N2 News

ISCT Survey

Frustrated by Regulations?

Please help us streamline clinical trials in Canada by completing the survey here: https://www.surveymonkey.com/r/ISCTGuidelines

If you are unable to access survey monkey, you can download the survey as a pdf file here.  Please send completed copies to kate.darling@n2canada.ca

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 button below to start the survey.

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.

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

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

The CAREB-ACCER 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.

NOTE: Comments, questions and other feedback should be directed to the REB SOP Committee Chair, Alison van Nie at alison.vannie@oicr.on.ca

Updated REB SOP 701

Notice: Updated REB SOP 701

Please note that REB SOP 701 has been updated to version 701.002_1 and is effective immediately. The revisions are described in the SOP History at the end of the document. This is a minor revision, in keeping with recent policy changes, and the SOP retains the version 2 date of March 8, 2016.

Access to the REB SOP documents and associated information can be obtained from the following link:  https://oicronca.box.com/s/ro3y57gpwhfmyp9oomeyr74jmwh9smcd

The previous version of the document will be archived and accessible.

 The V.1 N2 CAREB REB SOPs will be moved to Archive V.1 N2 CAREB REB SOP folder so they remain accessible.

NOTE: Comments, questions and other feedback should be directed to the REB SOP Committee Chair, Alison van Nie at alison.vannie@oicr.on.ca

N2 V.7 SOPs now available!

The N2 SOPs Version 7 with an effective date of May 15, 2017 are now available to N2 members. They include English and French versions. Please do not share them outside of N2. If you are interested in finding out how to become a member of N2, please click here.

N2 Partnerships

N2 Has Partnered With the Metrics Champion Consortium and Life Sciences Ontario

N2 is proud to announce two new partnerships that will continue to expand the high-quality resource and training offerings available to members. Formal agreements have been signed with the Metrics Champion Consortium (MCC), and Life Sciences Ontario (LSO).

The Metrics Champion Consortium (MCC)—a trusted partner in the clinical trials industry—identifies what to measure, how to assess the critical components of what is changing and how the industry is responding to address the changes to make improvements. MCC continually brings you new insights into the leading trends within the industry.

N2 and MCC are working together to develop mutually attractive benefits for the two organizations and their members. Through the N2-MCC collaboration, MCC’s eLearning and Master Certification Programs will be available to N2 members at a substantial discount. Participants will gain expertise in the design, implementation and effective use of clinical research performance metrics. eLearning courses include The Elements that Make Metrics EffectiveDeveloping Effective Metrics Using a Structured Process and Effective Metric Visualizations to Gain Valuable Performance Insights. The Master Certification Program allows participants to apply the knowledge they have gained from the eLearning courses to an independent project relevant to their organizations. Certification program participants receive one-on-one guidance from an MCC advisor and upon successfully completing the program receive an MCC Metric Master Certificate. This is one example of the benefit that the collaboration with MCC brings!

For more information about MCC metric sets & tools, metric education programs and how you can participate in MCC work groups, please visit www.metricschampion.org. Instructions regarding how N2 members can access the education programs at a discounted rate will be shared with N2 members as these details become available.  Specific questions can be directed to N2’s coordinating office at n2@n2canada.ca.

Life Sciences Ontario (LSO) is a member-driven organization that represents and promotes the province’s vibrant and diverse life sciences sector. LSO collaborates with governments, academia, industry, and other life science organizations in Ontario and across Canada to promote and encourage commercial success throughout the sector. Membership in Life Sciences Ontario includes individuals, students, emerging companies, investors, service providers, and companies with marketed products. The organization provides a wide range of networking and educational events, and operates a mentorship program that is helping to develop highly-skilled talent and build new business opportunities for the life sciences sector. LSO is an effective conduit for delivering policy options to governments, and is dedicated to promoting Ontario’s life sciences sector internationally.

N2 and LSO will collaboratively promote membership benefits of each others’ organizations, events, and educational opportunities.  More details on this partnership will be provided to members as they become available.

For more information, please visit www.lifesciencesontario.ca