The Fall 2017 N2 Newsletter is here! Did you miss it?
The N2 Metrics Committee is pleased to announce the launch of the collaborative education initiative between N2 and the Metrics Champion Consortium (MCC). MCC (www.metricschampion.org) is the leading industry association dedicated to the development of standardized performance metrics to improve clinical trials. N2 and MCC are working together to bring MCC’s training resources to the N2 membership at a substantial discount. Members will be able to access MCC’s eLearning and Master Certification Programs at half the price that MCC charges non-MCC members. For access information please contact your N2 representative.
The Spring N2 Newsletter is here. Didn’t see it in your inbox? View it here: http://mailchi.mp/92c378dc7763/n2-spring-2017-newsletter
Frustrated by Regulations?
Please help us streamline clinical trials in Canada by completing the survey here: https://www.surveymonkey.com/r/ISCTGuidelines
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.
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 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 firstname.lastname@example.org