AHS is a member of N2 and has made the N2 SOPs available to AHS-affiliated researchers and staff. Please do not share the SOPs outside of Alberta Health Services. Please note that the curent Version 7 & 6 are now available in both English and French. V.5 has been archived but available upon request should you be required to use them during audits and inspections.If you require the archived documents or have any questions, please contact Becky Wong (email@example.com).
We are happy to announce that V.7 N2 SOPs are now available through the Provincial Research Administration SharePoint site. The SOPs include adjustments due to the changes to ICH E6. For all SOPs, changes are documented in the revision section at the back of the SOP. The effective date is May 15th 2017.
Access to the SOP documents and collection of tools can be obtained at the following link: N2 SOPs adopted by AHS
AHS' N2 membership grants permission to AHS researchers and AHS-affiliated research staff use the SOPs in PDF format within AHS clinical research sites ONLY.
Regulatory authorities require that clinical research sites utilize standard operating procedures (SOPs) to ensure that their research is conducted in manner that protects the rights and safety of study subjects and the integrity of the research data collected. SOPS need to reflect the regulations and guidance documents that govern clinical research and do NOT need to be site/institution specific. The SOPs must be compliant with the regulations and guidelines and there needs to be a mechanism in place to ensure ongoing compliance by way of regular expert review.
The Network of Networks’ (N2) SOPs have been developed to be a national standardized set of operating procedures that are applicable to any therapeutic area. The goal was to develop one set of well-written SOPs that would cross all therapeutic areas in any given institution or research environment. This will greatly facilitate distribution, adoption and maintenance of one standard. It is strongly recommended that only one set of SOPs and related documents be used. Changes to the formal set of SOPs at the site/institutional level are NOT recommended and may result in the SOPs no longer being compliant. It is for this reason that the SOPs appear as print only PDF documents. Documents that assist the sites to ‘bridge’ between the SOPs and site-specific/local procedures (tools, checklists, sample forms, local guidance documents) are not part of the official SOP and can be created or adapted as needed, to meet the needs of the end user and as such, these tools are provided in Word format.
These SOPs are externally reviewed by an independent expert every two years or sooner, if dictated by changes in the above-noted regulations or guidance documents. They are compliant with Health Canada and US Food and Drug (FDA) regulations, the ICH-GCP Guidelines and the revised Canadian Tri-Council Policy Statement on Research Involving Human Subjects.
It should be noted that the SOPs contain minimal text copied from regulations and explanations of why procedures are done. This information belongs in policies, not procedures. SOPs are designed to reflect ‘how’ a procedure is done, not ‘why’ it is done; the ‘why’ component is part of the training process. Study team members need to understand the ‘why’ concepts in order to be deemed suitably trained to perform these procedures. The reference list of regulations at the end of the procedure includes the applicable ‘why’ documents.
The SOP review will occur every second year, unless urgent changes are required. In these cases changes will be made as soon as possible. The next version of SOPs can be anticipated for 2017.
Training slides, along with a list of Frequently Asked Questions (FAQ) to support your training efforts, are available upon request. Additionally, the N2 SOP committee has also developed a quiz to help train research staff. There are two documents: (1) one copy that lists the SOP numbers, the associated questions and a column where the answers can be provided, (2) one copy that lists the SOP numbers, the associated questions and a column where the correct answer and the justification for the correct answers is provided. These documents are available on upon request as well. Please email Becky Wong (firstname.lastname@example.org) for access.
Comments, feedback and requests for additional SOPs or tools can be directed to Becky Wong (email@example.com).