E-Newsletter - March 2016

Clinical Research Professional Committee Launches
New Group Meeting Format to Improve Training

The 2015 Alliance Fall Group Meeting included more than 15 Clinical Research Professional (CRP) workshops and presentations, providing the latest updates and education for current clinical trials and processes. The meeting included multiple breakout sessions to provide CRPs tailored education and training to enhance protocol implementation at the site level and allow for sites to share successful strategies with other sites. In addition, most CRP sessions were made available by phone conference for those unable to attend the meeting in-person. Granted there were a few technical glitches and other issues beyond our control, we truly appreciated the effort by all CRPs and others to fully participate in the meeting. The CRP Committee is committed to improving the process for future meetings.

Here are some highlights from the meeting.

  • Alliance auditors will begin looking for documentation of the informed consent process, including date and time.  This process can be documented in a Note to File documenting the informed consent process or in the investigator’s progress note.  While the auditors will begin looking for this information on audits, it will not yet be noted as a deficiency.  The Policies and Procedures will be revised in Section to add:
    • Per FDA regulations, the medical record should contain documentation in the case history for each study volunteer that the study consent document was explained to the patient, questions were answered, and informed consent was obtained. This documentation should be included in a progress note, nurse’s note, or elsewhere in the medical record to verify informed consent was obtained.
  • Alliance Data Timeline Requirements in accordance with the NCI guidelines:
    • Baseline Forms: Due within 15 days of the target date
    • Treatment Forms: Due within 15 days of the target date
    • Follow up Forms: Due within 30 days of the target date
    • Queries: Due within 2 weeks of being issued.
  • The Alliance Statistics and Data Center is currently updating the Lost to Follow Up procedure. Look for the new procedure in future Alliance publications.
  • With the transition of data capture through iMedidata Rave, please remember the data submission schedule and paper Case Report Forms can be found on the Alliance website under Protocol Listings – Disease Site – Study Title – Case Report Forms or on the CTSU website under Protocol - LPO Documents -  Case Report Forms
  • CRP session presentations are posted on the Alliance website under Quick Links – Meeting Presentations & Materials – 2015 Group Meeting – PRESENTATIONS: Sessions and Workshops.
    They include:
    • Audit Preparation
    • Making the Job Your Own
    • It’s All the Rave
    • IROC Imaging & Radiation Oncology
    • Navigating Studies under the CIRB
      And Many More!
  • Some taped CRP presentation sessions will be made available on the Alliance website in the upcoming weeks.

The CRP Committee is currently planning for the 2016 Alliance Spring Group Meeting. If there are topics you would like to see presented, please e-mail Jen Dill at jdill@dom.wustl.edu.


For other articles in the March issue of the Alliance E-News newsletter, see below.