N2 fall newsletter includes updates to French CITI courses, info on the N2 SOP tool, and how to access ACRP Ethics and Human Subjects Protection course free of charge

Excerpts from the newsletter are below–read the whole newsletter at https://mailchi.mp/6669b546f52d/read-the-fall-n2-newsletter

Updates to CITI Courses!

The French GCP Refresher course is now available to N2 members. It has been translated into French from the current CITI Canada E6 (R2) compliant GCP Refresher course. Shelley is working with institutional administrators to add the course to N2 member sites. Please allow 5-10 business days for the requests to be processed.

ACRP Ethics and Human Subjects Protection courses available at no charge!

After registering select Pricing Without Contacts Hours at the following link:

www.acrpnet.org/courses/ethics-human-subject-protection/

  • Note: there is currently not the ability to generate a completion certificate, instead participants are instructed to take a screenshot of the transcripts area that indicates they have taken the course
  • Sometime in November, ACRP will launch the Refresher course (about 45 minutes in length) to this topic.
  • If there are any questions, David Burnham can be reached at david.burnham@acrpnet.org

Standard Operating Procedure (SOP)

  • The SOP committee is reviewing V7 N2 SOPs to prepare for V8, scheduled to be distributed in April 2019.
  • This committee is encouraging new members to join. Please contact N2 if you are interested.
  • N2 CAREB/ACCER REB SOP committee will reconvene this Fall, working on V.3 to be released in 2019.

N2’s Featured Tool: Standard Operating Procedures (SOPs)

  • Maintenance of one set of investigative site SOPs (version 7) for all Canadian trial sites (community & academic), accepted by Health Canada
  • All “regular” clinical trials, Natural Health products, Medical Devices, Equipment Calibration, Investigator Initiated Research
  • BiospecimenManagement related SOPs via OICR
  • REB SOPs created with CAREB
How to Use This Tool?  Please log onto your N2 Box account from the login page from n2canada.ca. If you have any trouble accessing your account please contact Shelley King at shelley.king@n2canada.ca. Please contact N2 if you need any further help with using SOPs.

Quality Committee Update

There are three tools the committee are working to complete:

  • Quality Management System policy and procedure
  • Study Risk Assessment Tool is a two-level resource
  • Risk-Based Monitoring Plan

The committee has collaborated with Health Canada to collate and analyze feedback received regarding the final draft of the Part C, Division 5 regulations guidance document GUI-0100.

Education & Training Committee Update

There are two courses that are in the process of being reviewed and finalized:

  • RCR Mega Course which is a combination of Life Sciences, Physical Sciences and Social Humanities- Expected release date: end of 2018)
  • Clinical Research Coordinator Course (CRC) – Expected release: early 2019

French GCP Refresher released early this month. The French GCP Basic course is currently being translated and is expected to be released next year.

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