalances.  Because electrolyte imbalances can contribute to a prolonged Q-Tc interval, it is important to consider stopping the study medication in participants experiencing excessive vomiting or diarrhea […]

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