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.
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 email@example.com
Canadian Tumour Repository Network (CTRNet): update on 3CTN collaboration to develop standardized clinical trial biospecimen collection processes
The 3CTN is a pan-Canadian initiative to improve the efficiency and quality of clinical trials in Canada in order to ensure that Canadians with cancer and those at risk will have the best available cancer treatments. 3CTN and The Canadian Tumour Repository Network (CTRNet) are working together to help ensure there is access to adequate numbers of high-quality biospecimens across their network.
As part of the establishment phase, 3CTN wants to provide education on research biospecimen handling for at least one 3CTN team member per site to ensure there is access to adequate numbers of high-quality biospecimens through standardization of clinical trial biospecimen collection processes. 3CTN is collaborating with the UBC Office of Biobank Education and Research (OBER) to assist research sites in assessing their clinical trial biospecimen collection practices. This affects any site that collects samples in the context of clinical trials, and not just those sites with a formal biobank.
More information regarding the education initiative will be circulated to the C17 sites.
To learn more about CTRNet, visit www.ctrnet.ca.