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Did you know that N2 visual graphics about clinical trials are available for your co-branding and use? (available in English and French)

Have you noticed that N2 posts visual graphics on social media about clinical trials? We are now packaging these materials as tools that can be co-branded for our members! These images are available in both English and French. Keep an eye out for new images added on a regular basis! Examples of these images include:

  • clinical trial phases
  • tips for patients in a clinical trial
  • impacts of clinical trials
  • reasons for participating in a clinical trial

The link to the images can be viewed here. To access the tool kit log into N2 at n2canada.ca and click ‘Access to N2 Materials’ and login in using your login information.

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Read the N2 fall newsletter: updated SOPs, new tools and courses (English and French)

Read the newsletter in English here: https://mailchi.mp/587559ff05d3/read-the-n2-fall-newsletter

Read the newsletter in French here: https://mailchi.mp/b4b0337a1ad6/lisez-le-bulletin-dautomne-n2

Newsletter Topics

  • Version 8 of N2 SOPs released in both French and English
  • Vanessa’s Law: Update & Implications for Members Courtesy of HealthCareCAN
  • New Quality Committee tools
    • Overview of research quality management system (QMS)
    • QMS institutional gap analysis tool
    • Study risk assessment tool
    • Risk-based monitoring plan
  • Vanessa’s Law: Update & Implications for Members Courtesy of HealthCareCAN
  • Upcoming releases for courses
    • RCR mega course
    • CRC course
    • Rivised E6 R2 compliant French GCP refresher

Don’t forget to register for the N2 stakeholder meetings!

  • August 19, 2019       (2:00-3:00 PM EST)      Click to register
  • November 18, 2019  (2:00-3:00 PM EST)      Click to register
  • Save the date for the next N2 Annual Conference, which is scheduled for February 6-7, 2020 at Vantage Venues in Toronto. Stay tuned for more information to come soon!

Updated N2 SOPs are now available at the N2 website

V.8 N2 SOPs are now available through the N2 website. The SOPs include adjustments due to the changes to ICH E6 R2. Not sure how to access them? Talk to your CRA!

The effective date is May 15th, 2019. Should a site roll them out after this date, all that is required is a note to file to explain the different effective date.

Available for download:

  • FAQs
  • English SOPs with changes documented in the revision section at the back of the SOP.
  • Two quiz versions (one with answers and justifications and one student copy) are available in both English and French.
  • The compliance letter.
  • A template roll-out letter
  • The French translation is underway and will be available in the near future.

Register for the N2 AGM by Jan 22.

REMINDER: Please register online no later than Tuesday January 22, 2019.

One of the benefits of membership in N2, either through C17 or your local institutional or provincial membership, is that you can attend the annual meeting of members. This meeting has an educational and information focus, providing updates and presentations on current issues impacting clinical trials in Canada, as well as updates from the various N2 committees.

You are cordially invited to attend the 12th Annual N2 Meeting to be held at Vantage Venues (previously the St. Andrew’s Club and Conference Centre) http://www.vantagevenues.com in downtown Toronto on February 5-6, 2019. (Please note this is a Tuesday and Wednesday).

The full agenda can be found HERE.

As a member of N2, you are encouraged to attend this important meeting and network with your colleagues. The N2 Annual Meeting is also open to additional members of your clinical research organization. If they wish to accompany you to the meeting, they are welcome to attend.

To view information about the event and register, please follow this link: https://n2canada.ca/n2-annual-meeting/

Attendees requiring travel assistance must contact Karen Arts karen.arts@n2canada.ca for pre-approval. Assistance of a maximum of $750 is available for one member per organization, outside the greater Toronto area for the cost of travel to and from Toronto. The funds may be used for flight and/or rail costs only.

For anyone in your clinical research organization wishing to attend, please ensure they register by completing the on-line registration here: https://secure.e-RegisterNow.com/cgi-bin/mkpayment.cgi?state=2772

Due to increasing economic pressures, the N2 Board of Directors has approved a registration fee of $50.00 (+HST) per person. This fee of $50 plus HST is payable by credit card only. This fee is to offset some charges incurred on catering, venue rental and AV equipment required to hold the two-day annual meeting. To ensure accurate catering estimates it is imperative we know the total number of attendees ahead of time by having everyone register. Please register online no later than Tuesday January 22, 2019.

We hope to see you at the meeting.

Shelley

N2 Year-End Newsletter: Insights and Updates 2018

Seasons greetings from everyone at N2! 2018 was a year full of lots of changes, and as the year is coming to a close, we would like to take a moment to reflect on our accomplishments this year. Thank you to all our members and diligent committee members who continue to work on our content and campaigns, we look forward to the things to come in 2019!

 

https://gallery.mailchimp.com/3701881b24851f487859ab8c8/files/9ec7caf8-9105-4fa0-8e25-bbbb5b1eec67/END_OF_YEAR_NEWSLETTER_2018.pdf

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.

Sign up for the free informational webinar hosted by CARA about clinical research tools and resources to support your work from N2!

CARA is hosting a free webinar for both CARA and N2 members about clinical research tools and resources that are available to support your work and available through your N2 membership. Details are below. After registering, you will receive a confirmation email containing information about joining the webinar

Date and Time: Friday, November 2, 2018
Time: 12:00 PM EST
Cost: Free!

Register at: https://zoom.us/webinar/register/WN_l2IktXiWTUqfVwDWMoqL0g

SAVE THE DATE: N2 Annual Meeting to be held on Feb 5/6, 2019

The 2019 N2 annual meeting dates are February 5-6, 2019.

Vantage Venues, (previously St. Andrews Club and Conference Centre)

Please note that the 2019 annual meeting will be held on a
Tuesday and Wednesday.

Stay tuned for updates as they are made available!