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.
Good Morning N2 members (yes, all C17 sites are members):
N2 happy to announce that V.7 N2 SOPs are now available through the N2 website; the SOPs include adjustments due to the changes to ICH E6. The effective date is May 15th 2017. Should the site roll them out after this date, all that is required is a note to file to explain the different effective date. For all SOPs, changes are documented in the revision section at the back of the SOP.
Also, available for download:
- two quiz versions (one with answers and justifications and one student copy)
- the compliance letter
- the French translation is underway and will be available in the coming weeks
The CAREB and N2 organizations are pleased to announce the release of the second version of the English language version of the Canadian REB SOPs – the French language documents to follow.
The REB SOPs are specific to ethics boards that review health sciences research and are compliant with applicable Canadian and US regulatory, and ethics guidance criteria. The implementation of the REB SOPs will facilitate the distribution, adoption and maintenance of a single standard for REBs in Canada.
Please note that changes to the formal set of REB SOPs may result in the SOPs no longer being compliant and it is for this reason that the SOPs appear as print only PDF documents.
Documents that assist the organization to ‘bridge’ information in the SOPs with specific/local procedures (tools, checklists, sample forms, local guidance documents, contact information) are not part of the official SOPs but can be created or adapted as needed, to meet the needs of the organization.
Access to the REB SOP documents and associated information can be obtained from the following link: https://oicronca.box.com/s/ro3y57gpwhfmyp9oomeyr74jmwh9smcd
The V.1 N2 CAREB REB SOPs will be moved to Archive V.1 N2 CAREB REB SOP folder so they remain accessible.
— Alison van Nie, Chair, REB SOP Committee
NOTE: Comments, questions and other feedback should be directed to the REB SOP Committee Chair, Alison van Nie at firstname.lastname@example.org
Do you have patients who have been asked to participate in a clinical trial? Canadian Researchers need their feedback (www.bccrin.ca/survey). See post and http://www.bccrin.ca/whats-new/canadas-clinical-research-community-needs-public-input/
Have you ever been asked to participate in a clinical trial? Canadian researchers need your feedback! www.bccrin.ca/survey
BCCRIN is conducting a Canadian Clinical Research Participation Survey. Clinical researchers in Canada would like to hear from patients and study volunteers about their experience with clinical trials. Any Canadian who has ever been approached to participate in a clinical trial and either declined, did not qualify or participated is invited to respond. The survey is web-based and completely anonymous. Results from this survey will be used to inform researchers, research sponsors and policymakers to aid in improving study design, clinic operations and research site procedures in order to reduce barriers to research participation and improve the experience for study participants in Canada. These results will be shared with N2 members and various knowledge translations pieces will be made available for your use.
The link to the survey is http://www.bccrin.ca/survey
BCCRIN is seeking your help to post this survey link and the invitation where patients/public can find it. There are materials available for use on your websites, in paper or electronic mailings and social media. French translations of the materials and survey are in progress but not yet available. Materials below have been approved by the UBC Behavioural Research Ethics Board and provided your site is not actively enrolling for this survey, local REB approval may not be required. Please check with your institution regarding which approvals are required to post the survey link.
See promotional materials listed below:
- Suggested Tweet: Have you ever been asked to participate in a clinical trial? Canadian researchers need your feedback! www.bccrin.ca/survey
- Text for website post/notification
- BCCRIN-N2-CCTCC National Survey Press Release for circulation