It is important to note that these SOPs are not meant to replace existing SOPs of any research group, centre and/or institute. If you are satisfied that your SOPs meet current regulatory requirements, you can elect to continue using your documents.

Clinical research SOPs help to ensure consistency, compliance, accountability, and the efficiency of the investigator and the investigator’s team in the conduct of clinical trials; they are critical to quality performance and the ethical conduct of clinical trials. Clinical research SOPs maintain a level of professionalism at our institutions. Investigators who do not have clinical research specific SOPs run a high risk of non-compliance with Health Canada Food and Drug regulations, ICH Good Clinical Practice guidelines, and Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans Guidelines; and the US Food and Drug Administration regulations.

SOPs provide documented procedural guides for your clinical research activities as expected by regulatory authorities. When inspected by regulatory authorities, individual investigators or research groups who are unable to refer to a full set of SOPs for their clinical research activities can face a number of consequences, including the halting of research activities. The best way to prevent consequences is to be familiar with current regulatory guidelines and to have a well- developed set of SOPs.

Investigators need to ensure their SOPs meet current regulatory requirements (in accordance with ICH, Health Canada Food and Drug regulations, Division 5 Drugs for Clinical Trials and Good Clinical Practice Guidelines). N2 set of SOPs have been adopted as the minimum standard for good clinical practice that are consistent, compliant, accountable and efficient with respect to the expectations of regulatory authorities. It is required, as a measure of good practice and quality assurance, that investigators and their research teams reference the current adopted set of institutional SOPs and tools applicable to conducting clinical research activities. Your institution may have developed additional Site-Specific N2 institutional SOPs providing specific guidelines to common research activities carried out under the auspices of the institution. In addition to the N2 SOPs, investigators and research teams must adhere to these Site-Specific Institutional N2 SOPs. (Refer to details under Note at the end of this memo).

No, each institution selected the SOPs as a means to provide minimum standards compliant with

requirements from regulatory authorities and provide best practices to clinical research areas where SOPs do not exist or are not readily available. It is very likely that you will need to generate additional SOPs customized to your specific clinical research activities/studies, as these SOPs provided by N2 are designed to be very broadly applicable, so they may be implemented by virtually any study team and therapeutic area. It is the responsibility of the Investigator to review the full suite of SOPs provided institutionally and document which are applicable to their research team and studies. It is often necessary to add study or research area-specific addendums to the more general N2 SOPs, and implement these as the study or research area specific SOPs. It is best not to modify the body of the SOP as this has been vetted by regulatory inspection, but to add the specific language in an addendum.

These SOPs are compliant with Health Canada Food and Drug regulations, ICH Good Clinical Practice guidelines, and Tri-Council Policy Statement: Ethical conduct for Research Involving Humans, and the US Food and Drug Administration regulations. While we do not recommend making changes to the formal set of SOPs provided, you may find a need to develop additional documents to ‘bridge’ any gaps identified between the SOPs and site-specific or local procedures applicable to your clinical research activities. To meet this need, the documents and templates are made available in Word format to facilitate modification.

The updated SOPs, and a contact to help you with any questions and access, are available to each institution as noted below. The web links below provide easy access to all documents in word format to allow customization and creation of additional SOPs for any study-specific needs.

Please take note of the following access restrictions:

• You may only copy, distribute and use the SOPs within your own clinical research area(s);
• It is prohibited to sell, distribute, export, lease, loan or rent these SOPs to any third/external party; and
• When required, study sponsors, regulatory inspectors or auditors can be granted access to view, but not copy, the SOPs at the clinical research sites

Hamilton Health Sciences (HHS) has identified a number of N2 SOPs as Site-Specific Institutional SOPs. These apply to all common research activities conducted at HHS Sites and contain further guidelines specific to Hamilton Health Sciences in the form of addendums.

Please direct any questions or feedback about the SOPs to your respective institution contact noted above. We hope that the provision of these SOPs is helpful to you and your research team in conducting your clinical research activities.