N2 News

Do you have questions about CITI courses?

 

Are you currently registered or interested in taking a CITI Canada course? N2 fulfills the Helpdesk functions for all questions or queries related to CITI Canada.  Please contact shelley.king@n2canada or 519-777-7716 for assistance.

Here is a list of questions to commonly asked questions…

 

 

Updates to CITI Canada’s GCP Courses

CITI Canada’s GCP Courses were revised to reflect the updated ICH Harmonised Guideline Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). GCP Courses – Version 2 –  now specifically refer to the current ICH E6(R2) guideline and provide ICH E6(R2) training.

Both CITI Canada GCP courses meet the minimum criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

Good Clinical Practice (GCP) 

  • Version 1 – 28 Mar 2014
  • Version 2 – 4 Apr 2018 (includes E6 R2 updates)

CITI Canada GCP Refresher

  • Version 1 – 19 Mar 2015
  • Version 2 – 25 Jan 2017 (includes E6 R2 updates)

Clinical Trials Research Management Symposium

Are you attending Fraser Health​’s 13th Annual Research Week?

Don’t forget to bookmark the Clinical Trials Research Management Symposium, scheduled for June 15 from 9:14 am -12:30 pm. Networking lunch from 12:30-1:15 pm will follow the event.

The themes of the symposium including:

  • Connecting Patients and the Public to Health Research Opportunities: The B.C. Health Research Connection Project
  • Embedding Patient Engagement in Clinical Research
  • Association of Clinical Research Professionals (ACRP) Canada: The True North Strong and Leading
  • Workshop – Using ADKAR to Develop Your Leadership Skills: A Behaviour Change Model

Registration is free, so click here to RSVP!

For more information and a breakdown on the agenda visit the event website.

Exciting CITI News!

N2 is pleased to announce the release of the ICH E6 R2-GCP updated Good Clinical Practice (GCP) Basic Course. The 10-module course is now available through the Collaborative Institutional Training Initiative (CITI).

Previously 13-modules, this 10-module course discusses good clinical practice as it relates to clinical trials. The discussion is focused on the International Council for Harmonisation (ICH)-E6 (R2) guidelines and applicable regulations in Canada such as Health Canada-Division 5, and The Tri-Council Policy Statement 2.

This is significant in that N2 has worked with TransCelerate to assure that the high-quality CITI Canada GCP course accessible to N2 members meets their standards. This means if you are working with a TransCelerate affiliated company you can assure them that your CITI Canada training has formal approval and recognition from TransCelerate. Meeting TransCelerate training criteria is the latest milestone in a trend that has seen many biopharmaceutical companies as well as research networks, hospitals and universities accept the CITI Canada GCP course as their gold standard.

For more information please review the article “How to Determine if a GCP Course Meets TransCelerate BioPharma Minimum Criteria” which provides a brief overview of the TransCelerate certification.

For more CITI updates please click here.