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:
- 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.
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 email@example.com 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.
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!
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:
- 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 firstname.lastname@example.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
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
Register at: https://zoom.us/webinar/register/WN_l2IktXiWTUqfVwDWMoqL0g
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!
Want to celebrate Clinical Trials Day (May 20), but don’t know what to do? Read here to download a printable poster and videos from N2 and ItStartsWithMe.ca. Share at your site or on social media
- Print out the poster below by clicking here and post it at your site this week to engage and inform patients and the public about why we celebrate Clinical Trials Day.
- Share the “It Starts With Me” video about clinical trials through e-mail and social media, or play it on televisions in waiting rooms. This brief, 1-minute video gives individuals an overview of the potential benefits of clinical trials and information on how they can get involved. You can see the video in English here and in French here.
- Join our “Ask Me” campaign by contacting Dawn Richards, our Business Development Specialist, at email@example.com, and create dialogue at your site around clinical trials and how to get involved.
Happy Clinical Trials Day, and a huge thank you to all clinical research professionals for your contributions to public health and medical progress!
Une version française du cours de formation de CITI sur la division 5 est maintenant disponible; les institutions du C17 ont accès via l’inscription du C17 au N2
Le Cours de CITI sur la Division 5: Drogues destinées aux essais cliniques sur des sujets humains de Santé Canada a été traduit en français. Cette traduction a été possible grâce a l’aide financière généreusement offerte par le FRSQ. Vous pouvez y accéder en consultant le site Web de CITI: http://n2canada.us14.list-manage2.com/track/click?u=3701881b24851f487859ab8c8&id=b17362d464&e=33118d4f3d.
The Health Canada Division 5: Drugs for Clinical Trials Involving Human Subjects CITI Course has been translated into a French version. The FRQS has generously provided financial support to make this translation possible. It can now be accessed through the CITI website: http://n2canada.us14.list-manage2.com/track/click?u=3701881b24851f487859ab8c8&id=fc3e54cb50&e=33118d4f3d.
Frustrated by regulations? Here’s your opportunity to provide feedback to Health Canada. Take this 10 question survey to help inform future directions of the Initiative to Streamline Clinical Trials (ISCT) Working Group
Initiative to Streamline Clinical Trials: Have The Guidelines Helped Cut Through the Red Tape?
Completing this 10-question survey will inform future directions of the Initiative to Streamline Clinical Trials (ISCT) Working Group, and provide information to be presented in discussions with Health Canada. We appreciate your support in taking a minute to complete the survey. Even if you are unfamiliar with the ISCT guidelines or have not implemented them, your responses will help shape future work on this initiative. The survey is anonymous and results will be aggregated. Click the link below to start the survey.
In 2011, the Canadian Cancer Research Alliance (CCRA) report on the State of Cancer Clinical Trials In Canada identified the magnitude of the threat to the conduct of oncology clinical trials. The report noted that with falling performance metrics, increasing complexity and workload, and an increasingly onerous regulatory environment, clinical trials were at risk, and observed that “Without clinical trials, the outcomes of cancer patients will not continue to improve”. One of the recommendations in the report recommended engaging with Health Canada and other key stakeholders to foster agreement in appropriate interpretations of the Health Canada Food and Drug Regulations and ICH Good Clinical Practice (GCP) guidelines.
In response, the Initiative to Streamline Clinical Trials (ISCT) Working Group was organized in 2012, and included members who are experts in clinical trial conduct across many therapeutic areas. The primary objective of the ISCT was to develop specific, pragmatic, and practical interpretations of current regulations, laws and guidelines, in order to facilitate, rather than limit, Canadian clinical trials, by expanding on recommendations such as those of the CCRA and OECD. The guidelines were finalized in February 2014 and are available at http://n2canada.ca/isct/.
Since the 2011 CCRA report, the ISCT Guidelines has been one of many initiatives underway nationally to address threats to the clinical trial enterprise. While results are promising, understanding of the current environment as well as the implementation and impact of the ISCT Guidelines by academic Investigators, Institutions, and Sponsors is needed to determine future actions required.