Information about new CCTO committees

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CCTO Quality Standards on Education Committee (QSE)

This is a team that will develop, refine, and maintain the CCTO educational program through time. Our first objective will be to define what new staff should be able to do when they finish an onboarding program. From there, we’ll gather information on existing clinical research educational programs and resources throughout the University. The hope is to better integrate with existing educational programs and create a learner-controlled program for training. We will also work on updating the program based on changes to the SOPs and continuing education for ongoing staff.

CCTO Quality Standards on Standard Operating Procedures and Guidelines Committee (QSSG)

This will be a group of individuals in diverse roles across different groups within the CCTO. We will work collaboratively to develop and maintain SOPs, applicable guidelines and tools. You must have the drive for improving processes to help direct your peers to perform research in compliance with regulations and GCP. You must not be afraid of doing yeoman’s work!

If you are interested in participating in either, we encourage you to discuss with your manager.
For QSSG: Sophie Bertrand
For QSE: Ben Priestley

Reminder about IRB Renewals

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With the holidays approaching, here’s a reminder for clinical research staff to start the continuing review process for their studies as soon as they can. Some of you may delay it until few weeks prior to the expiration date but the IRB sends reminders 3 months in advance, so don’t wait until the last minute!

Four W’s of SmartPhrases

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  • WHAT are SmartPhrases?
    • Used to document research related visits and the details associated with each of these visits
  • WHO uses SmartPhrases?
    • Clinical Research Coordinators, PAs, NPs, Nurse Coordinators
  • WHEN are SmartPhrases used?
    • Consenting note, eligibility note, research related clinic note, drug accountability note
  • WHY use SmartPhrases?
    • To meet the elements of ALCOA for documentation
      • Attributable (traceable to person, date and subject visit),
      • Legible (clear enough to read),
      • Contemporaneous (record events as they happen),
      • Original (have the earliest record of source) and
      • Accurate (reflect true observations)
    • SmartPhrases are shortcuts that allow investigators to capture valuable information based on protocol requirements
    • Allows data managers to pull important clinical research information from progress notes to clinical databases with ease
    • Decreases potential protocol deviations
    • Time utilized upfront to capture valuable information decreases the amount of time and effort at a later date

For examples of completed SmartPhrase Tables, … Full Story>

Coordinator Corner

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We will periodically be featuring useful information for study coordinators here. If you have anything you’d like to be featured in Coordinator Corner please contact us.

The following documents have been updated on the Coordinator Corner page:

Read of the week:
This week’s read is from the ACRP blog: Is it OK to backdate documents?