Archive | N2 RSS for this section

The fall 2017 N2 newsletter is now available! Includes information on metrics training and other resources that are available to C17 as a N2 member

https://oicronca.app.box.com/s/dcn63qqkrapg3xe3ou4hcm5prxk7s516

 

Advertisements

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 dawn.richards@n2canada.ca, 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

Remarque: Le C17 est membre N2 (Réseau des Réseau): les institutions du C17 ont accès à toutes les ressources d’enseignement et de formation N2, y compris la formation  CITI.

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.
www.surveymonkey.com/r/ISCTGuidelines
Background
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.

New N2 SOPs are now available that reflect changes to ICH E6 (V7, effective date May 15)

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

Release of the Second Version of the N2/CAREB REB SOPs

 

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 alison.vannie@oicr.on.ca

 

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:

 

Results of “Good Clinical Practices” Health Canada inspections now posted on public database

As part of Health Canada’s (HC) commitment to regulatory transparency, information on all clinical trial inspections performed in Canada will be published by December 11, 2015 in Health Canada’s existing Drug and Health Product Inspections Database.

The database will include three main elements:

Lists of Inspections

  • A list of all Good Clinical Practices inspections conducted since January 1, 2012 to present will be included within the database.  The list includes general information such as sponsor name, date of inspection and rating.

Initial Inspection Deficiencies

  • The Initial Inspection Deficiencies provide a preliminary overview of the inspection findings and are published within 3 days of the inspection.  Initial Inspection Deficiencies will be published for all inspections which occur after the launch of Good Clinical Practice inspections in the database.

Inspection Report Cards: The Inspection Report Cards offer plain language summaries of inspections.  They are published within 30 days of the inspection and will include the following:

  • information identifying the sponsor and drug name
  • date of the inspection
  • trial phase
  • region of the site inspected
  • inspection type
  • inspection rating
  • observations made by the inspector
  • measures taken by Health Canada.

Inspection Report Cards will be published for all inspections conducted on or after September 15, 2015.

Inspection Report Cards will be published for any inspection conducted between January 1, 2012 and September 15, 2015 that received a non-compliant rating.
If you have inquiries about this initiative, please contact Health Canada at the following e-mail address: gcp_bpc@hc-sc.gc.ca

Further information about Health Canada’s Regulatory Transparency and Openness Framework can be found here.

Would you like to understand why families decline participation in clinical trials? Read this press release to learn more about the BCCRIN anonymous survey for patients/families who have declined or participated in clinical trials.

 

Clinical researchers would like to learn about Canadian’s experience with clinical trials.

The Canadian Clinical Trials Coordinating Centre (CCTCC) is pleased to partner with the BC Clinical Research Infrastructure Network (BCCRIN) on the national expansion of the BC Clinical Trials Participation Survey. This survey recognizes the importance of engaging and learning from patients and the public about the clinical trial process. From the BC only data, researcher have found that patients/families that decline participation in clinical trials have a very different understanding of the clinical trial process than those that participated in a clinical trial.

Access the full press release here.

If you have participated in a clinical trial, were asked to participate and declined, or if you are the parent of a child who has been asked or has participated, your feedback is important to the future of research in Canada.

The anonymous survey can be accessed at: www.bccrin.ca/survey

C17 addendum: please note this survey does not appear to work in older browsers.

N2 November Newsletter Available

The N2 November newsletter is available and can be found here.