Regulatory authorities require that clinical research sites use 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 you will receive 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 SOPs have been reviewed by an expert regulatory consultant and 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. N2 will ensure the 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. 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.
N2 SOPs (V.8, May 2019) are available to University of Alberta researchers conducting biomedical and clinical research. Contact us for your copy.